FDA disclaimer on dietary supplements wording and placement
The FDA disclaimer on dietary supplements applies only to certain claims. Use the exact two-sentence wording and the current placement rules.
The FDA disclaimer on dietary supplements is required for certain claims, including structure/function claims, not automatically for every supplement. Use the full two-sentence statement and connect it to each applicable claim, following 21 CFR 101.93.
FDA's December 11, 2025 letter says the agency intends to exercise enforcement discretion for repeating the disclaimer on each claim-bearing product-label panel. It does not make the disclaimer optional, and it does not drop the link to each applicable claim.
Exact FDA disclaimer wording
For one statement, use the singular wording in §101.93(c)(1):
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 statements, the plural wording in §101.93(c)(2) is:
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Copy both sentences. Do not shorten "Food and Drug Administration" to "FDA," replace "statements" with "claims," or omit the disease sentence. "These claims have not been evaluated by the FDA" is not the standard FDA disclaimer statement. FDA's labeling guide says the wording may not be modified.
Where several statements appear, each can carry its own singular disclaimer. Alternatively, use a plural disclaimer with the required placement and linkage. The regulation permits both approaches in §101.93(c).
When the DSHEA statement is required
Check the claim first. Section 403(r)(6) covers a statement about a nutrient or dietary ingredient's role in body structure or function. It also covers a documented mechanism by which that nutrient or ingredient maintains structure or function, and general well-being from consuming it. A statement about a benefit related to a classical nutrient deficiency disease is covered only when it discloses that disease's prevalence in the United States. Those categories are in the official 2024 U.S. Code, §343(r)(6).
A dietary supplement disclaimer belongs with those statements. It is not a universal line for every claim category. FDA's labeling guide distinguishes structure/function claims from other claims, including health claims.
The disclaimer cannot make a disease-treatment claim lawful. Under §101.93(f), a disease claim subjects the supplement to drug regulation unless the claim is an authorized health claim for which the product qualifies. §101.93(g) covers explicit and implied disease claims, including context from names, pictures and symbols. Adding "not intended to treat" cannot neutralize a contradictory treatment claim elsewhere on the label.
Placement rules and the December 2025 policy
The text of §101.93(d) still requires the disclaimer on each panel or page bearing an applicable statement.
But FDA's December 2025 letter says the agency intends to exercise enforcement discretion for that repetition on product-label panels. That's an enforcement policy, not an amendment to the regulation. FDA does not intend to exercise that discretion for the requirement to include the disclaimer on the product label and link it to each applicable claim. The other requirements of §101.93 remain. The letter says FDA is considering an amendment and is likely to propose a rule if its review identifies no significant concerns. That proposal is not a completed rule change.
For label artwork, check these FDA disclaimer rules:
- Put the disclaimer immediately adjacent to the claim, with no intervening material, or use a symbol link.
- For a symbol link, put a symbol such as an asterisk at the end of each applicable statement. Place the matching symbol next to the disclaimer.
- Put a nonadjacent disclaimer in a box. An immediately adjacent disclaimer does not always need a box.
- Use boldface letters with a typesize no smaller than one-sixteenth inch.
These mechanics come from §101.93(d) and (e). The statute also requires the disclaimer to be prominently displayed and in boldface, under §343(r)(6). A disclaimer elsewhere on the bottle, with no link, does not meet the linkage requirement.
The letter addresses product-label panels. Do not automatically extend that discretion to every page of a pamphlet, catalog or other labeling. For those materials, check the regulation's page requirement rather than treating the label-panel policy as a general waiver.
Two illustrative label layouts
These layouts show placement mechanics, not FDA-approved claims or a sign-off on a finished label. The placeholders still need their own claim review. Check type size and the box on the printed artwork. This page cannot show either one.
One claim with an adjacent disclaimer
[Substantiated structure/function claim]
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.
In the artwork, place the disclaimer immediately next to the claim without intervening material. Keep it boldface and at least one-sixteenth inch in typesize. This follows the adjacent-placement option in §101.93(d) and (e).
Two claims linked to a boxed disclaimer
[First substantiated structure/function claim]*
[Second substantiated structure/function claim]*
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
In this example, put the full disclaimer inside an actual box on the same panel as both claims. Use the matching asterisk beside it and at the end of both claims. Those lines illustrate the text. They are not the box. Check boldface and the physical minimum type size against §101.93(d) and (e).
Before releasing the label
Check the evidence behind each claim as well as the artwork. The responsible firm must have substantiation that the statement is truthful and not misleading. Adding a disclaimer does not replace that obligation under §343(r)(6). RegAffairs AI provides a cited answer on disclaimer wording and the underlying regulatory placement rules. Read that answer alongside FDA's December 2025 policy when checking panel repetition.
Keep notification separate from approval. Structure/function claims do not require FDA preapproval, according to FDA's labeling guide. Under §101.93(a), the manufacturer, packer or distributor must notify FDA no later than 30 days after first marketing the supplement with the relevant statement. The notice names the firm and its address, the claim text, the ingredient or supplement concerned and the product name, including the brand. A responsible person must certify that the firm has substantiation that the statement is truthful and not misleading.