“FDA approved” is one of the most-misused phrases in the nutra industry. The FDA does not approve dietary supplements. It approves drugs. What it does for supplements is something else entirely, and understanding the difference is the difference between a brand that runs smoothly and one that gets a warning letter.
What FDA registration actually is
Under section 415 of the U.S. Federal Food, Drug, and Cosmetic Act, every facility that manufactures, processes, packs, or holds food (including dietary supplements) for U.S. consumption must register with the FDA. This is a registration, not an approval.
PharmScale’s facility holds FDA Registration No. 14287957814, with our DUNS / UFI 672262583. That means: the U.S. government knows our address, our scope of activity, and has the authority to inspect us under the Bioterrorism Act of 2002 and the FDA Food Safety Modernization Act (FSMA) of 2011.
What it does NOT mean
- It does not mean the FDA has tested or approved any of our products.
- It does not mean any specific dietary supplement we make has been evaluated.
- It does not mean we are exempt from compliance obligations, the opposite, we are obligated.
You may not (and we will not) put “FDA approved” on a supplement label. You can say the manufacturer is “FDA registered.” Wording matters here.
21 CFR Part 111: the cGMP we work under
The real compliance backbone is FDA’s 21 CFR Part 111, the current Good Manufacturing Practice for dietary supplements. It covers:
- Personnel hygiene and training
- Physical plant and equipment
- Production and process controls
- Quality control with written specifications
- Holding and distribution records
- Returned dietary supplements protocols
- Consumer complaint handling
We are audited under these standards. The result of that audit (alongside ISO 22000 and ISO 22716) is a documented quality system you can point to in any due-diligence conversation.
What YOU as the brand owner are responsible for
Even with us doing the manufacturing, the U.S. side has obligations that stay with you (the “brand owner of record”):
- Label compliance. The Supplement Facts panel, claims, ingredient declarations, your name and address.
- Structure/function claims with disclaimer. If you make any function claim, you need the standard FDA disclaimer.
- NDIN filing for any new dietary ingredient that wasn’t marketed in the U.S. before October 15, 1994. We help draft these but the filing is in your name.
- Adverse event reporting. 21 CFR Part 4 requires you to maintain a system for receiving and reporting serious adverse events within 15 business days.
FSMA and the supply chain
The Food Safety Modernization Act extended FDA’s reach to imports. Every shipment we send into the U.S. requires FDA Prior Notice (typically 4–8 hours before arrival) and full FSMA-compliant documentation. We file these on every shipment so your import broker isn’t scrambling.
Practical timeline for new U.S. brands
| Step | Who | Time |
|---|---|---|
| Confirm formulation has no NDIs | PharmScale regulatory | 2–3 days |
| Label design with Supplement Facts | PharmScale design | 5–7 days |
| FDA Prior Notice for first shipment | PharmScale logistics | same week |
| Customs clearance to U.S. warehouse | Your freight forwarder | 5–7 days from departure |
Total realistic time from signed contract to product in a U.S. warehouse for a standard formulation: about 30 days.