FDA Health Claim Regulations for Food and Dietary Supplements

FDA health claim regulations for food and dietary supplements sort every label statement into one of three pathways: authorized health claims, qualified health claims, and structure/function claims. Which pathway applies depends on whether the statement mentions a disease and how strong the scientific evidence is. Get the category wrong and the product is misbranded, which can lead to warning letters, seizure, injunction, or criminal charges under the Federal Food, Drug, and Cosmetic Act.¹

The Line Between a Health Claim and a Structure/Function Claim

The single question that decides which rules apply is whether the label mentions a disease. “Supports immune health” describes normal body function and is a structure/function claim. “Reduces the risk of heart disease” links a substance to a disease and is a health claim that needs FDA authorization. Cross that line without authorization and the FDA can treat the product as an unapproved drug.

Health claims (authorized and qualified) describe a relationship between a food substance and reduced risk of a specific disease. Structure/function claims describe how a nutrient affects normal structure or function in the body without naming a disease.² The distinction sounds simple. In practice, wording like “lowers cholesterol” sits close enough to a disease risk factor that the FDA may view it as a disease claim.

Authorized Health Claims

An authorized health claim is one the FDA has approved by rulemaking after finding significant scientific agreement among qualified experts that the substance-disease relationship is real. The agency looks at the totality of publicly available evidence, including clinical trials and epidemiological studies, and asks whether a stable consensus exists.³ Once the FDA authorizes a claim, any manufacturer whose product meets the nutritional conditions in the regulation can use it.

Two regulatory definitions bound the analysis. A “substance” is a specific food or food component, whether conventional or a supplement ingredient. A “disease or health-related condition” means damage to a body organ or system that prevents it from functioning properly. Diseases caused by essential nutrient deficiencies, such as scurvy, fall outside this definition.⁴ Authorized claims must address risk reduction in healthy populations. They cannot state or imply that the food treats, cures, or mitigates an existing disease.⁵

Examples

The FDA has authorized roughly a dozen claims. Common ones include:

Adequate calcium and vitamin D throughout life, as part of a balanced diet, may reduce the risk of osteoporosis.
Diets low in sodium may reduce the risk of high blood pressure.
Diets low in saturated fat and cholesterol may reduce the risk of coronary heart disease.
Adequate folate in women of childbearing age may reduce the risk of a pregnancy affected by spina bifida or other neural tube defects.
Sugar alcohols such as xylitol and sorbitol do not promote tooth decay.⁶

Each authorized claim has its own regulation that spells out permitted wording, the nutrient the food must contain, and the nutrient limits the food must meet.

Disqualifying Nutrient Levels

Even a qualifying substance in the right amount cannot save a food that is too high in nutrients associated with health risks. Per reference amount, per labeled serving, and (for foods with servings of 30 g or less) per 50 g, a food is disqualified from carrying any health claim if it contains more than:

Meal products and main dish products have higher thresholds. The underlying principle is that a food should not claim to reduce disease risk while simultaneously raising risk through excess fat, cholesterol, or sodium.

Qualified Health Claims

When the science supports a substance-disease relationship but falls short of significant scientific agreement, the FDA can allow a qualified health claim through a letter of enforcement discretion. The agency weighs the available evidence and, if the relationship is at least plausible, permits the claim with specific qualifying language attached.⁷

The required disclaimer is not optional wording. A typical qualified claim reads: “Some scientific evidence suggests that consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA has determined that this evidence is limited and not conclusive.” Manufacturers must use the exact disclaimer the FDA approves for that claim.⁸ If later research contradicts the claimed relationship, the FDA can withdraw its enforcement discretion and effectively end use of the claim.

Structure/Function Claims

Structure/function claims are the label statements consumers see most often. They describe what a nutrient does in the body (“fiber maintains bowel regularity”) or how it supports normal function (“vitamin D helps the body absorb calcium”) without naming a disease.² No pre-approval is required, but the rules differ for supplements and conventional foods.

For a dietary supplement, the manufacturer must notify the FDA within 30 days of first marketing with the claim, and the label must carry this mandatory disclaimer in boldface: “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.”⁹ The disclaimer must sit adjacent to the claim or connect to it with a symbol such as an asterisk, and the type must be at least one-sixteenth of an inch.

Conventional food manufacturers face lighter rules. They do not need to notify the FDA and do not need a disclaimer for structure/function claims. They still need substantiation that the claim is truthful, but the FDA does not review it up front.

How to Petition the FDA for a New Health Claim

Any person or company can petition the FDA to authorize a new health claim, and the requirements sit in 21 CFR 101.70. Incomplete or rushed submissions are the most common reason petitions stall.¹⁰

A petition must include:

An explanation of how the substance and the disease meet the definitions in 21 CFR 101.14.
A summary of the scientific data showing how the totality of evidence supports the claim, addressing both supportive and contrary studies.
Analytical data on how much of the substance appears in representative foods that would carry the claim.
The exact model claim language the petitioner proposes for labels.
A complete literature package: all search results, all studies relied upon, all studies showing adverse consequences, and all studies pertaining to the U.S. population.

Nonclinical laboratory studies must state whether they complied with good laboratory practice regulations. Clinical studies involving human subjects must comply with institutional review board and informed consent requirements, and the petition must confirm that compliance. The proposed claim language must avoid any wording that would categorize the food as an unapproved drug, so no wording that treats, cures, or prevents disease. Leaving out unfavorable data can get the petition rejected outright.

Review Timeline After You File

The review process has statutory deadlines at each stage.

Within 15 days of receipt, the FDA sends a letter either assigning a docket number or telling the petitioner the submission is incomplete.
Within 100 days of receipt, the FDA formally files the petition for full review or denies it. If the agency does not act within 100 days, the petition is treated as denied unless both sides agree to an extension.
Within 90 days after filing, the FDA either denies the petition or announces it will publish a proposed regulation in the Federal Register, which opens a public comment period.
Within 270 days after publishing the proposed rule, the FDA issues a final rule authorizing or rejecting the claim.
For cause, the FDA can extend the post-proposal period twice, each extension up to 90 days. The absolute maximum from receipt to final rule is 540 days.¹⁰

At any stage the FDA can request additional information, and petitioners have to respond quickly to avoid a petition being deemed denied by inaction.

What Happens If You Use an Unauthorized Claim

A product carrying an unauthorized health claim is misbranded under the Federal Food, Drug, and Cosmetic Act, and introducing misbranded food into interstate commerce is a prohibited act.¹¹

The FDA’s usual first step is a warning letter identifying the violations and asking for a written response within 15 days. The letter spells out which label statements are unauthorized and the legal basis for the finding. The manufacturer can correct the labeling or explain why the FDA’s assessment is wrong. The FDA verifies corrections through follow-up inspections and can take enforcement action without further notice if violations continue.¹²

Stakes escalate from there. If a label claims the product will diagnose, treat, cure, or prevent a disease without authorization, the FDA can reclassify it as an unapproved drug, which opens the door to more aggressive enforcement. Criminal penalties under the FD&C Act reach up to one year in prison and fines up to $1,000 for a first offense. Where the violation involves intent to defraud or mislead, or follows a prior conviction, penalties rise to up to three years in prison and fines up to $10,000.¹³ The FDA can also seek product seizure and court injunctions.

Help for Small Manufacturers

The FDA offers technical assistance to small businesses through its Human Foods Program, including educational workshops, informational materials, and exchange meetings. The Food and Cosmetic Information Center can be reached at 1-888-723-3366, Monday through Friday from 10 a.m. to 4 p.m. Eastern Time.¹⁴ There is no fee waiver for the petition process, but contacting the information center before filing can catch the kinds of gaps that lead to automatic denials.

1
Office of the Law Revision Counsel. 21 U.S. Code 343 – Misbranded Food
2
U.S. Food and Drug Administration. Structure/Function Claims
3
eCFR. 21 CFR 101.14 – Health Claims: General Requirements
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eCFR. 21 CFR 101.14 – Health Claims: General Requirements
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U.S. Food and Drug Administration. Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard
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eCFR. 21 CFR Part 101 Subpart E – Specific Requirements for Health Claims
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U.S. Food and Drug Administration. Guidance for Industry: FDA’s Implementation of Qualified Health Claims
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U.S. Food and Drug Administration. Questions and Answers on Health Claims in Food Labeling
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eCFR. 21 CFR Part 101 Subpart F – Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims
10
eCFR. 21 CFR 101.70 – Petitions for Health Claims
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Office of the Law Revision Counsel. 21 U.S. Code 331 – Prohibited Acts
12
U.S. Food and Drug Administration. About Warning and Close-Out Letters
13
Office of the Law Revision Counsel. 21 U.S. Code 333 – Penalties
14
U.S. Food and Drug Administration. Small Business Assistance