21 CFR 101.93 — Structure/Function Claim Disclaimer Requirements
21 CFR 101.93 codifies two mandatory requirements for dietary supplements making structure/function claims: the label must bear a specific FDA disclaimer in a prescribed format, and the manufacturer must notify FDA within 30 days of first marketing the claim. These requirements apply to every structure/function claim on every dietary supplement label — missing the disclaimer is misbranding, regardless of how strong the underlying science is.
21 CFR 101.93 governs the disclaimer and notification requirements for structure/function claims on dietary supplement labels. It was established pursuant to DSHEA and finalized in January 2000 (65 Fed. Reg. 1000). The regulation was amended in March 2023 (88 FR 17718) to clarify requirements for conventional food structure/function claims.
This regulation applies specifically to dietary supplements making structure/function claims. The broader regulatory framework for what constitutes a permissible structure/function claim — and how it differs from a prohibited disease claim — is addressed in the parent regulation and FDA's final rule at 65 Fed. Reg. 1000.
The Required FDA Disclaimer
Under 21 CFR 101.93(c), every structure/function claim on a dietary supplement label must be accompanied by the following disclaimer, verbatim:
"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."
This disclaimer language is fixed by regulation. Brands may not modify, abbreviate, or paraphrase it. Any variation in the disclaimer text renders the label non-compliant.
Disclaimer Placement and Formatting Requirements
Under 21 CFR 101.93(c)(1) and (2), the disclaimer must meet specific placement and format requirements:
Placement
The disclaimer must appear immediately adjacent to or directly below the structure/function claim it accompanies — not on a different panel, not in a footnote at the bottom of the label, and not separated by other text or graphic elements
When multiple structure/function claims appear on the label and the disclaimer is used for all of them, the disclaimer may appear in one location on the label with a referencing symbol (such as a dagger †) placed next to each claim and next to the disclaimer
Formatting
The disclaimer must appear in boldface type
The disclaimer must be in a type size no smaller than one-half the type size of the statement it accompanies, with a minimum of 1/16-inch space between the disclaimer and the surrounding printed matter
The disclaimer text must be set off from other information on the label (e.g., by surrounding whitespace or a box)
Symbol Cross-Reference Method
When using a dagger (†) or other symbol to cross-reference multiple claims to a single disclaimer:
The symbol must appear immediately following each structure/function claim
The disclaimer must appear in the same panel as the claim(s) it accompanies
The disclaimer must include the same symbol before the disclaimer text: "† These statements have not been evaluated..."
The 30-Day Notification Requirement
Under 21 CFR 101.93(a), a manufacturer or distributor of a dietary supplement that bears a structure/function claim must notify FDA no later than 30 days after first marketing the product with that claim.
The notification must include:
The text of the structure/function claim as it appears on the label
The name and address of the manufacturer, packer, or distributor
A statement that the claim meets the requirements of 21 CFR 101.93
This is a post-market notification, not a pre-approval process. The manufacturer may begin marketing the product with the claim before FDA responds. FDA does not approve or disapprove structure/function claims through this process — the notification simply creates a record.
How to Submit
Notifications are submitted to FDA's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS). FDA has an electronic submission portal for structure/function claim notifications.
Consequences of Non-Notification
Failure to submit the 30-day notification is a labeling violation but has historically not been FDA's primary enforcement focus for structure/function claim compliance. FDA typically focuses enforcement on (1) claims that cross into disease claim territory and (2) missing or improperly formatted disclaimers.
Disclaimer for Conventional Foods
The March 2023 amendment (88 FR 17718) clarified that structure/function claims on conventional foods (not supplements) may also be made, but:
No FDA disclaimer is required for conventional food structure/function claims
The 30-day notification requirement does not apply to conventional foods
The claim must still be truthful and not misleading, and the disease claim prohibition applies equally
What Triggers the Disclaimer Requirement
The disclaimer is required whenever any of the following types of claims appear on a dietary supplement label or in labeling:
Claim Type | Example | Disclaimer Required? |
|---|---|---|
Structure/function claim | "Supports immune function" | Yes |
General well-being claim | "Helps maintain energy levels" | Yes |
Nutrient deficiency claim | "Vitamin C prevents scurvy" | Yes (with separate deficiency disclosure) |
Disease claim | "Treats arthritis" | Not applicable — claim is prohibited |
A disease claim converts the product to a drug requiring FDA approval — the disclaimer cannot cure a prohibited disease claim.
Common Violations Under 21 CFR 101.93
Missing disclaimer — Structure/function claim on label without any FDA disclaimer
Disclaimer on wrong panel — Disclaimer appears on back panel while claim is on front; they must be adjacent
Disclaimer too small — Disclaimer type size below one-half the size of the accompanying claim
Paraphrased disclaimer — "This product has not been approved by the FDA" or similar alternate language does not satisfy the requirement
No dagger symbol on claims — When using the cross-reference method, each claim must be marked with the symbol
Late or missing 30-day notification
How Truli Helps with 101.93 Disclaimer Compliance
Disclaimer presence detection: Truli identifies all structure/function claims on a label and verifies that a compliant FDA disclaimer is present
Format validation: Truli checks that the disclaimer appears in bold, meets the type size requirement relative to the claim, and is properly placed
Cross-reference symbol audit: Truli verifies that all claims are marked with a consistent symbol and that the disclaimer references the same symbol
Claim classification: Truli evaluates label copy to distinguish permissible structure/function claims from prohibited disease claims, flagging language that may require reformulation
Related Regulations
FDA Structure/Function Claims for Dietary Supplements — What qualifies as a permissible structure/function claim and how it differs from a disease claim
DSHEA — The statutory authority under which structure/function claims are permitted
21 CFR 101.36 — Supplement Facts Panel — Label panel requirements for dietary supplements
FTC Health Claims in Advertising — FTC's parallel substantiation requirements for advertising claims
Frequently Asked Questions
Does the disclaimer need to appear on my website and social media as well?
FDA's labeling disclaimer requirement applies to product labels and labeling (packaging materials and materials accompanying the product). For website and social media advertising, FTC's substantiation requirements apply, and many brands include the disclaimer on product pages as a best practice — but the 21 CFR 101.93 disclaimer requirement technically applies to product labels, not all advertising.
Can the disclaimer be in a smaller font to save space?
The disclaimer must be at least half the type size of the structure/function claim. There is a practical minimum — if the claim is in 10-point type, the disclaimer must be at least 5-point type, which is effectively unreadable. FDA expects the disclaimer to be legible. Brands should not use this ratio as license to make the disclaimer so small as to be invisible.
Does adding the disclaimer protect me from FDA enforcement if my claim is actually a disease claim?
No. The disclaimer cannot transform a prohibited disease claim into a permissible structure/function claim. If the label says "treats arthritis," adding the FDA disclaimer does not make that claim compliant — the claim itself must be reformulated to describe normal structure or function rather than disease treatment.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Reflects 21 CFR 101.93 as amended through March 2023. Truli monitors FDA guidance and warning letters on structure/function claim compliance. Book a demo to see how.
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