Are Ear Candles Medical Devices? FDA Thinks So.

The FDA believes that ear candles are dangerous and should be regulated as medical devices.In Don't Get Burned: Stay Away From Ear Candles, FDA warns consumers against using ear candles, and [...]

Misleading advertising of health products triggers FTC Complaint and Penalties

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 [...]

Michael H. Cohen quoted in The Tan Report

Attorney Michael H. Cohen was quoted as a legal authority in FDA and FTC law in an article in the popular industry weekly “The Tan Sheet” (vol. 20, no. 35) about European herbal regulation [...]

Robocare Expands with IRobot’s Telemedicine Practice

Telemedicine laws continue to define online health ventures, but meanwhile industry expands robotic telemedicine options.

Longevity and Anti-Aging Medicine Legal & Regulatory Issues

Entrepreneurs who fail to properly take into account legal and regulatory issues before opening a longevity and anti-aging medical clinic or health education (or telehealth / telemedicine) [...]

FDA reports $40 million settlement with Skechers over unfounded health claims

If you have a dietary supplement or any product for that matter, be sure you have substantiation for your claims. Complying with substantiation legal rules is part of dietary supplement / FDA and [...]

FDA Regulation of Wireless Devices

What if everyone wore mobile wireless devices, but some nefarious parties could somehow send signals and interfere with them? This dark scenario was brought to my attention in an article [...]

Off-label marketing of Vioxx results in a $950 million settlement for violation of marketing laws

Off-label marketing by Merck of its pain-killer, Vioxx, resulted in a $950 million settlement for violation of marketing laws

Texas Medical Board approves new stem cell therapy rules

The Texas Medical Board approved new stem cell therapy rules