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
As the U.S. population ages, demand for Botulinum Toxin (“Botox”) continues to rise. The American Society of Plastic Surgeons reported that in 2022, Botox was the most commonly performed minimally invasive procedure, with 7.2...more
Last week’s jury convictions of Safe Chain Solutions’ co-owners in United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.) coupled with US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enforcement...more
On July 1, 2025, Florida’s new “Stem Cell Therapy” legislation became effective, adding Fla.Stat. § 458.3245 to Florida’s Medical Practices statutes and § 459.0127 to Florida’s Osteopathic Medicine statutes. Florida’s new...more
The US Food and Drug Administration (FDA) recently issued warning letters to more than 40 compounding pharmacies, demanding that they cease certain advertising practices for a variety of compounded drug products, including...more
In September 2025, the U.S. Food and Drug Administration (FDA) issued more than 50 warning letters to U.S. and international companies that compound or manufacture glucagon-like peptides (GLP-1) semaglutide and...more
Key Takeaways - FDA has launched an aggressive new crackdown on direct-to-consumer (DTC) drug advertising, issuing nearly 100 cease-and-desist letters and thousands of notices — many targeting compounding pharmacies,...more
On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer...more
FDA’s two-part strategy for reining in DTC advertisements involves greater enforcement combined with rulemaking to require more risk information in broadcast advertisements....more
Channeling Tracy Chapman’s 1988 hit, the Food and Drug Administration and the Department of Health & Human Services (“HHS”) are “talkin’ bout a revolution” in drug promotion. While many have described the latest actions as...more
On September 9, 2025, the U.S. Food and Drug Administration (FDA) announced it is launching a targeted initiative to combat deceptive drug advertising. According to the announcement, the FDA sent thousands of letters warning...more
In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...more
The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more
On July 29, 2025, the U.S. Food and Drug Administration (FDA) announced its recommendation to schedule 7-hydroxymitragynine (7-OH)—a concentrated byproduct of the kratom plant—under the Controlled Substances Act (CSA)....more
In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more
FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
The Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets...more
On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit...more
On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and...more
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