Are supplements defined as food? The Surprising Legal and Regulatory Answer

December 21, 2025 •

3 min read

Since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the U.S. Food and Drug Administration (FDA) has regulated dietary supplements as a special subcategory of foods, not drugs. This classification has profound implications for their safety, labeling, and market oversight, creating a distinction many consumers are unaware of.

Quick Summary

Dietary supplements are legally a subcategory of food under US law but are regulated differently from conventional foods. They do not undergo pre-market FDA approval and have unique labeling rules.

Key Points

Legal Classification: In the U.S., dietary supplements are regulated by the FDA as a special subcategory of foods, not as drugs.
No Pre-Market Approval: The FDA does not approve dietary supplements for safety and effectiveness before they are sold.
Manufacturer Responsibility: Ensuring a dietary supplement's safety and truthful labeling rests with the manufacturer.
Distinct Labeling: Supplements feature a “Supplement Facts” panel, different from the “Nutrition Facts” panel on conventional foods.
Structure/Function Claims: Supplements can make claims about how a nutrient affects the body's structure or function, requiring a specific FDA disclaimer.
Post-Market Regulation: The FDA monitors the market and takes action against unsafe or misbranded products post-release.
Cannot Replace Meals: A dietary supplement cannot be marketed as a sole item of a meal or the diet.

The Legal Framework: DSHEA and the Special Category of Food

In the United States, the legal classification of dietary supplements is primarily governed by the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act defines dietary supplements as a special category of food, distinct from drugs. This classification significantly impacts their regulation, particularly regarding market entry and oversight, differing from the stringent pre-market approval required for new drugs.

Under DSHEA, manufacturers are responsible for the safety and truthful labeling of their products. Unlike drugs, dietary supplements do not require FDA approval before being sold. The FDA must prove a supplement is unsafe after it is on the market to take action, a contrast to the pre-market safety requirements for conventional foods or drugs.

Labeling: The Telling Difference Between 'Nutrition Facts' and 'Supplement Facts'

A key difference between conventional foods and dietary supplements is their labeling. Conventional foods feature a “Nutrition Facts” panel, while dietary supplements are required to display a “Supplement Facts” panel. The content within these panels also varies. The 'Supplement Facts' panel lists “dietary ingredients” and their amounts per serving, even for ingredients without an established Recommended Daily Intake (RDI). It can also specify the source or part of a plant used for an ingredient, which is typically not allowed on a 'Nutrition Facts' panel.

Required Label Disclaimers for Dietary Supplements

Supplements often make 'structure/function claims' about the body's processes. These claims must include a mandatory disclaimer that the statement has not been evaluated by the FDA and the product is not intended to diagnose, treat, cure, or prevent any disease. This reinforces the product's status as a food, not a drug, and indicates that the FDA has not scientifically validated the claim.

Key Ingredients and Intended Use

The composition and intended purpose are crucial for distinguishing conventional foods from supplements. Dietary ingredients permitted in supplements include vitamins, minerals, herbs, amino acids, and other substances, and cannot be marketed as conventional food or a meal replacement.

A Global Perspective on Supplement Regulation

Regulatory approaches for supplements vary globally. In the European Union, supplements are also under food law but must meet specific EU legislation and safety procedures. Health claims require prior approval from the European Food Safety Authority (EFSA), indicating a different level of pre-market review compared to the U.S.

Comparison of Conventional Food and Dietary Supplements


Feature	Conventional Food	Dietary Supplements
Regulation	FDA regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA).	FDA regulated under DSHEA (1994) as a special subcategory of food.
Premarket Approval	Food additives must be FDA-approved or GRAS before use.	No FDA pre-market approval for safety or efficacy required.
Labeling Panel	Requires a "Nutrition Facts" panel.	Requires a "Supplement Facts" panel.
Ingredient Claims	Nutrient content claims focus on nutritive value; strict rules on health claims.	Can make structure/function claims, but with a specific disclaimer.
Primary Purpose	Consumed for taste, aroma, and nutritive value.	Intended to add nutritional value to the diet.
Consumption Form	Eaten as part of meals or snacks.	Typically taken in controlled doses (capsules, tablets, liquids).
Safety Oversight	Focus on food additives and ensuring overall product safety.	Post-market enforcement action taken if product is unsafe or misbranded.

The Role of the Consumer in Navigating the Supplement Market

Due to the different regulatory approach, consumers must be proactive in evaluating supplement safety and quality. Unlike drugs, efficacy is not established before market entry. Resources like the National Institutes of Health (NIH) provide safety information. Third-party testing certifications can also help verify product quality.

Conclusion

While the U.S. legally classifies dietary supplements as a subcategory of food under DSHEA, they are not regulated identically to conventional food products. This difference is clear in labeling requirements, the absence of pre-market FDA approval, and the types of claims allowed. Informed choices require understanding this framework.

Frequently Asked Questions

In the U.S., the FDA classifies dietary supplements as a special subcategory of foods, but they are regulated differently than both conventional foods and drugs.

No, the FDA does not have the authority to approve dietary supplements for safety or effectiveness before they are marketed.

The Supplement Facts label is required for dietary supplements and reports differently, such as including dietary ingredients without established Daily Values and indicating the source of a botanical ingredient.

No, supplements cannot be represented for use as a conventional food or as a sole item of a meal or the diet.

No, unlike food additives, a dietary supplement ingredient does not have to be Generally Recognized As Safe (GRAS) or approved by the FDA prior to marketing.

These claims describe the role of a nutrient or ingredient in affecting the body's structure or function and must include a disclaimer that the FDA has not evaluated the claim.

The FDA monitors the supplement market post-release and can take action against manufacturers if products are found to be unsafe or misbranded.