Recognizing that dietary supplements play a valuable role in promoting improved health and well-being, in 1994 the Congress enacted a comprehensive new law changing the way in which vitamins, minerals, herbs and specialty supplements are regulated by the federal government. Called the Dietary Supplement Health and Education Act (DSHEA), this law gives considerable power to the federal government to ensure the safety of supplements and the accuracy of health claims. At the same time, DSHEA recognized the importance of funding additional scientific studies on the relationship between supplements and disease prevention and created the Office of Dietary Supplements within the National Institutes of Health to coordinate this research.
We founded the DSIB to ensure that the goals of the Dietary Supplement Health and Education Act (DSHEA) are met by providing meaningful information about the health benefits and responsible use of dietary supplements to all Americans.
Because DSHEA set up a new framework for regulating dietary supplements, questions persist about how these products are regulated at the federal level. Accordingly, what follows is a review of the regulations now in place to ensure that only safe, beneficial, and quality supplements are marketed to the American public.
Dietary Supplements: Establishing a Formal Definition
In passing DSHEA, Congress recognized that consumers would benefit from having expanded and well-informed access to properly regulated vitamins, minerals, amino acids, herbs and other substances. For this reason, DSHEA defines a "dietary supplement" as a product that:
Contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract or combination of these ingredients
Is intended for ingestion in pill, capsule, tablet or liquid form, unless…
It is not represented for use as a conventional food or as the sole item of a meal or diet
It is labeled as a "dietary supplement"
An Emphasis on Safety
Before DSHEA, there was considerable confusion over how to regulate dietary supplements. Specifically, the U.S. Food and Drug Administration (FDA) regulated these products either as foods or as drugs, depending on their intended use, or sometimes as food additives like artificial colors. To resolve these inconsistencies, Congress determined that the FDA should regulate supplements with the same safety requirements that the agency applies when regulating commonly used foods. This means that like most other foods, it is the manufacturer's responsibility to ensure that the company's products are safe and properly labeled prior to marketing.
Just as the FDA doesn't require pre-market approval for foods with a very long history of safe use, the new law applies the same principle to dietary supplements that do not contain new dietary ingredients. For products containing a new ingredient (one not marketed in the U.S. before 1994), DSHEA requires manufacturers to submit data to the FDA demonstrating that the new ingredient does not present a safety risk under the conditions of use. Another option is for manufacturers to petition the FDA, asking the agency to establish the conditions under which the new dietary ingredient would reasonably be expected to be safe.
In addition, the FDA has considerable enforcement authority over dietary supplements that are on the market. Specifically, the FDA has the power to:
Stop any company from selling a dietary supplement that is "adulterated" or misbranded
Stop the sale of a dietary supplement that makes false or unsubstantiated claims
Take action against any dietary supplement that poses "a significant or unreasonable risk of illness or injury"
Stop any company making a claim that a product cures or treats a disease
Require dietary supplements to meet strict manufacturing standards, including potency, cleanliness and stability
Comprehensive Labeling Requirements
Like foods, dietary supplements are required to carry ingredient labeling. This information must include the name and the net quantity of contents on the principle display panel. The label must also list all ingredients that do not appear in the supplement facts information panel in the order of their amount in the product.
But unlike foods, the law spells out a number of labeling requirements for dietary supplements that are unique. Specifically, these rules call for:
Inclusion of the term "dietary supplement" (or similar terms such as "herbal supplement") as part of the statement of identity
Stating the quantity of each dietary ingredient or for combination products, the total quantity of all dietary ingredients in the blend
Most importantly for consumers, the new law requires that dietary supplements provide nutritional labeling. This labeling, called a "Supplement Facts" information panel, lists the amount of calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins, and minerals. The Supplement Facts panel must also include the quantity per serving for each dietary ingredient (or blend) and may describe the source of a dietary ingredient (for example, "calcium from Calcium gluconate").
Regulating Health Benefit Claims
To help consumers make informed decisions about using dietary supplements, the law sets out very stringent requirements for when manufacturers can make claims about the health benefits of their products. Based upon DSHEA and specific food labeling laws, FDA has issued regulations that allow dietary supplement manufacturers to make three types of claims: 1) nutrient-content claims, 2) health claims, and 3) structure-function claims.
With nutrient-content claims, the regulations are straightforward: based on FDA's requirements, when a supplement contains a high enough level of a nutrient, the product can carry a claim such as "high in calcium" or "an excellent source of vitamin C." FDA also authorizes health-related claims for foods and dietary supplements when there is a documented link between a food/dietary supplement and a health-related condition. Here, FDA has by regulation established approved health-related claims based on a review of the scientific evidence for significant scientific agreement, or based upon an authoritative statement from a scientific body like the National Academy of Sciences. The following six claims apply to dietary supplements:
Folic acid and a decreased risk of birth defects
Calcium and a lower risk of osteoporosis
Potassium and the reduced risk of high blood pressure and stroke
Psyllium seed husk (as part of a diet low in cholesterol and saturated fat) and a reduced risk of coronary heart disease
Soy protein and the reduced risk of coronary heart disease
Plant sterol/stanol esters and the reduced risk of coronary heart disease
Finally, the law allows information describing the supplement's effect on the body's structure or function, such as Vitamin E supports a healthy heart, or fiber maintains bowel regularity. To use these claims, manufacturers must have scientific data to substantiate the statement and the product label must bear this notice: "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." In addition, FDA requires marketers to inform the agency of the use of the claim no later than 30 days after the product is first marketed and to certify that they can substantiate the claim, if challenged. Knowingly filing a false certification is a crime.
While DSHEA permits manufacturers that qualify to make structure-function claims, the law specifically prohibits disease claims for dietary supplements. For this reason, FDA has developed regulations that distinguish between a structure-function claim and a disease claim. Under these regulations, for example, a product cannot carry the claim "cures cancer" or "treats arthritis" or make statements that the product is a substitute for an approved therapy.
While FDA has primary responsibility for regulating the safety and labeling of dietary supplements, the Federal Trade Commission (FTC) has authority over claims in advertising, infomercials, catalogs, web sites, and direct marketing materials. Accordingly, FTC issued "Dietary Supplements: An Advertising Guide for Industry" in which the agency states that both strong scientific substantiation and a careful presentation of the facts are the criteria that FTC relies on in regulating the advertising and Internet marketing of dietary supplements.
When FTC determines that the claim is unfounded, the agency has the power to:
Challenge and stop advertising that is not adequately substantiated
Investigate complaints or questionable trade practices. Here, the agency has the power to require a company to produce documents, give testimony, and provide answers to written questions
Negotiate a consent order or work through the administrative and/or federal courts to obtain a cease and desist order, which can be very broad in scope
Seek preliminary or permanent injunctions to stop false advertisements or other marketing practices
Seek civil penalties from violators
As this description makes clear, the dietary supplement industry is subject to extensive laws and regulations at the federal level, all of which are designed to ensure that safe, beneficial and quality supplements are available for health promotion and disease management. When viewed in this manner, the public can have confidence that the regulatory framework now in place gives consumers greater access to a wide range of dietary supplements while making sure that products that don't meet government requirements are removed from the market.