Federal Food Drug and Cosmetic Act
FDA Holds Public Meeting Exploring Scope of Dietary Supplement Ingredients
On March 27, the U.S. Food and Drug Administration (FDA) hosted a public meeting on the scope of dietary supplement ingredients. The event was held in-person from 9 a.m. to 3 p.m. EST at Wiley Auditorium, 5001 Campus Drive in College Park, MD and virtually. FDA’s Office of Dietary Supplement Programs (ODSP) invited stakeholders to ...
FDA Issues Letter on DSHEA Disclaimer Amendment, Industry Responds
On Dec. 11, the U.S. Food and Drug Administration (FDA) published a letter to the dietary supplement industry regarding the agency’s labeling regulations that govern the placement of the disclaimer on dietary supplements labels under the Federal Food, Drug, and Cosmetic Act (FD&C) and Dietary Supplement Health and Education Act of 1994 (DSHEA). The agency ...
CRN Calls Out New York Supplement Law in DOJ Filing
On Sept. 15, the Council for Responsible Nutrition (CRN) submitted a new filing to the Department of Justice (DOJ) regarding the New York State supplement law. On Oct. 25, 2023, New York Governor Kathy Hochul signed Assembly Bill A5610-D/Senate Bill S5823-C, banning the sale of weight-loss and sports nutrition supplements to minors. In its filing, ...
FDA Approves Three Natural Food Colors
On May 9, the U.S. Food and Drug Administration (FDA) announced it granted three new color additive petitions that will expand the palette of available colors from natural sources that can be used safely in food. The FDA is in line with the U.S. Department of Health and Human Services (HHS)’s plan to phase out ...
Trade Associations Respond to Section 232 Investigation
In April, the U.S. Department of Commerce began an investigation under Section 232 of the Trade Expansion Act of 1962 to determine the effects on the national security of imports of pharmaceuticals, pharmaceutical ingredients and derivative products. After the investigation is complete, President Donald Trump will decide what action to take which could include tariffs. ...
CRN Challenges Preliminary Injunction on New York Age-Restriction Lawsuit
The Council for Responsible Nutrition (CRN) filed an appellate brief in the U.S. Court of Appeals for the Second Circuit challenging a New York federal court’s denial of CRN’s preliminary injunction against the age-restriction law on muscle building and weight loss supplements. The law was signed in October 2023 and went into effect in ...
Amazon Receives FDA Warning Letter Over Tainted “Supplement” Products
On Dec. 20, the e-commerce platform Amazon received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the distribution of products in violation of the Federal Food, Drug and Cosmetic Act. An FDA investigation revealed that various products labeled as “energy-enhancing supplements” or “dietary supplements” on Amazon contain undisclosed and potentially dangerous ...
NPA Argues New York Supplements Ban is Unconstitutional
On Dec. 5, 2023, the Natural Productions Association (NPA) filed a complaint in the U.S. District Court for the Eastern District of New York, asserting the recent supplements ban in New York is unconstitutional. The law bans the sale of supplements to anyone under 18 years of age and in certain situations may require a ...
FDA Takes Action Against Products Claiming to Treat Disease, Seeks to Strengthen Oversight
On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a ...
FDA Takes Action Against 14 Companies For Selling Illegal Cancer Treatments
On April 25, the U.S. Food and Drug Administration (FDA) posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms. “Consumers should not use ...
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