At FDA Compliance Simplified, we focus on Food and Drug Administration regulations that cover a wide variety of products used in and on the bodies of humans and animals. However, no product is regulated by only one governing authority. At the federal level, all products [...]
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 [...]
Update February 17, 2022: Please use this link to view the UNPA webinar "In the BEginning"... Dietary Supplements Supply Chain Starts with Ag mentioned in the original post. The webinar opens with a general introduction and the presentations begin as indicated below. Good Agricultural and [...]
Very few vegan protein products found in the U.S. market include corrected protein daily values in their nutrition or supplement facts boxes.
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 [...]
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 [...]
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. [...]
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 [...]
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 [...]
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 information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]
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 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” [...]