How to choose a healthcare lawyer or FDA attorney and regulatory consultant

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]

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 rules say a cosmetic is sometimes just a cosmetic – and sometimes a “drug”

To paraphrase Freud, sometimes a cosmetic is just a cosmetic – and sometimes it’s a drug.... Which is it—drug or cosmetic? The answer, FDA says, depends on intended use.

Court upholds FDA’s legal authority to regulate stem cell therapies

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative [...]

Stem cell laws and regulations: FDA regulation of stem cell therapies

If you wanted to upgrade the old film, "The Graduate," you'd have Dustin Hoffman's character shouting out "stem cells!" instead of "plastics!" Of course, he would immediate meet his favorite [...]

FDA proposes updates to Nutrition Facts label on food packages

The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information.

The Future of Medicine: From Physical to Online to Mobile to Wearable to Implantable

Just as the silicon "ink" dried on Telemedicine: The Future of Medicine, someone, somewhere, pronounced that there is a future for medicine beyond the future. This was no sweat for me, since I'm [...]

FDA Mobile Medical App Guidance continues to exert pressure on health-related apps

The FDA's final Guidance for Industry and FDA staff on mobile medical apps continues to constrain industry development of new health apps. Like the draft mobile medical app FDA guidance, the [...]

FDA exerts authority over medical devices with genomics

FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal [...]

Ancient Wisdom & Modern Technology: Legal Issues in Online Health, Mobile Health, E-Health, and Future Medicine

Healthcare and FDA lawyer Michael H. Cohen spoke on "Ancient Wisdom & Modern Technology" on ExitCoach Radio. Today, there are many healthcare and wellness related businesses popping up