DSHEA, the Dietary Supplement Health and Education Act of 1994, is a United States federal law that defines and regulates dietary supplements, establishing a distinct regulatory framework separate from conventional food and drug products. This legislation allows manufacturers to market supplements without pre-market approval regarding safety and efficacy, provided they do not make claims to treat, cure, or prevent a specific disease. The Act is foundational in the hormonal health and wellness space, as it governs the vast majority of vitamins, minerals, and herbal preparations utilized for endocrine support.
Origin
The Act was passed by the U.S. Congress in 1994 as an amendment to the Federal Food, Drug, and Cosmetic Act, largely in response to public demand and industry pressure to protect consumer access to dietary supplements. Its establishment codified the definition of a dietary supplement and placed the burden of ensuring safety and truthful labeling primarily on the manufacturer, rather than requiring the FDA to prove harm before a product is removed from the market.
Mechanism
DSHEA’s mechanism is purely regulatory, not physiological; it dictates the rules of commerce and communication for supplement products. It permits “structure/function claims” which describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the human body, such as “supports bone health” or “helps maintain hormonal balance.” This regulatory pathway allows for the promotion of wellness benefits without the stringent, expensive, and time-consuming process of pharmaceutical drug approval.
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