On February 13, the FDA released the final installment of guidance to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA …
On January 24, 2020, the Food Safety Inspection Service (FSIS) announced that it had received a Petition by Marler Clark LLP, on behalf of several individuals (victims of food poisoning from Salmonella containing meat or poultry products) and three consumer advocacy organizations (Food & Water …
Yesterday’s announcement by the U.S. Federal Trade Commission (“FTC”) that it was issuing so-called “6(b) Orders” to heavyweights in the tech industry at first glance, might not seem relevant to most readers of the blog, but it is. As the announcement reminds us, “Section 6(b) …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Karin Moore has become its newest Director. Drawing on her years of experience as a former general counsel to leading trade associations, Karin is an industry expert and thought leader in the areas of …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
In a letter dated January 9, 2020, the Center for Science in the Public Interest (CSPI) asked FDA to take immediate enforcement action to prevent what CSPI argues are misleading and unauthorized implied “low sugar” and “reduced sugar” claims, such as “lightly sweetened” and “less …
Lystn, LLC (also doing business as Answers Pet Food; Lystn) is a pet food manufacturer of raw pet food. Lystn has been in a battle with FDA and the Colorado Department of Agriculture (CDA) since 2018 when CDA collected a sample of Lystn’s Straight Beef …
As we previously reported, in 2016, FDA issued significantly revised nutrition labeling regulations for foods and dietary supplements. The compliance date is January 1, 2020 for all entities except those with less than 10 million dollars in annual sales. The updated regulations resulted in many questions …
In ongoing litigation over the FDA’s approval of AquAdvantage bioengineered salmon, the District Court for the Northern District of California issued an order upholding FDA’s authority to regulate as a new animal drug genetic material that is used to modify an animal (for background on …
On October 23, 2019, the U.S. Cattlemen Association (USCA) petitioned USDA regarding Made in USA and Product of USA and similar claims on beef. USCA explains that it is concerned that voluntary “Made in USA” labeling for beef products, without a clear definition of what constitutes …
Final rule regarding vending machine calorie labeling Almost 5 years ago, as part of nutrition labeling requirements under the ACA, FDA issued a final rule which requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending …
On October 8, 2019, the California Chamber of Commerce (CalChamber) filed a lawsuit in federal district court against the State of California requesting that the Court enjoin the State, its agents and private enforcers from requiring Prop. 65 warnings on foods that contain acrylamide. Plaintiff …
On August 29, 2019, the Center for Science and Public Interest (CSPI) and Consumer Reports (CR) submitted a Petition to the Food Safety and Inspection Service (FSIS) of USDA concerning FSIS labeling requirements for meat and poultry products, such as bacon, hot dogs, and pepperoni, …
On August 19, the Center for Food Safety (CFS) and Center for Environmental Health (CEH) filed suit against the FDA. According to the two consumer groups, FDA has failed to promulgate final regulations and complete actions by mandatory deadlines set by the Food Safety Modernization …
Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. The recent Supreme Court ruling in Kisor …
