---
kind: "section"
citation: "21 C.F.R. § 111.1"
title: "21"
number: "111.1"
heading: "Who is subject to this part?"
url: "https://uscodex.org/cfr/21/111.1"
---

# §111.1. Who is subject to this part?

- (a) Except as provided by [paragraph (b)](#b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:
  - (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and
  - (2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
- (b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.