FDA Mobile Medical App Guidance Reads FDA Medical Jurisdiction Expansively

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 [...]

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.

LARTA Commercialization Assistance Program

Michael H. Cohen participated in the LARTA Commercialization Assistance Program in Los Angeles (April 2013), sponsored by the National Institutes of Health, as a mentor to provide guidance to [...]

FDA takes aggressive stance on dietary supplement promotion and labeling

The FDA has taken an aggressive stance on dietary supplement promotion and labeling in recent warning letters involving dietary supplement manufacturers' and distributors' response to consumer [...]

FTC Charges Settled on Fake Endorsements and Deceptive Acai Berry Weight Loss Claims

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."

Off-label drug promotion and marketing yields significant penalties: Part 2 (Misbranding in interstate commerce)

Misbranding can also occur when a product is "held for sale after shipment in interstate commerce.

Off-label drug promotion and marketing yields significant penalties: Part 1 (Amgen settlement)

Off-label drug use is not illegal, but off-label drug promotion and marketing can result in significant legal penalties.

FDA Announces Draft Compliance Policy Guide on Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats

The federal Food and Drug Administration (FDA) announced a draft compliance policy guide (CPG) entitled, “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, [...]

California Chiropractic Board Adopts New Regulations for the Use of Laser in Chiropractic

The Board of Chiropractic Examiners in California has adopted new regulations for the use of lasers in chiropractic

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 [...]

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