On April 13, the Federal Trade Commission (“FTC” or “Commission”) issued a press release that it had sent letters to “almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims.” FTC indicates that the notices were sent to companies …
Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Though not …
On Dec. 20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). FTC staff prepared the new Guidance to update and replace Dietary Supplements: An Advertising Guide for Industry, issued in 1998 (“1998 Guidance”). The new Guidance provides the first update …
On December 23, 2022, when many of us were distracted by the cold weather, Congress passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act of 2023. FDORA includes, as subtitle E, the Modernization of Cosmetics Regulation …
On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. As we reported previously, here, and here, as a result of …
Early Nov. 2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the …
On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The healthy claim has been the topic of much discussion and challenged in consumer class actions. The term healthy, as an implied nutrient claim, was first …
As we previously reported, about two years ago, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (“Plaintiffs”) filed a complaint against USDA challenging USDA’s the final rule implementing the …
On September 9, 2022, FDA published two notices regarding draft guidance related to labeling of drug products: a notice on the publication of a draft guidance on the Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products and …
On August 5, the United States Department of Agriculture’s Agricultural Marketing Service (AMS) announced a proposal to amend the organic livestock and poultry production requirements by adding new provisions for livestock handling, transport for slaughter, and avian growing/living conditions, as well as provisions to clarify …
A couple of weeks ago, Senator Durbin and Representative DeLauro introduced the Food Safety Administration Act. The legislation would create the Food Safety Administration (FSA), a food safety agency that would incorporate FDA’s food safety and veterinary medicine centers and the Office of Regulatory Affairs’ …
Last month, the People for Ethical Treatment of Animals (PETA) submitted a petition to the Food Safety and Inspection Service of the U.S. Department of Agriculture (FSIS) requesting that FSIS initiate rulemaking to remove animal raising claims from the label approval process because, according to …
On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348). While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to …
Last month, the FTC announced and posted a prepublication of its proposed changes to its guides concerning the use of endorsements in advertising (Endorsement Guides). The Endorsement Guides date back several decades. Since the publication of the original Endorsement Guides in 1975, FTC has made several …
On Monday May 9, 2022, FDA issued an “update” announcing that it had sent 11 Warning Letters to companies that distributed dietary supplements alleged to be adulterated because one or more ingredients in the companies’ products contained an illegal dietary ingredient. (Two days later, one …
