Major Cosmetic Regulation Update March 27, 2023 - FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program FDA issued an update today stating that they are no longer accepting voluntary cosmetic establishment registration and that information in the VCRP will not be transferred [...]
The FDA has proposed a new definition of healthy and related terms for the purpose of food labeling. The current definition became effective in 1994 and focuses on limited levels of total fat, saturated fat, cholesterol, and sodium to establish a food as “healthy”. Under [...]
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 [...]
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 [...]
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 [...]
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. [...]
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. [...]
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 [...]
Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc, presented information on packaging, labeling, and compliance. I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that [...]
I know the name of this blog is FDA Update but my team provides USDA regulatory help from time to time and that agency has caught my attention today. My favorite blog, FDA Law Blog by Hyman Phelps & McNamara posted about the new USDA [...]
The FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements. The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA [...]
Once again I’d like to share information about FDA’s recent warning letters. This time, several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling. The first involves the use [...]
I wanted to share with you another interesting post by Kurt Karst at FDALawBlog.com. This one discusses a recent court ruling on patents that has implications for FDA regulated industries. The decision, in part, states “Whoever marks upon, or affixes to, or uses in advertising [...]
As 2009 draws to a close FDA continues their ramped up enforcement activities based upon new guidance documents and letters to industry. A draft guidance document published on December 7, 2009 lets us know that FDA is eyeing functional beverages and liquid dietary supplements for [...]
I will be speaking at the Nutritional Genomics Conference at California State Polytechnic University, Pomona CA, November 12. What is nutritional genomics? It is the study of the impact of diet on health through gene expression. Just as some genetic markers can indicate a person’s [...]
Everyone is aware of today’s trend towards natural foods. Many manufacturers now substitute refined sugar with other cane products including “evaporated cane juice”. Yesterday the FDA issued a new guidance on labeling foods containing this ingredient. The guidance states that in FDA’s view “evaporated cane juice” [...]