FDA recently published a guidance document reminding proponents of GRAS status of their obligations under the FFDCA and its implementing regulations (which we refer to as the “Reminder Guidance,” available here). FDA also published a draft guidance document setting out best practices for convening a …
On November 14, 2017, the USDA Agricultural Marketing Service (AMS) announced that it will further delay and reconsider the Organic Livestock and Poultry Practices (OLPP) regulations. This is not the first delay of the effective date for the OLPP regulations. The OLPP final rule amends the …
Small business owners and managers of chain restaurants subject to FDA’s menu labeling rule remain confused as to the criminality of adding an extra dollop of ketchup to a hamburger. One thing is now clear — the only way to stop FDA’s years of wasteful …
As we previously reported, the integrity of imported organic products has been questioned. International supply chains are becoming increasingly “complex” and frequently involve a number of businesses which may be certified under different programs. Foreign organic operations are subject to the same requirements as domestic organic …
As we previously reported, the integrity of imported organic products has been questioned. International supply chains are becoming increasingly “complex” and frequently involve a number of businesses which may be certified under different programs. Foreign organic operations are subject to the same requirements as domestic organic …
I understand if this title made you think for a minute, did I read that right? You probably did. Another Citizen Petition regarding pyridoxamine was filed. This one asks that FDA essentially undo what it did in 2009. Pyridoxamine is a form of vitamin B6. In July …
In January 2017, the Federal Trade Commission (FTC) and New York Attorney General (collectively, “Plaintiffs”) announced a lawsuit charging that Quincy Bioscience, related entities, and two individuals (collectively “Defendants”), the marketers of the dietary supplement Prevagen, made false and unsubstantiated claims that Prevagen improved memory. …
On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on FDA’s domestic food facility inspections. The “key takeaway”: “FDA should do more to ensure that the food supply is safe by taking swift and …
Occasionally we peruse FDA’s inventory of food and color additive petitions under review as a reminder of what might lie on the horizon. The current list includes some that have gotten considerable attention, and others that have largely flown below radar. Among the latter, one stands …
Earlier this year, a front page story in the Washington Post spotlighted several cases of fraudulent organic certificates, raising questions about organic certification practices overseas. Now, a new report by USDA’s Inspector General (IG) report confirms those doubts. The IG reviewed the process used by the …
In what may appear to the uninitiated as a step to cooperate with industry on FDA development of a rational policy for new dietary ingredients (NDIs), FDA is holding a public meeting on October 3 with the goal of developing an authoritative list of old …
As readers of this blog know, in 2016 FDA published a final rule amending the nutrition labeling regulations. Although the industry requested more time to come into compliance with that final rule (which requires revision of virtually every food label), FDA set the compliance date …
Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack will be presenting on “Food Safety: Ingredient Preclearance/Intentional Components of Food” and on “Food Labeling: General Requirements” at the Introduction to U.S. Food Law and Regulation course, sponsored by the Food and Drug Law Institute on October 11-12, in Washington DC. …
Two public interest groups that are suing FDA over the Agency’s extension of the menu labeling compliance date have agreed to stay the litigation if FDA issues additional guidance before the end of the year and publicly confirms that it will not provide another extension. As …
As part of the development of mandatory disclosure requirements for bioengineered foods, USDA is required to complete and report on a study to identify potential technological challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital links, such …
