FDA News

From the Governor's desk to the FDA's updated guidance, connected medical devices are under the microscope in 2026 It Started with a Patient Monitor and a Chinese IP Address In January 2026, the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) issued alerts warning that certain Chinese-manufactured patient monitoring devices contained a backdoor in their firmware. The backdoor connected to a third-party IP address and transmitted data without notifying the

A new inspection pilot, an AI tool called Elsa, and a Texas labeling fight that is still not over FDA Just Changed How It Knocks on Your Door In April 2026, the FDA quietly started showing up at food facilities for something new: single-day inspectional assessments. On May 6, 2026, the agency made it official, announcing at the Food and Drug Law Institute's annual conference that it had launched a pilot program of one-day inspections for facilities identified by artificial in

What the agency's 2026 ingredient rulemaking push means for your business and your labels The FDA Is Asking a Deceptively Simple Question What exactly is a dietary ingredient? You would think that after more than 30 years under the Dietary Supplement Health and Education Act (DSHEA), we would have a clean answer to that. We do not. And the FDA is now making it official that the ambiguity has to go. In March 2026, the FDA held a public meeting titled "Exploring the Scope of Di

The FDA's Own Report Should Get Your Attention In December 2025, the FDA released a congressionally mandated report on the use of PFAS (per- and polyfluoroalkyl substances) in cosmetic products. The headline finding was not reassuring: the agency determined that toxicological data for the majority of PFAS used in cosmetics is incomplete or unavailable, leaving significant uncertainty about consumer safety. The full press release is available at FDA.gov. Based on mandatory cos

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