What Is 30-Day Notification?
The legal requirement under DSHEA to notify FDA within 30 days of first marketing a dietary supplement bearing a structure-function claim. The notification includes the text of the claim and the disclaimer.
Why It Matters for Supplement Brands
Failing to file a 30-day notification is a technical violation of DSHEA that can appear in FDA Warning Letters. It's a simple compliance step that many brands overlook. While FDA does not 'approve' the claim, the notification creates a record of your claim and demonstrates good faith compliance.
How It Works
Within 30 days of first marketing a supplement with a structure-function claim, you must:
1. Submit a written notification to FDA's Office of Dietary Supplement Programs 2. Include the exact text of the claim(s) 3. Include the name and address of the company 4. Identify the dietary supplement and specific ingredient(s) that are the subject of the claim
The notification can be submitted electronically through FDA's online system.
FDA may review the notification and respond if they believe the claim is actually a disease claim, but they do not 'approve' structure-function claims. The notification is a regulatory requirement, not an approval process.
Common Mistakes to Avoid
- ✗Not filing the 30-day notification at all — many brands are unaware of this requirement
- ✗Filing the notification late (must be within 30 days of FIRST marketing)
- ✗Assuming FDA's lack of response means the claim has been approved or endorsed
- ✗Not re-notifying when changing or adding new claims to existing products
Related Terms
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