FDA News

Spiking, the practice of secretly adding undeclared prescription drug ingredients to dietary supplements, is one of the FDA's most aggressive enforcement priorities in 2026. Recent recalls and public health alerts have named brands across the supplement industry, including Primal Herbs (undeclared sildenafil), GURU INC's Infla-650 capsules (hidden drug ingredients), and FAonline's ForeverMen capsules (undeclared prescription drugs). The reputational damage from a spiking alle

Infant formula importer Able Groupe, Inc. pleaded guilty in the U.S. District Court for the Northern District of Texas to importing food without providing prior notice to the FDA, with intent to defraud or mislead, and to smuggling goods into the United States. According to court documents, the company used false commodity descriptions to evade FDA detection. This case marks the first time a defendant has pleaded guilty to a felony prior notice violation under the Federal Foo

In fiscal year 2025, the FDA issued 44 Warning Letters to medical device manufacturers. That number is more than double the average from the late 2010s and early 2020s, when annual totals ranged between 11 and 21. Of those 44 Warning Letters, 38 cited violations of the Quality System Regulation under 21 CFR 820. Eleven more than the prior fiscal year. The data tells a clear story. The FDA is reasserting its enforcement posture in the medical device space, and the Quality Syst

On April 1, 2026, the FDA issued a Warning Letter to Pure Indulgence Aesthetics, a medical spa in Southlake, Texas. Industry observers are calling it a milestone. It is reportedly the first-ever Drug Supply Chain Security Act (DSCSA) Warning Letter issued to a dispenser, and it carries direct implications for any beauty brand, aesthetic clinic, or cosmetics company that touches prescription products. If you sell, source, or administer anything that crosses the line from cosme

A medical device startup invested two years and $2 million developing an innovative Class II diagnostic tool. They believed their 510(k) submission was airtight, relying on a consultant who promised a quick path to market. Instead, the FDA issued an Additional Information (AI) request, citing inadequate clinical data and poorly defined intended use statements. The launch was delayed by nine months, investor funding dried up, and a competitor beat them to market. This catastro