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 …
As we previously reported, in 2013, the Food Safety and Inspection Service (FSIS) of the USDA updated its regulations to expand the type of labels that can be generically approved, i.e., are not subject to FSIS pre-market review and approval. Under the revised regulations, only …
This case caught our eye for a few reasons, none of which directly relates to the business activities of most of our blog readers but may relate to their happy-hours activities. As most know, FDA regulates foods, including beverages, but Congress delegated most of the …
On August 13, 2019, FDA announced that it has issued the first Warning Letter (WL) for a violation of the requirements for a Foreign Supplier Verification Program (FSVP). This is a good reminder for importers that they must have a FSVP for each food for …
The Food Allergen Labeling Consumer Protection Act (FACLPA) amended the FDC Act to require that foods containing a “major food allergen,” defined as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans, must declare the food source of the allergen using its common or …
As we discussed previously, FDA’s 2016 final regulation updating nutrition labeling requirements included a requirement to declare added sugars. This requirement created quite a stir among several segments of the industry. Among others, the honey and maple syrup manufacturers pushed back on the requirement to …
In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government. Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …
