Dietary supplements occupy a distinctive position in the United States. They are consumed as products intended to supplement the diet, but they are regulated differently from conventional foods and pharmaceutical drugs. A dietary supplement may contain vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to increase total dietary intake, or concentrates, metabolites, constituents and extracts of those ingredients.

These products are sold in numerous forms, including tablets, capsules, softgels, gelcaps, gummies, powders, sachets, liquids, drops and certain bars. The product format does not, by itself, determine whether an item is legally a dietary supplement. Its ingredients, intended use, labeling, advertising, directions and claims must all be considered.

The U.S. market creates significant opportunities for established manufacturers and emerging brands. A multivitamin producer in the United States, a botanical extractor in India, a fish-oil manufacturer in Norway, a probiotic company in France, a magnesium supplier in Germany, a ginger processor in Peru or an amino-acid manufacturer in South Africa may all participate in the same supply chain.

However, access to the American market requires more than producing a popular formula. Companies must evaluate the regulatory status of every dietary ingredient, register covered facilities, establish appropriate quality systems, prepare compliant labels, control marketing claims, investigate complaints, maintain records and coordinate import responsibilities.

FDA generally does not approve a conventional dietary supplement before it is marketed in the same manner that it approves a new drug. This does not mean dietary supplements are unregulated. Responsibility rests heavily on the manufacturer, distributor and other responsible firms to ensure that products are not adulterated or misbranded and that all applicable statutory and regulatory requirements are satisfied before distribution.

 

 

Dietary supplements are regulated under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 and other legislation. Requirements may also arise under the Food Safety Modernization Act, the Fair Packaging and Labeling Act and specific FDA regulations addressing food-facility registration, dietary supplement current good manufacturing practice, labeling, claims, serious adverse event reporting and imports.

A product’s legal category depends partly on its intended use. A capsule containing vitamin D and labeled to supplement dietary intake may qualify as a dietary supplement. A product promoted as curing, treating, mitigating or preventing a disease may be considered a drug based on its claims, even when it contains ingredients commonly used in supplements.

Website statements, social-media posts, testimonials, brochures, marketplace listings, videos, influencer campaigns and links to disease information may contribute to intended use. Compliance review should therefore extend beyond the physical bottle or carton.

A company should also determine whether the product contains only lawful dietary ingredients. The inclusion of a substance in a capsule, powder or gummy does not automatically make that substance a lawful dietary ingredient. Ingredients associated with excluded drug-status provisions, unsafe conditions of use, adulteration or unresolved new dietary ingredient issues can create significant enforcement exposure.

 

 

Domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the United States generally must register with FDA unless an exemption applies. Dietary supplements are regulated as a category of food for purposes of the food-facility registration requirements.

Registration obligations should be evaluated separately for each physical location in the supply chain. A contract manufacturer, capsule filler, packer, labeler or warehouse may have its own obligations. A brand owner’s registration does not automatically replace the registration required for a separate manufacturing or packing facility.

Covered registrations must be renewed during FDA’s biennial renewal period in each even-numbered year. Companies should also update a registration when required information changes and cancel a registration when a facility is no longer engaged in covered activities.

 

Unique Facility Identifier

A food-facility registration submission must contain a unique facility identifier recognized as acceptable by FDA. FDA currently recognizes the Data Universal Numbering System, commonly called the DUNS number, as an acceptable UFI for food-facility registration.

The facility name and address associated with the UFI should correspond with the information submitted to FDA. Differences involving legal names, address formatting, suite numbers, postal codes or recently moved facilities can delay registration processing or create verification problems.

 

U.S. Agent for a Foreign Facility

A foreign food facility must designate a U.S. Agent for FDA registration. The U.S. Agent must be located or maintain a place of business in the United States and serves as a communications contact between FDA and the foreign facility.

FDA may communicate with the U.S. Agent concerning registration, inspections, emergencies and other regulatory matters. The designated agent must affirmatively confirm the appointment through FDA’s system. A foreign facility should therefore select an agent that monitors communications, understands FDA processes and can promptly reach the responsible company personnel.

 

 

Ingredient review should begin before commercial production, label printing or shipment. Companies should create a complete formula inventory showing every dietary ingredient and other ingredient, including ingredient source, supplier, manufacturing method, specification, intended amount per serving and proposed conditions of use.

A new dietary ingredient is generally a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. Subject to statutory exceptions, a manufacturer or distributor may be required to submit a new dietary ingredient notification to FDA at least 75 days before introducing or delivering for introduction into interstate commerce a supplement containing the new dietary ingredient.

Determining NDI status can be complex. A familiar plant name does not automatically establish that every extract, plant part, concentration, manufacturing process or chemically altered form has the same regulatory history. A novel solvent, selective concentration process, synthetic pathway, fermentation system or altered chemical profile may require additional analysis.

Companies should document the basis for concluding that an ingredient is not new, qualifies for an exception or is covered by an appropriate notification. Supplier assurances alone may be insufficient when they do not identify the specific ingredient, manufacturing process or evidence relied upon.

 

Supplier Qualification and Specifications

A robust ingredient program evaluates more than price and availability. Qualification may include supplier questionnaires, technical documentation, certificates of analysis, audit reports, manufacturing flow diagrams, allergen information, contaminant controls and regulatory history.

Specifications should address attributes needed to ensure identity, purity, strength, composition and limits on contaminants. Depending on the ingredient, relevant hazards may include heavy metals, pesticide residues, pathogenic microorganisms, mycotoxins, residual solvents, undeclared pharmaceutical ingredients, allergens, oxidation, adulteration with cheaper species or contamination during storage and transportation.

 

Dietary supplement manufacturers, packers, labelers and holders are subject to current good manufacturing practice requirements under 21 CFR Part 111 when the regulation applies to their operations. These requirements are intended to help ensure that supplements possess the identity, purity, strength and composition they are represented to have and are packaged and labeled as specified.

Foreign companies are not exempt merely because production occurs outside the United States. Dietary supplements manufactured abroad and offered for import into the United States must satisfy applicable U.S. requirements.

 

 

Contract Manufacturing Does Not Eliminate Brand Responsibility

 

Many supplement companies outsource manufacturing, laboratory testing, packaging, fulfillment or warehousing. Outsourcing an activity does not remove the need to understand how the activity is controlled. A brand owner should qualify its contractors, define responsibilities in written agreements, review product specifications, approve labels and maintain access to records needed to support compliance.

Certificates of analysis should be evaluated rather than automatically accepted. The company should understand who performed the test, which method was used, whether the sampled material represents the relevant lot, what acceptance criteria were applied and whether the laboratory is qualified for the test.

 

A compliant label normally includes a statement of identity identifying the product as a dietary supplement, an accurate net quantity of contents statement, a Supplement Facts panel, an ingredient statement where needed, allergen declarations when applicable and the name and place of business of the manufacturer, packer or distributor.

The Supplement Facts panel must accurately declare serving size, servings per container, dietary ingredients, amounts per serving and percentages of Daily Value where established. Dietary ingredients for which no Daily Value has been established must be handled in accordance with applicable formatting and declaration requirements.

Other ingredients—such as capsule materials, flavors, colors, binders, sweeteners and processing ingredients that remain in the product—must be declared appropriately outside the Supplement Facts panel. Botanical ingredients may require identification of the plant part, and proprietary blends must be presented in the manner allowed by the dietary supplement labeling regulations.

 

Structure and Function Claims

 

A structure/function claim may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body. Examples may include statements about supporting normal bone, digestive or immune function when the claim is truthful, not misleading and adequately substantiated.

A company marketing a dietary supplement with a qualifying structure/function claim generally must submit a notification to FDA no later than 30 days after the product is first marketed with the claim. The label must also carry the required disclaimer explaining that FDA has not evaluated the statement and that the product is not intended to diagnose, treat, cure or prevent any disease.

 

Avoiding Disease Claims

 

Statements claiming that a supplement treats heart disease, cures arthritis, prevents influenza, reverses diabetes, eliminates depression or replaces prescription treatment can cause the product to be regulated as a drug. Implied claims can create the same problem even when the word “treat” is not used.

Product names, website headings, consumer testimonials, images of diseased organs, references to medication reduction, symptom lists and links to scientific articles may collectively communicate a disease claim. Marketing review must therefore examine the complete context.

 

Health and Nutrient Content Claims

 

Health claims characterize a relationship between a substance and a disease or health-related condition. Nutrient content claims characterize the level of a nutrient, using terms such as “high,” “good source,” “free” or “low.” These claims may be used only when applicable regulatory requirements are met.

 

 

Imported dietary supplements and dietary ingredients must meet the same applicable U.S. requirements as domestically produced products. FDA may review entry data, registration information, prior notice, product descriptions, manufacturer identity, labeling, shipment documents, laboratory results and compliance history.

A foreign manufacturer’s FDA registration does not automatically make a shipment admissible. Registration is one element of a broader compliance system. The product must also be properly manufactured, lawfully formulated, truthfully labeled and supported by the required import and supplier-verification arrangements.

 

Foreign Supplier Verification Programs

The FSVP regulation generally requires the FSVP importer to develop, maintain and follow a program for imported food, unless an exemption or modified requirement applies. Dietary supplements and dietary supplement components are addressed through provisions that depend partly on whether the importer is subject to and complying with specified dietary supplement CGMP requirements.

The responsible company should determine the correct FSVP importer for each transaction. The FSVP importer is generally the U.S. owner or consignee of the food at the time of entry. When there is no U.S. owner or consignee at entry, a qualifying U.S. agent or representative of the foreign owner or consignee may perform the role through written consent.

FSVP responsibilities may involve hazard analysis, supplier evaluation, supplier approval, verification activities, corrective actions, reevaluation and recordkeeping. For dietary supplements, the precise duties must be determined based on the importer’s activities and the applicable modified or standard requirements.

 

Regional Considerations