Supplement Law, From the 1938 Food Act to DSHEA in 1994

The 1938 Food, Drug and Cosmetic Act and the 1994 DSHEA law still decide what a supplement label can say. This history follows the rules from a 1937 poisoning through the 1976 potency amendments, the new ingredient notice and the serious adverse event reporting duty.

Jump to: - [A 1937 poisoning set the direction of the 1938 act](#a-1937-poisoning-set-the-direction-of-the-1938-act) - [The 1973 vitamin rules led to the 1976 amendments](#the-1973-vitamin-rules-led-to-the-1976-amendments) - [DSHEA in 1994 defined the supplement](#dshea-in-1994-defined-the-supplement) - [Structure and function claims stop short of disease](#structure-and-function-claims-stop-short-of-disease) - [New ingredients and serious adverse events have their own rules](#new-ingredients-and-serious-adverse-events-have-their-own-rules) - [The Supplement Facts panel changed in 2016](#the-supplement-facts-panel-changed-in-2016) The history of supplement law runs from a 1937 poisoning to a 1994 statute that still decides what a supplement label can say. Industry and consumers protested FDA's vitamin rules in the 1970s, Congress answered in 1976, and the Dietary Supplement Health and Education Act (DSHEA) set the claim, notice, and labeling rules that govern supplements today. ## A 1937 poisoning set the direction of the 1938 act The Elixir Sulfanilamide deaths happened during September and October 1937. The liquid, made by dissolving sulfanilamide in diethylene glycol, killed more than 100 people in 15 states, according to [FDA's account of the incident](https://www.fda.gov/about-fda/histories-product-regulation/sulfanilamide-disaster). The new formulation had not been tested for toxicity, and the food and drugs law did not require safety studies on new drugs. Selling it was not illegal. FDA says the deaths hastened the Federal Food, Drug, and Cosmetic Act of 1938, which increased the agency's authority to regulate drugs. Its New Drug section was added to prevent such tragedies. By the 1930s, the Food and Drugs Act of 1906 was already widely seen as obsolete. ## The 1973 vitamin rules led to the 1976 amendments In 1973, FDA issued regulations that prohibited certain representations on vitamin and mineral supplement labels, set standards of identity for those products, and classed any preparation with more than 150 percent of the U.S. Recommended Dietary Allowance (RDA) per serving as a drug. Both industry and consumers protested. Congress answered with the 1976 Vitamins and Minerals Amendments, often called the Proxmire Amendments, which barred FDA from setting standards that limit the potency of vitamins and minerals in food supplements. The Institute of Medicine's [2002 background chapter on supplement regulation](https://www.ncbi.nlm.nih.gov/books/NBK220865/) recounts this history. DSHEA later amended the vitamin and mineral section of the statute, [21 U.S.C. 350](https://www.govinfo.gov/content/pkg/USCODE-2021-title21/html/USCODE-2021-title21-chap9-subchapIV-sec350.htm). For one vitamin's path from scurvy remedy to labeled ingredient, see our [vitamin C history](/blog/history/history-of-vitamin-c-from-scurvy-to-ascorbic-acid). ## DSHEA in 1994 defined the supplement The Dietary Supplement Health and Education Act was approved October 25, 1994, as Public Law 103-417. It defines a dietary supplement as a product, other than tobacco, intended to supplement the diet that bears or contains a vitamin, a mineral, an herb or other botanical, an amino acid, or another listed dietary substance. [Magnesium](/ingredients/magnesium) falls in the mineral category. A supplement cannot be represented as a conventional food or as a sole item of a meal or the diet, and it must be labeled as a dietary supplement ([DSHEA text](https://ods.od.nih.gov/About/DSHEA_Wording.aspx)). For most purposes, the law treats a dietary supplement as a food. In any proceeding to show that a supplement is adulterated, the United States bears the burden of proof. Supplement labels had to follow the new rules after December 31, 1996, and the law created an Office of Dietary Supplements within the National Institutes of Health. ## Structure and function claims stop short of disease DSHEA lets a supplement carry a statement that describes the role a nutrient or dietary ingredient plays in the structure or function of the body, or that describes general well-being. The maker must have substantiation that the statement is truthful and not misleading. The label must show this sentence, prominently and in boldface type: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." The maker must also notify FDA no later than 30 days after first marketing the product with that statement ([DSHEA section 6](https://ods.od.nih.gov/About/DSHEA_Wording.aspx)). The line is disease. A structure or function statement may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. ## New ingredients and serious adverse events have their own rules DSHEA's section 8 covers new dietary ingredients, which the law defines as ingredients not marketed in the United States before October 15, 1994. A supplement with one is deemed adulterated unless the ingredient was present in the food supply in a form that has not been chemically altered, or there is a history of use or other evidence of safety. The second route requires the maker to give FDA that safety information at least 75 days before the product enters interstate commerce. FDA's notification rule is [21 CFR 190.6](https://www.fda.gov/food/new-dietary-ingredient-ndi-notification-process/how-submit-notifications-new-dietary-ingredient), published September 23, 1997. Serious adverse event reporting came later. Under [21 U.S.C. 379aa-1](https://www.govinfo.gov/content/pkg/USCODE-2020-title21/pdf/USCODE-2020-title21-chap9-subchapVII-partH-sec379aa-1.pdf), the company responsible for a supplement must send FDA each serious adverse event report it receives within 15 business days. ## The Supplement Facts panel changed in 2016 FDA published its final rule on the Nutrition Facts and Supplement Facts labels on May 27, 2016, and it took effect July 26, 2016. The rule updated the reference values behind percent Daily Values on both labels and made "Calories" more prominent. On food Nutrition Facts labels, it made vitamin D and potassium required and left vitamins A and C optional. Our [vitamin D complete guide](/health/vitamin-d-complete-guide) covers the nutrient that the rule made a required declaration on food labels ([Federal Register](https://www.federalregister.gov/documents/2016/05/27/2016-11867/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels)). The rule set compliance dates of July 26, 2018 for manufacturers with $10 million or more in annual food sales, and July 26, 2019 for smaller ones. FDA's [food label changes page](https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label) now lists January 1, 2020 and January 1, 2021 as the food-label compliance dates. ## Bottom line Read a supplement label by its claim type. A structure or function statement should carry the FDA disclaimer and should not claim to treat a disease. A label that says a product treats, cures, mitigates, or prevents a disease falls outside what DSHEA allows, so treat it as a warning sign. For a specific condition, the next step is a clinician. ## Frequently asked questions ### What did the 1938 Food, Drug and Cosmetic Act say about food and drugs? The act followed a 1906 law that was widely seen as obsolete by the 1930s, and it increased FDA's authority to regulate drugs. Its New Drug section was added after the 1937 elixir deaths. ### Why did the 1970s fight over vitamin doses matter? In 1973, FDA treated any vitamin or mineral preparation above 150 percent of the U.S. RDA per serving as a drug, and it restricted certain label claims. The 1976 amendments then barred FDA from setting potency standards that limit vitamins and minerals in food supplements. ### What did the 1994 law change for supplements? DSHEA defined the dietary supplement and treated it as a food for most purposes. It put the burden of proof on the United States in adulteration cases, set rules for structure and function statements and new dietary ingredients, and created the Office of Dietary Supplements at NIH. ### How does a structure and function claim differ from a disease claim? A structure and function claim describes a nutrient's role in the body's structure or function, or general well-being. It needs substantiation, the boldface FDA disclaimer, and a notice to FDA no later than 30 days after first marketing. A claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases is outside that category. ### What is a New Dietary Ingredient notification? For a new dietary ingredient, the maker either shows the ingredient was in the food supply in unaltered form or gives FDA safety information at least 75 days before the product enters interstate commerce. An ingredient counts as new if it was not marketed in the United States before October 15, 1994. FDA's rule is 21 CFR 190.6. ### How did the 2016 Supplement Facts rule change labels? The rule updated the reference values behind percent Daily Values on Nutrition Facts and Supplement Facts labels, and it made "Calories" more prominent. Its compliance dates were July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for smaller ones. ### What do current FDA rules require for supplement safety reporting? Under 21 U.S.C. 379aa-1, the company responsible for a supplement must send FDA each serious adverse event report it receives within 15 business days. ## Next reads - [Magnesium monograph](/ingredients/magnesium): the reference page for a mineral that falls under DSHEA's definition. - [Vitamin C history, from scurvy to ascorbic acid](/blog/history/history-of-vitamin-c-from-scurvy-to-ascorbic-acid): how one vitamin went from a scurvy remedy to a labeled ingredient. ### Related reading - [the 1938 food and drug act and the 1994 supplement law](/blog/history/history-of-food-fortification-from-iodized-salt-to-folic-acid-flour) - [the 1994 law that set the rules for supplement labels](/blog/history/history-of-the-recommended-dietary-allowance-from-1941-to-daily-value)