If you think you have suffered a harmful effect or illness (an "adverse event") from a dietary supplement, the first thing you should do is contact or see your health care provider immediately. Then, you or your health care provider can report the adverse event to FDA by submitting a report through the Safety Reporting Portal. We also ask that you inform us at Prime Time Health so that we can be aware of the issue and help to resolve it in a speedy and professional manner.
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product intended for ingestion that, among other requirements, contains a "dietary ingredient" intended to supplement the diet. The term "dietary ingredient" includes vitamins and minerals; herbs and other botanicals; amino acids; "dietary substances" that are part of the food supply, such as enzymes and live microbials (commonly referred to as "probiotics"); and concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient from the preceding categories.
There are two types of ingredients that may be used in dietary supplements: “dietary ingredients,” discussed above, and “other ingredients.” These “other ingredients” include substances such as fillers, binders, excipients, preservatives, sweeteners, and flavorings.
Dietary supplements are products that are ingested – specifically, they must be swallowed – so, for example, topical or inhaled products are not supplements. Dietary supplements may be found in many forms, such as pills, tablets, capsules, gummies, softgels, liquids, and powders. They can also be in the same form as a conventional food category, such as teas or bars, but only if the product is not represented as a conventional food or as a "sole item of a meal or the diet." To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term "dietary supplement" or equivalent (e.g., "iron supplement" or "herbal supplement").
Generally, the dietary supplement definition excludes ingredients that are approved as new drugs, licensed as biologics, or authorized for clinical investigation under an investigational new drug application (IND) that has gone into effect, unless the ingredient was previously marketed as a dietary supplement or as a food. In the case of ingredients authorized for clinical investigation under an IND, the exclusion from the dietary supplement definition applies only if "substantial clinical investigations" have been instituted and the existence of such investigations has been made public.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the terms "dietary ingredient" and "new dietary ingredient." To be a "dietary ingredient," an ingredient in a dietary supplement must be one of the following:
A "new dietary ingredient" is an ingredient that meets the definition of a "dietary ingredient" and was not marketed in the United States before October 15, 1994.
Yes. FDA advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use a dietary supplement. For example, some supplements might interact with medicines or other supplements.
Please see Information for Consumers on Using Dietary Supplements for additional educational materials.
The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a new regulatory framework for dietary supplements. Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed. Generally, a firm does not have to provide FDA with the evidence it relies on to substantiate safety before or after it markets its products; however, there is an exception for dietary supplements that contain a new dietary ingredient that is not present in the food supply as an article used for food in a form in which the food has not been chemically altered. At least 75 days before introducing such a dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to FDA with the information on the basis of which the firm has concluded that the NDI-containing dietary supplement will reasonably be expected to be safe. In addition, FDA’s regulations require those who manufacture, package, or hold dietary supplements to follow current good manufacturing practices that help ensure the identity, purity, quality, strength, and composition of dietary supplements. FDA generally does not approve dietary supplement claims or other labeling before use.
Under the FD&C Act, a firm is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated, misbranded, or otherwise in violation of federal law. If a manufacturer or distributor makes a structure/function claim (a claim about effects on a structure or function of the human body), a claim of a benefit related to a classical nutrient deficiency disease, or a claim of general well-being in the labeling of a dietary supplement, the firm must have substantiation that the claim is truthful and not misleading. Facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States must register with FDA, as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and implementing regulations, before beginning such operations.
FDA is responsible for enforcing the laws and regulations governing dietary supplements. To identify violations, the agency conducts inspections, monitors the marketplace, examines dietary supplements and dietary ingredients offered for import, and reviews NDI notifications and other regulatory submissions for dietary supplements (e.g., postmarket notifications of a structure/function claim or other claim made under section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)). We also investigate adverse event reports and complaints from consumers, health care professionals, other regulatory agencies, and industry.
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA in advance and submit safety information if it intends to market a dietary supplement in the United States that contains a "new dietary ingredient," unless the new dietary ingredient is present in the food supply as an article used for food in a form in which the food has not been chemically altered. The notification must be submitted to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce. Along with information about the new dietary ingredient and the dietary supplement in which it will be marketed, the notification must include the safety information on which the notifier has based its conclusion that the new dietary ingredient will be reasonably expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement.
FDA regulations require dietary supplement labels to bear a product name and a statement that it is a "dietary supplement" or equivalent term replacing "dietary" with the name or type of dietary ingredient in the product (e.g., "iron supplement" or "herbal supplement"); the name and place of business of the manufacturer, packer, or distributor; nutrition labeling in the form of a "Supplement Facts" panel (except for some small volume products or those produced by eligible small businesses); a list of "other ingredients" not declared in the Supplement Facts panel; and the net quantity of contents. The Supplement Facts panel must list the serving size and number of servings per container, declare each dietary ingredient in the product, and except for dietary ingredients that are part of a proprietary blend, provide information on the amount of the dietary ingredient per serving. Depending on the type of ingredient, the amount per serving must be declared as a quantitative amount by weight, as a percentage of the Daily Value, or both. Finally, dietary supplement labels must provide a domestic address or domestic phone number for reporting serious adverse events to the manufacturer, packer, or distributor whose name and place of business are listed on the label.
Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "Other Ingredients" list beneath. The types of ingredients listed there could include the sources of dietary ingredients, if not listed in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), food additives, and color additives. Gelatin, starch, stabilizers, preservatives, and flavors are additional examples of ingredients commonly declared in the "Other Ingredients" list.
Other than the manufacturer's responsibility to meet the safety standards and labeling requirements for dietary supplements and to comply with current good manufacturing regulations, there are no laws or regulations that limit the serving size of a dietary supplement or the amount of a dietary ingredient that can be in a serving of a dietary supplement. This decision is made by the manufacturer and does not require FDA approval.
Because FDA does not approve dietary supplements before they are marketed, the agency often does not know when new products come on the market. Therefore, we are not able to keep a complete list of all dietary supplements sold in the United States. If you want more detailed information about a specific dietary supplement than the label provides, we recommend that you contact the manufacturer of the product directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.
Because the law prohibits the distribution and sale of adulterated dietary supplements, manufacturers and distributors have initial responsibility for ensuring that their dietary supplements meet the safety standards for dietary supplements. When manufacturers and distributors do not fulfill that responsibility and adulterated dietary supplements reach the market, FDA has authority to enforce the law to protect consumers. In general, FDA is limited to postmarket enforcement because, unlike drugs that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to approve dietary supplements for safety before they reach the consumer. However, manufacturers and distributors of dietary supplements must record, investigate, and forward to FDA any reports they receive of serious adverse events associated with the use of their products. FDA evaluates these reports and any other adverse event information reported by health care providers or consumers to identify early signals that a product may present safety risks to consumers. You can find more information on reporting adverse events associated with the use of dietary supplements at How to Report a Problem with Dietary Supplements.
It is important to be well informed about health-related products before purchasing them. FDA advises consumers to consult with a health care professional before deciding to take a dietary supplement. Consumers should also carefully read the label of any dietary supplement they are thinking of using. To help consumers in their search to be better informed, FDA has prepared additional educational materials. Please visit Information for Consumers on Using Dietary Supplements.
Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the agency's oversight of these products. FDA’s role in regulating dietary supplements includes (among other things) inspecting dietary supplement manufacturing establishments, reviewing new dietary ingredient (NDI) notifications and other regulatory submissions for dietary supplements, investigating complaints, monitoring the dietary supplement marketplace, examining dietary supplements and dietary ingredients offered for import to determine whether they meet U.S. requirements, and reviewing adverse event reports from firms, consumers, and health care providers to identify products that may be unsafe. However, by law, FDA does not approve dietary supplements or their labeling, although certain types of claims sometimes used in dietary supplement labeling require premarket review and authorization (e.g., health claims).
No. FDA has limited resources to analyze the composition of food products, including dietary supplements, and, therefore, focuses its resources first on public health emergencies and products that may have caused injury or illness. Priority then goes to products suspected to be adulterated, fraudulent, or otherwise in violation of the law. The remaining resources are used to analyze product samples collected during inspections of manufacturing firms or pulled from store shelves as part of FDA’s routine monitoring of the marketplace. FDA does not test dietary supplements before they are sold to consumers. Consumers may contact the dietary supplement manufacturer or a commercial laboratory for an analysis of a product’s content.
No, a product sold as a dietary supplement and represented explicitly or implicitly for treatment, prevention, or cure of a specific disease or class of diseases meets the definition of a drug and is subject to regulation as a drug.
The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements. FDA and FTC share responsibility for the oversight of dietary supplements and related promotion, with FDA generally responsible for safety, quality, and labeling, and FTC generally responsible for advertising. Both FDA and FTC have the authority to take enforcement actions against dietary supplements and firms if they identify violations. In addition, FDA considers advertising when evaluating the intended use of a product labeled as a dietary supplement. For more information on FTC’s role in regulating dietary supplement advertising, please visit the FTC website. Advertising and other promotional material sent through the mail are also subject to regulation by the U.S. Postal Inspection Service.
Among the claims that can be used on dietary supplement labels are three categories of claims that are defined by the FD&C Act and FDA regulations: health claims (claims about the relationship between a dietary ingredient or other food substance and reduced risk of a disease or health-related condition), structure/function claims (claims about effects on a structure or function of the human body), and nutrient content claims (claims characterizing the level of a nutrient or other dietary ingredient in a dietary supplement). Different requirements apply to each of these claim types. For more information on the regulation of health claims, structure/function claims, and nutrient content claims, please see Label Claims for Conventional Foods and Dietary Supplements.
Two less common types of dietary supplement labeling claims defined by statute are claims of a benefit related to a classical nutrient deficiency disease (when accompanied by a statement disclosing the prevalence of the nutrient deficiency disease in the United States) and claims of general well-being from consumption of a nutrient or other dietary ingredient. These dietary supplement claims are subject to the same requirements as structure/function claims, including the disclaimer that must accompany the claim and the requirement for the manufacturer to have substantiation that the claim is truthful and non-misleading. Finally, dietary supplements, like conventional foods, may make other labeling claims that are not defined by statute or regulation (e.g., claims about taste or ingredient quality), as long as those claims are not false or misleading.
The U.S. Department of Agriculture (USDA) regulates the use of the term “organic” under the National Organic Program (NOP). NOP is a federal regulatory program that develops and enforces consistent national standards for organically produced agricultural products sold in the United States.
This statement, known as a "disclaimer," is required by law (21 U.S.C. 343(r)(6)(C) and 21 CFR 101.93(b)–(d)) when a manufacturer makes a structure/function claim or certain other claims in dietary supplement labeling. In general, structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans or characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function. The other dietary supplement labeling claims that require the disclaimer are claims of a benefit related to a classical nutrient deficiency disease and claims of general well-being from consumption of a dietary ingredient. These three types of claims are not approved by FDA and do not require FDA evaluation before they are used in dietary supplement labeling. Accordingly, DSHEA requires that when a dietary supplement label or other labeling includes such a claim, the claim must be accompanied by a disclaimer informing consumers that FDA has not evaluated the claim. The disclaimer must also state that the product is not intended to "diagnose, treat, cure, or prevent any disease" because only a drug can legally make such a claim.
If you think you have suffered a harmful effect or illness (an "adverse event") from a dietary supplement, the first thing you should do is contact or see your health care provider immediately. Then, you or your health care provider can report the adverse event to FDA by submitting a report through the Safety Reporting Portal.
FDA would like to know when you experience a health problem thought to be related to a dietary supplement, even if you are unsure the product caused the problem and even if you do not visit a doctor or clinic. Anyone may report an adverse event thought to be related to a dietary supplement directly to FDA by accessing the Safety Reporting Portal.
Consumers are also encouraged to report instances of product problems using the Safety Reporting Portal. Examples of product problems are foreign objects in the packaging or other apparent quality defects.
NOTE: The identity of the patient and the reporter of the adverse event are kept confidential. For a general complaint or concern about food products, including dietary supplements, visit Industry and Consumer Assistance.
