Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
4Plants intended for food use producing new proteins
Recombinant-DNA plants used in food production
Regulated by EPA, excluded from this guidance; evaluating the safety of pesticides, including plant-incorporated protectants
Source of the new protein being evaluated.
Stakeholders
2Entity responsible for submitting applications under section 524B
Includes sponsors, researchers, or individuals interacting with CVM
Regulatory Context
Attributes
1resistance of the protein to enzymatic degradation
Identified Hazards
Hazards
5Potential safety concern for new proteins
Potential safety concern for humans or animals; Consideration in the early food safety evaluation of a new protein.
Production of novel substances not ordinarily produced
guidance was updated to include updates on allergens
identify toxins or classes of toxins in related plants; identify toxins known to be present in the same species; identify any toxins known to be present in the same species
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)