30-Day Notification for Dietary Supplements

What Is a 30-Day Notification for Dietary Supplements?

Dietary supplements may carry claims that describe how a nutrient or ingredient affects the structure or function of the body, such as “supports healthy joints” or “helps maintain a healthy immune system.” FDA does not approve these claims in advance. In exchange, DSHEA requires the company to notify FDA that it is making the claim, no later than 30 days after the product first goes on the market with that claim.

This filing is known as the 30-day notification or DSHEA notification. It applies to three types of claims under section 403(r)(6) of the FD&C Act:

• Structure/function claims, which describe the role of an ingredient in affecting normal body structure or function
• General well-being claims, which describe general well-being from consuming a dietary ingredient
• Nutrient deficiency claims, which describe a benefit related to a classical nutrient deficiency disease and disclose how common that disease is in the U.S.

Requirements for Making a Structure/Function Claim

A supplement can lawfully make a structure/function claim only when all of the following are met:

• The claim is truthful and not misleading, and the company has substantiation to support it
• The claim does not suggest the product treats or prevents disease, either directly or by implication
• The label carries the required FDA disclaimer, formatted and placed as the regulations require
• FDA is notified no later than 30 days after first marketing the product with the claim

Missing any one of these can cause FDA to treat your supplement as misbranded, or as an unapproved drug if the claim crosses into disease territory.

What the 30-Day Notification Must Include

Under 21 CFR 101.93(a), the notification must contain:

That certification is a legal statement made to a federal agency. It should not be signed until the claims and supporting evidence have been reviewed.

The Required FDA Disclaimer

Every structure/function claim must be accompanied by this disclaimer, as set out in 21 CFR 101.93(c):

“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.”

The disclaimer must appear on each panel of the label where a claim appears, in boldface type no smaller than one-sixteenth of an inch. When it is not placed directly next to the claim, it must be linked to the claim with a symbol such as an asterisk and set off in a box. When a panel carries more than one claim, the plural form “These statements have not been evaluated…” may be used.

Structure/Function Claims vs. Disease Claims

The most common problem we see is not a missed filing. It is a claim that should never have been made. A notification does not protect a disease claim, and filing one can draw FDA’s attention to it.

FDA’s criteria in 21 CFR 101.93(g) also treat claims as disease claims when they are implied through product names, pictures, symbols, citations to studies, or testimonials. Learn more about structure/function claims.

What’s Included in Our 30-Day Notification Service

• Claim review of every structure/function statement on your label, packaging, website and marketplace listings
• Disease claim screening against FDA’s criteria, with compliant rewrites for risky claims
• Substantiation check to confirm your evidence supports the claim under FDA and FTC standards
• Disclaimer and label review for wording, type size, placement and linking symbols
• Drafting the notification with all elements required by 21 CFR 101.93(a)
• Submission to FDA and a record of the filing for your compliance files
• Handling FDA follow-up, including responses to any FDA letter about your claims
• Catch-up filings for products already on the market without a notification

Our 30-Day Notification Process

1. Send your materials: label artwork, claim list, product names, launch date, and any supporting studies
2. Attorney review: we screen each claim for disease language and check substantiation and disclaimer compliance
3. Revisions: we suggest compliant wording for any claim that creates risk
4. Draft and certify: we prepare the notification for your review and signature
5. Submit and document: we file the notice with FDA within the 30-day window and send you a copy for your records

Most notifications are prepared within a few business days of receiving your label and claims. Rush filings are available when your 30-day window is closing.

Why Work With an FDA Attorney on Your 30-Day Notification

The form itself is short. The legal risk sits in the claims behind it and the certification you sign.

• Claims review before filing. We make sure you are not notifying FDA of a disease claim.
• Accurate certification. We confirm your substantiation supports the claims before you certify to a federal agency.
• Attorney-client privilege. Your internal claim discussions and evidence reviews stay protected.
• Enforcement readiness. If FDA or the FTC questions your claims, your attorney already knows your product.

This page provides general information and is not legal advice. Reading it does not create an attorney-client relationship. Regulatory requirements may change; contact our office for advice about your specific products.