Navigating the Rules for Selling Supplements Legally

November 16, 2025 •

4 min read

The global dietary supplement market is projected to reach over $300 billion by 2030, but navigating regulatory requirements is crucial for success. All businesses must know and follow the rules for selling supplements to protect consumers and avoid serious legal penalties.

Quick Summary

A guide covering the complex regulations for selling dietary supplements, including federal requirements in the U.S. and EU. It details crucial areas such as Good Manufacturing Practices (cGMP), accurate product labeling, and truthful advertising claims controlled by the FDA and FTC.

Key Points

Know the Federal Rules: In the U.S., the FDA (for safety and labeling) and FTC (for marketing) regulate supplements, requiring manufacturers and sellers to ensure product safety and truthful claims under DSHEA and other acts.
Adhere to cGMP: Follow Current Good Manufacturing Practices (21 CFR Part 111) for production, quality control, and testing to prevent adulteration and ensure consistent product quality.
Master Labeling Compliance: Ensure all labels include mandatory information like a 'Supplement Facts' panel, ingredient list, and manufacturer details to avoid products being deemed 'misbranded'.
Make Only Substantial Claims: Use structure/function claims (with required FDA disclaimer) and avoid illegal disease claims that suggest preventing, treating, or curing a disease.
Register Your Business and Facilities: Manufacturers, packers, and distributors must register their facilities with the FDA. Secure all necessary business licenses and EINs as per federal and state laws.
Vet Third-Party Vendors: If you resell or use contract manufacturing, confirm your partners are cGMP-certified and follow rigorous quality control standards to protect your brand and consumers.

Federal Regulations for Selling Supplements

In the United States, the Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Unlike drugs, supplements do not require pre-market approval from the FDA. However, manufacturers and sellers are responsible for ensuring their products are safe and that all claims are truthful and not misleading. The Federal Trade Commission (FTC) is also heavily involved, overseeing advertising and marketing claims to protect consumers from deceptive practices. Failure to comply with these rules can result in product seizures, large fines, and legal action. For those selling in the European Union (EU), compliance with Directive 2002/46/EC is necessary, along with individual member state regulations.

Good Manufacturing Practices (cGMP) for Dietary Supplements

One of the most critical rules for selling supplements is adherence to Current Good Manufacturing Practices (cGMP) regulations, as outlined in 21 CFR Part 111. cGMPs are a set of requirements and guidelines that govern the production, packaging, and holding of dietary supplements to ensure product quality and purity. While the FDA does not approve individual supplements, it does inspect manufacturing facilities to ensure they meet these standards. For sellers who outsource manufacturing, partnering with a cGMP-certified facility is essential.

Some key areas covered by cGMPs include personnel qualifications and training, maintaining clean and functional facilities, implementing controls for consistent production, proper procedures for holding and distribution, establishing quality control operations, and ensuring accurate packaging and labeling.

Mandatory Labeling Requirements

Dietary supplement labels in the U.S. must include specific information for legal sale. This includes stating it is a "Dietary Supplement," providing the manufacturer's or distributor's details, listing all ingredients, including a "Supplement Facts" panel detailing active ingredients and serving size, declaring the net contents, and including a child safety warning. Online listings must also make this information clear and accessible.

Making Permissible Claims and Avoiding Pitfalls

Regulatory bodies closely scrutinize marketing claims. Disease claims, suggesting a supplement can diagnose, treat, or prevent a disease, are prohibited by the FDA. Instead, sellers can use structure/function claims, describing how a nutrient affects the body (e.g., "calcium builds strong bones"). These claims require a specific FDA disclaimer stating the statement hasn't been evaluated by the FDA and the product isn't for diagnosing, treating, curing, or preventing any disease. Manufacturers must also inform the FDA of structure/function claims within 30 days of marketing.

Comparative Overview of Regulatory Agencies

The roles of key regulatory bodies in the U.S. and Europe differ regarding dietary supplements.


Aspect	U.S. Food and Drug Administration (FDA)	U.S. Federal Trade Commission (FTC)	European Authorities (e.g., EFSA, Member States)
Primary Role	Regulates safety, manufacturing, and labeling of dietary supplements.	Oversees advertising and marketing practices to prevent deception.	Governs food supplements and health claims, with additional country-specific rules.
Key Legislation	Dietary Supplement Health and Education Act (DSHEA), 21 CFR Part 111 (cGMP).	Federal Trade Commission Act.	Directive 2002/46/EC, Regulation (EC) No 1924/2006 on health claims.
Premarket Approval	No, for supplements. Manufacturers must ensure safety.	Not applicable, regulates advertising after the fact.	No, in most cases, but some ingredients require notification and authorization.
Labeling	Prescribes required elements: product name, manufacturer info, Supplement Facts panel, etc..	Enforces that claims on labels and packaging are truthful and substantiated.	Mandates specific information, uses pre-approved claims, requires national language labeling.
Marketing Claims	Enforces rules on structure/function claims and prohibits disease claims.	Ensures all advertising claims are truthful, not misleading, and scientifically substantiated.	Regulates health claims, which must be scientifically substantiated and on an approved list.
Enforcement	Facility inspections, warning letters, product seizures, and legal action for non-compliance.	Enforcement actions for false or misleading advertising, including fines and orders.	Penalties for false or misleading claims and non-compliant labeling vary by member state.

Best Practices for Successful and Compliant Selling

Proactive compliance is essential for selling supplements successfully, especially for online sellers facing platform-specific requirements like third-party testing. Key practices include carefully selecting a cGMP-compliant manufacturer, ensuring labels are compliant and reviewed by experts, substantiating all marketing claims with scientific evidence, registering manufacturing facilities with the FDA if applicable, and staying updated on evolving regulations.

Conclusion

Successful and legal dietary supplement sales depend on a thorough understanding of regulations. By adhering to cGMP, ensuring accurate labeling, and making truthful advertising claims, businesses can build consumer trust and avoid significant legal issues. Prioritizing compliance is not just a legal obligation but a key business strategy in the competitive supplement market. For more details on FDA regulations, visit the official {Link: FDA Dietary Supplement page https://www.fda.gov/food/dietary-supplements)}.

Frequently Asked Questions

No, the FDA does not approve dietary supplements before they are marketed. Manufacturers and sellers are responsible for ensuring their products meet all regulatory requirements, including safety and labeling laws.

A structure/function claim describes the effect of a nutrient on the body's structure or function (e.g., 'calcium builds strong bones'). A disease claim, which is illegal for supplements, suggests the product can cure, treat, or prevent a disease.

Yes. While basic federal rules apply, online marketplaces like Amazon often have their own specific policies, including requirements for third-party testing and stricter verification of claims.

cGMP regulations (21 CFR Part 111) set standards for the manufacturing, packaging, and holding of dietary supplements to ensure identity, purity, quality, and strength. Manufacturers must be compliant and are subject to FDA inspection.

There is no federal license required to resell supplements, but local and state business permits are often necessary. However, manufacturers must register their facilities with the FDA.

Making illegal or unsubstantiated claims can lead to FDA warning letters, product seizures, and Federal Trade Commission (FTC) enforcement actions, including significant fines and legal consequences.

cGMP requires manufacturers to maintain comprehensive documentation and record-keeping, including master manufacturing records, batch production records, and records for product complaints and returns.