The FDA 30-Day Structure/Function Claim Notification: Who Must File and How (21 CFR 101.93)

Most Amazon supplement sellers can recite the disclaimer from memory. Far fewer have ever filed the FDA notification that goes with it. The structure/function claim notification is the least-known obligation in supplement marketing: a mandatory filing with a 30-day clock that many brands, especially private-label brands, have simply never made. Here is the rule, who it binds, and how to comply.

The rule in one sentence

Under 21 CFR 101.93(a), no later than 30 days after the first marketing of a dietary supplement that bears a structure/function claim, a general well-being claim, or a classical nutrient deficiency claim, the manufacturer, packer, or distributor must notify FDA that the statement is being made.

This is one of three conditions DSHEA attaches to structure/function claims, alongside having substantiation on file and displaying the required disclaimer. Miss any of the three and the claim no longer qualifies for the statutory safe harbor. If you are unsure whether your claims are structure/function claims at all, start with our guide to the line between structure/function and disease claims; a disease claim cannot be fixed by notification.

Who must file

The regulation names the manufacturer, packer, or distributor of the supplement. In practice:

• You own the brand on the label, you file. A private-label brand owner is a distributor under the regulation, even if a contract manufacturer makes the product. FDA expects the party marketing the claim to notify.
• Do not assume your co-packer did it. Contract manufacturers rarely file for their customers, because the claims live in the customer's labeling and listings, not theirs.
• One party filing is enough. The obligation does not require every entity in the chain to file separately, but someone must, and as the seller making the claims you are the one with the exposure if no one did.

What the notification contains

Per 21 CFR 101.93(a), the notification must include:

1. The name and address of the manufacturer, packer, or distributor.
2. The exact text of the statement being made. Every distinct claim, not a paraphrase.
3. The name of the dietary ingredient or supplement that is the subject of the claim, if it is not clear from the statement itself.
4. The name of the dietary supplement, including its brand name.
5. The signature of a responsible individual who can certify the information is complete and accurate, and who certifies that the firm has substantiation that the statement is truthful and not misleading.

That last item deserves attention. The signature is a certification that your evidence exists at the time of filing. Filing a notification for a claim you cannot substantiate converts a paperwork gap into a false certification. Get your substantiation and compliance documents in order first, then file.

How to submit it

FDA encourages electronic submission through its Centralized Online Submission Module (COSM), which confirms receipt and provides status updates by email. The agency describes the process on its page for structure/function claim notification electronic submissions. The regulation also permits mailing the notification to FDA's Office of Dietary Supplement Programs at the College Park, Maryland address listed in 21 CFR 101.93(a), with an original and two copies for paper filings.

Submission mechanics change more often than the underlying rule, so before filing, check FDA's current instructions on its page covering notifications for structure/function and related claims.

The disclaimer that travels with the claim

Every notified claim must also carry this disclaimer on the label, prominently and in boldface:

"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."

For multiple claims, the plural version begins "These statements have not been evaluated..." The disclaimer and the notification are separate requirements. Printing the disclaimer does not file the notification, and filing the notification does not excuse a missing disclaimer.

Common misconceptions

"FDA approved my claim." No. This is a notification, not an application. FDA does not review claims for approval, does not issue approvals, and usually does not respond at all. If the agency believes a notified claim is actually a disease claim, it may send a courtesy letter saying so. Silence means only that you filed.

"The clock starts when I found out about the rule." The 30 days run from first marketing of the product bearing the claim. Learning about the requirement in year three does not reset anything. The practical move if you are late: file now. A late notification on record beats an absent one when FDA, or an Amazon document request, comes asking.

"I filed once, so I am covered forever." The notification covers the statements in it. Add a materially new claim to your label or listings and you have a new statement that needs its own notification within 30 days of first marketing it.

"Filing makes the claim legal." The notification is procedural. It does not transform a disease claim into a structure/function claim, and it does not substitute for substantiation.

What happens if you never filed

Failure to notify means the claim does not meet the conditions of section 403(r)(6) of the Food, Drug, and Cosmetic Act, which can render the product misbranded. FDA warning letters to supplement companies routinely cite the missing notification alongside claim violations, because it is the easiest count to prove: either the filing exists or it does not.

The commercial risk is closer to home. Amazon's supplement enforcement increasingly runs on documentation, from third-party cGMP verification to label-match reviews under the March 2026 misleading-claims policy. A brand whose regulatory paper trail has an obvious hole starts every appeal from behind.

The Amazon angle: your listing is marketing

Sellers sometimes read "first marketing" narrowly, as if only the physical label counts. That is not how FDA approaches it. Marketing a supplement with a structure/function claim starts the clock, and FDA has long treated online content used to sell a product, including product detail pages, as labeling. Adding "supports healthy stress response" to your Amazon bullets is marketing a product bearing that claim.

The clean operating rule: every structure/function claim that appears anywhere, label, listing, A+ content, or images, should appear in a filed notification, and every claim in your notification should have substantiation behind it. That alignment between label, listing, and paperwork is exactly what VERID8 checks: it scans your listing text and images against FDA, FTC, and Amazon rules, flags claims that cross into disease territory or drift from your label, and provides a compliant fix for each finding. You can audit one listing free to see what your claim inventory actually looks like.

The notification takes an afternoon. The consequences of skipping it surface at the worst possible moment, inside a warning letter or an appeal you are already losing. File it.