Should The FDA Oversee Nanotechnology Dietary Supplements?

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Updated October 15, 2022:

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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If you read this Project On Emerging Nanotechnologies publication, you'll probably say yes, A Hard Pill to Swallow - Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements. Historically, the regulation of dietary supplements has been a significant challenge for the U.S. Food and Drug Administration (FDA), and the fact that some of these products are now being manufactured using nanotechnology creates an additional layer of complexity. The use of engineered nanoparticles in dietary supplements raises serious questions about whether such products are safe. Congress has generally allowed dietary supplements to be marketed without any pre-market demonstration of safety, based largely on the assumption that these products have been used for many years. There is, however, no basis for concluding that dietary supplements containing engineered nanoparticles are safe. The authors ask, "Is FDA equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials?" Here's their conclusion . . .

• There is no basis for concluding that dietary supplements containing engineered nanoparticles are safe.
• While it is not possible to determine the prevalence of dietary supplements containing engineered nanoparticles, it is likely that the public’s exposure to these products will grow significantly in the next several years. Congress should adopt legislation granting FDA the authority to collect additional information about these products and to ensure that they are tested for their effects on human health. Such legislation should prohibit the sale of new dietary supplements containing engineered nanoparticles until they have been demonstrated to be safe, and it should provide FDA with sufficient resources to regulate these products.
• Until Congress acts, consumers who take dietary supplements containing engineered nanoparticles will be at additional, unknowable, and potentially serious risk.

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