21 CFR § 1.1370 General Enforcement Regulations

§ 1.1370 What must be included in a petition requesting modified requirements or an exemption from the requirements?

Current through Sep 8, 2026 · Read all of Part 1

In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting modified requirements or an exemption from the requirements of this subpart must:

(a) Specify the food or type of entity to which the modified requirements or exemption would apply;

(b) If the petition requests modified requirements, specify the proposed modifications to the requirements of this subpart; and

(c) Present information demonstrating why application of the requirements requested to be modified or from which exemption is requested is not necessary to protect the public health.

← § 1.1365 When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?§ 1.1375 What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available? →