Keeping Supplements Safe for All Americans
Health specialists and dieticians have long sought to provide food-based products with certain health benefits to consumers in a safe and legal manner. To that end, Senator Hatch teamed with key regulators, industry stakeholders, and concerned citizens to create the Dietary Supplement Health and Education Act of 1994 (DSHEA). This bipartisan legislation created a clear definition for dietary supplements and established the framework for their regulation as foods.
DSHEA defined the term "dietary supplement" as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms, such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also come in other forms such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever the form, DSHEA places dietary supplements in a special category under the general umbrella of "foods"—not drugs—and requires that every dietary supplement be labeled as such.
Over the years, Senator Hatch and the Food and Drug Administration (FDA) have sought to clarify misconceptions about dietary supplement regulation. While dietary supplements are regulated differently than drugs, they are responsibly regulated by the FDA, the Federal Trade Commission (FTC), and state government agencies in each of the 50 states. In fact, the FDA and FTC oversee nearly all aspects of dietary supplement manufacturing, labeling, and marketing with extensive regulations and enforcement actions.
The materials below have been compiled from Senator Hatch’s own work as well as from materials provided by the FDA.
- Why has Senator Hatch taken such a strong particular interest in the regulation of the supplement industry?
- What is Senator Hatch’s connection to the supplement industry?
- What has Senator Hatch done personally to ensure that harmful products are regulated?
- What is FDA's oversight responsibility for dietary supplements?
- What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
- Who validates claims and what kinds of claims can be made on dietary supplement labels?
- When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
- What information must the manufacturer disclose on the label of a dietary supplement?
- Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
- Must all ingredients be declared on the label of a dietary supplement?
- 1. Why has Senator Hatch taken such a strong particular interest in the regulation of the supplement industry?
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Senator Hatch has been a champion of reforming the federal bureaucracy for over thirty years, and his approach to regulating the supplement industry follows the same principles.
Senator Hatch has long worked to eliminate the red tape that unjustifiably burdens our economy and our liberties. Studies show that the cost of federal regulations is nearly $2 trillion every year—a greater cost than corporate and individual taxes combined. A recent survey by Business Roundtable shows that businesses see regulatory compliance as their “top business challenge.” The average U.S. company pays a stunning $10,000 per employee every year to comply with federal regulations—costs that are passed on in the form of higher prices for consumers and lower earnings for employees.
Too often, the federal bureaucracy responds to any real or perceived problem by adding additional layers of regulations to an already-massive federal regulatory burden. Instead of piling up unnecessary rules, Senator Hatch firmly believes that we should instead pursue smart, well-tailored regulation. His approach has consistently emphasized the need to reexamine existing regulatory frameworks, ensure that regulators are doing their jobs, and seek the most efficient solutions possible while preserving important health and safety standards.
return to top - 2. What is Senator Hatch’s connection to the supplement industry?
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In Utah, the natural supplement industry has long been a major part of the economy, employing tens of thousands of Utahns. Referred to as the “Silicon Valley of the nutritional supplement industry,” Utah was a leader in supplements long before DSHEA, and Senator Hatch has always worked to make sure Utahns have a voice in Washington. Just as senators from California represent their constituents’ interests by working with the tech and entertainment industry, Senator Hatch works with the supplement industry to ensure that Utah’s economy remains strong and is not targeted by unnecessarily burdensome regulations.
return to top - 3. What has Senator Hatch done personally to ensure that harmful products are regulated?
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Senator Hatch has long worked to ensure the proper classification of dangerous substances. For example, in 2014, he sponsored the Designer Anabolic Steroid Control Act (DASCA), which made it easier to classify harmful products as controlled substances. This legislation also increased the criminal penalties for importing, manufacturing, or distributing these harmful products under false labels. DASCA is just one example of Senator Hatch’s efforts to complement the FDA’s work in regulating dangerous substances and separating them from health products and dietary supplements.
return to top - 4. What is FDA's oversight responsibility for dietary supplements?
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From FDA: “Because dietary supplements are under the ‘umbrella’ of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.”
For more information about FDA’s oversight responsibility, read here.
In short, FDA maintains numerous enforcement tools to guard against unsafe products. The agency can and should remove any demonstrably unsafe product from the shelves, and it has done just that in numerous cases.
return to top - 5. What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
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From FDA: “In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products. Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.”
For more information about FDA’s regulatory role, read here.
DSHEA provides FDA with explicit authority under the law to act against companies that may pose a risk to public health. In June 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices (CGMPs) for those who manufacture, package, or hold dietary supplement products. Compliance with CGMPs requires manufacturers to conduct appropriate tests or examination to verify the identity of any ingredient. Moreover, manufacturers must also test their finished products to assure they meet specifications for identity, purity, quality, strength, and composition. The FDA can enter into consent decree agreements with firms to stop the sale of products and it can shut down firms or seize products that do not adhere to CGMPs. In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement must submit to FDA all serious adverse event reports associated with use of the dietary supplement.
For more information about CGMPs, read here.
return to top - 6. Who validates claims and what kinds of claims can be made on dietary supplement labels?
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From FDA: “FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, the Federal Trade Commission. By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure and function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim.”
For more information about the validation process, read here.
return to top - 7. When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
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From FDA: “DSHEA requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply. There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements it sells, containing the dietary ingredient, were marketed before October 15, 1994.”
For more information about the notification process, read here.
return to top - 8. What information must the manufacturer disclose on the label of a dietary supplement?
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From FDA: “FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a "Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.”
For more information about disclosure requirements, read here.
If a dietary supplement label inaccurately represents the identity or quantity of ingredients, FDA considers the product adulterated and misbranded, making it subject to seizure, recall, and detention.
return to top - 9. Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
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From FDA: “This statement or "disclaimer" is required by DSHEA when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.”
For more information about disclaimers, read here.
return to top - 10. Must all ingredients be declared on the label of a dietary supplement?
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From FDA: “Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation, 62 Fed. Reg. 49,826 (Sept. 23, 1997).”
For more information about ingredient disclosure requirements, read here.
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| Date | Title |
|---|---|
| 1/9/17 | Politico: Hatch could be unlikely tech ally in Trump administration |
