HOW DIETARY SUPPLEMENTS ARE REGULATED
In the USA, Dietary supplements are regulated by DSHEA (the Dietary Supplement Health and Education Act of 1994, and their manufacture is controlled by the FDA (Food & Drug Administration), as they may comply with the terms of the current Good Manufacturing Practices [cGMP] as defined in section 21/110 and 111 of the Federal Register (21CFR110/111). DSHEA defines dietary supplements as foods and/or products that are intended to supplement the diet, and not drugs. If supplements were categorized as drugs and required to go through the drug or new-drug approval process, we would see most supplements disappear, mainly because of the significant costs associated with the drug approval process (millions or tens of millions of dollars).
DSHEA spells out regulations regarding the manufacture and sale of dietary supplements and defines a Dietary Supplement as “a product (other than tobacco) intended for ingestion and to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or a combination of any of these ingredients.”
DSHEA defines permissible labeling claims and places the burden of proof on the FDA to show that a product is unsafe. It also outlines safety requirements for New Dietary Ingredients.
DSHEA grants the FDA the authority to regulate dietary supplements in two important respects:
- Product Labeling: Whenever a marketer wants to make a claim about a supplement, it must submit the proposed claim to the FDA within 30 days after its first use. Claims are limited to “general structure function” and as a rule may not assert that a product treats, cures, prevents or mitigates any disease. The FDA may stop the manufacturer from advertising the claim if it is deemed impermissible.
- Good Manufacturing Practices (GMP): DSHEA holds supplement manufacturers to industry standards for maintaining product quality. In addition, the Federal Trade Commission (FTC) maintains authority over supplement advertising: Manufacturers must report truthfully what their products contain and must have proof backing up any claims they make.
What are the allowable claims?
Among the claims that can be used on food and dietary supplement labels are three categories of claims that are defined by statute and/or FDA regulations: health claims, nutrient content claims, and structure/function claims.
These describe a relationship between a food substance (a food, food component, or dietary supplement ingredient) and reduced risk of a disease or health-related condition. There are three ways in which FDA exercises its oversight in determining which health claims may be used on a label or in labeling for a conventional food or dietary supplement:
1) The 1990 Nutrition Labeling and Education Act (NLEA) provides for FDA to issue regulations authorizing health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative;
2) The 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research; such claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification does not include all the required information; and
3) As described in the FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If the FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling.
A “health claim” by definition has two essential components: (1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or health-related condition. A statement lacking either one of these components does not meet the regulatory definition of a health claim. For example, statements addressing a role of dietary patterns or of general categories of foods (e.g., fruits and vegetables) in maintaining good health are considered to be dietary guidance rather than health claims. Dietary guidance statements used on food labels must be truthful and non-misleading.
NLEA Authorized Health Claims. The Nutrition Labeling and Education Act of 1990 (NLEA) provides for the use in food labeling of health claims that characterize a relationship between a food, a food component, or dietary ingredient and risk of a disease (for example, “adequate calcium throughout life may reduce the risk of osteoporosis”), provided the claims meet certain criteria and are authorized by an FDA regulation. FDA authorizes these types of health claims based on an extensive review of the scientific literature, generally as a result of the submission of a health claim petition, using the significant scientific agreement standard to determine whether the substance/disease relationship is well established.
Nutrient Content Claims
The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with the FDA’s authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise “characterize” the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as “only 200 mg of sodium” characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value. The requirements that govern the use of nutrient content claims help ensure that descriptive terms, such as high or low, are used consistently for all types of food products and are thus meaningful to consumers. Healthy is an implied nutrient content claim that characterizes a food as having “healthy” levels of total fat, saturated fat, cholesterol or sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there are no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as “40% omega-3 fatty acids, 10 mg per capsule,” and comparative percentage claims, e.g., “twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg).”
Structure/Function Claims and Related Dietary Supplement Claims
Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. DSHEA established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.
Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body; for example, “Calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “Fiber maintains bowel regularity,” or “Antioxidants maintain cell integrity.” General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. These types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading, and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. Structure/function claims may not explicitly or implicitly link the claimed effect of the nutrient or dietary ingredient to a disease or state of health leading to a disease.
Structure/function claims for conventional foods focus on effects derived from nutritive value, while structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects.