Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Podcast: Federal and State Cannabis Rules Are Moving in Different Directions - Diagnosing Health Care
AFSA Extra Credit Podcast: Navigating Advertising During COVID-19
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more
In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more
The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters on July 16, 2024, to five companies for illegally selling and introducing into the market copycat food products...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
When it comes to dietary supplement class actions, there’s a little less class and a lot more action. In this episode of Speaking of Litigation, Epstein Becker Green litigators Teddy McCormick, Jack Wenik, and Robert Lufrano...more
On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its...more
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical...more
What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more
The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more
Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more
Businesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal Trade Commission (FTC) released at the end of December...more
On November 16, 2022, the United States Food and Drug Administration (FDA) issued Warning Letters to five companies that market food and beverage products containing cannabidiol (CBD). FDA takes the position that the...more
On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC)...more
This week, the U.S. Food & Drug Administration (FDA) posted warning letters to five hemp companies for, in the words of the FDA, "illegally selling products containing cannabidiol (CBD)." The warning letters and additional...more
The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more
“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more
On May 13, the FDA issued a public warning regarding reports of accidental ingestion of food products containing tetrahydrocannabinol (THC) by children. The FDA warned that edible products containing THC “can be easily...more
The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD). In addition to the various violations...more