The Daily Intake

Legal and Regulatory updates for the food and supplement industry

Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” applies to voluntary recalls of all products subject to FDA’s jurisdiction, including food, drug, and devices intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco…
The Washington State legislature has passed a bill that restricts the marketing of degradability products, including food packaging and food service ware. The bill, HB 1569, was passed by the senate on April 15 and signed by the Speaker of the House on April 18. HB 1569 specifies that products labeled as compostable must either be comprised only of wood or fiber-based substrate OR must meet the American Society of Testing and Materials (ASTM)…
In a proposed rule published on April 17, 2019, FSIS proposes to amend its labeling regulations to remove provisions that require packages of meat or poultry products that contain at least one pound or one pint, but less than four pounds or one gallon, to express the net weight or net contents in two different units of measurement on the product label. 84 FR 15989. Currently, under 9 CFR 317.2(h)(5) and 381.121(c)(5), dual declaration…
On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.” The guidance announces FDA’s intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining “Calories” on the Nutrition…
FDA has accepted a qualified health claim petition submitted by Danone North America on the ability of yogurt to reduce the risk of type 2 diabetes.  FDA is accepting comments on the petition until June 11, 2019. Danone is requesting FDA’s consideration of the following qualified claims: (1) “Eating yogurt regularly may reduce the risk of type 2 diabetes.  FDA has concluded there is limited information supporting this claim;” or (2) “Eating yogurt regularly may…
As our readers may remember, earlier this year the FDA announced a plan for modernizing and strengthening dietary supplement regulation and oversight. Under the plan, the FDA stated their intent to preserve consumers’ access to lawful supplements, while also upholding the Agency’s obligation to protect the public from unsafe and unlawful products. And as part of those efforts, on April 16, the FDA Deputy Commissioner for Food Policy and Response, Frank Yiannas, announced a…
As previously reported on this blog, FDA’s Nutrition Innovation Strategy (NIS) is intended to improve public health via education regarding, and encouraging innovation in, the use of nutrition to promote health. The NIS was initiated under the leadership of FDA Commissioner Scott Gottlieb. Areas of emphasis are modernizing the approach to label claims, modernizing standards of identity, modernizing ingredient labels, and the use of healthy symbols. FDA held a public meeting on July 26, 2018…
As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) have issued a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here).  The agreement provides helpful answers regarding many regulatory aspects of the cell-cultured food industry,…
The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug, and Cosmetic Act to create the current regulatory framework for dietary supplements.  At the time the law was passed, there were roughly 4,000 dietary supplements on the market in the United States.  The number of dietary supplements on the market is now estimated to be between 50,000 and 80,000.  Under DSHEA, producers of dietary supplements with new dietary ingredients must provide…
On February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). Under the proposed rule, hog slaughter plants may voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit animals and identifying defects before FSIS inspection. FSIS inspectors who currently perform this function would be moved to other areas…