FDA & FTC Law

If you think medical device advertising is immune from criminal prosecution, look to the current charges against the CEO of Vascular Solutions.

Recent press calls into question widespread “regenerative” and anti-aging medicine, and physician practices that use stem cell therapies.

FTC's aggressive enforcement of federal law prohibitions against false and deceptive advertising have hit marketers of healthcare products hard, while class action lawsuits are reaching the [...]

FDA would have significantly greater authority over cosmetic products under the Personal Care Products Safety Act. The Personal Care Products Safety Act would increase regulation over many [...]

Senators Bennet and Hatch reintroduced the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, to "cut red tape at the Food and Drug Administration (FDA) and help [...]

The federal Food and Drug Administration (FDA) has been responding to an avalanche of new health technologies in ways that signal less, rather than more enforcement. The first wave of FDA [...]

FDA approved marketing for 23and Me's Bloom Syndrome Carrier test, months after halting the company's marketing of direct-to-consumer genetic tests. FDA now classifies genetic carrier screening [...]

New York's Attorney General initiated the investigation against major retailers of herbal supplements, based on DNA testing of plant materials suggesting contaminants, and mislabeling; was the [...]

If you market your healthcare products, FTC enforcement can stop your sales in their tracks. All it takes is a search - yes, good old keywords - and you're in line for significant penalties for [...]

FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk