21 CFR 111.410
What requirements apply to packaging and labels?
21 CFR 111.410 is the regulation titled “What requirements apply to packaging and labels?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.12, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 111.410 (eCFR, as of Sep 1, 2026)
(a) You must take necessary actions to determine whether packaging for dietary supplements meets specifications so that the condition of the packaging will ensure the quality of your dietary supplements;
(b) You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies. Label reconciliation is not required for cut or rolled labels if a 100-percent examination for correct labels is performed by appropriate electronic or electromechanical equipment during or after completion of finishing operations; and
(c) You must examine, before packaging and labeling operations, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the master manufacturing record; and
(d) You must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.410.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion1 letter cites both
- 21 CFR 101.13Nutrient content claims, general principles1 letter cites both
- 21 CFR 101.15Food; prominence of required statements1 letter cites both
- 21 CFR 101.2Information panel of package form food1 letter cites both
- 21 CFR 101.3Identity labeling of food in packaged form1 letter cites both
- 21 CFR 101.36Nutrition labeling of dietary supplements1 letter cites both
- 21 CFR 101.4Food; designation of ingredients1 letter cites both
- 21 CFR 101.5Food; name and place of business of manufacturer, packer, or distributor1 letter cites both
Latest letters citing it
The letter citing 21 CFR 111.410 that FDA posted most recently.
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