- What is a dietary supplement?
- Are dietary supplements regulated by the federal government?
- Why should consumers feel secure about the safety of the dietary supplement products they purchase?
- Should consumers discuss what dietary supplement products they are taking with their doctor?
- How can consumers be sure the products they are taking contain what is indicated on the labeling?
- Are dietary supplement products allowed to claim to treat diseases?
- What type of claims can be made about dietary supplement products?
- What is a dietary supplement?
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 may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders.
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- Are dietary supplements regulated by the federal government?
Yes. This is probably the most commonly misunderstood fact about the dietary supplement industry. Most of the misunderstanding occurs when people confuse dietary supplements with drugs and expect them to be regulated in the same manner. 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. Under DSHEA, the U.S. Food and Drug Administration (FDA) has several post-marketing responsibilities to ensure the safety of dietary supplements. Among those is enforcement of the final rule on dietary supplement Good Manufacturing Practices (GMPs), released on June 25, 2007. This rule establishes uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and holding 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.
In addition, the U.S. Federal Trade Commission (FTC) regulates dietary supplement advertising. For more information on FDA’s and FTC’s responsibilities, click here.
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- Why should consumers feel secure about the safety of the dietary supplement products they purchase?
The manufacturer of a dietary supplement product is 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, that the ingredients are safe, and that the content matches the amount declared on the label. Manufacturers also must tell FDA when they make structure/function claims. Manufacturers of dietary supplements with new dietary ingredients 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. CHPA and the National Consumers League also have a consumer information brochure available to the public free of charge.
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- Should consumers discuss what dietary supplement products they are taking with their doctor?
Yes! Consumers should always be sure to inform their healthcare professional about ALL of the products they are taking—prescription drugs, over-the-counter (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.
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- How can consumers be sure the products they are taking contain what is indicated on the labeling?
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. That is why the final rule (published June 25, 2007) by FDA on Good Manufacturing Practices (GMPs) for dietary supplements is so important. This new, uniform set of standards establishes the GMPs needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplement products and will provide consumers with confidence that the products they take are manufactured under strict controls. CHPA members have long had exacting quality standards in place, and this rule will help ensure that all manufacturers comply with the same stringent standards to safeguard quality against contaminants and impurities, and to certify that all products are accurately labeled with the type and amount of dietary ingredients they contain.
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- Are dietary supplements allowed to claim to treat diseases?
No. But the bad news is that the dietary supplement industry, like any other 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. One example of this cooperation was an April 2003 joint industry coalition press release advising consumers not to use dietary supplement products that claim to treat Severe Acute Respiratory Syndrome, or SARS. FDA and FTC followed this effort by initiating a joint agency campaign warning web site operators to remove misleading or deceptive claims from the Internet immediately. Most recently, a joint industry coalition issued a release advising against the use of dietary supplements as a remedy or cure for swine flu.
To view FDA’s latest series of warning letters, visit www.fda.gov/foi/warning.htm.
To view FTC’s dietary supplement advertising guidelines for industry, visit http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm.
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- What type of claims can be made about dietary supplement products?
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.
- Health claims describe the connection between a nutrient or food substance and a disease or health-related condition. FDA must authorize a claim based on a review of scientific evidence or based on a statement from certain authoritative scientific bodies. FDA recently announced a new science-based labeling process that will use expertise from other government agencies or information from companies to review qualified health claims before they appear in food (including dietary supplements) labeling. While qualified health claims are not actually approved by FDA under the normal standard, the Agency permits their use provided they are accompanied with appropriate disclaimers to ensure their truthfulness. The goal of the Agency is to encourage more science based labeling through a competitive grading system. 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.”
- 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.”
- 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 maintains 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.”
For more information about the three categories of dietary supplement claims, visit http://www.cfsan.fda.gov/~dms/hclaims.html.
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