Can Paying Attention to These Common FDA Mistakes Save Your Healthcare Company from a Plaintiffs’ Lawsuit?
Common FDA mistakes that cause healthcare companies to get sued
How to avoid FDA enforcement by not avoiding FDA in the first place – the top mistake companies typically make when marketing healthcare products
Starting a healthcare company without having prior FDA legal and regulatory review can place your company in serious jeopardy.
Is your therapy an FDA-regulated medical device? How would you know?
Today’s legal strategy sessions involved a healthcare business that is really a healthcare practice in disguise. Let’s look at what legal strategy lessons we can learn here.
Study: Scientifically Unproven Marketing Claims Very Common on Websites
Michael H Cohen has been interviewed by the Medical Ethics Advisor, a well established publication that focuses on current healthcare issues.
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Animal dietary supplement manufacturers and distributors beware of FDA warning letters
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 [...]
Dietary supplement legal review could save your company
If you want to sell healthcare products online, the legal hurdles can be steep.
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?
FDA is hands-off Low Risk General Wellness Products
FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk
Weight Loss Products FTC Weighs In
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 [...]
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.
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.
HHS Lambasts Dietary Supplement Companies and Weight Loss & Immune Support Dietary Supplements
The Department of Health and Human Services Office of Inspector General issued two reports lambasting dietary supplement companies, particularly over structure-function claims related to weight [...]
