Would you like to lose weight without diet or exercise, by a magical fat-burning, calorie-busting, body-slimming dietary supplement or cream? Here's how.......
Can a dietary supplement company link to scientific references that show that that the dietary supplement product is effective in treating a disease such as cancer, diabetes, or hypertension?
Advertising health products online? Check FTC endorsements guides on testimonials and endorsements, as FTC enforcement action can come with huge penalties.
If you want to know where the next healthcare revolution will come from, look inside. Physical medicine becomes virtual medicine, becomes mobile healthcare, becomes wearable health and then [...]
If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? [...]
If you've designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test [...]
Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.
Predictive analytics will push the frontiers of clinical care; the question is whether FDA regulation will promote or stifle innovation in the name of consumer protection.
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