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 …
As readers of this blog may recall, last year on July 29, 2016, the National Bioengineered Food Disclosure Standard Act (“the Act”) was signed into law. This Act directs the Agricultural Marketing Service of the USDA to develop “a national mandatory bioengineered food disclosure standard” …
Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or successfully challenging FDA’s denial of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our …
Facing a lawsuit from the food industry and pressure from FDA, the City of New York agreed on Friday to not enforce menu labeling requirements against many restaurants, convenience stores, and other retail food establishments until May 7, 2018. The move aligns the City’s enforcement …
In November 2013, the Food Safety Inspection Service (FSIS) of the USDA issued a regulation expanding the circumstances in which labels were eligible for generic label approval (see our previous post here). Under that regulation, meat and poultry labels need not be submitted for label …
In a blog posting that cited the agency’s goal of educating while regulating, FDA released the Food Safety Plan Builder (FSPB) – a software program “designed to assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities …
In June 2017, two consumer advocacy organizations, the Center for Science in the Public Interest and the National Consumer League (“Plaintiffs”), sued FDA challenging the Agency’s interim final rule extending the compliance date for menu labeling and request for comments (see our previous post here). …
Natural claims remain fodder for litigation. Although FDA’s December 2015 request for comments certainly impacted the filing of lawsuits (as discussed in our previous post), new cases continue to be filed, and plaintiffs bring up new arguments against natural claims. One relatively recent trend sees plaintiffs …
