Avadim Health could get FTC scrutiny after it declines to comply with two findings by an industry self-regulation group to discontinue 26 claims for its Theraworx Relief homeopathic products. It says the analysis “misapplied the well-recognized standards of substantiation” established by FTC. 

FTC attorneys say homeopathic claims should meet the same standard of proof the commission contends is required for dietary supplement advertising – randomized, controlled clinical trials. An industry groups says 92%-99% of participants in its study understood FDA does not review homeopathic drug label claims.

Health care professionals provide naloxone in an outpatient setting in “highly successful programs,” but FDA approval of a switch rests on whether “just putting the drug on the store shelf for anyone to purchase with no training or guidance on use” will be safe, says nonprescription drug division head Theresa Michele.