Animal dietary supplement manufacturers and distributors can run afoul of FDA prohibitions against “drug” claims and receive an FDA warning letter, unless they understand how FDA regulates animal [...]
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.
False and misleading educational products incur FTC wrath, particularly when it comes to claims about training pr protecting or improving the brain, treating ADD and ADHD, and marketing to children.
Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.
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 [...]
FTC tackles native advertising and sponsored content in an Enforcement Policy Statement on Deceptively Formatted Advertisements.
If you want to sell healthcare products online, the legal hurdles can be steep.
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 [...]
FTC false advertising legal traps can hurt any business, small or established. Here's how to walk the compliant side of marketing healthcare products.
Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market - why?
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 [...]
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.......
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?
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 [...]
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 [...]
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 [...]
You could burn 50 calories just by reading this blog post. Or not. But if you sell a weight loss product with false, deceptive, and misleading claims, you'll burn a lot more calories when the [...]
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.
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 [...]
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 [...]
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?
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 [...]
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.
The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]
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.
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.
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
The FTC's guidance for digital (online) advertising applies to all business advertising on websites, mobile phone applications, or anywhere online (i.e., including on Facebook, smartphones, etc.).
Health and wellness mobile apps and online programs raise a variety of legal and regulatory issues that require legal expertise in structuring a health education or healthcare products or [...]
The FTC put out a press release on a settlement regarding data breaches on mobile smartphones and cellphones.
The FTC Statement to Congress on Deceptive Marketing of Dietary Supplements is a good place to begin to understand legal compliance issues regarding marketing
The Federal Trade Commission (FTC) settled a $2 million complain against "an operation that allegedly used fake news websites to deceptively market acai berry weight-loss products."
Dietary supplement manufacturers, medical device manufacturers and distributors, and makers of cosmetics should have legal review of their website advertising and marketing claims for Federal [...]
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