OTC drug marketing legal checklist: 5 legal strategy steps

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

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

Digital health advances set healthcare law on edge

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

Is an online healthcare services directory a medical referral service?

Is an online directory of healthcare centers a medical referral service? We’ve had several online directories of healthcare services ask us what legal rules govern their operation. Below we [...]

“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation

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 [...]

4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products

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 [...]

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?

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 [...]

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 [...]

Do HCG Weight Loss Products Work? FTC Cracks Down on Homeopathic HCG Drops

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 [...]

How to Piss Off the FTC After Offending the FDA

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.

Marketing “wearable caffeine” can get you in trouble with FTC, the regulatory watchdog over advertising

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 [...]

FTC requires mobile apps to include disclosures, adding to FDA mobile medical app regulatory requirements

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 [...]

Neurofeedback Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe–Part 5: Marketing Your Neurofeedback Practice—Legal Issues in Case Studies

How do you market an emerging healthcare practice, without running afoul of regulatory walls, from federal and state advertising law to licensing laws, and the law governing unfair business practices?

FTC wins advertisement substantiation case against online marketer of health products

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 [...]

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

The FDA now requires that mobile app developers create a cyber security plan and submit it to the FDA along with their mobile medical app / medical device submission.

Michael H. Cohen Speaking on FDA & Related Legal Issues in Online Health Ventures

Attorney Michael H. Cohen speaks on "FDA & Related Legal Issues in Online Health Ventures" at a prominent LA law firm's Restaurant, Food & Beverage Group on July 9.

Mobile App Developers Can Be Slammed by FTC or FDA

The Federal Trade Commission (FTC) requires that advertising be truthful and not misleading, and will take enforcement action if mobile app developers make deceptive claims about their apps.

Bloggers must take care to not provide clinical health advice

Attorney Michael H. Cohen was quoted in The Tan Sheet (2/25/13) in "Turning Blogger Relationships Into Gold Takes Careful Management," by Lisa Gillepsie

FTC settles charges based on mobile device data breach

The FTC put out a press release on a settlement regarding data breaches on mobile smartphones and cellphones.

FTC Statement to Congress on Deceptive Marketing of Dietary Supplements

The FTC Statement to Congress on Deceptive Marketing of Dietary Supplements is a good place to begin to understand legal compliance issues regarding marketing