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Industry Roundup: FTC, FDA Enforcement, Mannatech CEO, Quell Distribution

FTC commissioner questions enforcement; Mannatech adds CEO to Bala’s title; Quell wearable pain relief heads for stores; ED drug in ‘Herb Viagra’; and more news in brief.

Commissioner Maureen Ohlhausen says Federal Trade Commission enforcement against firms that FTC officials allege made unsubstantiated claims for purported “melanoma detection” applications could stifle consumer health product development. FTC litigation against UK firm L Health Ld. and other marketers linked to the devices relies on “an unduly expansive interpretation of advertising claims to justify imposing an inappropriately high substantiation requirement on a relatively safe product,” Ohlhausen said in a dissent she made for each agency action against the firms. She added that “this course of action will inhibit the development of beneficial products and chill the dissemination of useful health information to consumers.” FTC said Aug. 13 that L Health settled charges in connection with the “Mole Detective” apps after advertising the apps online beginning in August 2012 after a separate company, New Consumer Solutions LLC, ceased marketing the products following FTC enforcement.

According to FTC’s complaint filed in federal court in Illinois, the Mole Detective apps instructed users to photograph a mole...

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• By Sarah Karlin-Smith

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• By Alaric DeArment and Cathy Kelly

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• By Cathy Kelly

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• By Sue Sutter

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More from North America

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 
• By Michael McCaughan

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.