OTC Homeopathic Labels Must Include Scientific Disclaimers – FTC
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.
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Decisions in US Circuit and District courts for District of Columba are on complaint by Rx drug firm MediNatura, but should resonate for OTC homeopathic firms as well as all businesses across the sector. MediNatura appealed district ruling rejecting request for injunction against FDA’s withdrawal of 1988 homeopathic CPG.
"It's pretty agonizing now. Our plan is to settle with them as fast as possible and move forward," says Jason Cardiff of Redwood Scientific Technologies in Upland, Calif. FTC alleges firm made unsubstantiated claims for dissolvable film strips for smoking cessation, weight loss and sexual performance; billed customers for unauthorized sales; made "abusive telemarketing through robocalls"; and stated false earnings claims to attract multilevel marketing distributors.
American Association of Homeopathic Pharmacists says Borneman "contributed to monumental changes in the development of homeopathic drugs and their regulation" and "represented and defended homeopathy against uninformed regulation and vanity medical products masquerading as homeopathic."