FDA & FTC Law

Substance abuse treatment centers must steer carefully when sending patients for labs. Self-referral, anti-kickback, and fee-splitting rules can create legal enforcement issues and must be [...]

WHEN ESTABLISHING YOUR FUNCTIONAL MEDICINE PRACTICE, YOU’LL BE WADING INTO CLINICAL WATERS THAT ARE OFTEN NAVIGATED BY MANY MEDICAL COLLEAGUES, YET NOT NECESSARILY ADOPTED WITHIN THE MAINSTREAM [...]

Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.

For an OTC drug marketing legal checklist, 5 legal strategy steps can propel you to market.

Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.

According to FDA medical device guidance - substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.

FTC Big Data regulation tells companies how to use big data legally and responsibly, in FTC’s report, Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues,

Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]

Healthcare fraud remains a broad regulatory category that enforcement authorities can use against the manufacturer or distributor of a healthcare product that raises questions in the minds of [...]

By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.

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?

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

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.

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 [...]

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 [...]

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 [...]

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

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.

What do we call our emerging futurist healthcare-- digital health, e-health, m-health, mobile medicine, tele-health, or old-fashioned "medicine?" FDA is "hip" with its terms, "connected health."

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.

The Federal Trade Commission (FTC) has proposed to settle charges with two marketing companies promoting "shapewear garments" with "slimming claims for caffeine-infused products." FTC vigorously [...]

LegalZoom published Wearable Health Technology: Health Care Dream or Privacy Nightmare, on the heels of Apple's announcement of the Apple Watch. The article makes the point that the Apple Watch [...]

The Federal Trade Commission (FTC) won a $2.2 million judgment against health food marketer Wellness Support Network, Inc. (WSN) in federal court for the “Diabetic Pack” and the “Insulin [...]

To paraphrase Freud, sometimes a cosmetic is just a cosmetic – and sometimes it’s a drug.... Which is it—drug or cosmetic? The answer, FDA says, depends on intended use.

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 [...]

The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information.

FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal [...]

Healthcare & FDA attorney Michael H Cohen spoke in Woodland Hills, California to the SoCal IP Law Group on "Our Designer Future: How FDA Legal Issues Shape Human Health–From Medical Devices to [...]