What are Dietary Supplements?
Dietary supplements are foods, as defined by the Federal Food Drug and Cosmetic Act (FDCA), and are regulated by the Food and Drug Administration (FDA). However, dietary supplements are never conventional foods and conventional foods are never dietary supplements. Dietary supplements are unique in that they are ordinarily ingested, like foods, but in the form of a pill, tablet, capsule, gel cap, liquid concentrate or elixir. They are taken to supplement the diet, promote general health and well-being, and affect the structure or function of the human body (like drugs). Because dietary supplements must be ingested, they are never topical creams or ointments, or oral or nasal sprays, regardless of their ingredients. FDA has special jurisdiction over dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). FDA regulations differentiate between supplements and similar items; failure to clearly differentiate a dietary supplement from a food, beverage, or drug can lead to FDA action.
The primary regulatory issues of concern for those who manufacture, import, or distribute dietary supplements are: advertising and marketing claims, label compliance, ingredient safety, Good Manufacturing Practice (GMP) regulations, notification filing to FDA, and United States Department of Agriculture (USDA) permitting requirements that apply to some dietary supplement components. Under the DSHEA, responsibility for these concerns falls on manufacturers and distributors. While barriers to entry in the dietary supplement market are lower than other FDA-regulated areas (for example FDA does not approve dietary supplements), FDA still creates and enforces regulations, and non-compliance can be costly.
As food, dietary supplement manufacturers, packers and storage facilities are subject to FDA food facility registration regulations. The Food Safety Modernization Act (FSMA) also applies to manufacturers of dietary supplement ingredients and finished products. Dietary supplement ingredient manufacturers and importers are subject to Foreign Supplier Verification Program (FSVP) rules (Dietary Supplements under FSMA Video ). In addition, liquid dietary supplements that are also low acid canned foods or acidified foods are also subject to FDA’s Food Canning Establishment (FCE) and Scheduled Process Identification (SID) filing regulations.
Created by the regulatory staff at FDAImports, this free guide includes what to expect if FDA examines your shipment and a checklist to help you prepare shipments for importation into the US.
The FDCA empowers FDA to regulate claims made about dietary supplements. FDA and the Federal Trade Commission (FTC) work cooperatively to set and enforce regulations on claims made about dietary supplements, including external advertising (such as online advertisements) and labeling of products. Under DSHEA, dietary supplement labels may bear general health and well-being claims and structure or function claims. However, the person marketing a dietary supplement with such claims in dietary supplement labeling must submit a Structure Function Claim Notification to FDA identifying the claims that are used in connection with the dietary supplement. Probably the most common dietary supplement claim mistake is using language implicitly or explicitly making drug claims, which can have serious consequences. Claims that a product can cure, mitigate, treat, or prevent a disease are drug claims and may not appear on dietary supplement labeling. However, the line between an improper and illegal drug claim and a permissible structure or function claim can be very thin. For instance, a claim that a dietary supplement helps establish and maintain normal blood sugar levels may be interpreted by FDA as an implied disease claim (related to diabetes). However, if the claim includes the qualifier that its effect is achieved only in healthy individuals, it could be a permissible function claim. Read more about claims.
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The FDCA and DSHEA require dietary supplements to be labeled with specific elements, such as a dietary supplement statement of identity and a Supplement Facts table (as opposed to the Nutrition Facts table for conventional food). Like claims, labels are regulated by both FTC and FDA, and label regulations apply to other claims made on the product. The design of the packaging (size, shape, coloring), graphics on the labels, advertising, directions for use, serving size, recommended daily intake (RDI), and ingredients may all influence whether FDA considers a product to be a dietary supplement, or something else. There are very specific FDA regulations that govern when traditional nutrients may (or must) be declared on a dietary supplement label in comparison with dietary ingredients for which FDA has not established a recommended daily intake or daily value. The names of the dietary ingredients (in the ingredient list or in the Supplement Facts table) are strictly regulated by FDA, and dietary supplements often have mislabeled ingredients. FDA enforcement focuses heavily on labeling violations, especially when importing, because they are the easiest to detect. Read more about labels.
Dietary Supplement Ingredients
Dietary supplements must contain one or more dietary ingredients, such as: vitamins, minerals, herbs or other botanicals, amino acids, or other substances found in the human diet, such as enzymes. Manufacturers, importers, and distributors are responsible for substantiating that their products are safe, sanitary, and unadulterated with adequate evidence; this also applies to bulk ingredients. For dietary supplements already on the market, FDA bears the burden of proof that a supplement is unsafe. However, for imported bulk dietary ingredients, the level of evidence needed is very low (only the appearance of a violation is necessary for detention or refusal). FDA also conducts certain post-marketing surveillance of dietary supplements on the market, by receiving FDA Center For Food Safety and Nutrition (CFSAN) Adverse Event Reports in their system (CAERS).
New dietary ingredients are regulated under the Food Drug and Cosmetic Act (FDCA) and are defined by FDA as dietary ingredients that were not in the United States food supply in a chemically unaltered form before October 15, 1994. Because there is no authoritative list of these ingredients, FDA regulations place the responsibility for determining if an ingredient is new on the manufacturer, importer, and distributor. Marketing or sale of new dietary ingredients requires FDA notification, including scientific data supporting the safety of these new dietary ingredients or supplements containing them, under the labeled conditions of use. Ingredients which were already in the US food supply prior to October 15, 1994 may require documentation supporting this.
If FDA becomes aware of new dietary ingredients reported to have safety risks associated with them (for example organ damage, or significant cancer risk in lab animals), and no new dietary ingredient notification has been submitted to FDA (as may be required by the FDCA or FDA regulation), the agency will detain imported shipments of the bulk dietary ingredients alleging they appear to be unsafe. A new dietary ingredient notification is usually sufficient to resolve this, but for bulk dietary ingredients, there is often insufficient information about the intended use or even final formulation of finished dietary supplements.
Good Manufacturing Practice (GMP)
Like other industries, FDA has established Good Manufacturing Practices (GMPs) for dietary supplement producers. All foreign and domestic dietary supplement manufacturing facilities making products for the US market are subject to FDA inspectional authority; these inspections focus on dietary supplement GMPs. The goal of GMPs is to ensure consistent manufacturing of dietary supplements in terms of identity, purity, strength, and composition. GMPs include specifications for the design and construction of production plants, proper procedures for cleaning plants and equipment, proper manufacturing operations, quality control procedures, product testing, handling consumer complaints, and maintaining proper records. Companies whose facilities have not established compliant GMPs will be subject to a range of administrative, civil, and even criminal penalties. FDA can revoke a facility’s registration, issue a warning letter, request a recall, or involve the Department of Justice for civil or criminal proceedings.
FSMA, FSVP and Preventive Controls
Dietary Supplement manufacturers of finished products that comply with the Dietary Supplement GMPs under DSHEA are exempt from FSMA mandates as long as they continue to comply with the GMPs. If FDA charges the manufacturer of a finished Dietary Supplement with a major GMP violation, the agency may tack on an additional charge for violating FSMA, because the finished product manufacturer has forfeited their exemption. Foreign dietary ingredient manufacturers should meet the requirements of Preventive Controls and FSVP, including a written plan anticipating potential hazards, along with a prevention strategy. Ingredient manufacturers with secondary suppliers may shift some of the burden for hazard analysis and prevention to them. However, FSVP mandates all food importers to verify that their foreign suppliers produce food in accordance with US standards. Overlaps with Preventive Controls allow importers to lessen the burden of compliance. If a company purchases ingredients from a supplier to make finished dietary supplements, but also sells some of those ingredients to other companies the company is subject to the conventional food GMPs for its ingredients and the dietary supplement GMPs for its manufacturing operation that uses the same ingredients. The safe course in this instance is to follow the more stringent GMPs. Additionally, as a Dietary Ingredient supplier, such a company would need to have in place a Preventive Controls plan and a program to verify that their entire supply chain is operating according to FDA standards in accordance with FSVP if it is an importer.
We at FDAImports represent many foreign and domestic dietary supplement manufacturers, importers, marketers, and distributors of all sizes and in all dietary supplement genres. We make clear the way through FDA and FTC regulations and requirements to help our clients import and sell dietary supplements in the United States. We review labels and claims, deal with FDA detentions and refusals (including Import Alerts), deal with FDA inspections and new ingredient/product evaluation, and register our clients with FDA and USDA.