FDA Compliance Simplified Blog

Covering FDA regulations and other topics of interest to FDA-regulated companies

FDA Updates the List of Recognized Dietary Fibers

On June 14, 2018 FDA published two guidance documents on dietary fiber.  “Dietary fiber” was not defined per se prior to the publication of the revised nutrition labeling regulations of 2016.  The 2016 definition for dietary fiber has two parts.  First, it includes “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants.  This part of the definition includes the fiber found in whole grains, fruits, vegetables, nuts and seeds along with fibers in food ingredients that have been mechanically processed, chopped or ground for instance, but not chemically derived or isolated.  Examples of mechanically processed fibers include

  • Cereal bran (oat, rice, wheat, etc.)
  • Cocoa powder
  • Fruit & Vegetable purees
  • Some isolated plant proteins*

*In the 2016 final rule FDA pointed out that plant cell wall fibers, cellulose and pectin, as well as lignin, are present in de-hulled soybeans that are used for producing soy protein concentrates.

The second part of FDA’s definition of dietary fiber includes “isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”  These recognized physiological effects are:

  • Lowering blood glucose and cholesterol levels
  • Lowering blood pressure
  • Improved laxation and bowel function
  • Increased mineral absorption in the intestinal tract
  • Reduced energy intake (for example, due to the fiber promoting a feeling of fullness).
  • Other physiological endpoints could be added to the complete list if scientific evidence exists to support their inclusion.

Only seven isolated or synthetic fibers were recognized as having physiological benefits when the updated regulations on nutrition labeling were published in 2016:

  1. Beta-glucan soluble fiber
  2. Psyllium husk
  3. Cellulose
  4. Guar gum
  5. Pectin
  6. Locust bean gum
  7. Hydroxypropylmethylcellulose.

The June 14, 2018 guidance document on declaring dietary fiber in nutrition and supplement facts panels is in response to citizen petitions regarding dietary fiber.  FDA reviewed the data submitted in the petitions and is proposing that eight more isolated or synthetic non-digestible carbohydrates be added to the list of “dietary fibers”.  The guidance explains that the rule making process must still occur but that during that period, the agency will exercise enforcement discretion, effectively allowing immediate use of the eight newly-approved dietary fibers in food and supplement products.  This no doubt made many food and dietary supplement companies very happy since it restored several commonly used fibers to inclusion in nutrition and supplement facts panel declarations of dietary fiber.

The eight fibers subject to this enforcement discretion are:

  1. Arabinoxylan;
  2. Alginate;
  3. Inulin and inulin-type fructans;
  4. High amylose starch (resistant starch 2);
  5. Galactooligosaccharide;
  6. Polydextrose;
  7. Resistant maltodextrin/dextrin
  8. Mixed plant cell wall fibers.

“Mixed plant cell wall fibers” refers to ingredients that contain two or more of the following plant cell wall fibers in varying proportions: cellulose; pectin; lignin; beta-glucan; and arabinoxylan. Mixed plant cell wall fibers can be obtained from food sources that have undergone other processing.  FDA provided a list of some mixed plant cell wall fiber sources in a foot note in a second guidance document also published on June 14th: “Review of the Scientific Evidence on the Physiological Effects of Certain Non-Digestible Carbohydrates‘.  The footnote states,  “While not an exhaustive list, examples of mixed plant cell wall fibers that we have identified are apple fibers, bamboo fibers, barley fibers, carrot fibers, citrus fibers, cocoa fibers, corn fibers (e.g., corn hull fiber), cotton seed fibers, oat fibers (e.g., oat hull fiber), pea fibers (e.g., pea hull fiber, pea seed coat fiber, inner cotyledon pea fiber), rice bran fibers, soy fibers (e.g., soy hull fiber, soy polysaccharide, soy cotyledon fiber), sugar beet fibers, sugar cane fibers, and wheat fibers.”

When declaring dietary fiber in nutrition or supplement facts panels, keep in mind that  there are recordkeeping requirements as part of this regulation. Other nutrients such  added sugars, vitamin E and folate are also subject to recordkeeping requirements when they are declared in nutrition or supplement facts panels. The fiber recordkeeping requirements are detailed in the regulations as follows:

21 CFR 101.9(g)(10) The manufacturer must make and keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows:

(i) When a mixture of dietary fiber, and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food, a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber .

(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.

(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.

Here’s hoping that this post gave you something to chew on that will keep things moving smoothly for your business.  Be sure to contact us with any questions!

FDA Press Release on Updated Nutrition Facts, Added Sugars, Fiber, Serving Sizes and Honey

Today FDA published a press release and statement from Commissioner Scott Gottlieb on efforts to advance implementation of the new nutrition (and supplement) facts regulations. The Commissioner noted that FDA needs to help industry implement and consumers understand the changes, which became effective in July 2016 but will not be enforced until January 2020.  The FDA will undertake a consumer education program once the new rules are implemented but today the agency published several updated guidance documents intended to help industry make the required changes to the nutrition facts box by the implementation dates.

I had hoped that FDA would someday rescind the requirement to list added sugars in the nutrition facts since it is confusing and since there are no test methods that would enable FDA to determine whether the amount of added sugars is properly stated on a label.  I had also hoped that FDA would continue to allow pre-2016 isolated and manufactured fibers to be declared as dietary fibers for 3 to 5 years while testing could be done to demonstrate effectiveness per the 2016 regulations.  While my hopes seem to have no chance of coming true, FDA did provide a couple of helpful clarifications in the guidance documents issued today:

March 1, 2018 Guidance Documents

  • The most helpful new guidance for food labelers is the Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products This guidance allows the use of a symbol after added sugar declarations in the nutrition facts box for pure honey, pure maple syrup and certain cranberry products.  The symbol is used to guide the consumer to text outside the facts box explaining, in the case of pure honey and pure maple syrup, that no sugar was added to the product.  FDA’s sample explanatory text is, “All these sugars are naturally occurring in honey.” In the case of cranberry juice and dried cranberries, FDA will allow use of a symbol leading consumers an explanation that cranberry products are minimally sweetened when those products “have been sweetened with added sugars and that provide total sugars at a level no greater than the amount of total sugars in comparable products with endogenous sugars and no added sugars.”  FDA’s sample language for this is, “Sugars added to improve the palatability of naturally tart cranberries. The 2015-2020 Dietary Guidelines for Americans state that that there is room for limited amounts of Added Sugars in the diet, especially from nutrient dense food like naturally tart cranberries.”
  • FDA also issued a clearer Guidance for Industry: Proper Labeling of Honey and Honey Products.  The format and citations used in this updated guidance are more typical of FDA documents than the 2014 draft guidance.
  • The March 1st flurry of guidance documents included two on Reference Amounts Customarily Consumed (RACC) serving sizes; one is the final guidance and the other is the small entity compliance guide, which provides detailed examples of foods in each category.  The only revised RACC I spotted was the addition of serving sizes for dietary supplements,
    • “The maximum amount recommended, as appropriate, on the label for consumption per eating occasion or, in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonful, etc.”
    • This has always been the requirement for dietary supplement serving sizes but is now part of the RACC table in the regulations.
  • Finally, March 1st saw the publication of a Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30) .  This is a final version of a draft guidance issued in November 2016.  There are some clarifications made to the language but the requirements for the studies required to document the physiological effects of fiber have changed very little.  However, the final guidance includes a helpful appendix that discusses some types of studies that may be used to support a fiber as having a physiological effect.  The most interesting addition, which upturns a portion of the draft guidance,  allows the use of studies on diseased populations.  The final guidance states, “We have reconsidered this approach [prohibiting the use of studies on diseased populations] and determined that, for certain endpoints, studies conducted on individuals diagnosed with a specific disease can be considered as part of our evaluation of the totality of the evidence when deciding whether an NDC [non-digestible carbohydrate] meets our definition of dietary fiber.”

Today’s press release reiterated FDA’s proposal to extend compliance dates for the 2016 food labeling regulations from July 2018 to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales and to Jan. 1, 2021, for smaller manufacturers.  It further stated that they plan to issue a final rule on the extended compliance dates this spring.  I do not expect the dates to be pushed further back, but if they change, we’ll keep you updated.  As always, contact us with any questions!


Gluten in Foods, Drugs and FDA Surveillance

Near the end of 2017 FDA published test results from a gluten free food product surveillance project. By way of background, recall that in 2013 FDA published a final rule on gluten free labeling of foods, including dietary supplements. The rule, codified in 21 CFR 101.91, allows terms such as “gluten free”, “without gluten”, “no gluten”, etc. on products that contain less than 20 parts per million (ppm) of gluten.

In 2015 FDA issued a proposed rule on gluten free labeling of fermented or hydrolyzed foods that can be summed up in this quote:
“Because the current gluten tests do not adequately detect and quantify gluten in fermented and hydrolyzed foods or ingredients, FDA proposes that, in order to make a “gluten-free” claim, manufacturers of these foods would have to make and keep records to show all of the following:

  • The food meets the definition for “gluten-free” in 21 CFR 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis.
  • The manufacturer adequately evaluated the processing for any potential for gluten cross-contact.
  • Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.”

Most recently, in December 2017, FDA published a draft guidance on gluten in drug products. The guidance pertains to “human drug products that pass through the small intestine [including]

  • Orally ingested drug products.
  • Topical drug products applied to or near the lips (e.g., lip sunscreens)
  • Drug products applied inside the mouth (e.g., cold sore treatments, drugs delivered to or via the oral cavity).”

While noting that “wheat gluten itself is never or very rarely added as an inactive ingredient to oral drug products”, the guidance states that “any oral drug product that contains wheat gluten as an intentionally added ingredient should be labeled to indicate its presence.” The guidance recommends that drug manufacturers be aware of any wheat-derived ingredients used in their products and notes that the agency would be “likely to question [the use of wheat gluten] as an ingredient in an oral drug product for which few or no alternative treatments are available” and “in an oral drug product intended for long-term administration or intended to treat comorbidities of celiac disease.”

FDA expects that the amount of gluten in a dose of a drug product would be less than that found in a 30 gram cookie labeled as ‘gluten free’ but the guidance does not establish a ‘gluten free’ claim for drugs. The draft guidance instead allows for a statement similar to, “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” as long as such a statement can be substantiated.

More interesting than these rules and guidance is FDA’s November 2017 publication of the results of their surveillance of gluten-free foods. The agency tested 702 samples from cereals, grain bars and flours between July 2015 and August 2016. The agency found that all but 5 of those sampled products met the standards of less than 20 ppm of gluten.

I won’t dwell on the fact that FDA did not issue a press release on this finding of wide-spread compliance but I would like to point out the salient notion that FDA actually caries out product surveillance and sample testing. This made me wonder what other things FDA might be surveilling and testing. In addition to FDA’s robust testing of imported products for prohibited ingredients or to determine whether declared nutrient levels are accurate, I wonder whether the agency tests based on other label claim. Would they ever test for parabens in cosmetics labeled as “paraben free”? Will there perhaps be testing for amino acid ratios in the many new vegan food products whose labeling includes protein claims but whose manufacturers failed to undertake a close reading of 21 CFR 101.9(7) regarding protein declarations? I cannot predict what the agency will do but I’ll keep reading what FDA writes and let you know. In the meantime, my team and I are here to simplify your FDA compliance process and help you avoid running afoul of FDA regulations. Contact us with your questions.

Here’s to an A-MAZE-ing year!

2017 was a bit of a wild year with many twists and turns, stops and starts in the form of FDA actions.  The agency once more delayed enforcement of restaurant menu labeling regulations; now set for May 7, 2018.  The enforcement date for the revised nutrition/supplement facts and serving size regulations was changed to January 1, 2020 (January 1, 2021 for companies with less than $10 million in annual foods sales.)   There were also changes to some of the 7 sets of regulations based on the Food Safety Modernization Act.

It wasn’t all delays with FDA though. The agency also took some big steps forward in catching up to the state of science by publishing guidance documents on medical devices produced by 3D printing (termed “additive manufacturing” by FDA); gene therapies and other regenerative medicine therapies.   FDA also cleared the first medical device accessory for the Apple watch late in 2017.

Other FDA efforts in 2017 involved nanotechnology and labeling of drugs that contain gluten allergens.

Coming up in 2018 are  the ban on the use of partially hydrogenated oils in foods, effective June 18th and fallout from the draft guidance on homeopathic medicines, which is likely to turn the industry upside down.

No doubt much more will follow and FDA Compliance Simplified will be here to help you map your path to success.

All the best to you and yours in 2018!


A Tweet and Speculation about Labeling Regulations

Update September 29, 2017:  FDA announced extension of the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule to January 1, 2020, for manufacturers with $10 million or more in annual sales.  The new date for manufacturers with less than $10 million in annual sales would  is January 1, 2021.

Original post:  In June of this year FDA announced that there would be a delay in enforcement of the new food and dietary supplement labeling regulations that were to be enforced beginning July 26, 2018.  Unfortunately, they did not announce a new enforcement date or say much more about it, except that “FDA will provide details of the extension through a Federal Register Notice at a later time.”  While there still has not been a Federal Register notice, on September 14th FDA Commissioner, Scott Gottlieb tweeted:

This tweet suggests that the new labeling rules will not be enforced until 2020, giving FDA plenty of time to write guidance documents to clarify several vague aspects of the regulations and to publish technical amendments to correct discrepancies in the published final rule.

In a previous post I speculated that enforcement of the new facts box labeling regulations would be delayed.  I based this on FDA’s delay of the restaurant menu labeling requirements.  That delay was a result of presidential orders to review all new regulations for “unnecessary regulatory burdens placed on the American people.”  I am going to speculate again and propose that FDA will revisit the new rules on declaration of added sugars and the new definition of fiber and reopen the comment period. This prediction is based on what FDA did with the restaurant menu labeling requirements—they reopened the comment period for portions of the regulations that caused a great deal of confusion that the agency was unable to clear up for industry.  You may read about my reasoning here.

The new definition of fiber and the requirement to declare added sugars in the nutrition facts box are the two most difficult and controversial changes to the regulations. In June the Natural Products Association petitioned FDA to stay enforcement of the new labeling regulations and to reconsider the fiber and added sugar rules.  The petition lists the grounds for the request as follows:

  1. Implementation of the Final Rule is Inconsistent with the Administration’s Regulatory Agenda and Directives;
  2. The Food Labeling Final Rule Presents Serious Issues with Respect to First Amendment Protections for Commercial Speech;
  3. Inclusion of a Daily Value (DV) for Added Sugar in the Final Rule but Not in the Proposed Rule was an Example of Impulsive Behavior to Hastily Circumvent the Public Rulemaking Process;
  4. FDA’s Own Consumer Studies Do Not Support the Addition of Added Sugars to the Nutrition Facts and Supplement Facts Labels;
  5. Eye-Tracking Studies Do Not Support FDA’s Position to Include Added Sugars as a New Declaration in Nutrition Facts and Supplement Facts Labels;
  6. The Food Labeling Final Rule’s Change in How Dietary Fibers are Declared is Unjustified, Unduly Burdensome, and Does Nothing to Advance Consumer Health; and
  7. FDA failed to submit an economic impact analysis with this guidance to the Office of Management and Budget (OMB), regarding this new cost burden to the food and supplement industries.and supplement industries.

You may read the entire petition here.

Other groups have also petitioned FDA for delay of enforcement for various reasons, one of which is to coordinate with USDA on the compliance date for new (and as yet unpublished) rules for ‘non-GMO’ labeling, which is set by Congress for 2020.

In the meantime, let me know what questions you have about new or old FDA regulations.

Will Enforcement for New Nutrition and Supplement Facts Boxes be Delayed?

Updated June 13, 2017:  Today FDA announced that they will extend the compliance dates for the new nutrition facts labels but they have not announced what the new dates will be.  Here is the information published on the FDA website:

“FDA Intends to Extend Compliance Dates for Nutrition Facts Label Final Rules

In May 2016, the U.S. Food and Drug Administration finalized the Nutrition Facts and Supplement Facts Label and Serving Size final rules and set the compliance date for July 26, 2018, with an additional year to comply for manufacturers with annual food sales of less than $10 million. After those rules were finalized, industry and consumer groups provided the FDA with feedback regarding the compliance dates. After careful consideration, the FDA determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.

As a result, the FDA intends to extend the compliance dates to provide the additional time for implementation. The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace. The FDA will provide details of the extension through a Federal Register Notice at a later time.” (emphasis added).


Original 5/3/17 post: On May 1, 2017 FDA announced a year long delay for compliance with restaurant menu labeling regulations that were to have become effective May 5, 2017. The Interim Final Rule, which will be published in the May 4, 2017 Federal Register lists several reasons for the delay that seem pertinent to the new nutrition and supplement labeling regulations.  Most notably:

Delay reason 1:  “We are taking this action consistent with Executive Orders 13777, 13771, and 13563,…”

Comment: These executive orders call for review of regulations with an eye to the alleviation of “unnecessary regulatory burdens placed on the American people” and to control regulatory costs.

Delay reason 2:   “…The continued, fundamental questions and concerns with the final rule suggest that critical implementation issues, including some related to scope, may not have been fully understood and the agency does not want to proceed if we do not have all of the relevant facts on these matters…”

Comment:  The nutrition labeling regulations are full of vagaries and inconsistencies.  Regulations that are impacted by the new labeling rules, such as those for nutrient content claims, have not even been updated to reflect the rules on which they rely.

There is no doubt that the new rules are complex, expensive, and impose burdensome record keeping requirement for added sugars, folate and vitamin E declarations.  In addition, there are many other valid complaints from industry.  As written about by Hyman, Phelps & McNamara, The American Bakers Association has petitioned FDA to revoke or revise the new rules on dietary fiber.  Other industry groups have asked that the compliance date be delayed to coincide with the Congressional-directed GMO labeling rules that USDA has yet to write for an effective date in 2021.   There have been many articles in trade publications noting that Scott Gottlieb, the nominee for FDA Commissioner stated that he is “philosophically in favor of trying to make sure we do these things efficiently, not only because it imposes undue costs on manufacturers to constantly be updating their labels, but we also have to keep in mind it creates confusion for consumers if the labels are constantly changing.”

I will spare you my rant and list of complaints about the new regulations but I will say that it has been a frustrating task to read, understand and try to implement the new labeling rules for foods and dietary supplements.  Up until now I have doubted that implementation or enforcement of the new nutrition labeling regulations would be delayed.  However, the reasoning behind the menu labeling delay mirrors similar problems with the new nutrition labeling regulations.  I don’t typically place bets but I think there is a very good chance that enforcement of the changes to the nutrition facts boxes will be delayed.  I would expect that the changes to the dietary supplement facts boxes that were part of the same final rule would also be delayed.

Watch this space–we’ll keep you updated!


Lead, Heavy Metals and Microbeads in Cosmetics

In December of 2016 FDA published the first new cosmetic guidance document since June of 2014.  The draft guidance covers the agency’s recommendation to limit lead in lip and other applied cosmetic products to 10 parts per million (ppm).  This action brings FDA guidelines into conformance with the International Cooperation on Cosmetics Regulation, Canada and the European Union, which previously set a limit of 10 ppm for lead as an impurity in cosmetics. FDA notes in the guidance that most of the products they tested in 2011 and 2012 had lead levels lower than 10 ppm.

It is interesting to note that at about the same time FDA published a notice about lead levels in ceremonial and other specialty cosmetics that are used by some Middle Eastern, African and Southeast Asian cultures.  This page entitled, Kohl, Kajal, Al-Kahal, Surma, Tiro, Tozali, or Kwalli: By Any Name, Beware of Lead Poisoning, notes that none of these products are legal in the US due to violation of the color additive regulations.  The agency has placed these products under import alert and they are to be barred entry into the US.

Other Heavy Metals:

In 2012 FDA also conducted testing on the levels of the heavy metals arsenic, cadmium, chromium, cobalt, mercury, and nickel in eye shadows, blushes, lipsticks, lotions, mascaras, foundations, body powders, compact powders, shaving creams, and face paints. Most products contained very low levels of these heavy metals and FDA has not issued guidance on safe levels of use for these substances in cosmetics.

Plastic Microbeads:

In July of this year the Microbead-Free Waters Act of 2015 comes into effect.  This law amends the Federal Food, Drug, and Cosmetic Act and prohibits the manufacture and sale of rinse-off cosmetics containing intentionally-added plastic microbeads in the US.  The statue includes toothpaste in the definition of ‘rinse off cosmetic’ and defines `plastic microbead’ as “any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof.“

Effective July 1, 2017 rinse off cosmetic products may not be manufactured in the US using plastic microbeads. Such products may not be distributed or introduced into US interstate commerce as of July 1, 2018. The effective dates for products that are both rinse-off cosmetics and nonprescription drugs are July 1, 2018 for manufacturing and July 1, 2019 for introduction into interstate commerce.

It is unlikely that any new FDA Commissioner will greatly increase the number of new guidances or regulations for the cosmetic industry but we’ll keep you updated if they do.  In the meantime, let us know what questions you have about cosmetic regulations or topics you would like to read about.

Import Alert: Foreign Food Facilities Should Check Their Registration

Update February 22, 2017:  Many foreign manufactures of foods and dietary supplements are finding that their FDA Food Facility Registrations have been invalidated.  These are companies that updated their registration between October and December 2016 as required but whose US Agent failed to confirm the registration.  FDA’s Ombudsman for the Office of Regulatory Affairs, Jessica Zeller, described the issue as “a systemic matter”.

The problem was caused by a change in the process that came as a surprise to US Agents.  Since inception of the registration requirement US Agents were informed that they were listed as agent on a facility registration by email that required no action if the information about them in the registration was correct.  This year the email from the registration system looked very much like those sent in previous years but there was a new requirement to confirm the registration.  Ombudsman Zeller stated that, “there was obviously some confusion this year and communication could have been better.”

Most companies have learned of the invalidation of their registration only when they tried to notify FDA of a new import.  The problem is easily and almost immediately rectified by re-registering the facility and ensuring that the US Agent confirms the registration.  All foreign food and dietary supplement facilities should log into the facility registration system to ensure they remain registered prior to shipping product to the US.

Original Post October 20, 2016:

It’s Time to Renew Food Facility Registrations

All facilities that manufacture, process, package or warehouse food or dietary supplements for sale in the US must renew their facility registration between October 1st and December 31st of even-numbered years.  2016 is of course an even-numbered year and the renewal period is open. This requirement applies to domestic as well as foreign facilities and also includes facilities handling medical foods and animal foods.

The Food Safety Modernization Act has affected this process by requiring that the registration include the facility’s “activity type”.  The form lists 39 types of activities for human food facilities and 28 for animal food facilities.  Also new with this year’s registration is the requirement that the facility agree to FDA inspection by checking a box next to this statement:

“FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food, Drug, and Cosmetic Act”.

Failure to check the box will result in rejection of the registration.  If the company later refuses inspection, FDA can revoke the registration and prohibit distribution of the registrant’s products in the US.

Electronic registration is required using FDA’s online system, which can be accessed here.  If you do not already have an account you can create one there as well.

Step by step instructions for registering food facilities are available and you may preview registration form as a PDF. If you have trouble downloading the form, let me know and I will email it to you.  If you have questions about the form, let me know.

Another note for food and dietary supplement companies is to begin asking your suppliers to provide data on the levels of vitamin D, potassium and added sugars in the ingredients you use so you can get ready to comply with the new nutrition facts regulations.  These regulations became effective July 26, 2016.  While the new regulations will not be enforced until 2018 it may take time for your supplier to understand that they need to provide this data and then test their products to get the values.  Based on my experience when trans fat labeling was first required, it can take many months for suppliers to provide the data.

Submit questions to FDA at the Rocky Mountain Dietary Supplement Forum

The helpful and informative Rocky Mountain Dietary Supplement Forum will be held again this year on September 15th & 16th (see details here).  FDA will be present at the forum again this year for a panel discussion where attendees ask and get answers to issues important to their dietary supplement business.

The forum organizers sent the following message to registered attendees:
“As in past years, our FDA panel has asked that our attendees submit questions on issues, problems, challenges or procedures that they would like to be addressed during their Friday, September 16 presentation.  Last year with 50+ questions, this Q&A session was one of the most informative of the Forum, resulting in a far ranging discussion by both industry representatives and the Agency.”

I will be attending the forum and will be pleased to submit questions on your behalf.  I will report on FDA’s answers in a future newsletter.  Contact me with your questions.

I look forward to hearing from you.


FDA Revises Draft Guidance on New Dietary Ingredient Notifications

On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.  The guidance contains numerous requirements that will significantly affect the dietary supplement industry and establishes a 60 day comment period if manufacturers wish to affect the final rule.  The draft guidance is written in a question and answer format and about half of the 102 page document provides detailed information on the type of information and format that FDA expects of New Dietary Ingredient Notification.

I will be reading and re-reading the details of the draft guidance in coming weeks and sharing details with you but for now I would like to list a few items that stood out to me on first reading. Let’s begin with some non-surprises:  FDA reiterated the definition of dietary ingredients and noted that there is no authoritative list of dietary ingredients that were marketed in the US prior to October 15, 1994.  Interestingly, FDA did note

“that the present definitions of “dietary supplement” and “dietary ingredient” were not added to the FD&C Act until after October 15, 1994, and that many products now marketed as dietary ingredients for use in dietary supplements were marketed under other product categories, such as foods for special dietary use or food additives. Therefore, we interpret “dietary ingredient” to refer to ingredients that (1) if marketed today, would qualify as “dietary ingredients” under 21 U.S.C. 321(ff)(1); and (2) when marketed before October 15, 1994, were intended for use as or in a product that would now be a “dietary supplement” as defined in 21 U.S.C. 321(ff) and that would not also meet the definition of a drug.”

In general the document reiterated the concept that supporting data for safety must be based on studies using substances that match the new dietary ingredient in chemical form, method of preparation, intended use and level of use, just as is required for substantiation of dietary supplement claims.

One portion of the draft guidance will be of comfort to many manufacturers:

“If I want to market a dietary supplement containing several pre-DSHEA ingredients that haven’t previously been marketed together, do I have to submit an NDI notification?
No. The NDI notification requirement applies only to dietary supplements that contain at least one NDI. If each of the dietary ingredients in a dietary supplement was marketed in the United States before October 15, 1994, marketing these ingredients together for the first time in the same dietary supplement does not create an NDI or trigger the NDI notification requirement.”

 The section of the draft guidance that discusses “chemical alterations” that render a dietary ingredient “new” will greatly trouble a number of dietary supplement manufacturers since it includes the following:

• Changing agricultural or fermentation conditions to alter the chemical or molecular composition or structure of the ingredient. Examples: sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.
• Fermentation using a fermentation medium different from the one used to make conventional foods in the food supply. Example: use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese.
• Use of a botanical ingredient that is at a different life stage than the life stage of the botanical ingredient used as a conventional food. Examples: making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.”

The processes listed above are used for many dietary ingredients that are common today and will require New Dietary Ingredient Notifications for the products to remain on the market. I encourage every dietary supplement manufacturer and marketer to become acquainted with this document.  Let me know what questions you have and I will do my best to answer them.

FDA Warns Cosmetic Companies About Anti-Aging Claims

In 2012 FDA issued warning letters to Avon and Lancôme citing wrinkle reduction, regeneration and anti-aging claims. Over the past twelve months FDA has issued many warning letters to smaller cosmetic companies for making similar drug effect claims.  The letters issued between August 2015 and June 2016 were the result of inspections at the cosmetic manufacturing facilities.  However, in last week of July and the first week of August 2016 FDA issued several warning letters based on visits to cosmetic company websites.

Per FDA regulations cosmetics may be marketed for “cleansing, beautifying, promoting attractiveness, or altering the appearance.”  Many of you will recognize discussions we have had about proposed claims on your cosmetic products in the list of statements below that FDA has characterized as drug claims in those recent warning letters to cosmetic companies.

Effects on Wrinkles and Skin Structure

  • “relaxes facial tension leading to the reduction of facial lines and wrinkles”
  • “Will diminish fine lines and wrinkles, eradicate crow’s feet …”
  • “Improves the firmness and elasticity of skin, removes crow’s feet…”
  • “…enhance the production of elastin and collagen in the skin…”
  • “reduces the depth of wrinkles…by attenuating muscle contraction…”
  •  “strengthens capillaries to minimize discoloration”
  • “…ingredients that can help increase fatty tissue volume to…plum up…”
  • “Special new peptides and additional ingredients can help increase the volume of fatty tissue.”
  • “known to stimulate acetylcholine, thus helping aging skin achieve improved facial contours.”
  • “firming effects are believed to involve the signaling of acetylcholine in the skin.”

Regeneration & Inflammation Claims

  •  “essential oils offer …cellular regeneration…”
  • “EFA’s reduce inflammation and protects from accelerated aging.”
  • “anti-inflammatory, regenerative…”
  • “Supports the synthesis of new skin fibers, boosts cell regeneration…”
  • “Activates the skin receptors stimulating…skin regeneration”
  •  “inhibition of collagenase and hyaluronidase…
  • “skin immune cell macrophage activation…”
  •  “inhibits elastase (protects elastin) …”
  •  “ vegan stem cells…a new way for your skin to build collagen, repair itself and prevent aging.”
  • “This serum will increase skin hydration by inhibiting hyaluronidase…”
  • “support cell communication.”
  • “proven in laboratory studies to stimulate growth in cultures of aged human epidermal stem cells”
  • “…has antioxidant effects”

Skin Whitening Claims

  • “Proven significant whitening activity”
  • “Targets all types of pigmentation concerns: dark spots, age spots, melisma, freckles, and blotchiness and helps to prevent future appearance of pigmentation”
  • “… break down stubborn melanin deposits.”
  • “lighten skin by inhibiting or interrupting the skin’s production of melanin.”

Prevention, Healing & Drug Effect Claims

  • “Heal damaged skin from scars and burns.”
  • “Reduce scar tissue and stimulate the growth of new skin tissue.”
  • “beneficial for many skin conditions such as rosacea, dermatitis, eczema, acne and psoriasis.”
  •  “Beneficial for many skin conditions, including … cracked skin, sun burn, chapped lips…”
  • “Made with organic oils… calming, anti-inflammatory and healing properties.”
  • “helps fade and clear bruises.”
  • “Also helps treat red, irritated areas on the face, spider veins and rosacea…”
  • “…prevents damage to collagen and elastin production…”
  • “will repair the DNA of the skin…”
  • “Effects similar to Botox”
  • “Revitalize your body’s natural abilities to heal itself…”
  • “proven to improve acne…”
  • “helps to protect the skin against damage from UV rays…”
  •  “Soothes and reduces redness and irritation”
  • “Reduces blemish-causing bacteria…”

With FDA’s review of cosmetic claims extending to websites and companies of all sizes, it is time to carefully review your labeling ensure that claims such as those listed above are edited or removed.




FTC Takes Action Against False Natural Claims

Natural claims continue to be prominent on a variety of food and cosmetic product labels.  As discussed in a previous post, FDA  has not defined  natural but requested public input on what the term should mean when used on food labels.  The comment period closed May 10, 2016 and according to the  Regulations.gov website, the agency received 7,690 comments.  It will take some time for the agency to review all the comments and then write a definition, nevertheless, other forces continue to shape the meaning of “natural”.  As I have discussed with several clients, plaintiff attorneys have been at work for a number of years on the meaning of natural.  It would seem obvious that ingredients that are not extracted from plants or animals but synthesized through chemical processes are not natural–even when the resulting ingredient is a chemical found in nature, such as vanillin, the major flavorant from vanilla beans.  What may be less obvious is that the consumers and courts seem to agree that certain processing steps can cause an ingredient to cease to be natural.

Last week the Federal Trade Commission (FTC) announced final settlements with four personal care companies that marketed lotions, shampoos and sunscreens as “all natural” or “100% natural” when they contained synthetic ingredients such as dimethicone, ethyhexyl glycerin, and phenoxyethanol, caprylyl glycol and polyquaternium compounds.  In these cases, even if the product only contained a fraction of a percent of man-made ingredients the claims were false since “all” and “100%” natural mean that there can’t be a speck of synthetic ingredients.  These cases are worse in that in these synthetic ingredients often made up significant portions of the product formulations.  The claims failed the basic requirement that all label statements be “truthful, not misleading and supported by data”.

While the cases cited above are egregious, the requirement that all label statements be “supported by data” should always be carefully considered, even for ‘natural’ claims whether on cosmetics, foods, pet foods or dietary supplement products.   It is best to ask your ingredient suppliers about the methods used to produce the ingredients in your products.  If they cannot provide the source and derivation of the ingredients, you should consider other suppliers or modify the label claim.





New Rules for Nutrition Facts Boxes Annouced

Update May 22, 2016: Here is a brief summary of the changes to the Nutrition Facts Box:

The side by side graphic below shows the current and soon to be required versions of the Nutrition Facts Box. The changes also apply to Supplement Facts Boxes.  While the changes include much larger font sizes for serving size and calories listings and a new required listing for added sugars, the large calorie chart footnote has been eliminated so that the average overall size of the facts box has not changed.

final new nutrition facts box


This image is taken from the FDA webpage.

In addition to the numerous changes to the look of the graphics, the percent daily values (DVs) have changed for many nutrients.  The newly required nutrient, “Added sugars” also has a daily value, 50 grams and at last the B vitamin Choline has been assigned a daily value of 550 mg.  Here are a few more highlights: The DVs for total carbohydrates, sodium and many of the B vitamins have been reduced while those for total fat, dietary fiber, vitamin C, vitamin D, calcium and magnesium have been increased.

FDA also announced changes to the serving sizes required for use in food product labeling.  New items such as tortillas and wonton wrappers have been added.  The serving size for most beverages has increased from 8 to 12 ounces.

Another important change to note is that all product packages that contain at least 200% and up to 300% of the applicable serving size must list nutrition information for the serving size and the entire container as shown in this image from FDA’s announcement:

Dual column Fact Box for entire container

These changes also apply to the Supplement Facts Boxes on dietary supplement products but the most pronounced changes such as the large size for Calories and the listing of ‘Added Sugars’ will not affect the majority of dietary supplement products.

It is interesting to note that the preamble to the final rule discusses many comments that were received about protein declaration and protein quality and digestibility.  In the discussion of and response to these comments, FDA reiterates the requirement to correct protein values for products whose quality/digestibility scores are less than 40%.  This affects some vegetarian protein products that do not rely on soy as their primary source of protein.

The  new rules become effective on July 26, 2016 but compliance is not required until July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales.  If you are updating labels or planning a new product introduction after July 25, 2016, you may wish to consider working with the new format.


Update May 20, 2016: Today FDA announced the final rule for changes to the Nutrition Facts Box. The new rules become effective on July 26, 2016 but compliance is not required until July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales.

Most of the proposed changes that we discussed in our February 2014 post below are part of the final rule. The look of the revised facts box is a little different than proposed in 2014 (see image below).  We will update this post as we review the new rules.


Original Post February 27, 2014: You’ve no doubt heard the news today that FDA is proposing a number of changes to the Nutrition Facts and Dietary Supplement Facts boxes that appear on US products.  The proposed rules are based on review of the state of Americans’ health, dietary patterns and newer understandings of nutritional science. The official announcement will be made at 3:00 pm Eastern Time and the rule is only proposed at this time and will not be in effect for about two years but I’ve spent some time this morning reviewing the proposed rule and thought you might be interested in a few of the highlights:

  1. The number of calories present in food and dietary supplement products will be much larger—larger than the current “Nutrition Facts” title.  The number of servings per container will be much larger as well. (see image below).
  2. The “%Daily Value” declaration would be moved to the left side of the panel.
  3. There is a proposal to eliminate the declaration of Calories from fats from the facts boxes
  4. FDA wishes to require the declaration of “added sugars” in addition to total carbohydrates and the levels of naturally-occurring sugars.  This particular proposal will require excellent record keeping by manufacturers and distributors since there are no analytical methods that can differentiate between naturally occurring and added sugars.
  5. There are some changes proposed to the RDIs and Percent Daily Values for some nutrients and to the units used to express others.  Sodium’s RDI would decrease from 2400 mg to 2300 mg per day. The fat soluble vitamins, A, D, E and K would now be expressed in milligram or microgram amounts rather than the current (and confusing)
    International Units. The RDI for calcium would be increased from 1000 mg to 1300 mg. See table below for details except that for some reason sodium was left out of this table.
  6. The proposed rule would require the mandatory declaration of vitamin D and potassium, retain the current mandatory declaration of calcium and iron and make the declaration of vitamin A and vitamin C voluntary.
  7. FDA also proposes that records be kept in support of label declarations of dietary fiber, sugars that undergo fermentation (including those in yeasted breads), various forms of vitamin E, and folate and folic acid.  The proposal would require maintenance of such records for two years.

New facts box image for mail chimp

It is important for manufacturers to consider how the proposed rule would affect their businesses and to consider submitting comments to FDA regarding the proposed rule.  We will provide updates and insights as the process moves forward and in the meantime can help you with the current regulations

Menu Labeling Regulations Enforcement Delayed to May 2018

Another Delay for Menu Labeling Enforcement

On May 1, 2017 FDA announced a year long delay of enforcement of menu labeling regulations that were to have become effective May 5, 2017.  This is the third delay to regulations that applied to restaurants and other food service businesses with 20 or more outlets.

The Interim Final Rule, which will be published in the May 4, 2017 Federal Register gives several reasons for this delay,which I am excerpting as bullet points for your reading pleasure:

  • “We are taking this action consistent with Executive Orders 13777, 13771, and 13563, as well as in response to the diverse and complex set of stakeholders affected by the rule and continued, numerous, and fundamental questions they raise regarding the final rule and its implementation.
  • “The continued, fundamental questions and concerns with the final rule suggest that critical implementation issues, including some related to scope, may not have been fully understood and the agency does not want to proceed if we do not have all of the relevant facts on these matters.
  • “Retailers with many different and diverse business models have raised concerns about how the rule lacks flexibility to permit them to provide meaningful nutrition information to consumers given their type of business and different operations.
  • “Moreover, we continue to receive many questions about calorie disclosure signage for self-service foods, including buffets and grab-and-go foods.
  • “We do not want to proceed with a rule that might turn out to be too inflexible to support innovation in delivering information to consumers.
  • “In addition, we have received questions regarding how to distinguish a menu, which requires the posting of calorie information, from advertisements and other marketing pieces, which do not require calorie information.
  • “Many of these menu questions are complex and have highlighted for the agency the need for further consideration and clarification.
  • “How to address the natural calorie variations for foods has also been raised by stakeholders as an issue that needs additional guidance and clarity.
  • “Finally, some entities with certain business models have stated that they continue to have questions about what provisions of the final rule are applicable to them.
  • “We believe questions like this still need to be addressed.”

Indeed.  Many restaurant and grocery companies have worked hard and have gone to considerable expense to make sense of the regulation and have even undertaken extensive redesign of their menu boards to meet the now defunct deadline.

May 19, 2016:  Menu Labeling Update

Early in May 2016 FDA published their long-awaited guidance on how to comply with menu labeling regulations. The enforcement date for menu labeling regulations is now set as May 5, 2017.  The new guidance is in the form of Questions and Answers and appears to use many questions submitted by regulated restaurants.  There is nothing in the guidance that makes the process magically easy but many specific circumstances are thoroughly addressed.  I will highlight those I found unique, interesting or otherwise noteworthy:

  1. Prisons and executive dining rooms where the food is not ‘sold’ are not covered under the menu labeling regulations.
  2. Apps and links to websites may be used to provide the more complete nutrition information that must be available upon request as long as devices to use the apps and links are also available in the ‘covered establishment’/restaurant.
  3. Any advertising, flyer or even coupon that list a menu item and a price must include calorie information.

It is well known that the menu labeling regulations will require restaurants to list calorie and other nutrition information on alcoholic beverages even though the producers of beers, wines and spirits are not required to provide that information.  FDA notes that the restaurants are responsible for determining what a ‘reasonable basis’ is for the caloric/nutrition values. The May 2016 guidance includes this question and answer pair on page 50:

“7.9  If nutrition information on certain alcoholic beverages, such as flavored liqueurs, cordials, ports, or champagne categories, are not available in USDA’s National Nutrient Database or other nutritional databases, how do I get nutrition information for these alcoholic beverages when TTB does not require nutrition labeling for products bearing no nutrition claims? If other databases are not available, is a covered establishment expected to undertake analytical testing?

Answer: As provided in the menu labeling final rule, there are several reasonable bases that can be used to determine calorie and other nutrient content of standard menu items. (See 21 CFR 101.11(c)) Determining calorie and other nutrient contents may require the use of more than one reasonable basis or a combination of two or more reasonable bases or other reasonable means. It is up to the covered establishment to determine the appropriate basis that it uses to determine nutrient values and that the basis is valid for the item and is complete and accurate.”

Two other scenarios are discussed in detail in the guidance and should be reviewed if they apply to your organization.

  1. For cafeterias, buffets and ‘watch and build’ customer lines, the serving size used to determine calories may be based on the utensil used if the utensil dispenses a uniform serving. However, if tongs or other imprecise utensils are used, the calories must be based on a common household measure, such as a cup or tablespoon or a unit of weight.  The guidance gives the example of “200 calories per cup” or “150 calories per 4 ounces.”
  2. “Grab and go” items sold in grocery stores are to be treated as ‘restaurant foods’ with the calorie and nutrition information reflecting the contents of the entire package or the store could label the food as required for packaged foods.

All restaurants should carefully review the substantiation and certification requirements noted in the menu labeling guidance document (pages 42 -50). First, in addition to having a “reasonable basis” for determining the calorie and nutrient information, the values presented

“must be accurate and consistent with the nutrient values you determined using a reasonable basis. You must take reasonable steps to ensure that how you prepare your product (that is, the types and amounts of ingredients you use, the cooking process, temperatures, etc.) and how you serve your product (that is, the amounts of that item that are offered for sale in a typical serving) are the same as those used to determine the calorie and nutrient declarations. (21 CFR 101.11(c)(2))”

The values should be substantiated by

“keep[ing] records of how you arrive at your nutrient values for standard menu items being offered for sale at your covered establishment. FDA recommends that any such records should be maintained either at the covered establishment or the corporate headquarters for the duration of the time that the standard menu items are offered for sale at the covered establishment. Upon request and within a reasonable period of time, you must supply to FDA, information used to substantiate the required calorie and nutrient values that you use for your standard menu items listed on your menus, menu boards or on display, and for your written nutrition information. This information must include both the data and the method you used to derive these nutrient values, as specified in 21 CFR 101.11(c)(3). FDA considers a reasonable period of time to be about 4-6 weeks after the request is made.”

The following certifications are required:

  1. A statement that is signed and dated by a responsible individual who is employed at the covered establishment, its corporate headquarters, or parent entity who can verify that the information in the nutrient analysis is complete and accurate. (21 CFR 101.11(c)(3)(i)(F)) [This certification may cover multiple establishments—even the entire restaurant chain.]
  2. A statement that is signed and dated by a responsible individual employed at the covered establishment (such as, the manager of the establishment or someone designated by the establishment manager or owner that is also employed at the specific covered establishment) certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (such as the types and amounts of ingredients used, the recipe, and the cooking times and temperatures) and the amount of the standard menu item offered for sale are the same as that on which the nutrient values were determined. (21 CFR 101.11(c)(3)(i)(G)). For example, such a statement could read “I, (name of the responsible individual), certify that (name of the covered establishment) has taken reasonable steps to ensure that the recipe for (name(s) of standard menu item) that was used to determine the calorie declaration and other nutrient values was followed to prepare (name(s) of standard menu item). The ingredients were properly measured, the specified cook times and temperatures were followed, and the specified portion sizes were served to the customer.” Any other statement or format that includes the required information in 21 CFR 101.11(c)(3)(i)(G) would also be acceptable. [This certification only covers a single establishment/restaurant.]

These guidelines signal the dawn of a new day for the manager and kitchen staff at chain restaurants.

You may also be interested in reading about the new final rules on nutrition labeling, which become effective July 26, 2016 and will apply to the additional menu information restaurants must provide upon request.

Waiting on FDA

Once again in 2016 industry is waiting for action from FDA. I have listed just a few topics that various industry sectors hope to have clarified in 2016 below.

Food: In February of 2014 FDA proposed dramatic changes to nutrition labeling regulations and industry continues to wait for the final rule. Will the final rule require that ‘Added Sugars’ be listed in the nutrition facts box as originally proposed? Industry has objected to this particularly since the amount of sugar added to jams, applesauce, etc. can vary with the inherent sweetness of the fruit. Since there is no lab test that can distinguish between naturally-occurring and added sugars, it is difficult to understand how FDA, which prides itself on being a science based organization, can ensure compliance with this rule.

Restaurant Menu Labeling: The publication of the final rules for calorie declarations on restaurant menus was delayed in 2013 and then in 2015 the compliance date for this regulation was delayed by one year to December of 2016 and in early 2016, enforcement of the rule has been delayed indefinitely. Will chain restaurants really be required to post caloric values on their menus and menu boards? While seemingly simple, there are genuine challenges with complying with this rule. First, the accuracy required by the regulation could be tough to meet since even though restaurants are careful about portioning, there is variation. Second, the regulation requires chain restaurants to list the calories on alcoholic beverages but the wine, beer and spirits industries are not required to provide calorie information. How is a restaurant supposed to comply? (Read more about Restaurant Menu Labeling.)

Pet Foods: In 2007 Congress mandated that FDA take over regulation of pet food. Since that time FDA has been working with State pet and animal food regulators to come up with ingredient definitions that would meet FDA criteria. As that progresses, FDA’s Center or Veterinary Medicine is scheduled to publish draft guidance documents that pertain to the pet food industry:

Animal Food Current Good Manufacturing Practices

Hazard Analysis and Risk-Based Preventive Controls for Animal Food

Human Food By-Products for Use as Animal Food

Dietary Supplements: The first draft of the proposed guidance on New Dietary Ingredients was published in July of 2011 . In 2013 FDA proposed that the final rule would be published in 2014. We are still waiting but it could be published any day!

Over the Counter Drugs: The FDA monograph that covers hand sanitizers and antibacterial soaps and body washes has been tentative since 1994. In 2010 a lawsuit was filed to try to force FDA to finalize the monograph. In December of 2013, FDA published a proposed rule stating that there was not sufficient data to support the safety of these products and that additional data on both safety and clinical benefit was required. The comment period closed in June of 2014 but no final rule has been issued.

Homeopathics: Both the FDA and FTC held hearings in 2015 looking into the regulation of homeopathic medicines. The tone of these hearings made it very clear that both agencies view homeopathic products as quackery and would like to change the regulatory framework for homeopathic products. Under the current policy, homeopathic products that comply with the Homeopathic Pharmacopoeia of the United States (HPUS) may be marketed in the US. Unfortunately, some companies have introduced products that do not comply with HPUS to the market. It seems that this is due, at least in part, to FDA’s complete failure to enforce the current regulations that apply to homoepathics. This industry is waiting to see whether it will have a place in the US marketplace.

Cosmetics: Will the voluntary cosmetic registration and GMP program become mandatory? For years there have been bills introduced in Congress to more tightly regulate the cosmetic industry. Discussions on Cosmetic Safety Legislation between the FDA and the cosmetic industry broke down in 2014 (See FDA and Cosmetic Industry Controversies). Will we see fundamental changes to the way cosmetics are regulated in 2016?

It can be difficult to keep up with all the possible regulatory changes that can affect your day to day operations. My associates and I work hard to stay abreast of FDA regulations, policies and related issues so we can help you stay compliant. Contact us with your questions and we’ll do our best to keep you up to date on FDA’s activities.

FDA is finally addressing requests for a definition of “Natural”

The agency has avoided the issue for years but on November 12, 2015 the FDA published a “Request for Information and Comments” on the use of the term “Natural” in the labeling of human food products  Note that the general term “food” includes dietary supplements. While cosmetics and pet foods are not part of this request for comments, it is highly likely that any definition of “natural” for use in food labeling will influence the labeling of other FDA-regulated products.

The Federal Register Notice provides a brief history of FDA’s stance on the term “natural” and lists a number of questions the agency would like respondents to the request for information and comments to answer. From the brief history: Three Federal district courts hearing cases on natural labeling for foods containing genetically engineered ingredients and a fourth with a case on natural labeling for high fructose corn syrup have made referrals or requests to FDA for a definition of natural. There have also been several citizen petitions regarding use of the term “natural” in food labeling, including one from Consumers Union that asked the agency to prohibit the use of the term “natural” in food labeling since consumer expectations of the meaning of the term differs so much from how the term is used in the marketplace.

Previously FDA regulations have only defined natural in terms of colors and flavors (21 CFR 101.22).  The agency considers any added color to be artificial even if derived from fruits, vegetables or other natural sources.  (Compare to dyeing hair with henna—even though henna is a plant extract, it still alters the hair’s natural color.)

According to FDA, natural flavors are substances used to impart flavor that are derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.

[Note that FDA provides this definition in a backhanded way since 21 CFR 101.22 actually only defines artificial flavors as “any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.” The definition of artificial flavor also includes any lab synthesized versions of flavor molecules.  It is interesting to note that European countries allow use of the term ‘natural identical’ for lab-synthesized flavors but FDA deems them artificial.]

The USDA Food Safety and Inspection Service (FSIS), which oversees the labeling of foods containing meat and poultry, defines a natural food as one that “contains no artificial ingredients and is only minimally processed.”  The FSIS’s Food Standards and Labeling Policy book (see link on this page: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/Labeling-Policies ) provides details on the meaning of ‘artificial’ and minimally processed:

(1) the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and (2) the product and its ingredients are not more than minimally processed. Minimal processing may include: (a) those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or (b) those physical processes which do not fundamentally alter the raw product and/or which only separate a whole, intact food into component parts, e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices.

As a matter of policy FDA has stated that they consider natural to mean, “that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there.”  This policy comes from FDA’s 1991 proposed rule for nutrient content claims in which the agency also proposed defining fresh and natural.

While the agency did define fresh (21CFR101.95) they were unable to define “natural” because, “none of the comments provided FDA with a specific direction to follow for developing a definition regarding the use of the term ‘natural.’  Clearly it is up to concerned citizens, including industry and anyone who eats to help FDA arrive at a meaningful definition of “natural”,

The recent request for comments includes a long list of questions FDA has on the topic including, whether the food preparation or manufacturing processes should be considered; whether agricultural practices should be considered and whether genetically engineered foods should be allowed to be labeled as natural. (Scroll down to see FDA’s full list of questions.)

You may submit comments on “natural” labeling by visiting http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm456090.htm ). Or if you prefer, send us your comments and we will collate them into a submission to FDA.


Here are the questions FDA is seeking input on as they develop a definition for natural in food labeling. (You do not have to address all of the questions in your comments.):

  • Should we define, through rulemaking, the term ‘‘natural?’’ Why or why not?
  • Should we prohibit the term ‘‘natural’’ in food labeling? Why or why not?
  • If we define the term ‘‘natural,’’ what types of food should be allowed to bear the term ‘‘natural?’’
  • Should only raw agricultural commodities be able to bear the term? Why or why not? Section 201(r) of the FD&C Act defines the term ‘‘raw agricultural commodity’’ as ‘‘any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.’’
  • Should only single ingredient foods, e.g., bottled water or bagged spinach, be able to bear the term? Why or why not?
  • If multi-ingredient foods should be able to bear the term, what type(s) of ingredients would disqualify the food from bearing the term? Please explain why such disqualification would be warranted.
  • We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term ‘‘natural’’ with ‘‘organic’’ (the USDA Agricultural Marketing Service administers the National Organic Program, which enforces laws and regulations regarding certified organic foods). We are interested in data and other information about consumers’ understanding of foods labeled ‘‘natural’’ versus ‘‘organic.’’ Is the term ‘‘natural’’ on food labels perceived by consumers the same way as ‘‘organic?’’ Or is ‘‘natural’’ perceived by consumers to be ‘‘better’’ (or not as good as) ‘‘organic?’’ Please provide consumer research or other evidence to support your comment.
  • If we were to revise our policy regarding the use of the term ‘‘natural’’ or engage in rulemaking to establish a regulatory definition for ‘‘natural,’’ should certain production practices used in agriculture, for example, genetic engineering, mutagenesis, hybridization, the use of pesticides, or animal husbandry practices, be a factor in defining ‘‘natural?’’ Why or why not?
  • We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term ‘‘natural’’ with ‘‘healthy.’’ We have a regulation that defines the term ‘‘healthy’’ when used as an implied nutrient content claim with specific conditions related to the food’s nutrient profile that must be met in order to use the term on the label or in labeling of a food (see § 101.65(d)). We are interested in data and other information about consumers’ understanding of foods labeled ‘‘natural’’ versus ‘‘healthy.’’ Is the term ‘‘natural’’ on food labels perceived by consumers the same way as ‘‘healthy?’’ Or is ‘‘natural’’ perceived by consumers to be ‘‘better’’ (or not as good as) ‘‘healthy?’’ Do consumers view ‘‘natural’’ and ‘‘healthy’’ as synonymous terms? Please provide consumer research or other evidence to support your comment.
  • Should manufacturing processes be considered in determining when a food can bear the term ‘‘natural?’’ For example, should food manufacturing processes, such as drying, salting, marinating, curing, freezing, canning, fermenting, pasteurizing, irradiating, or hydrolysis, be a factor in defining ‘‘natural?’’
  • Should the term ‘‘natural’’ only apply to ‘‘unprocessed’’ foods? If so, how should ‘‘unprocessed’’ and ‘‘processed’’ be defined for purposes of bearing the claim? If the term natural should include some processing methods, what should those methods be? In making determinations related to processing, should one look at the process to make a single ingredient of a food, or does one evaluate the process done to the formulated finished food product (or both)?
  • The current policy regarding use of the term ‘‘natural’’ hinges in part on the presence or absence of synthetic ingredients. For example, under the current policy synthetic forms of Vitamin D would not be used in a food claiming to be ‘‘natural,’’ whereas naturally sourced Vitamin D (e.g., from salmon or egg yolks) could be. Should the manner in which an ingredient is produced or sourced affect whether a food containing that ingredient may be labeled as ‘‘natural?’’ Please explain your reasoning.
  • What can be done to ensure that consumers have a consistent and accurate understanding of the term ‘‘natural’’ in food labeling to ensure that it is not misleading?
  • What are the public health benefits, if any, of defining the term ‘‘natural’’ in food labeling? Please provide supporting data and other information to support your comment.
  • Should ‘‘natural’’ have some nutritional benefit associated with it? If so, what should be the benefit? What nutrients should be considered? What data are available to support the association between ‘‘natural’’ and a given nutritional benefit, and/or between ‘‘natural’’ and certain nutrients?
  • How might we determine whether foods labeled ‘‘natural’’ comply with any criteria for bearing the claim?

Menu Labeling Coming to a Restaurant Near You

Updated May 19, 2016: New Menu Labeling Guidance was published on May 5, 2016 so the enforcement date for the regulations is May 5, 2017.  See the full post here: http://fdasimplified.com/blog/

Updated March 9, 2016:  FDA announced that they will delay enforcement of menu labeling requirements until one year after publication of the final rules; which effectively pushes back the compliance deadline indefinitely.  This very reasonable step to provide the restaurant industry with final rules before enforcing those rules comes as a result of of language in the omnibus appropriations bill enacted by Congress on December 18, 2015 (Public Law 114-113 Consolidated Appropriations Act, 2016).

We will provide updates once the final rules have been published.  In the meantime, we expect the broad outlines of the draft rule discussed in the original post below to remain.

Updated June 9, 2015:  The Menu Labeling compliance date was delayed by one year to December 1, 2016. Otherwise, the information below remains correct.

Original Post: Many of you know that six months from now, as of December 1, 2015, any restaurant or “similar retail food establishments” (SRFEs) that are part of a chain with 20 or more locations must comply with the new menu labeling regulations. These regulations require that calorie content be displayed along with pricing on all menus and menu boards for standard menu items as well as on any “food on display” as in restaurants that allow the customer to pick and choose from a range of ingredients such as sandwich or burrito fillings as they direct the assembly of their meal. Additional nutrition information (fat, carbohydrate, protein, cholesterol, sodium, etc.) must be available upon request. Similar regulations are also coming into effect for vending machines.

FDA wrote these regulations as a result of the passage of the Patient Protection and Affordable Care Act of 2010. The regulations identify the businesses subject to these rules as

  1. Retail establishments that sell “restaurant type food” that is meant to be eaten immediately or taken away for immediate consumption. This includes concession stands, self-serve salad or hot food bars in grocery stores and all kinds of cafes serving food.
  2. They are part of a chain with 20 or more fixed locations (food trucks do not count).
  3. The covered businesses do business under the same name or as part of the same parent entity, including slight variations in the name.
  4. They offer substantially the same menu items (even with name variations) that use the same general recipe and are prepared in substantially the same way with substantially the same ingredients. It is important to note that restaurants and SRFEs do not have to provide calorie/nutrition information on items that the patron customizes or for daily specials and condiments.

One of the most interesting requirements of the regulation is that alcoholic beverages that appear on a menu or menu board are included even though they are not otherwise subject to calorie labeling. Beers and other alcoholic beverages may voluntarily list nutritional information on their labels but I have been told by industry insiders many brewers do not even accurately know the amount of alcohol in their products let alone what the calorie content is. (FYI alcohol provides 7 calories per gram—almost as much as fat.).

It is also interesting that states or other localities (cities, counties) may petition the FDA to be exempt from the Federal preemption to their local menu labeling regulations. Some localities require menu labeling even for establishments with fewer than 20 locations. In a recent webinar (March 2015) on the topic FDA noted that they had already received a petition for exemption from preemption from the City of Philadelphia. The regulations also allow for petitions from companies with fewer than 20 that wish to be covered under the regulations and the accompanying inspections of their data. The voluntary registration also allows the restaurants to be subject to FDA’s regulations rather than to local menu labeling regulations.

Speaking of data, the regulations require that the nutrition information provided be accurate. They also require a statement certifying that the information contained in the nutrient analysis is complete and accurate The statement must be signed and dated by a “responsible individual” that is employed at the restaurant (or SRFE), corporate headquarters or parent entity. The regulations also require a statement signed and dated by a “responsible individual” employed at the restaurant certifying that the restaurant has taken reasonable steps to ensure that the preparation and amount of food provided conforms to the factors used to determine the nutritional information. In the case of violations of the requirement to be accurate, the FD&C Act along with the Park Doctrine allow FDA to take enforcement action against the signers of those statements. How’s that for added pressure for restaurant managers?

The nutritional data can be obtained from nutrient databases, cookbooks, ingredient nutrition facts labels, lab analysis or a combination of these. Based on my experience working in the food industry, it will be important to have this data checked and double checked. I also recommend carrying out laboratory analysis on at least a sampling of menu items to check that cookbook and database values enabled accurate calculations.

This brief post cannot begin to touch upon all the requirements and interpretations of the rule in the 104 page Federal Register Notice that was published December 1, 2014 so contact us with any questions you have on the topic.

FDA Update Purchasing Controls

I attended a meeting with FDA staff from the Denver District Office in November of 2014.  The meeting was an annual update from FDA addressed to the members of the Rocky Mountain Regulatory Affairs Society.  Since most of the members work with medical devices, the speakers from FDA focused on that industry sector and in particular talked about Purchasing Control Regulations since failure to comply with them results in a large number of failed inspections, warning letters and product recalls each year. The term “Purchasing Controls” is only used in the regulations for medical devices but the language of these regulations are informative for dietary supplement, food and cosmetic companies as well.

The regulations covering good manufacturing practices (GMPs) for dietary supplements commonly use the phrase, “ensure that the [product, components, labels and packaging] are consistent with your purchase order”.  The GMP regulations for foods and the GMP guidance for cosmetics both refer to specifications for ingredients.  Since it is impossible to consistently make quality products unless you have ingredients of consistent quality, it is imperative that your purchasing department have detailed information about the requirements for each ingredient or component used in your product.  In other words, purchasing needs detailed ingredient/component specifications.

Let’s take a brief look at the medical device purchasing control regulations to learn more:

21 CFR 820.50(b) states, “Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services…”

This could mean that the herbs you purchase must be accompanied by chromatograms that document the amounts of key phytochemical components.  It may mean that you must list a range for the required viscosity of certain oils to ensure that your cosmetic will have the right thickness. In the case of a food ingredient such as cayenne pepper, it may be important to define the acceptable Scoville Heat Units so that the final product will live up to your label claims of mild, medium and hellfire.

21 CFR 820.50(b) continues, “Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.”

This is a very important consideration for companies that are using contract manufacturers.  Your contract with your manufacturer should explicitly define not only which ingredients may be substituted but what substitutions are acceptable and that you are to be notified when the manufacturer finds it necessary to make any change to your product.
As specified in the device regulation, the best way to ensure that you always get quality ingredients and services is to first set requirements/specifications for your ingredients, components and service providers and then evaluate their ability to meet your requirements before you contract with them. If your company has purchasing controls that are followed and followed up on by the quality and manufacturing departments it is far more likely that the products, components, labels, etc. will be consistent with your purchase order and meet your specifications.
That, in turn, will please your customers!
I started my consulting business in 2001 after 15 years working in FDA-regulated industry.  Since that time my colleagues and I have served hundreds of dietary supplement, food, cosmetic and device companies from around the globe.  My colleagues and I are ready to help you determine which FDA regulations apply to your product and what you need to do to comply with them.


Updates for Food & Dietary Supplement Companies

I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) Food and Nutrition webinar.  The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements.  Most of the presenters that talked about labeling regulations focused on the proposed changes to the nutrition facts box, which we highlighted several months ago (http://tinyurl.com/me9rekg). I want to share with you a few things I found interesting.

I had heard some rumblings that the yet to be published final rule would very closely resemble the proposed rule and after listening to the FDA staff presentations, I expect that to be true.  As I read the proposed rule when it was first published I focused on the proposed changes and not FDA’s rationale for the various proposals.  The webinar presentations highlighted the rationale behind the proposals, convincing me that the agency is confident of the merits of the proposed rule and that much of it will remain intact in the final rule. For example, industry groups submitted comments on the proposed rule objecting to the proposal to declare total sugars and added sugars.  However, the proposal is rooted in the 2010 Dietary Guidelines for Americans that recommends reducing the intake of calories from solid fats and added sugars.  The presenter, Crystal R. Rivers of FDA’s Nutrition Programs in the Office of Nutrition, Labeling and Dietary Supplements, stated that on average, Americans get 16% of their total calories from added sugars and noted that labeling added sugars would encourage food manufacturers to reduce added sugars and help Americans to identify products with added sugars; compare products for amount of “added sugars” and reduce extra calories consumed by Americans. Another speaker, Cherisa Henderson, Nutrition Programs Staff, Office of Nutrition, Labeling and Dietary Supplements, talked about the proposal for dual nutrition labeling that would list the calories and nutrients both a single serving and in the entire package for products that “can reasonably be consumed in a single-eating occasion”.   The proposal would mean that any product with 4 or fewer servings per container would list the nutrition facts per serving and for the whole container. Ms. Henderson presented findings from consumer studies that demonstrated that consumers were more aware of serving sizes and calories when both sets of information were presented.  FDA prides itself on being a science based organization and based on the data presented, I expect that FDA’s proposal to list the nutrition data for entire packages to be in the final rule.
The FDA presenters were repeatedly asked when various final rules on Food Safety Modernization and nutrition labeling would be published.  None of the speakers would venture a guess and one even said, “Hopefully in my lifetime.”  We’ll let you know as soon as we know.

What’s not to like on Facebook? FDA’s View

Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19th warning letter to mention Facebook.  Some of these letters from the past three years have also cited Twitter and Tumblr as sources of violative claims.  While these letters were primarily directed at dietary supplement companies, food, cosmetic and even drug companies can easily run afoul of FDA regulations on social media sites.

The most recent warning letter to mention Facebook, which was sent to Zarbee’s Inc. of Draper, UT. not only cites the company’s own Facebook postings but notes that “Zarbees “liked” the following comment…” and goes on to quote from customer posts noting how well the products worked for coughs, insomnia and other ailments. In 2012 FDA had disliked the like that AMARC Enterprises, Inc. of El Cajon, CA gave to one of its customer’s posts about using their dietary supplement product for cancer.

The concept that testimonials presented on company websites and in other marketing materials are claims that are subject to regulatory scrutiny is not new.. In 2009 the Federal Trade Commission (FTC) issued a guidance document on testimonials and endorsements in advertising http://tinyurl.com/kdxnoqa  noting that they, like all marketing claims must be truthful, not misleading and supported by data.  FDA expands requirements for endorsements and testimonials to require that they comply with regulations on allowable claims.
All companies like positive comments and testimonials from customers. While consumer comments are not a new phenomenon, the consumer’s ability to publish their comments to the world on social media sites is new. So what is a company to do when a happy customer posts something that makes a claim that violates the regulations governing the compliant marking of their product?
Several of the Facebook warning letters included this note from FDA,
“We advise you review all the information on your websites, including testimonials, social media websites (e.g., Facebook and Twitter), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the FD&C Act. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.”
The last sentence makes it clear: Companies must closely monitor their social media for compliance with FDA regulations. If a post about a product goes beyond what is allowed by regulation, the posts must be deleted or edited to become compliant. If you are a dietary supplement company and a customer posts that your product cured an ailment or relieved pain; your product just became an unapproved new drug subject to FDA enforcement. If you are a cosmetic company and a happy customer states that your oil healed their skin condition, that oil just became an unapproved new drug subject to FDA enforcement. If you are selling an OTC drug and a customer posts about a use that is not covered in the approved labeling of your product, you are also subject to FDA enforcement action.

About the Author

About the Author

Evelyn has worked in regulatory affairs and product development for FDA-regulated products since 1997. In addition to her experience with dietary supplement, pharmaceutical, food, pet food and cosmetic products, she authored and edited chapters on dietary supplement, cosmetic and food regulations in Fundamentals of US Regulatory Affairs, 8th Edition.

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