21 CFR 201.128
Meaning of “intended uses”
21 CFR 201.128 is the regulation titled “Meaning of ‘intended uses’” in 21 CFR Part 201, Labeling. Since 2021, 321 FDA warning letters have cited it.
- Letters citing it
- 321 since 2021
- Jan 1 to Oct 30, 2026
- 81 against 58 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 60 letters
- Closed out
- 1% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 201.128 most often, as written in the letters.
- 2 lettersYou failed to meet the conditions of sections 503A and 503B of the FD&C Act
- 1 letter“Dissolve Mass (Stasis Breaker) helps dissipate nodules, palpable masses, and tumors by strongly invigorate [sic] the circulation of blood, qi, & lymph.”
- 1 letter“Erectin Stimulating Gel is nicknamed the INSTANT ERECTION formula.”
The regulation
Read the text of 21 CFR 201.128 (eCFR, as of Sep 1, 2026)
The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
[86 FR 41401, Aug. 2, 2021]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 201.128.
- 21 CFR 211.22Responsibilities of quality control unit60 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures60 letters cite both
- 21 CFR 330.1General conditions for general recognition as safe, effective and not misbranded55 letters cite both
- 21 CFR 201.115New drugs or new animal drugs50 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use50 letters cite both
- 21 CFR 211.165Testing and release for distribution49 letters cite both
- 21 CFR 211.100Written procedures; deviations43 letters cite both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling42 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 201.128 that FDA posted most recently.
- DrugsView Bella’s Nutri Shop Inc.Tawon LiarIssuedOct 26, 2026PostedNov 3, 2026
- DrugsView Jing Cheong Asia Inc. dba New York Tong Ren TangOphthalmic and traditional Chinese medicine products sold onlineIssuedOct 26, 2026PostedNov 3, 2026
- DrugsView NatuzemTestitón Extra Strong vials, Reumofan Plus, Artrifan King, RMSOL Gracian, Kuka Flex Forte, Reuma KingIssuedOct 26, 2026PostedNov 3, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.