FTC Slams Fat Burning, Calorie-Blocking and Body Slimming Marketing

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.......

Will FDA Act if You Link Dietary Supplement Claims to Testimonials or Scientific References?

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?

Which disruptive healthcare innovations will push medical frontiers in the next 5 years?

Pundits prognosticate, but how do we measure a future for healthcare when every trend morphs asymptotically?

Advertising health products online? Check FTC endorsement guides for dos and don’ts

Advertising health products online? Check FTC endorsements guides on testimonials and endorsements, as FTC enforcement action can come with huge penalties.

The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us

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?

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? [...]

How are home health kits regulated under FDA and state law?

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 [...]

Dietary Supplements – Strategies to Reduce FDA Risk

Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.

How will FDA regulate predictive clinical software as predictive analytics pushes medical frontiers?

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.

Superintelligence, Artificial Intelligence, The Singularity, & Life in the Universe

Today a client asked me, "are you worried about the drought?" I said, "No, I'm worried about AI eating the world."

Medical device advertising: free speech or conspiracy?

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

Physician stem cell therapies legally ambiguous, while regenerative clinics prosper

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

When marketing healthcare products, review websites and materials for FTC and liability risk

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 cosmetics regulatory power enhanced by proposed Personal Care Products Safety Act

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 [...]

Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation

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 [...]

FDA eases regulation of medical device data systems (MDDS), medical image storage devices, and medical image communications devices

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 Approves 23andMe’s DNA Personal Genome Test for Bloom Syndrome Carrier

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 [...]

Herbal Supplements Investigated for Misbranding and Adulteration

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 [...]

9 Keys to Managing Risk of FTC enforcement (especially with anti-aging and weight loss claims)

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 is hands-off Low Risk General Wellness Products

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