21 CFR 111.70
What specifications must you establish?
21 CFR 111.70 is the regulation titled “What specifications must you establish?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 16 FDA warning letters have cited it.
- Letters citing it
- 16 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 201.5, in 14 letters
- Closed out
- 13% 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 111.70 most often, as written in the letters.
- 1 letterYou failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you did not establish component specifications…
- 1 letterYou failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or…
- 1 letterYou failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or…
The regulation
Read the text of 21 CFR 111.70 (eCFR, as of Sep 1, 2026)
(a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
(b) For each component that you use in the manufacture of a dietary supplement, you must establish component specifications as follows:
(1) You must establish an identity specification;
(2) You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and
(3) You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement.
(c) For the in-process production:
(1) You must establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement;
(2) You must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and
(3) Quality control personnel must review and approve the documentation that you provide under paragraph (c)(2) of this section.
(d) You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.
(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement.
(f) If you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order.
(g) You must establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.70.
- 21 CFR 201.5Drugs; adequate directions for use14 letters cite both
- 21 CFR 111.260What must the batch record include?13 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?12 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?11 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements10 letters cite both
- 21 CFR 101.4Food; designation of ingredients10 letters cite both
- 21 CFR 101.9Nutrition labeling of food9 letters cite both
- 21 CFR 111.210What must the master manufacturing record include?9 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.70 that FDA posted most recently.
- DrugsView Imu-Tek Animal Health, IncorporatedColostrum-5 Capsules and Colostrum-5 PowderIssuedJun 5, 2026PostedJun 23, 2026
- DrugsView Meta Labs Pharmaceuticals, LLCDietary supplements and unapproved drugs sold onlineIssuedMay 15, 2026PostedJun 2, 2026
- DrugsView Mericon Industries, Inc.Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 CapsulesIssuedJul 17, 2025PostedSep 16, 2025
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