What act permits manufacturers of supplements to make claims not approved by the FDA while ensuring safety standards?

The Dietary Supplement Health and Education Act of 1994 is significant because it allows manufacturers of dietary supplements to make claims about their products without prior approval from the FDA, provided these claims are truthful and not misleading. This act established a framework that distinguishes dietary supplements from conventional foods and drugs, thereby allowing for a degree of flexibility in marketing that is not available for pharmaceutical products.

Under this act, manufacturers must ensure their products are safe and adhere to specific labeling requirements, but they are not required to submit evidence of efficacy or safety to the FDA before marketing their products. This means that while the FDA monitors these products, it does not pre-approve their claims, allowing for broader expression of benefits as long as they meet defined criteria.

Other options do not pertain to dietary supplements in the same way; for example, the Food and Drug Administration Act relates broadly to the FDA's authority over food and drugs but does not specifically allow unapproved claims for supplements. The Health Insurance Portability and Accountability Act primarily focuses on healthcare privacy and the Affordable Care Act is centered around health insurance and access to care, neither of which addresses the regulation of dietary supplements in the context described.