Dietary Supplement

What is Dietary Supplement

The law defines dietary supplements in part as products taken by mouth that contain a “dietary ingredient.” Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet.

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.

How Are Dietary Supplements Regulated?

Dietary supplements are regulated by the FDA as food, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it is important to consult with a health care professional before using any dietary supplement.

You should know the following if you are considering using a dietary supplement.

• Federal law requires that every dietary supplement be labeled as such, either with the term “dietary supplement” or with a term that substitutes a description of the product's dietary ingredient(s) for the word “dietary” (e.g., “herbal supplement” or “calcium supplement”).
• Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
• For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
• In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
• Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
• Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
• Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
• Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
• It is not legal to market a dietary supplement product as a treatment or cure for a specific disease or to alleviate the symptoms of a disease.
• There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.

In-Depth Coverage: Importing Food Products 

• What is FDA Food Safety Modernization Act (FSMA)? 
• Prior Notice of Imported Foods
• FDA Food Facility Registration
• Risk-Based Preventive Controls for Human Food
• Risk-Based Preventive Control for Animal Food
• Protect Food against Intentional Adulteration
• What is Foreign Supplier Verification Program (FSVP)?
• What is FSMA Produce Safety Rule?

Regulatory Approach to Dietary Supplements and their Claims

Dietary Supplement – Label and Labeling

Federal law requires that every dietary supplement be labeled as such, either with the term “dietary supplement” or with a term that substitutes a description of the product's dietary ingredient(s) for the word “dietary” (e.g., “herbal supplement” or “calcium supplement”).

FDA Doesn’t Approve Dietary Supplements

Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed. Unlike new drugs, dietary supplements are not reviewed and approved by the FDA based on their safety and effectiveness. However, unless an exception applies, dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before Oct. 15, 1994) require a notification to FDA at least 75 days before marketing.

The notification must include the information that provides the manufacturer’s or distributor’s basis for concluding that the dietary supplement will reasonably be expected to be safe. When public health concerns arise about a dietary supplement after the product is on the market, the FDA evaluates the product’s safety through research and adverse event monitoring.

FDA regulations require nutrition information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and not misleading and must comply with any regulatory requirements for the type of claim.

Manufacturers must provide the serving size of the food and specified information about the nutrient content of each serving on the “Nutrition Facts” panel of the food label (or on the “Supplement Facts” panel for dietary supplements).

For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.

In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.

Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.

Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.

Contents of Dietary Supplement Labeling

The U.S. Food and Drug Administration (FDA) regulations require that dietary supplement labeling include:

• the statement of identity (name of the dietary supplement),
• the net quantity of contents statement (amount of the dietary supplement),
• the nutrition labeling,
• the ingredient list, and
• the name and place of business of the manufacturer, packer, or distributor.

Dietary supplement labeling must contain nutrition labeling in the form of a “Supplement Facts” panel which identifies the dietary ingredient(s) contained in the product.

You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).

What is the statement of identity for a dietary supplement?

The statement of identity for a dietary supplement is the name that appears on the label of the dietary supplement. As a general matter, the statement of identity of a food (including dietary supplements) is the name specified by federal law or regulation, or, if no such name is specified, the common or usual name of the food. If the food has no common or usual name and the nature of the food is not obvious, the statement of identity must be an appropriately descriptive term. In the case of dietary supplements, both the Federal Food, Drug, and Cosmetic Act and FDA’s regulations specify that the statement of identity must include the term “dietary supplement,” except that the word “dietary” may be replaced with a description of the type of dietary ingredient(s) in the product (e.g., “herbal supplement”) or the names of one or more dietary ingredients in the product (e.g., “bee pollen supplement”). You must place the statement of identity on the principal display panel of the dietary supplement and on any alternate principal display panels. Brand names are not considered to be statements of identity and should not be unduly prominent compared to the statement of identity.

What is the net quantity of contents statement for a dietary supplement?

The net quantity of contents statement for a dietary supplement is the statement that informs consumers of the amount of dietary supplement that is in the container or package.

You must locate the net quantity of contents statement on your product label as a distinct item in the bottom 30 percent of the principal display panel, in lines generally parallel with the base of the container. If the principal display panel of your product is 5 square inches or less, the requirement for placement within the bottom 30 percent does not apply when the declaration of net quantity of contents meets the other requirements of 21 CFR 101.

What is the nutrition label for a dietary supplement called?

The nutrition label for a dietary supplement is called a “Supplement Facts” panel. You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement. For example, when the net quantity of contents statement is 100 tablets and the “Serving Size” is one tablet, the “Serving Per Container” also would be 100 tablets and would not need to be listed.

What is an “ingredient”?

The Dietary Supplement Health and Education Act uses the term “ingredient” to refer to the compounds used in the manufacture of a dietary supplement. For instance, when calcium carbonate is used to provide calcium, calcium carbonate is an “ingredient” and calcium is a “dietary ingredient.” The term “ingredient” also refers to substances such as binders, colors, excipients, fillers, flavors, and sweeteners.

Ingredients that are sources of dietary ingredients may be listed within the “Supplement Facts” panel, e.g., “Calcium (as calcium carbonate).” When ingredients are listed in this way, they do not have to be listed again in the ingredient statement (also called an ingredient list).

What label statements must I place on the principal display panel?

You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.

How do I locate the principal display panel?

The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.

What label statements must I place on the information panel?

You must place the “Supplement Facts” panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the “Supplement Facts” panel in 21 CFR 101.36(i)(2)(iii) and (i)(5).

Where is the information panel?

The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.

What name and address must I list on the label of my product?

You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.

May I place intervening material on the information panel?

No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.

What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?

You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter “o,” and not be more than three times as high as they are wide unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.

Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?

Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.

Who regulates the statement “Made in the U. S. A.”? 

FDA does not have regulatory authority over such statements. The U.S. Customs Service regulates country of origin marking (i.e., “Made in the U.S.A.”) as authorized by the Tariff Act of 1930. Their website is www.customs.ustreas.gov.

How do I obtain a UPC bar code?

The UPC bar code may be obtained from the Uniform Code Council. Their website is www.uc-council.org. Click on the button that says “I Need a UPC Bar Code.”

Must expiration dating be included on the label of dietary supplements?

No. However, a firm may include this information if it is supported by valid data demonstrating that it is not false or misleading.

Dietary Supplement – Label Claims

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.

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.

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 the 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.

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 reviews the scientific evidence and exercise enforcement discretion to permit the use of the qualified claim in food labeling.

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 the FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in a dietary supplement or other food (e.g., “200 mg of folic acid,” “low fat,” or “high fiber”), or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite.

Structure/Function Claims and Related Dietary Supplement Claims

What is a Structure/Function Claim?

Structure/function claims may:

(1) 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;

(2) 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”; or

(3) 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.

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

Quick Link To U.S. Customs & Import Requirements

FDA-Regulated Products and Import Requirements

• What is Food Safety Modernization Act (FSMA)?
• Prior Notice of Imported Foods
• Food Facility Registration
• Risk-Based Preventive Controls for Human Food
• Risk-Based Preventive Control for Animal Food
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• What is Foreign Supplier Verification Program (FSVP)?
• Protect Food against Intentional Adulteration
• FDA Regulated Product in Foreign Trade Zone (FTZ)
• Entry Review Process for FDA Regulated Products
• Country of Origin  VS  Country of Manufacture
• Foods Regulated by FDA or USDA: What is the Difference?
• Label and Labeling Claims for Conventional Food and Dietary Supplements
• What is USDA Country of Origin Labeling (COOL)?
• Import for Export of FDA Regulated Products
• FDA Regulated Products in Personal Baggage or Sending by Mail or Courier
• International Mail Facility (IMF) and FDA Regulation
• Importing Biological Product Regulated by CBER
• Importing Cosmetics and Voluntary Cosmetic Registration Program (VCRP)
• Importing Drugs into the U.S.
• Importing OTC Drugs into the U.S.
• Importing Veterinary Drugs into the U.S.
• Importing Tobacco Products into the U.S.
• Importing Medical Devices into the U.S
• Importing Food Products into he U.S.
• Importing Radiation-Emitting Products into the U.S.

Customs Clearance and Import Requirements

• Entry of Imported Merchandise
• What is Section 321 Entry?
• What is Automated Commercial Environment (ACE)
• What is an Automated Broker Interface (ABI)?
• Who is Ultimate Consignee?
• What is Non-Resident Importer Program?
• Country of Origin of Imported Merchandise
• What is the Country of Assembly?
• What if the FDA's Country of Manufacture?
• Marking of Country of Origin on U.S. Imports
• What is Customs Bond?
• Reconciliation Prototype and Bond Rider
• Who Needs a Customs Broker?
• What is Customs Ruling Program?
• Classification of Imported Goods
• How is imported merchandise appraised?
• What are Import Quotas?
• What are Trade Remedy Duties?
• Antidumping Duty (AD) and Countervailing Duty (CVD)
• What is Foreign Trade Zone (FTZ)?
• What is Importer Security Filing (ISF)?
• What is Temporary Importation under Bond (TIB)
• What is In-Bond Process?