Just a few days before the presidential inauguration, FDA published a revised draft guidance on control of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods. The significance of the guidance to the food sector is difficult to overstate. Since FDA published the original draft guidance in February …
As we previously reported, FDA issued final rules updating the nutrition labeling regulations, 21 C.F.R. §§ 101.9 and 101.36, and the serving size regulation, 21 C.F.R. § 101.12, on May 27, 2016. Despite the rather extensive preamble, the final rules left many questions unanswered. FDA …
The meaning of product dating on foods and why companies use it (are they required to do so?) is a frequent question. With the exception of infant formula, which by regulation must include product dating, there are no federal regulations requiring product dating. (States may …
This week, FDA announced (here and here) that it is making available adverse event information for foods (including dietary supplements, food additives, and color additives) and cosmetics the Agency has received through its Center for Food Safety and Nutrition (CFSAN) Adverse Event Reporting System (CAERS). CAERS …
There has been a spate of recent news articles about the potential use of the Congressional Review Act (CRA) to overturn final rules issued toward the end of the Obama Administration. That prompted us to see which of FDA’s recently issued final rules might be …
On December 1, 2016, FSIS announced its proposal to amend the nutrition labeling regulations for meat and poultry. The proposed regulations contain few surprises and appear to be identical to FDA’s regulations. In addition, FSIS proposes to remove minor existing differences, such as the option …
By Riëtte van Laack – As we previously reported, in May 2016, FDA published a final rule amending the nutrition labeling regulations. Among other things, FDA defined dietary fiber as non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic …
By Riëtte van Laack – As previously reported, on May 27, 2016, FDA published the final rules regarding nutrition labeling and serving sizes. The amended regulations came into effect on July 26, 2016 and the compliance date is July 26, 2018 for all manufacturers, except for …
By Ricardo Carvajal – FDA recently announced the issuance of the 7th edition of the Agency's Questions and Answers Regarding Food Facility Registration. The latest edition includes nearly 60 new Q&As on a variety of registration-related topics, including: Biennial registration renewal – A facility’s registration must be renewed in …
That will be among several food policy topics discussed this Friday at a Food and Drug Law Journal Symposium titled Law and Food Systems: Institutional Pathways Toward a New Paradigm? Proposals for a single food agency have bubbled up over the years, and the impending election …
By Ricardo Carvajal – FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled. A disclosure requirement is included in four of the FSMA rules, namely the preventive controls rule for …
By Riëtte van Laack – A couple of weeks ago, the Food Safety Inspection Service of the USDA (FSIS) announced the availability of an updated compliance guideline regarding animal-raising claims. The previous guideline dated from 2002. Traditionally, the FSIS has interpreted the Federal Meat Inspection Act (“FMIA”) …
By Riëtte van Laack – On Sept. 27, 2016, FDA announced the availability of several documents regarding the “healthy” claim on foods. Under the current regulation, the term “healthy” (or similar terms) – when used with an explicit or implicit claim or statement about a nutrient in …
By Ricardo Carvajal – FDA’s issuance of a draft guidance for industry titled Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling marks the first issuance of a guidance that addresses structure/function (SF) claim substantiation for a conventional food. As FDA explains in the guidance, …
By Wes Siegner – After 20 years of marketing vinpocetine, and accepting without objection the filing of 5 new dietary ingredient notifications (NDINs), FDA has “tentatively concluded” that vinpocetine is an illegal dietary ingredient for two reasons: 1) it does not fit within the statutory list …
