The Dietary Supplement Health and Education Act of 1994 (DSHEA) sets the regulations for dietary supplements in the United States, and the Food & Drug Administration (FDA) controls their manufacturing to comply with terms of current Good Manufacturing Practices (cGMP) as defined in section 21/110/111 and 117 of the Federal Register (21CFR110/111/117).
DSHEA 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.”
Dietary supplements are not categorized as drugs, therefore they are not required to go through the expensive drug approval process, which can cost millions of dollars. The expense of this process would be prohibitive for most supplement suppliers.
Permissible dietary supplement labeling claims are defined by DSHEA, which also outlines new dietary Ingredients safety requirements. The FDA has the responsibility to provide the burden of proof to show that a product is unsafe.
Under DSHEA guidelines, the FDA is granted the authority to regulate two important aspects of dietary supplements:
- Good Manufacturing Practices (GMP). DSHEA upholds product quality by holding supplement manufacturers accountable for complying with industry standards.
- Product Labeling. When a marketer wants to make a claim about a supplement, the proposed claim must be submitted to the FDA within 30 days of its first use. Claims are limited to “general structure function,“ unless otherwise approved by the FDA. In any case, they may not assert that a product treats, cures, prevents or mitigates any disease, as these are considered drug claims. The FDA may deem the claim as impermissible and stop the manufacturer from advertising the claim.
Authority over supplement advertising is also in the hands of the Federal Trade Commission (FTC). What the product contains and its intended use must be reported truthfully, and manufacturers must have proof to back up any claims they make.
What are the allowable claims?
As defined by statute and/or FDA regulations, health claims, nutrient content claims, and structure/function claims are among the claims that can be used on food and dietary supplement labels.
Health claims describe a relationship between a food substance (a food, food component, or dietary supplement ingredient) and a reduced risk of a health-related condition or disease.
The FDA exercises its oversight in determining which health claims may be used in labeling a conventional food or dietary supplement in three ways:
1) The FDA can issue regulations authorizing health claims for foods and dietary supplements after it reviews and evaluates scientific evidence, on its own initiative or in response to a health claim petition. Their authority to do so is granted by the 1990 Nutrition Labeling and Education Act (NLEA).
2) 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 may be used 120 days after a health claim notification has been submitted to FDA, unless the notifier is informed by the agency that the notification lacks some required information. This authority is granted under the 1997 Food and Drug Administration Modernization Act (FDAMA).
3) The FDA reviews petitions for qualified health claims when scientific evidence does not meet the agency’s requirements for strength and quality. This process is described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. If the supporting evidence provided is found to be credible in supporting the proposed claim, and the claim will be qualified to prevent misleading consumers, a letter of enforcement discretion will be issued by the agency. The letter will specify qualifying language to accompany the claim, and it will describe the circumstances under which it intends to exercise enforcement discretion for using the claim on food labeling.
A “health claim” has two essential components:
(1) a substance (food, food component, or dietary ingredient) and
(2) a health-related condition or disease.
NLEA provides for use of such health claims on food labeling provided they meet certain criteria and are authorized by FDA. The FDA conducts an extensive review of scientific literature, using the significant scientific agreement standard to determine whether the relationship is well established, before authorizing a substance/disease relationship health claim.
Statements that address the role of general categories of food (e.g., fruits and vegetables) or dietary patterns would be considered dietary guidance, rather than health claims. Any dietary guidance statements on food labels must be truthful and not be misleading.
Nutrient Content Claims
Nutrient Content Claims describing the level of a nutrient in a food is allowed on food labeling under the NLEA, provided the they are authorized by the FDA and made in accordance with FDA regulations.
Nutrient content claims use the terms free, high and low to describe the level of a nutrient in a product, or terms such as more, reduced or lite to compare the level of nutrient in the food compared to another food.
A statement of the amount of nutrient (e.g., 20 mg of sodium) present may be used, if it doesn’t depict the nutrient level (high or low, etc.). However, if a statement is made that describes the ingredient with a qualifier (such as “only 13 mg of sodium”) that implies a low level, the food would need to meet the nutritional criteria for the qualifying term or display a disclosure statement such as “not a low sodium food.”
Nutrients that have an established Daily Value are the subject of most regulations for nutrient content claims.
Structure/Function Claims and Related Dietary Suppliment Claims
Special regulatory procedures and requirements have been established by DSHEA for structure/function labeling claims as well as claims of general well being and nutrient deficiency disease claims. Structure/Function claims indicate the intended effect on the normal structure or function of the human body of a nutrient or dietary ingredient.
A manufacturer must have substantiation of the truthfulness of the claim and submit a notification to the FDA with the text of the claim within 30 days after marketing the dietary supplement with the claim. The claim must be accompanied by a disclaimer that the claim has not been evaluated by the FDA, and by a statement that the product is not intended to “diagnose, treat, cure or prevent any disease”. A structure/function claim cannot link the ingredient or product to any disease.