If you are planning to sell dietary supplements in the United States, you will encounter the FDA — and the rules are more straightforward than most founders fear. The key insight: the FDA does not pre-approve supplements, but it does regulate how they are made and labeled. Most of that burden falls on your manufacturer, not your brand.
This guide explains exactly what the FDA requires, who is responsible for what, and how to make sure your product launches compliant.
First, The Good News: No Pre-Market Approval
Unlike pharmaceuticals, dietary supplements do not need FDA approval before they can be sold. You do not file a drug application and wait for a decision. The market-entry bar is about compliance with manufacturing and labeling rules, not about getting a stamp of approval.
This is what makes the supplement industry accessible to new brands — and it is also why choosing a compliant manufacturer matters so much.
The Four Things That Actually Matter
1. FDA Facility Registration
Under the Bioterrorism Act, any facility that manufactures, processes, packs, or holds food (which includes dietary supplements) must be registered with the FDA. Registration is renewed every two years.
Who handles this: Your contract manufacturer. If you import finished product, you will also complete a short facility registration for your importing entity.
What to ask: "Is your facility FDA-registered, and can you provide the registration confirmation?"
2. Good Manufacturing Practices (GMP / cGMP)
21 CFR Part 111 is the GMP rule for dietary supplements. It governs:
- Raw material identity and contamination testing
- Facility cleanliness and process controls
- Equipment maintenance and record-keeping
- Batch production records and traceability
- Finished product testing
A GMP-compliant factory tests every incoming lot, documents every process, and tests every finished batch before release.
What to ask: "Which GMP certification do you hold, and can I see your batch testing process?"
3. Labeling Compliance
The FDA has specific rules for supplement labels:
- Supplement Facts panel in the required format
- Structure/function claims must be truthful and not misleading, and must include the disclaimer "This statement has not been evaluated by the Food and Drug Administration"
- Identity, net quantity, ingredient, and manufacturer/distributor information
Who handles this: Your manufacturer's compliance team provides label templates and reviews your artwork. This is a service, not an obstacle.
4. Adverse Event Reporting
Brands are responsible for reporting serious adverse events associated with their products. This is a record-keeping obligation, not something that blocks your launch — but you should know it exists.
What the FDA Is Not Going To Do
- It will not "approve" your product. There is no approval process to wait for.
- It will not pre-review your claims. You are responsible for the truthfulness of your label claims.
- It does not normally inspect foreign facilities on a fixed schedule. But it can — which is another reason your factory's records must be immaculate.
EU Buyers: A Quick Note
If you are selling in Europe instead, the framework is different. The EU uses the Novel Food Regulation — certain ingredients need authorization before they can be used in supplements, and the process is longer and more involved than the US notification approach. If your target market is the EU, discuss Novel Food status with your manufacturer before finalizing a formula.
Red Flags in a Manufacturer
You can judge a lot from how a factory answers these questions:
- ❌ "FDA approval? Sure, we have it." — There is no FDA approval for supplements. This answer signals confusion.
- ❌ "Don't worry about certifications." — Your market entry depends on them.
- ✅ "Here is our FDA registration, GMP certification, BRCGS and NSF status, and our batch COA process." — This is the answer you want.
FAQ
Do I need FDA approval to sell dietary supplements? No pre-market approval is required. Supplements must be made in an FDA-registered, GMP-compliant facility and follow labeling rules.
Is my brand or the factory responsible for FDA registration? The manufacturing facility holds the registration. Your brand maintains records and handles adverse event reporting.
Can a Chinese factory be FDA-registered? Yes. Many international manufacturers, including MILDY Health in Guangzhou, hold FDA facility registration and export compliant products to the US market.
Does my supplement need a label claim disclaimer? Structure/function claims must include the FDA disclaimer line. Your manufacturer's compliance team will include it in your label template.
Launch in the US Market with a Compliant Partner
MILDY Health is FDA-registered with GMP, BRCGS AA, and NSF GMP certifications. Every batch ships with a complete Certificate of Analysis. Talk to our compliance team about your US-market launch — we will tell you exactly what your product needs.