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. The import alert is FDA’s guidance to their staff that inspect imported products. FDA lists the reason for the alert as, [...]
In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. I will discuss the guidances in detail below but will start with the parts that are particularly interesting: First, [...]
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 [...]
On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes. Products [...]
FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods. They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary [...]
On November 7, 2013 FDA published a ‘Request for Comments and for Scientific Data and Information’ regarding the use of partially hydrogenated oils in foods. The FDA has reviewed the scientific data and has determined that there is no longer scientific consensus on the safety [...]
The trade magazine, Natural Products Insider (NPI), recently published a slide show entitled, “Formulating Successful Products in Six Steps”. While the presentation focuses on the development of dietary supplement products, similar considerations are helpful for cosmetic and food products as well. The steps were written [...]
The weather is changing as a new season begins and it’s time to review recent FDA activity in the cosmetic sector. In June 2013 FDA published a draft guidance revising the Good Manufacturing Practices for cosmetics. While these GMPs remain voluntary, FDA Agents will use [...]
Earlier this summer the US National Institutes of Health (NIH) launched the Dietary Supplement Label Database (DSLD). This website provides label information from supplement products marketed in the US. The database is easily searchable by ingredient, product name and company name and provides a summary [...]
It has been a while since we have sent any updates for our dietary supplement clients. The FDA has remained busy inspecting supplement companies and writing many, many warning letters. The regulations for dietary supplement Good Manufacturing Practices (GMPs) include a section on quality control [...]