Start here: FDA doesn't approve supplements before sale
The Dietary Supplement Health and Education Act of 1994 (DSHEA) set up the rules for supplements in the United States. Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed, and FDA does not approve supplement labels or claims before they are used. Companies that make and sell supplements are responsible for making sure their products are safe and properly labeled. FDA's role is mostly after a product is on the market, for example through inspections, warning letters and recalls.
A few practical consequences:
- No supplement is "FDA approved." A label or ad that says so is wrong.
- Supplements may not claim to treat, cure or prevent a disease. When a label makes a claim about how the product affects the body's structure or function, it must carry a disclaimer that FDA has not evaluated the statement.
- Manufacturers must follow current good manufacturing practice (cGMP) rules in 21 CFR Part 111. That is a legal requirement, so "made in compliance with cGMP" describes the legal minimum.
Because there is no pre-market approval, private organizations offer seals that check different things. They fall into three broad groups.
Three kinds of seals
| Type | Main question it answers | What it usually involves | What it doesn't tell you |
|---|---|---|---|
| Sourcing verification | Does this product come from a legitimate, licensed supply chain? | Review of documents identifying the manufacturer and distributors, and their registrations and licenses. | Whether the contents match the label, unless testing is added. Whether the product works. |
| GMP certification or registration | Does the manufacturing facility follow good manufacturing practice? | An audit of the facility's processes, records and quality controls. | Which specific products came from that facility, or what any particular product contains. |
| Independent product testing | Does this product contain what the label says, without specified contaminants? | Lab testing of product samples against set criteria, often combined with facility audits and periodic retesting. | Whether the product is effective or right for you. Results cover the products and lots in the program. |
Two well-known testing programs
USP Verified. According to USP, the USP Verified Mark indicates a supplement contains the listed ingredients in the declared amounts, does not contain harmful levels of specified contaminants, will break down and release into the body within a specified time, and was made according to FDA cGMP. The program includes a facility audit, review of manufacturing and quality documents, testing of product samples, and off-the-shelf testing of verified products.
NSF Certified for Sport. According to NSF, this certification combines a GMP facility audit, label claim verification and contaminant screening, and testing of production lots for a list of substances banned in sport, with annual audits and retesting. Certified products and lots can be looked up at nsfsport.com and in NSF's app. Athletes subject to drug testing often look for it.
Neither program says a product is effective, and neither is government approval.
How to read and check a seal
- Find out who issued it. A legitimate seal names an organization you can look up, with a published standard. A generic badge like "lab tested" or "pharmaceutical grade" with no organization behind it tells you little.
- Read what it actually claims. Check whether it covers sourcing, the facility, or the product's contents, using the table above.
- Check that it covers this exact product. Seals are usually granted to specific products or facilities. A seal on a brand's homepage doesn't mean every product it sells is covered.
- Look it up. Good programs offer a public way to confirm a product is listed: a searchable directory, an ID on the label, or a QR code. Confirm the product name and status on the issuer's own site, not just on the seller's page.
- Check that it's current. Certifications can lapse or be withdrawn. Look for a status and a date.
A seal is also only as good as the product in your hand. A real seal can be copied onto a fake bottle, so pair seal checks with the buying and packaging checks in how to spot counterfeit supplements online.
Where PillWatch fits
The PillWatch Seal is a sourcing verification. It certifies that a product is made by a licensed manufacturer and sourced through licensed distributors, based on documents we review. As part of that review we ask for the manufacturer's FDA facility registration and evidence of cGMP compliance, but PillWatch does not audit facilities itself and does not certify a manufacturer's GMP.
What else to know:
- It isn't product testing by default. Only Ultimate plan members receive a test of one product by an accredited ISO/IEC 17025 lab, and results appear only if the brand chooses to publish them. Brands can also post their own certificates of analysis. The verify page shows whether lab results are on file.
- It is checkable. Every verified product has a seal ID (PW- plus five characters) and a public page at pillwatch.com/verify showing its status and when we last checked it.
- It is watched over time. We monitor major marketplaces monthly for misuse of member brands' names and our seal, re-verify at least yearly and when suppliers change, and mark seals inactive when sourcing can't be re-verified or a membership ends.
- We disclose our conflicts. PillWatch is run by Secure Medical, Inc., which also owns supplement brands. Those brands are labeled "Affiliated" on their verify pages and go through the same review.
- It is not FDA approval, and it says nothing about whether a supplement works.
Our full standard is on the what we check page.