21 CFR 1.226
Who does not have to register under this subpart?
21 CFR 1.226 is the regulation titled “Who does not have to register under this subpart?” in 21 CFR Part 1, General Enforcement Regulations. 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 201.5, 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.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 1.226 most often, as written in the letters.
- 1 letterWe do not have any records that your facility is registered with FDA. Your Immune Bio Green Cell product appears to be labeled as a dietary supplement. Under section 201(ff) of the Act (21 U.S.C. § 321(ff)), a dietary…
The regulation
Read the text of 21 CFR 1.226 (eCFR, as of Sep 1, 2026)
This subpart does not apply to the following facilities:
(a) A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States. A facility is not exempt under this provision if the further manufacturing/processing (including packaging) conducted by the subsequent facility consists of adding labeling or any similar activity of a de minimis nature;
(b) Farms;
(c) Retail food establishments;
(d) Restaurants;
(e) Nonprofit food establishments in which food is prepared for, or served directly to, the consumer;
(f) Fishing vessels, including those that not only harvest and transport fish but also engage in practices such as heading, eviscerating, or freezing intended solely to prepare fish for holding on board a harvest vessel. However, those fishing vessels otherwise engaged in processing fish are subject to this subpart. For the purposes of this section, “processing” means handling, storing, preparing, shucking, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, holding, or heading, eviscerating, or freezing other than solely to prepare fish for holding on board a harvest vessel;
(g) Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1.226.
Latest letters citing it
The letter citing 21 CFR 1.226 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.