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Whenever you market a healthcare product, beware of potential FDA and FTC enforcement as well as private plaintiffs who can sue for false advertising, unfair competition, deceptive and misleading [...]

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?

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 [...]

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 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 [...]

The Daily Journal published FDA’s General Wellness Guidance is Welcome News by healthcare and FDA lawyer Michael H. Cohen. The article (Cohen.P.0129) goes through FDA's general wellness guidance [...]

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 [...]

Virtual reality in medicine and health will augment and expand our sense of reality - yet it's only a harbinger of deeper access to consciousness.

The Daily Journal, California's largest legal news provider, published Future of Medicine is Just a Tap Away, by healthcare & FDA attorney Michael H. Cohen.

If you think Obamacare is the most important story in regulation of healthcare, you're missing these key trends that will shape the medicine of 2015 and beyond. Remember that technological [...]

The Federal Trade Commission (FTC) reports that mobile apps need to provide consumers with more disclosures, and also protect the privacy and security of consumer data--thus adding to the [...]

The FDA provides guidance for pharmaceutical and medical device manufacturers as to how to present risk and benefit information for their medical devices and products on social media.

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]

The federal appellate decision in U.S. v. Regenerative Sciences, LLC (see Court upholds FDA's legal authority to regulate stem cell therapies) also reflects FDA's evolving legal authority over [...]

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative [...]

If you wanted to upgrade the old film, "The Graduate," you'd have Dustin Hoffman's character shouting out "stem cells!" instead of "plastics!" Of course, he would immediate meet his favorite [...]

The FDA issued a warning letter citing a dietary supplement company for its online content.In its warning letter to dietary supplement manufacturer M.D.R. Fitness Corp., the FDA warned that [...]