Drugs

FDA Risk-Based Enforcement for Homeopathic Drugs

FDA says it will take a new risk-based enforcement approach to drug products labeled as homeopathic. “To protect consumers who choose to use homeopathic products,” an agency news release says, “this proposed new approach would update FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.”

The agency says it intends to focus its enforcement authorities on these kinds of products: products with safety concerns; products that contain or claim to contain ingredients associated with potentially significant safety concerns; products for routes of administration other than oral and topical; products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions; products for vulnerable populations; and products that do not meet standards of quality, strength, or purity as required under the law.

While FDA considers comments to the draft guidance, the release says, it intends to examine how it is implementing its current compliance policy. “Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public,” FDA says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome