Selling gummy supplements online brings federal and state obligations shaped by your business model, your location, and who makes the product. In the U.S., the FDA regulates dietary supplements as food under the Dietary Supplement Health and Education Act (DSHEA). There is no single license that covers the job.
Core Federal and State Requirements
At the federal level, dietary supplement companies must comply with FDA regulations. The FDA doesn't issue a license to sell supplements. What it requires is registration and cGMP compliance.
- FDA Facility Registration: A facility that manufactures, processes, packs, or holds dietary supplements for U.S. sale must register with the FDA before operations begin, and renew every even-numbered year between October 1 and December 31.
- cGMP Compliance: Manufacturing, packaging, and holding must meet the cGMP rules in 21 CFR Part 111, which cover identity, purity, strength, and composition. A contract manufacturer like KorNutra runs these processes if it is fully cGMP-compliant.
- Adverse Event Reporting: Set up a system to record adverse events and report serious ones to the FDA within 15 business days. Keep a record of each report.
If your name is on the label, you are the responsible person under FDA rules, even when a contract manufacturer makes the gummies. You still have to confirm the product meets specifications and approve release for sale.
State rules vary by where you incorporate, where you store product, and where your customers live. Common pieces:
- Business License: A standard license to operate in your city, county, and state.
- Sales Tax Permit: Register in states where you have economic nexus. Most states now have marketplace facilitator laws, so Amazon and Walmart collect and remit tax on marketplace orders; your own Shopify store sales are yours to handle.
- State Food or Agriculture Registration: Some states add their own layer. Texas requires firms that process or package dietary supplements to hold a food manufacturer license. Check each state where you make or ship product.
E-commerce Platform & Labeling Considerations
Your online store and product listings also have to comply:
- FDA Labeling Compliance: Every label must include a Supplement Facts panel, an ingredient list, net quantity, and the name and place of business of the manufacturer, packer, or distributor. Claims must be truthful and not misleading.
- Platform-Specific Seller Agreements: Marketplaces like Amazon and Walmart gate the category. Amazon wants a finished-product certificate of analysis (CoA) and a cGMP certificate from an accredited third-party certifier; Walmart treats supplements as a restricted category. Shopify is a storefront platform, not a marketplace, so it doesn't require CoAs to list products, but its Acceptable Use Policy and payment processing still restrict how you market supplements.
Supplement Claims vs. Drug Claims
The words on your label decide which set of rules applies. Under the Federal Food, Drug, and Cosmetic Act, a product intended to diagnose, cure, mitigate, treat, or prevent a disease is a drug, and selling a drug without FDA approval means selling an unapproved new drug. A disease claim on the label alone crosses that line.
Dietary supplements stay on the supplement side with structure/function language, such as "supports immune health." Each such claim must carry the boldface 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." You must notify the FDA within 30 days of first marketing the product with the claim, and back the claim with substantiation. The FTC enforces the same standard in ads.
Key Steps for Your Business
- Define Your Role: Are you a brand owner using a contract manufacturer, or a manufacturer yourself? A cGMP-compliant manufacturer handles most of the manufacturing work, but your name on the label keeps you responsible for the finished product.
- Consult a Lawyer: Hire an attorney or regulatory consultant in FDA and dietary supplement law to review your structure and claim language before launch.
- Secure Your Documentation: Get cGMP audit reports, batch CoAs, and product specifications from your manufacturer before you list anywhere; Amazon, Walmart, and an FDA inspection can all ask for them.
Most of this stack runs through your manufacturer, so pick a partner that keeps its cGMP paperwork current and hands over batch CoAs without being chased.