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.
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 [...]
Michael H Cohen Speaks on FDA Legal Issues to SoCal IP
Healthcare & FDA attorney Michael H Cohen spoke in Woodland Hills, California to the SoCal IP Law Group on "Our Designer Future: How FDA Legal Issues Shape Human Health–From Medical Devices to [...]
LegalZoom Publishes “Health Apps as Medical Devices: What It Means for Consumers”
"Health Apps as Medical Devices: What It Means for Consumers" by healthcare, FDA & business lawyer Michael H Cohen was published by LegalZooom in its online legal headlines on Technology. The [...]
FDA Attorney Michael H. Cohen Speaking on FDA Legal Issues at the Ventura BioScience Incubator
FDA Attorney Michael H. Cohen speaks on FDA Legal Issues at the Ventura BioScience Incubator on October 17, 2013.The talk will focus on FDA regulation of cosmetics, dietary supplements, and [...]
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.
FDA Requires Cyber Security Plan Submission for Medical Devices
FDA now requires a cyber security plan in your medical device submission. On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]
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.
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.
FTC Releases “.com Disclosures: How to Make Effective Disclosures in Digital Advertising”
The FTC's guidance for digital (online) advertising applies to all business advertising on websites, mobile phone applications, or anywhere online (i.e., including on Facebook, smartphones, etc.).
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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 settles charges based on mobile device data breach
The FTC put out a press release on a settlement regarding data breaches on mobile smartphones and cellphones.
FTC Prohibits pomegrenate juice disease claims
The Federal Trade Commission issued a final order prohibiting POM Wonderful, maker of POM pomegranate juice products, from claiming that any of its products is effective in diagnosing, treating, [...]
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FTC Statement to Congress on Deceptive Marketing of Dietary Supplements
The FTC Statement to Congress on Deceptive Marketing of Dietary Supplements is a good place to begin to understand legal compliance issues regarding marketing
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.
Weight Loss Advertisements Found Deceptive and Misleading – Conspiracy and Healthcare Fraud Violations
The 1-800-GET-THIN ad campaign is embroiled in a criminal investigation for healthcare fraud and other violationsThe FDA and FBI are investigating.
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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, [...]
