A dietary supplement is a product that contains a “dietary ingredient” intended to supplement the human diet. Dietary ingredients include: vitamins; minerals; herbs or other botanicals; amino acids; and other substances such as enzymes, extracts, or concentrates. Dietary supplements, including probiotics, which contain potentially beneficial bacteria or yeasts, may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders.
Dietary supplements are meant to supplement the diet; accordingly, the Dietary Supplement Health and Education Act of 1994 (DSHEA) defines them as a subset of foods, and they are regulated as such. As is the case with foods, FDA regulates the types of ingredients allowed in dietary supplements and the types of claims that can be made about an ingredient and/or a product. FDA also has detailed requirements for the labeling of dietary supplements (e.g., nutrition labeling, allergen labeling, statement of identity, and a net quantity statement, among others).
While dietary supplement manufacturers must ensure that their products are safe prior to marketing, FDA also has several post-marketing responsibilities to ensure the safety of dietary supplements. Among those is enforcement of the final rule on dietary supplement Current Good Manufacturing Practices (cGMPs), released on June 25, 2007. This rule is mandatory for all dietary supplement companies and it became effective for all companies in June 2010 following a three-year, phase-in period. cGMPs establish uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplement products.
FDA also oversees mandatory adverse event reporting by dietary supplement manufacturers. In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, requiring that dietary supplement manufacturers promptly communicate serious adverse events to FDA. This requirement went into effect December 22, 2007. Serious adverse events associated with the use of a dietary supplement should be reported to FDA’s MedWatch Program.
In addition, the U.S. Federal Trade Commission (FTC) regulates dietary supplement advertising. More information on FDA’s and FTC’s responsibilities are available online.
FDA does not review and approve dietary supplements based on their safety and effectiveness. Dietary supplements containing a dietary ingredient not marketed in the U.S. before October 15, 1994 (also known as a “new” dietary ingredient), require a notification to FDA 75 days before marketing. The notifcation must include information regarding the safety of the dietary supplement. FDA evaluates the safety of marketed dietary supplements through adverse event.
Consumers should feel secure that dietary supplement manufacturers are responsible for ensuring a dietary supplement product is safe before it is marketed. The manufacturer must ensure that the Supplement Facts label and ingredient list are accurate, the ingredients are safe, and the content matches the amount declared on the label. Manufacturers of dietary supplements with new dietary ingredients (defined as a dietary ingredient that was not marketed in the U.S. before October 15, 1994) must provide FDA with the information used to conclude that the product containing the new dietary ingredient is reasonably expected to be safe.
It is important for consumers to find out as much as possible about a dietary supplement before they take it. While the Internet provides a great deal of helpful information, often times it is difficult for a consumer to discern whether the information is accurate or not. The basic rule of thumb is for consumers to remember that if it sounds too good to be true, it probably is.
Consumers can always speak to their healthcare professional or contact the manufacturer of the product directly if they have any questions.
Yes! Consumers should always be sure to inform their healthcare professional about ALL of the products they are taking—prescription drugs or OTC medicines—AND dietary supplements, even if they are not asked. Dietary supplements, just like conventional foods, may potentially interact with some OTC medicines or prescription drugs, so it is very important for consumers to keep their doctor apprised.
A dietary supplement manufacturer must ensure that the Supplement Facts label and ingredient list for each product is accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. On June 25, 2007, FDA published a final rule on Current Good Manufacturing Practices (cGMPs) for dietary supplements. This uniform set of standards, which became effective for all companies in June 2010, establishes the procedures that dietary supplement manufacturers must undertake to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplement products. CHPA members have long had exacting quality standards in place, and this rule will help ensure that all manufacturers comply with stringent standards designed to prevent contaminants and impurities, and to certify that all products are accurately labeled with the type and amount of dietary ingredients they contain.
CHPA, in collaboration with the Council for Responsible Nutrition and the United Natural Products Alliance, participates in the Standardized Information on Dietary ingredients (SIDI) Workgroup, which is composed of expert volunteer member company representatives. The SIDI workgroup has developed a set of guidelines to assist dietary supplement manufacturers and ingredient or component suppliers with determining the acceptability of a potential vendor or supplier, ingredient or component for use in the manufacture of a dietary supplement. The guidelines are intended to help dietary supplement companies develop their own programs as part of complying with the Good Manufacturing Practices regulations.
Under the law, manufacturers of dietary supplement have three different categories of claims that can be used for dietary supplements: health claims, structure/function claims, and nutrient content claims. Of course, all of these claims must be truthful and not misleading. FDA provides more information on the types of claims that can be used on conventional foods and dietary supplements.
Health claims describe the connection between a nutrient or food substance and reduced risk of a disease or health-related condition and are regulated by the FDA. FDA can authorize a health claim in one of the following three ways:
Authorized Health Claim—These claims result from an extensive review of the scientific literature and the determination that the nutrient/disease relationship is well established. There must be significant scientific agreement among qualified experts regarding the relationship between the nutrient and the disease. An example of a health claim is: “Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers”. FDA has prepared a Guidance for Industry: A Food Labeling Guide, which provides a summary of approved health claims for food and dietary supplement labels.
Authoritative Statements—The Food and Drug Administration Modernization Act of 1997 allows health claims based on authoritative statements from a scientific body of the U.S. government or the National Academy of Sciences. Currently, this type of claim cannot be used for dietary supplements.
Qualified Health Claims—When the strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation, a qualified health claim may be allowed. As with a standard health claim, qualified health claims are reviewed for accuracy and to ensure that they are not misleading to consumers. The Agency permits their use provided they are accompanied with appropriate disclaimers to ensure their truthfulness.
Nutrient content claims describe the level of a nutrient in a food or dietary supplement. For example, a supplement containing at least 200 milligrams could carry the claim “high in calcium.” Percentage claims for dietary supplements, used to describe a percentage level of a dietary ingredient for which there is no established Daily Value, are another category of nutrient content claims. A summary of the rules for use of nutrient content claims can be found in the FDA Guidance on Food Labeling.
Structure/function claims are statements that describe the role of a nutrient or a dietary supplement intended to affect the structure or function of the body, the mechanism of how it helps to maintain that structure or function, or general well being. Because FDA does not pre-clear structure/function claims, they must be accompanied by the disclaimer: “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.” An example of a structure/function claim is: “Ginseng will help maintain your natural energy.”
FDA’s website provides additional information about the three categories of dietary supplement claims.
No1. But like any other industry, the dietary supplement industry is susceptible to fraudulent or disreputable marketers. The good news is that under the auspices of DSHEA, FDA has the authority to stop any company from making a claim that a product cures or treats a disease. In fact, FDA and FTC often work in concert with the support of reputable manufacturers, to chase down the industry’s “bad actors”. Over the past decade, the FTC has filed over one hundred cases challenging health claims made for supplements. FTC’s website provides a list of more recent actions taken against false or misleading health claims. Visit FTC’s webiste to report a claim that you think may be false or misleading.
While federal regulations do not require dietary supplement manufacturers to include an expiration date on their products, most dietary supplements have some type of expiration or “use by” date on the label.
Dietary supplement manufacturers must ensure that their products contain at least the labeled amount for each of the ingredients up until the expiration date (if there is an expiration date listed). As some ingredients in dietary supplements, such as vitamins, can naturally lose activity and or potency over time, dietary supplement manufacturers may need to increase the amount of the ingredient they add at the time of manufacturing to maintain compliance with the law. As is true for all dietary supplements, the manufacturer is responsible for ensuring that the product is safe.
Always check with your healthcare professional and read the label before taking any dietary supplement product. The Institute of Medicine has defined the Tolerable Upper Intake Level (UL) for 24 different nutrients. The UL is the maximum amount of daily nutrient you can take that is unlikely to pose any risk of adverse health effect for most people in the general population. As intake increases above the UL, your risk of experiencing an adverse event increases.
Prior to the initial implementation of FDA-enforced cGMPs in 2008, CHPA established a number of voluntary guidelines for dietary supplements that members agreed to follow. These include a number of ingredient specific guidelines, as well as additional guidelines on disclosure of added constituents, and a pregnancy/nursing labeling statement. More recently, CHPA, in collaboration with member companies, developed a guideline for use by manufacturers of dietary supplement products containing probiotic ingredients as well as one for caffeine-containing dietary supplements. In concert with the Current Good Manufacturing Practices regulations, these guidelines help to ensure quality in the manufacturing, packaging, advertising, and labeling of dietary supplements.