Avadim Adamant Its Support For Homeopathic Topical Ad Claims Meets FTC Standards
Two Reviews By Industry Self-Regulation Group Fault Avadim’s Supporting Evidence
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.
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Avadim Health argues National Advertising Division expects substantiation for its homeopathic topical claims at the same level FDA requires for NDAs. NAD also said although FTC’s competent, reliable scientific evidence standard is “flexible” to some degree, pain claims are held to a more rigid standard.
Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.
US trade regulator will require an "inherent contradiction" for homeopathic OTC labels: disclaimers to FDA-compliant label indications indicating a lack of scientific evidence that the product works.