Dietary supplements sold in the United States are regulated by the FDA, but not the way prescription drugs are. Under the framework Congress set up in the Dietary Supplement Health and Education Act of 1994, supplements are treated as a special category of food: manufacturers, not the government, are responsible for making sure a product is safe and honestly labeled before it goes on sale, and the FDA’s authority is mostly to act after a problem appears. The dietary supplement FDA regulations that follow from that basic choice cover manufacturing quality, labeling, what companies can claim, adverse-event reporting, and facility registration, with enforcement running from warning letters up to criminal penalties.
How Federal Law Defines a Dietary Supplement
A dietary supplement, by statute, is a product intended for ingestion that contains one or more “dietary ingredients”: vitamins, minerals, herbs and botanicals, amino acids, or concentrates and extracts of those substances.1Office of the Law Revision Counsel. 21 USC 321 – Definitions It has to be labeled as a dietary supplement and cannot be sold as a conventional food or as a meal replacement.
There is one exclusion worth flagging up front. If a substance was first approved or investigated as a drug before anyone sold it as a supplement, it generally cannot be marketed as a dietary supplement at all. That rule is why CBD, discussed at the end, sits outside the supplement regime.
No Pre-Market Approval, and What That Means
Prescription and over-the-counter drugs have to prove they are safe and effective before they reach consumers. Supplements do not.2National Institutes of Health. Dietary Supplement Health and Education Act of 1994 A manufacturer can bring a new product to market without submitting clinical trial data, without FDA clearance, and without demonstrating that the product does what the label suggests.
The tradeoff is that the manufacturer and distributor carry the full legal responsibility for making sure the product is not adulterated or misbranded before selling it.3Food and Drug Administration. Dietary Supplements When the FDA wants to pull a product off the market, the agency bears the burden of proving it is unsafe or that the labeling violates the rules. In court, the government has to prove each element of adulteration, and the judge reviews the evidence fresh rather than deferring to the FDA.4Office of the Law Revision Counsel. 21 USC 342 – Adulterated Food
Manufacturing Standards (CGMPs)
Even without pre-market approval, supplement manufacturers have to follow Current Good Manufacturing Practices in 21 CFR Part 111.5Legal Information Institute. 21 CFR Part 111 – Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements A supplement made under conditions that fail those standards is legally adulterated, whether or not anyone actually gets sick from it.4Office of the Law Revision Counsel. 21 USC 342 – Adulterated Food
The CGMP rules push quality control into every stage of production. Manufacturers have to test raw materials to confirm identity and purity, keep sanitary conditions to prevent contamination, and create batch records that trace each finished product back to its components. The regulations reach facility design, equipment maintenance, laboratory testing, and employee training. These are floors, not ceilings; reputable manufacturers often exceed them through third-party testing and certification.
When a New Ingredient Triggers Pre-Market Notice
Most supplements reach the market without ever notifying the FDA. One category is different. If a supplement contains an ingredient that was not sold in the United States before October 15, 1994, that ingredient is a New Dietary Ingredient (NDI).6U.S. Food and Drug Administration. New Dietary Ingredients in Dietary Supplements – Background for Industry The manufacturer or distributor has to file a New Dietary Ingredient Notification with the FDA at least 75 days before selling the product in interstate commerce.7Office of the Law Revision Counsel. 21 USC 350b – New Dietary Ingredients
The notification must include enough evidence for the FDA to evaluate whether the ingredient is reasonably expected to be safe under the conditions recommended on the label. Published research or the manufacturer’s own safety studies can support the submission. There is one narrow exception: if the ingredient has already been present in the food supply in a form that has not been chemically altered, no notification is required. Skipping a required NDIN makes the product adulterated as a matter of law, even if the ingredient itself turns out to be safe.
The Supplement Facts Panel and Other Label Rules
Every supplement has to carry a “Supplement Facts” panel, following formatting rules in 21 CFR 101.36.8eCFR. 21 CFR 101.36 – Nutrition Labeling of Dietary Supplements The panel has to list the serving size in units that fit the product (capsules, teaspoonfuls, and so on), the number of servings per container, and the amount per serving of each dietary ingredient.
Ingredients with an established Reference Daily Intake or Daily Reference Value need a “% Daily Value” column. Ingredients without one still appear on the panel, marked with a dagger and a footnote explaining that no daily value has been established. The panel can also identify the source of an ingredient, and for any botanical it has to name the plant part used.9U.S. Food and Drug Administration. Dietary Supplement Labeling Guide – Chapter IV Nutrition Labeling
The label also has to identify the product as a “dietary supplement” and include the name and address of the manufacturer, packer, or distributor. Miss any of these and the product is misbranded.
What Companies Can and Cannot Claim
Claims are where most companies get into trouble. Three types are allowed, each with its own requirements.
Health Claims
A health claim links a substance to reduced risk of a disease. To use one, a company has to go through an FDA petition process and meet the Significant Scientific Agreement standard, meaning qualified experts broadly agree the science supports the claim.10U.S. Food and Drug Administration. Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard This is the highest bar of the three, and relatively few supplement claims have cleared it.
Nutrient Content Claims
A nutrient content claim describes the level of a nutrient in the product, like “high in calcium” or “excellent source of Vitamin D.” These claims have to meet FDA-defined thresholds for the nutrient in question.
Structure/Function Claims
Structure/function claims are the ones you see on almost every supplement label. They describe how an ingredient affects normal body processes: “supports immune health,” “promotes joint flexibility.” They cannot name a specific disease. “Supports heart health” is fine; “reduces the risk of heart disease” is a health claim and needs FDA authorization.
Any product with a structure/function claim has to display a bold-type disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”11Food and Drug Administration. Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling The company also has to hold substantiation showing the claim is truthful and not misleading, and it has to notify the FDA within 30 days of first marketing a product carrying such a claim.12U.S. Food and Drug Administration. Structure/Function Claim Notification Electronic Submissions The notification is not a permission request; the FDA files it and can challenge the claim later if it disagrees.
Where the FTC Comes In
A detail that catches companies off guard: the FDA regulates labels, but the Federal Trade Commission regulates advertising. Under a longstanding memorandum between the two, the FTC has primary responsibility for the truthfulness of advertising other than labeling for foods, drugs, devices, and cosmetics, while the FDA handles the label itself.13Federal Trade Commission. Memorandum of Understanding Between the Federal Trade Commission and the Food and Drug Administration A label can be perfectly compliant with FDA rules while a website, social media ad, or TV spot violates FTC standards.
The FTC requires supplement advertising to be truthful, not misleading, and backed by competent and reliable scientific evidence before the ad runs.14Federal Trade Commission. Dietary Supplements: An Advertising Guide for Industry Health and safety claims face a higher evidentiary bar than general marketing puffery. Companies that receive a notice of penalty offense and keep making unsupported claims face civil penalties of up to $50,120 per violation.15Federal Trade Commission. FTC Warns Almost 700 Marketing Companies That They Could Face Civil Penalties
Adverse Event Reporting
When a consumer or health-care provider reports a serious health problem linked to a supplement, the company named on the label has to report it to the FDA within 15 business days. A “serious adverse event” includes death, a life-threatening experience, hospitalization, persistent disability, a birth defect, or any condition requiring medical intervention to prevent one of those outcomes.16Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements
The obligation continues after the initial report. Any new medical information received within a year has to be forwarded to the FDA within 15 business days of receipt. Companies have to keep records of both serious and non-serious adverse event reports for six years. Consumers can also report problems directly through the FDA’s Safety Reporting Portal.17Food and Drug Administration. How to Report a Problem with Dietary Supplements
Facility Registration
Every domestic or foreign facility that manufactures, processes, packs, or holds supplements intended for U.S. consumers has to register with the FDA. The Food Safety Modernization Act added a biennial renewal requirement and gave the FDA authority to suspend a facility’s registration if its products pose a reasonable probability of causing serious health consequences or death.18U.S. Food and Drug Administration. Registration of Food Facilities and Other Submissions
Registrations have to be renewed between October 1 and December 31 of each even-numbered year. The next renewal window is 2026. Miss the December 31 deadline and the registration expires and drops out of the system.19U.S. Food and Drug Administration. Food Facility Registration User Guide: Biennial Registration Renewal Operating without a valid registration is a prohibited act, and a suspended registration blocks any food or supplement from moving in or out of the facility.
How the FDA Enforces the Rules
Because the FDA works post-market, it watches supplements through facility inspections, market sampling, and adverse event reports. When it finds a violation, the response usually escalates.
The most common first step is a Warning Letter. It formally notifies a company that the FDA has identified a violation and expects corrective action within 15 business days. Warning letters are public, and for many companies the reputational damage alone drives quick compliance. If a company ignores the warning or the violation is serious, the FDA can seize products or ask a court for an injunction shutting down manufacturing and sales.3Food and Drug Administration. Dietary Supplements
FSMA also gave the FDA mandatory recall authority for any food, supplements included, when there is a reasonable probability the product is adulterated or misbranded in a way that could cause serious illness or death. The agency has to give the company a chance to recall voluntarily before ordering a mandatory recall.20U.S. Food and Drug Administration. FDA Finalizes Guidance on Mandatory Recall Authority In practice, almost all supplement recalls are voluntary, because companies would rather control the message than be forced.
Criminal Penalties
Enforcement can go past product seizures. Selling an adulterated or misbranded supplement violates the Federal Food, Drug, and Cosmetic Act, and violations carry criminal penalties. A first offense is a misdemeanor punishable by up to one year in prison, a fine of up to $1,000, or both. If the violation involves intent to defraud or mislead, or if the person has a prior conviction, it becomes a felony carrying up to three years in prison and a fine of up to $10,000.21Office of the Law Revision Counsel. 21 USC 333 – Penalties
Those statutory fines have not been updated in decades and look modest, but federal courts can also impose fines under Title 18 sentencing guidelines, which allow considerably higher amounts. The real financial exposure for companies usually comes from disgorgement of profits, injunctive relief, and parallel FTC actions rather than the criminal fines alone.
One Boundary: CBD Is Not a Dietary Supplement
A common question about supplement rules is whether CBD products fit inside them. As of 2026, they do not. The FDA has concluded that both THC and CBD are excluded from the dietary supplement definition, because CBD was an active ingredient in an approved drug (Epidiolex) and was authorized for investigation as a new drug before it was sold as a supplement.22U.S. Food and Drug Administration. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) The FDA could issue a regulation opening the door, and as of early 2026 a proposed CBD compliance and enforcement rule is under White House review, but no final rule has been issued.23Cannabis Business Times. White House Schedules Meeting for FDA’s New CBD Compliance Enforcement Policy Until that changes, companies selling CBD as a supplement are exposed to enforcement.