What is the FDA's Role in Regulating Dietary Supplements?

As an expert in the field of SEO, I understand the importance of providing accurate and up-to-date information on dietary supplements and their regulation. The US Food and Drug Administration (FDA) plays a key role in the regulation of dietary supplements, from inspecting manufacturing facilities to reviewing new dietary ingredient notifications and other regulatory submissions. Dietary supplements are regulated as foods, not drugs, but many contain ingredients that can interact with medications or medical conditions. The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the regulatory framework for dietary supplements in the US. However, there are still challenges in ensuring the quality and safety of available products.

This article will discuss the existing US regulatory framework for dietary supplements and describe the remaining regulatory barriers to ensure that safe, high-quality dietary supplements are offered on the market. The main challenge when it comes to regulating dietary supplements is the lack of international consensus on how this category of products is defined; there are no standards that guarantee quality and integrity in the global context. The FDA has published formal guidance on current good manufacturing practices (GMP) to ensure that processes for preparing, packaging, labeling and storing supplements and ingredients meet specifications to ensure purity, composition and concentration. However, the effectiveness of dietary supplements is not mandatory in the US.

Manufacturers must notify the FDA of products with new dietary ingredients before placing them on the market. The FDA also conducts post-market facility audits to ensure that manufacturers comply with GMP. The FDA and Federal Trade Commission (FTC) work together to regulate advertising claims related to dietary supplements; manufacturers are responsible for the accuracy of statements that are expressly indicated, suggested, or implied in an advertisement. The FTC has published a guide for the supplement industry to clarify its compliance policies and practices related to dietary supplements. There are several third-party verification programs available, and some manufacturers have adopted their standards and display their certification symbols on their packaging.

The Pharmacopoeia Convention (USP) has continuously developed and reviewed quality standards for science-based drugs and has recommended applying the public standards of the USP National Formulary to dietary supplements in order to strengthen the provisions on good manufacturing practices. Overall, it is important for consumers to consult with a health professional before using any dietary supplement, as safety issues such as adulteration and contamination still exist. There is still a need for continued efforts and improvements in techniques for evaluating the quality of dietary supplements, especially with regard to purity, bioavailability and safety.

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