Archives

The healthcare industry is a complicated, multi-trillion-dollar gargantuan and require that a healthcare law firm deploy its specialized knowledge across multiple domains.

Learn how to avoid these FDA legal traps when marketing your dietary supplement product.

Your dietary supplement products could be regulated as a new drug by FDA, unless you pay attention to these regulatory fundamentals.

Many of our dietary supplement companies come to us with various mistaken assumptions with respect to labeling their dietary supplement products. Let’s talk about 5 key dietary supplement [...]

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are [...]

Naturally, like any other business model, augmenting one’s clientele may be a priority for medical and other healthcare practitioners. Is it legal to offer coupons and discounts?

Physicians regularly work with businesses who want the doctors to use their products. To encourage physicians to choose their practice over competitor practices, vendors often offer incentives. [...]

FDA labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product. Indeed, ensuring that all [...]

Physicians, chiropractors, and other healthcare licensees often want to function as “health coaches” and avoid thorny laws. Can they?

A California investigation and disciplinary action against a California naturopathic doctors suggests how physicians can incur legal jeopardy when operating a medical spa, holistic healthcare [...]

FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on [...]

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.

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 [...]

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 [...]

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

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.

Healthcare & FDA lawyer Michael H Cohen speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation, at the Health Law Section of the Los Angeles County [...]

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 [...]

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

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.

Recently a physician called me, raving about HCG for weight loss, letting me know he recommends HCG to all his obese patients, because he lost over 150 pounds on HCG. "The scientific evidence is [...]

If you want to know how not to offend the FDA and FTC sequentially, here's an instructive lesson about a company that has gotten a big regulatory bruise.

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.