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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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.
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 [...]
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 [...]
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.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 [...]
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 [...]
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 [...]
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. [...]
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 [...]
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 [...]
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. [...]
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: https://fdasimplified.com/blog/ Updated March 9, 2016: FDA announced that they will delay enforcement of menu labeling [...]
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 [...]
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 [...]
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 [...]
Recently the trade publication, Cosmetics Design, published two articles that caught my eye. One discussed FDA’s Import Alert on cosmetics labeled as anti-aging creams (http://tinyurl.com/n5xq2e6). The import alert is FDA’s guidance to their staff that inspect imported products. FDA lists the reason for the alert [...]