Hindsight and 2020
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
Are you CBD curious?
We are based in Colorado, a state that has legalized both medicinal and recreational marijuana use. Colorado's industrial hemp farming program was initiated through legislation adopted in 2013. On the national scene, passage of the 2018 Agriculture Improvement Act removed hemp from the controlled substance [...]
There is Nothing Simple About Importing Products into the United States
Importing consumer products such as foods, pet foods, dietary supplements, cosmetics and over the counter drugs is very complicated. Not only must FDA regulations be met, so must those of Customs and Border Protection. This post focuses on Customs side of the issue and links to a post that focuses on the related FDA regulations.
Importing FDA Regulated Products into the United States
Successful launch of a product requires more than a good marketing plan. It is also important to know whether your product is subject to special regulations from various government agencies. While the Federal Trade Commission, Consumer Product Safety Commission and even the Environmental Protection Agency [...]
Happy 2019 & Year-End News from 2018
New rules on bioengineered food labeling along with updates to food labeling and the farm bill to end 2018.
Highlights of the National Bioengineered Food Disclosure Standard
On December 21, 2018 USDA published their final rule on bioengineered food disclosure labeling, commonly known as “GMO labeling”. The rule adheres to the stipulations in the enabling legislation and is based on the current science but may not satisfy consumers.
Activist FDA?
The Food and Drug Administration (FDA) has historically worked in a reactionary manner. The original Pure Food and Drugs Act was passed by Congress on June 30, 1906 in response to studies that showed deleterious effects of food additives that were already in use in [...]
2018 Food and Dietary Supplement Facility Registration and Renewal
All food, pet food and dietary supplement facility registrations must be renewed between October 1st and December 31st of even-numbered years. 2018 is a renewal year and prior to the renewal period FDA published two guidance documents on facility registration (guidance and supplemental guidance). All [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Lead, Heavy Metals and Microbeads in Cosmetics
FDA issues a guidance on lead levels in lip and other cosmetic products. Coming up this year the Microbead-Free Waters Act comes into effect.
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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. [...]