In 1976, Senator William Proxmire sponsored the Proxmire Amendment, which became section 411 of the Federal Food, Drug and Cosmetic Act. This amendment prohibited the FDA from establishing rules to limit the potency of vitamins in dietary supplements or from regulating them as drugs based solely on their potency. The dietary supplement industry is regulated by the Food and Drug Administration (FDA), primarily under the provisions of the Dietary Supplement Health and Education Act (DSHEA). This act has created a new regulatory framework for dietary supplements, but it has also led to multiple enforcement challenges with significant public health consequences.
These include inadequate safety assessment, inadequate effectiveness requirements, minimal oversight of unsubstantiated labeling and marketing claims, poor assurance and quality control, and gaps in EA reporting in the context of a post-marketing regulatory framework. A study published in JAMA Internal Medicine revealed that several brands of supplements containing at least one of the four banned stimulants are still on the market, even though the FDA had sent warning letters to their manufacturers and had issued public notices about the ingredients. This highlights the need for more stringent regulations to ensure that dietary supplements are safe for consumers. In 1976, Senator William Proxmire proposed an amendment to the Federal Food, Drug and Cosmetic Act that would prohibit the FDA from regulating vitamins in dietary supplements as drugs based solely on their potency.
This amendment, known as the Proxmire Amendment, was passed into law and has since been used as a basis for regulating dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) of 1994 further established a new regulatory framework for dietary supplements. This act has led to multiple enforcement challenges with significant public health consequences. In addition to the manufacturer's responsibility to comply with safety regulations and labeling requirements of dietary supplements, there are no laws or regulations that limit the serving size of a dietary supplement or the amount of a dietary ingredient that a serving of a dietary supplement can contain.
However, by law, the FDA does not approve dietary supplements or their labeling, although certain types of claims that are sometimes used in dietary supplement labeling require pre-marketing review and authorization (e.g., without the necessary regulatory application to ensure the quality and consistency of the product, the preponderance of evidence collected on dietary supplements may be confounded by the unmeasured variability of the supplements used and, therefore, be invalid; therefore, the conclusion that dietary supplements are not useful may be premature). Anyone can report an adverse event considered related to a dietary supplement directly to the FDA by accessing the safety reporting portal. The drug must then be manufactured under controlled conditions and packaged to meet strict labeling regulations before it is pre-approved by the FDA for use by consumers. These three types of claims are not approved by the FDA and do not require an FDA evaluation before being used on dietary supplement labels.
Scientific validation should only be kept archived for statements about structure and function, which state that a supplement maintains, supports, stimulates, regulates, or promotes proper functioning of the body. Two key issues that need to be addressed are the FDA's inability to know what supplements are on the market and its inability to require recall of supplements containing pharmacological ingredients. The main mechanism for monitoring safety of supplements is a voluntary reporting system established by the FDA Center for Food Safety and Applied Nutrition called AE Notification System of CAERS (Center for Food Safety and Applied Nutrition). For a list of possible serious reactions to watch out for and to learn how to report an adverse event, see the FDA website How to Report a Problem with Dietary Supplements.