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

Medico-Legal Issues in Cardiology published by Cardiology in Review

Healthcare & FDA attorney Michael H. Cohen is co-author of "Medico-Legal Issues in Cardiology," published by Cardiology in Review 2013;21:222-228. The article aims to educate physicians about the [...]

Cohen Healthcare Law Group Yelp attorney review

We appreciate a new review on Yelp for the Cohen Healthcare Law Group.

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

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.

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.

Healthcare lawyer Michael H Cohen quoted in the Tan Sheet on FDA Preemption Lawsuits

Healthcare lawyer Michael H Cohen was quoted in the Tan Sheet on an article about FDA Preemption Lawsuits involving Monster beverages.

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 Blasts POM for Disease Claims, Highlighting Substantation Issues

The FTC blasted POM Wonderful for making deceptive and unsupported advertising claims regarding their pomegranate products.

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 [...]

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