Dietary SupplementsFDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.This section provides detailed information about:Q&A on Dietary SupplementsFrequently asked questions about dietary supplements, including definitions, labeling requirements, and regulatory roles and responsibilities.Using Dietary SupplementsTips for dietary supplement users, including older supplement users.Report an Adverse EventLearn how consumers, health care providers, and others can report a complaint, concern, or problem related to dietary supplements. Includes links to guidance for dietary supplement manufacturers, packers, and distributors.New Dietary Ingredients Notification ProcessBackground information for industry, instructions for submitting premarket notifications, and links to relevant guidance and Federal Register documents.Ensuring the Safety and Accurate Labeling of Dietary Supplements

Although dietary supplement manufacturers must register their facilities with FDA,* they are not required to get FDA approval before producing or selling dietary supplements. Manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading.Under FDA regulations at 21 CFR part 111, all domestic and foreign companies that manufacture, package, label or hold dietary

supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control.In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.FDA regulates dietary supplement labels and other labeling, such as package inserts and accompanying literature. The Federal Trade Commission (FTC) regulates dietary supplement advertising.*Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with FDA. For more information, see Registration of Food Facilities.

Q&A on Dietary SupplementsWhat is a dietary supplement?

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.What is a "new dietary ingredient" in a dietary supplement?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must

be one or any combination of the following substances: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract.

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.back to topShould I check with my doctor or healthcare provider before using a supplement?

See Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information.What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current

Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information, see new dietary ingredients.What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.back to topMust all ingredients be declared on the label of a dietary supplement?

Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and

sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: Federal Register Final Rule - 62 FR 49826 September 23, 1997.Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.back to topWhere can I get information about a specific dietary supplement?

Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.What are some tips on searching the web for information on dietary supplements?

See Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information.Who has the responsibility for ensuring that a dietary supplement is safe?

By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products 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 or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. 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 that are reported to them

directly. FDA is able to evaluate these reports and any other adverse event information reported directly to us by healthcare 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 Dietary Supplements - Adverse Event Reporting.back to topDo manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?

No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information, see claims that can be made for dietary supplements

Label Claims for Conventional Foods and Dietary Supplements

December 2013

Among the claims that can be used on food and dietary supplement labels are three

categories of claims that are defined by statute and/or FDA regulations: health claims,

nutrient content claims, and structure/function claims.

I. Health Claims

Health claims describe a relationship between a food substance (a food, food component,

or dietary supplement ingredient), and reduced risk of a disease or health-related

condition. There are three ways in which FDA exercises its oversight in determining

which health claims may be used on a label or in labeling for a conventional food or

dietary supplement: 1) the 1990 Nutrition Labeling and Education Act (NLEA) provides

for FDA to issue regulations authorizing health claims for foods and dietary supplements

after reviewing and evaluating the scientific evidence, either in response to a health claim

petition or on its own initiative; 2) the 1997 Food and Drug Administration

Modernization Act (FDAMA) provides for 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; such

claims may be used 120 days after a health claim notification has been submitted to FDA,

unless the agency has informed the notifier that the notification does not include all the

required information; and 3) as described in FDA’s guidance entitledInterim Procedures

for Qualified Health Claims in the Labeling of Conventional Human Food and Human

Dietary Supplements, the agency reviews petitions for qualified health claims where the

quality and strength of the scientific evidence falls below that required for FDA to issue

an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is

credible and the claim can be qualified to prevent it from misleading consumers, the

agency issues a letter of enforcement discretion specifying the qualifying language that

should accompany the claim and describing the circumstances under which it intends to

exercise enforcement discretion for use of the claim in food labeling. The differences

between these three methods of oversight for health claims are summarized below.

Appendix C of The Food Labeling Guidecontains a summary of those health claims that

have been approved for use on food and dietary supplement labels. A Food Labeling

Guide - Appendix C: Health Claims.

A "health claim" by definition has two essential components: (1) a substance (whether a

food, food component, or dietary ingredient) and (2) a disease or health-related condition.

A statement lacking either one of these components does not meet the regulatory

definition of a health claim. For example, statements that address a role of dietary

patterns or of general categories of foods (e.g., fruits and vegetables) in maintaining good

health are considered to be dietary guidance rather than health claims. Dietary guidance

statements used on food labels must be truthful and non-misleading. Statements that

address a role of a specific substance in maintaining normal healthy structures or

functions of the body are considered to be structure/function claims; see

Structure/Function Claims. Unlike health claims, dietary guidance statements and

structure/function claims are not subject to premarket review and authorization by FDA.

NLEA Authorized Health Claims. The Nutrition Labeling and Education Act of 1990

(NLEA) provides for the use in food labeling of health claims that characterize a

relationship between a food, a food component, or dietary ingredient and risk of a disease

(for example, "adequate calcium throughout life may reduce the risk of osteoporosis"),

provided the claims meet certain criteria and are authorized by an FDA regulation. FDA

authorizes these types of health claims based on an extensive review of the scientific

literature, generally as a result of the submission of a health claim petition, using the

significant scientific agreement standard to determine whether the substance/disease

relationship is well established.

Health Claims Based on Authoritative Statements. The Food and Drug Administration

Modernization Act of 1997 (FDAMA) provides a second way for the use of a health

claim in food labeling to be authorized. Under FDAMA, a new health claim can be

authorized by submitting a notification to FDA of a claim based on an "authoritative

statement" from certain scientific bodies of the U.S. Government or the National

Academy of Sciences. FDA has issued guidance on how a firm can submit such a

notification and make use of authoritative statement-based health claims. This guidance

can be found at: Notification of a Health Claim or Nutrient Content Claim Based on an

Authoritative Statement of a Scientific Body. FDAMA does not include dietary

supplements in the provisions for health claims based on authoritative statements.

Consequently, this method of oversight for health claims cannot be used for dietary

supplements at this time. Examples of health claims based on authoritative statements

may also be found at: A Food Labeling Guide - Appendix C: Health Claims.

Qualified Health Claims. FDA's Interim Procedures for Qualified Health Claims in the

Labeling of Conventional Human Food and Human Dietary Supplements describes the

agency’s process for considering petitions for the use of a qualified health claim in food

labeling. When there is emerging evidence for a relationship between a food substance (a

food, food component, or dietary ingredient) and reduced risk of a disease or health-

related condition, but the evidence is not well enough established to meet the significant

scientific agreement standard required for FDA to issue an authorizing regulation, the

qualified health claim petition process provides a mechanism to request that FDA review

the scientific evidence and exercise enforcement discretion to permit the use of the

qualified claim in food labeling. If, after evaluating the quality and strength of the totality

of the scientific evidence, FDA finds that credible evidence supports the claim, the

agency issues a letter outlining the circumstances under which it intends to consider the

exercise of enforcement discretion for use of the claim in food labeling. Qualifying

language is included as part of the claim to indicate that the evidence supporting the

claim is limited. Although FDA's letters of enforcement discretion are issued to the

petitioner requesting the qualified health claim, the qualified claims are available for use

on any food or dietary supplement product meeting the enforcement discretion conditions

specified in the letter. FDA has issued guidance on interim procedures for qualified health

claims (see Interim Procedures for Qualified Health Claims in the Labeling of

Conventional Human Food and Human Dietary Supplements) and on the scientific

criteria the agency uses in conducting health claim evaluations (see Evidence-Based

Review System for the Scientific Evaluation of Health Claims). Qualified health claim

petitions that are submitted to FDA will be available for public review and comment. A

listing of petitions open for public comment is at the FDA Dockets Management website.

A summary of the qualified health claims authorized by FDA may be found at: Qualified

Health Claims Subject to Enforcement Discretion. For more information see Qualified

Health Claims.

II. Nutrient Content Claims

The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label

claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if

they have been authorized by FDA and are made in accordance with FDA's authorizing

regulations. Nutrient content claims describe the level of a nutrient in the product, using

terms such as free, high, and low, or they compare the level of a nutrient in a food to that

of another food, using terms such as more, reduced, and lite. An accurate quantitative

statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient

level may be used to describe the amount of a nutrient present. However, a statement

such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is

low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient

content claim or carry a disclosure statement that it does not qualify for the claim (e.g.,

“not a low sodium food”). Most nutrient content claim regulations apply only to those

nutrients that have an established Daily Value: A Food Labeling Guide - VII. Nutrition

Labeling. The requirements that govern the use of nutrient content claims help ensure that

descriptive terms, such as high or low, are used consistently for all types of food products

and are thus meaningful to consumers. Healthy is an implied nutrient content claim that

characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and

sodium, as defined in the regulation authorizing use of the claim. Percentage claims for

dietary supplements are another category of nutrient content claims. These claims are

used to describe the percentage level of a dietary ingredient in a dietary supplement and

may refer to dietary ingredients for which there is no established Daily Value, provided

that the claim is accompanied by a statement of the amount of the dietary ingredient per

serving. Examples include simple percentage statements such as "40% omega-3 fatty

acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3

fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." (See 21 CFR

101.13(q)(3)(ii)). A summary of the rules for use of nutrient content claims can be found

in Chapter VI of The Food Labeling Guide. Examples of nutrient content claims can be

found in Appendices A and B of The Food Labeling Guide: Appendix A: Definitions of

Nutrient Content Claims and Appendix B: Additional Requirements for Nutrient Content

Claims.

III. Structure/Function Claims and Related Dietary Supplement Claims

Structure/function claims have historically appeared on the labels of conventional foods

and dietary supplements as well as drugs. The Dietary Supplement Health and Education

Act of 1994 (DSHEA) established some special regulatory requirements and procedures

for using structure/function claims and two related types of dietary supplement labeling

claims, claims of general well-being and claims related to a nutrient deficiency disease.

Structure/function claims may describe the role of a nutrient or dietary ingredient

intended to affect the normal structure or function of the human body, for example,

"calcium builds strong bones." In addition, they may characterize the means by which a

nutrient or dietary ingredient acts to maintain such structure or function, for example,

"fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-

being claims describe general well-being from consumption of a nutrient or dietary

ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient

deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they

also say how widespread the disease is in the United States. These three types of claims

are not pre-approved by FDA, but the manufacturer must have substantiation that the

claim is truthful and not misleading and must submit a notification with the text of the

claim to FDA no later than 30 days after marketing the dietary supplement with the claim.

If a dietary supplement label includes such a claim, it must state in a "disclaimer" that

FDA has not evaluated the claim. The disclaimer must also state that the dietary

supplement product is not intended to "diagnose, treat, cure or prevent any disease,"

because only a drug can legally make such a claim. Structure/function claims may not

explicitly or implicitly link the claimed effect of the nutrient or dietary ingredient to a

disease or state of health leading to a disease. Further information regarding

structure/function claims can be found in FDA's January 9, 2002 Structure/Function

Claims Small Entity Compliance Guide.

Structure/function claims for conventional foods focus on effects derived from nutritive

value, while structure/function claims for dietary supplements may focus on non-nutritive

as well as nutritive effects. FDA does not require conventional food manufacturers to

notify FDA about their structure/function claims, and disclaimers are not required for

claims on conventional foods.

This document was issued on March 20, 2001 and revised October 2001, September 2003, and December 2013.

How can consumers inform themselves about safety and other issues related to dietary supplements?

It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase (see previous question "Where can I get information about a specific dietary supplement?"). In addition, to help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for

Conventional Foods and Dietary Supplements, (provides information on what types of claims can be made for dietary supplements).back to topWhat is FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.Does FDA routinely analyze the content of dietary supplements?

In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.back to topIs it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?

No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--

drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.Who validates claims and what kinds of claims can be made on dietary supplement labels?

FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and aredescribed in more detail.back to topWhy do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.How are advertisements for dietary supplements regulated?

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is

directed by different laws. For more information on FTC, go to the FTC web site . Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.back to topHow do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?

If you think you have suffered a serious harmful effect or illness from a dietary supplement, the first thing you should do is contact or see your healthcare provider immediately. Then, you or your health care provider can report this by submitting a report through the Safety Reporting Portal. If you do not have access to the internet, you may submit a report by calling FDA's MedWatch hotline at 1-800-FDA-1088.FDA would like to know when a dietary supplement causes a problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic. Anyone may report a serious adverse event or illness thought to be related to a dietary supplement directly to FDA by accessing the SRP mentioned above.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.In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.NOTE: The identity of the reporter and/or patient is kept confidential. For a general complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: Consumer Complaint Coordinators15.