Dietary Supplement Health and Education Act of 1994
The Dietary Supplement Health and Education Act (DSHEA), enacted on October 25, 1994, established federal regulations for the manufacturing, marketing, and use of dietary supplements in the United States. This legislation emerged in response to the rising popularity of dietary supplements, with studies indicating that 50 to 70 percent of adults utilize these products. DSHEA defined dietary supplements for the first time, categorizing them as products intended to enhance one's diet and including a variety of ingredients such as vitamins, minerals, herbs, and amino acids.
Under DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as food rather than drugs, meaning the responsibility for demonstrating safety primarily falls on manufacturers. The act also created guidelines for labeling, ensuring that claims made about supplements are backed by credible information without misleading consumers. Although the dietary supplement industry has seen significant growth, raising sales from $4 billion in 1994 to over $53 billion in 2023, concerns persist about the safety and regulation of these products. Critics advocate for continued reforms to enhance consumer protection and ensure rigorous quality control. The FDA is currently exploring potential updates to DSHEA to address these ongoing challenges, emphasizing the need for collaboration among government entities, consumers, and medical professionals.
Dietary Supplement Health and Education Act of 1994
DEFINITION: Established federal regulations for manufacturing, marketing, and using dietary supplements in the United States.
DATE: Signed October 25, 1994
History of the Act
The Dietary Supplement Health and Education Act (DSHEA) was created in response to the growing popularity of dietary supplements in the United States. The act amended the Food, Drug, and Cosmetic Act of 1938. In response to the federal government’s priority of citizen health, members of Congress proposed DSHEA after studies revealed that 50 to 70 percent of adults use dietary supplements. Congress also recognized that the dietary supplement industry is a significant contributor to the US economy and that its regulation made sense for consumers and the industry.
Industry lobbyists and other consumer groups strongly supported DSHEA, which US President Bill Clinton signed into law on October 25, 1994.
Rules and Regulations
DSHEA marked the first time that dietary supplements were defined by law. A dietary supplement is a product other than tobacco intended to supplement a person’s diet. According to DSHEA, a supplement must contain either a vitamin, mineral, herb, or other botanical, amino acid, concentrate, metabolite, or extract (or a combination of these ingredients). The dietary supplement must be listed as such and cannot be labeled as the only component of a meal or diet, nor can it be a food additive. The DSHEA also stipulates the forms in which these supplements may be sold: capsule, powder, soft gel, gel cap, tablet, or liquid.
To enforce safety standards, the US Food and Drug Administration (FDA) has regulatory power over dietary supplements as food rather than as medication. Under the DSHEA, the FDA determines if a supplement is unsafe or if insufficient information exists regarding the risk of a significant illness or injury. The FDA, however, does not test or evaluate a given product. The manufacturer must submit safety information at least seventy-five days before marketing a new dietary ingredient and notify the FDA within thirty days of marketing the product.
Under the Nutrition Labeling and Education Act of 1990, companies were not required to obtain authorization from the FDA before labeling a product a dietary supplement. The DSHEA, however, changed this when it created the Commission on Dietary Supplement Labels to evaluate the best means for providing consumers with current, accurate, and scientifically valid information.
According to DSHEA, the product must first claim a benefit related to a nutrient deficiency, must include information on the prevalence of the disease or condition the product addresses, and must include information on the product’s mechanism of action. Also, the label must specifically state that the product is not intended to diagnose, treat, cure, or prevent any disease. The supplement label also must list each ingredient's name and per-serving quantity. Unlike prescription medications, supplement labels do not include recommended daily intake (RDI) or daily recommended value (DRV).
DSHEA also regulates the marketing of dietary supplements. Written works, such as book chapters or scientific journal articles, may only be used in marketing a supplement if they contain data that is correct, balanced, and not misleading. This supporting literature may not endorse a specific brand or manufacturer or be displayed adjacent to the supplement for sale.
Implications and Controversies
The enactment of DSHEA allowed the dietary supplement industry to grow substantially. In 1994, the year DSHEA was enacted, total sales for the industry averaged $4 billion, but, by 2023, total sales for the dietary supplement industry in the United States rose to more than $53.58 billion as more transactions occurred online and consumers became increasingly interested in complementary and alternative medicine.
DSHEA increased the FDA’s ability to establish and enforce new labeling and potency standards. The FDA can take criminal action against violating companies and ban supplements from the market. One case in which the FDA removed a product from the market was the well-publicized weight loss supplement Ephedra, which was banned after several reports of adverse side effects in persons who had taken the supplement.
DSHEA brought greater attention and oversight to a previously unregulated industry. Still, critics of DSHEA call for even greater reform. Years after Congress proposed that the act’s passage would reduce major illness and economic burden, the United States has seen neither result.
Even with DSHEA in place, dietary supplements are assumed to be safe unless proven otherwise. Manufacturers, rather than the FDA, determine the quality specifications of their product. Unlike prescription medications, dietary supplements do not come with package inserts describing potential negative interactions or side effects. Thus, consumers are left without a clear way of determining if a supplement is safe.
Although DSHEA has had a substantial impact on the dietary supplement industry, collaborative work among the US government, consumers, and medical researchers and providers is still needed to further improve the industry. This quality control will ensure that consumers make the best-informed medical decisions. In June 2022, the FDA proposed a rule requiring manufacturers and distributors of dietary supplements to submit detailed information about their products to the FDA, allowing it to create a comprehensive database. Additionally, there have been calls to modernize the DSHEA and for legislators to indicate any potential changes in the regulation of dietary supplements that have become necessary since the passage of the original DSHEA.
Bibliography
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Melville, Scott. "Modernizing Dietary Supplement Regulations: A Comprehensive Approach." Supply Side Supplement Journal, 5 Sept. 2024, www.supplysidesj.com/supplements/modernizing-dietary-supplement-regulations-a-comprehensive-approach. Accessed 14 Sept. 2024.
"Office of Dietary Supplements (ODS)." National Institutes of Health, ods.od.nih.gov. Accessed 14 Sept. 2024.
"S.784 - Dietary Supplement Health and Education Act of 1994." Congress.gov, www.congress.gov/bill/103rd-congress/senate-bill/784#:~:text=Dietary%20Supplement%20Health%20and%20Education%20Act%20of%201994%20%2D%20Amends%20the,a%20concentrate%2C%20metabolite%2C%20constituent%2C. Accessed 14 Sept. 2024.
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"U.S. Dietary Supplements Market Size - Industry Report 2030." Grand View Research, www.grandviewresearch.com/industry-analysis/us-dietary-supplements-market-report. Accessed 14 Sept. 2024.