Description
For many years, the agency has recommended the seizure not only of violative articles but also the labeling which causes them to be violative.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Dietary Supplements
Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Stakeholders
2Manufacturer
Entity responsible for submitting NDINs
Distributor
Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
2Injunction
A pending judicial enforcement action that prevents listing
Seizure
Anticipated legal action under section 304 of the FD&C Act
Document Types
1Compliance Policy Guide
FDA regulatory reference documents (CPG 527.300, 555.300)
See Also (8)
- CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention
- CPG Sec. 101.100 FDA Considerations for Recommending Charges for Causing the Introduction of Violative Products into Interstate Commerce
- CPG Sec. 160.600 Payment of Expert Witnesses
- CPG Sec. 110.500 Food and Drug Guaranty - Imports
- CPG 230.120- Human Blood and Blood Products as Drugs
- Compliance Policy Guides Index
- CPG Sec 590.600 Wigs Compliance Policy Guide 7128.05