21 CFR 101.5
Food; name and place of business of manufacturer, packer, or distributor
21 CFR 101.5 is the regulation titled “Food; name and place of business of manufacturer, packer, or distributor” in 21 CFR Part 101, Food Labeling. Since 2021, 7 FDA warning letters have cited it.
- Letters citing it
- 7 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.3, in 7 letters
- Closed out
- 43% 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 101.5 most often, as written in the letters.
- 1 letterYour Hydro Brew Unsweetened Green Tea, Silver Bullet Green Tea with Zinc, and Hydro Shot products are misbranded within the meaning of section 403(e)(1) of the FD&C Act [21 U.S.C. 343(e)(1)] in that the product labels…
- 1 letterYour John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that…
The regulation
Read the text of 21 CFR 101.5 (eCFR, as of Sep 1, 2026)
(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.
(c) Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as “Manufactured for ______”, “Distributed by ______”, or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP code shall appear either on the label or the labeling (including invoice).
(e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 101.5.
- 21 CFR 101.3Identity labeling of food in packaged form7 letters cite both
- 21 CFR 101.9Nutrition labeling of food7 letters cite both
- 21 CFR 101.4Food; designation of ingredients6 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use6 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements5 letters cite both
- 21 CFR 101.7Declaration of net quantity of contents5 letters cite both
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion3 letters cite both
- 21 CFR 101.15Food; prominence of required statements3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 101.5 that FDA posted most recently.
- DrugsView Lone Star Botanicals Inc.ready-to-eat seasoning blends and Dr. Botanical Health superfood powdersIssuedNov 6, 2023PostedJan 2, 2024
- DrugsView Spartan Enterprises Inc. dba Watershed Wellness Centerdietary supplementsIssuedMar 8, 2023PostedApr 25, 2023
- DrugsView Deggeh Foods, Inc.Actibest Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, Moringa Tea BagsIssuedJul 29, 2022PostedAug 16, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.