OTC Device Claims Regulation: FTC Targets Quell On Pain Relief, FDA Warns Zona Plus On BP
An FTC member doubts NeuroMetrix crossed all FDA regulatory lines in advertising for Quell wearable pain relief technology that attorneys alleged. FDA warning letter says Zona Health executives said they “would ‘remain in all regulatory guidelines’" when the agency in 2018 explained claims violations.
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NeuroMetrix plans to market the prescription-based Quell in the fourth quarter to US rheumatologists and pain medicine physicians.
Confirmations by the Senate mark FTC ’s first-ever complete leadership turnover at once and fill out the roster for the first time since President Trump’s election in 2016. The agency has been operating with two commissioners since soon after the election.
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.