Homeopathic Firm's Teething Remedy Touches FDA Enforcement Nerve
Executive Summary
FDA warns OHM Pharma for promoting topical formula containing homeopathic ingredients as teething product for infants. The firm also warned about drug and supplements GMP violations and was an easy target for FDA following release of draft guidance outlining its enforcement priorities.
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FDA Adds Homeopathic Enforcement Details, Subtracts Compliance Policy Guide
Revised draft guidance identifies types of homeopathics posing "higher risks to public health."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.
Warnings In 2019, AERs In 2009: Touchstones Toward Homeopathic Guidance
Priority enforcement areas listed in draft guidance note delivery formats other than oral and topical, such as nasal gel product that was early alarm in FDA's evaluation of safety and efficacy across homeopathic market. Recent warnings also noted in revised draft.
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
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