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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FTC alleged core ad messages for Quell have been that the wearable device activates areas of the brain responsible for the central inhibition of pain to produce widespread relief of chronic and severe pain throughout the body.

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