FDA Examination Of Homeopathic Regulation Looks Beyond Safety History
This article was originally published in The Tan Sheet
CDER Director Janet Woodcock says the current regulatory framework limits FDA’s direct regulation of homeopathics to post-market surveillance. During a two-day public hearing, agency officials question stakeholders about trials, labeling and how well consumers understand their products.
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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.
Problems stated in a draft guidance where FDA will "prioritize enforcement and regulatory actions" includes products with routes of administration other than oral and topical or intended to be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.
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or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.