---
title: "What foods and businesses fall under the applicability of the FDA preventive controls rule in 21 CFR 117.1? Answer in under 100 words."
canonical: https://www.m-i-n-d.ai/minds/food-safety/foods-businesses-fall-under-applicability-fda-preventive-controls-rule-21-cfr
jurisdiction: "US Federal · FDA"
last_verified: 2026-08-26
license: CC BY 4.0 — https://creativecommons.org/licenses/by/4.0/
attribution: "Source: MIND (m-i-n-d.ai)"
---

# What foods and businesses fall under the applicability of the FDA preventive controls rule in 21 CFR 117.1? Answer in under 100 words.

21 CFR 117.1 applies to food manufactured, processed, packed, or held for sale in the United States if the facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subparts C through G of 21 CFR Part 117.

## Details / How it works

The criteria and definitions in 21 CFR Part 117 apply in determining whether a food is adulterated under Section 402(a)(3) or 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, or in violation of Section 361 of the Public Health Service Act (42 U.S.C. 264).

## Numbers & thresholds

| Requirement | Description |
|-------------|-------------|
| Adulteration (402(a)(3)) | Food manufactured under conditions that make it unfit for food. |
| Adulteration (402(a)(4)) | Food prepared, packed, or held under insanitary conditions leading to contamination or health injury. |

## Exceptions & edge cases

Food covered by specific current good manufacturing practice regulations is also subject to the requirements of those regulations, as stated in § 117.1(c).

## Sources

- [1] U.S. National Archives, Electronic Code of Federal Regulations — 21 CFR 117.1 — Applicability and Status · https://www.ecfr.gov/current/title-21/section-117.1 · as of 2026-08-26