FDA 'Evolving' Homeopathic Drug Enforcement With Risk-Based Approach
This article was originally published in The Rose Sheet
Problems stated in a draft guidance where FDA will "prioritize enforcement and regulatory actions" includes products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions.
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Revised draft guidance identifies types of homeopathics posing "higher risks to public health."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.
FDA says Newton Laboratories sells unapproved Rx homeopathics because its products are labeled to treat diseases and conditions including allergies, chicken pox and “suicidal tendency.” Warning letter says firm also has repeatedly violated same GMPs across more than a decade of inspections.
FDA warns King Bio, three other homeopathic product marketers. In addition to GMP deficiencies, "we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer,” says FDA Commissioner Gottlieb.