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 …
FTC and FDA issued a blog posting co-authored by senior officials that encourages the public to report potentially violative dietary supplements to one or both agencies. The posting lists the following as circumstances that should prompt a report: “You bought a dietary supplement that didn’t work …
Earlier this week, USDA/AMS posted “Proposed Rule Questions Under Consideration” on its web page dedicated to the establishment of a National Bioengineered Food Disclosure Standard. The posting asks for comment on 30 questions relating to different aspects of what such a standard might entail. Most of …
A coalition of consumer advocates filed a lawsuit challenging FDA’s final rule that formally established the GRAS notification system. The complaint alleges that the rule “unlawfully subdelegates statutory authority to private parties,” that the “secret GRAS system is contrary to the FDCA,” and that the “criteria for …
A citizen petition (Docket No. FDA-2017-P-2626) recently submitted to FDA asks the agency to exercise enforcement discretion with respect to the regulatory prohibition on interstate shipments of milk products that have not been pasteurized (21 CFR 1240.61). There have been previous petitions asking FDA to allow the …
The Interagency Food Safety Analytics Collaboration (IFSAC) has issued a strategic plan for the 5-year period beginning in 2017. This is the second such plan issued by IFSAC, a collaboration between FDA, USDA/FSIS, and CDC that aims “to improve coordination of federal food safety analytic efforts …
On Monday, March 27, FDA and the Society of Toxicology (SOT) will present a colloquium (chaired by Bernadene A. Magnuson, PhD, Health Science Consultants, Inc., and Sabine Francke, DVM, PhD, CFSAN FDA) on Considerations for the Determination of Adversity in Food Chemical Safety Evaluations, the …
With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue. Although the issue …
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 …
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 …
By Ricardo Carvajal & John R. Fleder – On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella. Until the order …
By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues. Although nominally a veterinary drug case, …
By Ricardo Carvajal & John R. Fleder – In Federal Trade Commission v. Medlab, Inc., the United States District Court for the Northern District of California granted summary judgment on April 21, 2009, to the FTC in an action against a marketer of weight loss products, which …
By Ricardo Carvajal & John R. Fleder – On April 20, 2009, the U.S. Supreme Court let stand the Third Circuit’s decision in Fellner v. Tri-Union Seafoods. As we discussed in a prior posting, Fellner’s lawsuit contends that Tri-Union is guilty of negligence under New Jersey …
By Ricardo Carvajal & John R. Fleder – On April 17, 2009, DOJ’s Office of Information Policy (“OIP”) issued guidance to federal agencies on President Obama’s FOIA Memorandum of January 21st and Attorney General (“AG”) Holder’s subsequent FOIA March 19th guidelines. The President’s FOIA memorandum directed …
