| This Guide covers all aspects of FDA regulation of dietary supplements under the Dietary Supplement Health and Education Act (DSHEA), an amendment to the Federal Food, Drug, and Cosmetic Act , as well as Federal Trade Commission (FTC) regulation of dietary supplement advertising.
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- CHAPTER 1: INTRODUCTION
- I. HISTORICAL OVERVIEW
- II. GOVERNING LAWS
- III. REGULATORY AUTHORITIES
- A. FDA
- B. Federal Trade Commission and National Advertising Division
- C. Customs
- IV. STATUTORY DEFINITIONS
- A. Definition of “Dietary Ingredient”
- V. PRODUCTS THAT MAY BE DIETARY SUPPLEMENTS
- VI. PRODUCTS THAT MAY NOT BE DIETARY SUPPLEMENTS
- VII. DIETARY SUPPLEMENTS IN RELATION TO OTHER FDA-REGULATED PRODUCTS
- Chapter 2: FORMULATION AND SAFETY
- I. FORMULATION
- A. Definition of “Dietary Ingredient”
- B. “New Dietary Ingredients”
- C. Articles Excluded from Use in Dietary Supplements
- D. Other Ingredients
- II. SAFETY
- A. DSHEA Safety Standard
- B. Dietary Supplements and Dietary Ingredients Prohibited
- C. Substances Prohibited or Restricted in All Foods
- D. FDA Import Alerts
- E. FDA Warnings
- F. Other Safety Issues
- Chapter 3: LABELING REQUIREMENTS
- I. Overview of Labeling Requirements
- A. General Misbranding Provisions
- B. Specific Misbranding Provisions
- C. Terminology
- D. Placement of Label Information
- E. English and Foreign Languages
- F. National Uniformity
- II. Mandatory Label Information
- A. Statement of Identity
- B. Net Contents Declaration
- C. Nutrition Labeling - “Supplement Facts”
- D. Ingredients or Other Ingredients Declaration
- E. Signature Line
- III. Additional Labeling Exemptions
- IV. Label Information Required for Certain Products
- A. Flavor Labeling
- B. Allergen Labeling
- C. Warning and Notice Statements
- D. Country of Origin Marking
- V. Non-Mandatory Label Information
- A. Claims
- B. Other Non-Mandatory Label Information
- CHAPTER 4: LABELING CLAIMS
- I. NUTRIENT CONTENT CLAIMS
- A. General Requirements and Scope
- B. Permitted Nutrient Content Claims
- C. Claims Authorized by FDA Regulation - Global Provisions
- D. Claims Authorized by FDA Regulation - Definitions and Specific
- Eligibility Requirements
- F. Claims Reflecting Authoritative Statements
- G. Claims Reflecting Authoritative Statements
- II. HEALTH CLAIMS AND QUALIFIED HEALTH CLAIMS
- A. General Requirements and Scope
- B. Permitted Health Claims
- C. Health Claims Approved by FDA Regulation
- D. Health Claims Prohibited by FDA Regulation
- E. Qualified Health Claims - Claims Authorized by FDA
- F. Qualified Health Claims - Claims Not Authorized by FDA
- III. STRUCTURE/FUNCTION CLAIMS
- A. Structure/Function Claims Differentiated
- B. Substantiation
- C. 30-Day Notification
- D. FDA Disclaimer
- Chapter 5: THIRD-PARTY LITERATURE
- I. OVERVIEW OF EXEMPTION
- II. GENERAL REQUIREMENTS
- III. THIRD-PARTY LITERATURE AS EVIDENCE OF INTENDED USE
- Chapter 6: CURRENT GOOD MANUFACTURING PRACTICES
- I. OVERVIEW OF CGMP REQUIREMENTS
- A. Background
- B. Purpose of the CGMPs
- C. Written Procedures and FDA Access to Records
- D. Consequences of Failure to Follow CGMPs
- E. Compliance Dates
- II. GENERAL PROVISIONS
- A. Who Is Subject to the Rule?
- B. Definitions
- III. PERSONNEL
- A. Written Procedures
- B. Preventing Contamination from Sick or Infected Personnel
- C. Personnel and Supervisor Qualifications
- D. Record Keeping and Records Access
- IV. PHYSICAL PLANT AND GROUNDS
- A. Written Procedures
- B. Sanitation Requirements
- C. Design and Construction Requirements
- D. Record Keeping and Records Access
- V. EQUIPMENT AND UTENSILS
- A. Written Procedures
- B. Equipment and Utensils Requirements
- C. Automatic, Mechanical or Electronic Equipment
- D. Record Keeping and Records Access
- VI. PRODUCTION AND PROCESS CONTROLS
- A. Implementing a Production and Process Control System
- B. Design Requirements
- C. Quality Control Operations
- D. Establishing Specifications
- E. Determining Whether Specifications Are Met
- F. Actions Required When Specifications Not Met
- G. Requirement to Collect Samples
- H. Record Keeping and Records Access
- VII. REQUIREMENTS FOR QUALITY CONTROL
- A. Written Procedures
- B. Quality Control Personnel
- C. Laboratory Operations
- D. Material Review and Disposition Decisions
- E. Equipment, Instruments, and Controls
- F. Components, Packaging, and Labels
- G. Master Manufacturing Record, etc.
- H. Packaging and Labeling Operations
- I. Returns and Complaints
- J. Record Keeping and Records Access
- VIII. REQUIREMENTS FOR COMPONENTS, PACKAGING AND LABELING
- A. Written Procedures
- B. Components
- C. Packaging and Labels
- D. Product Received for Packaging and Labeling
- E. Rejected Components, Packaging and Labels
- F. Record Keeping and Records Access
- IX. MASTER MANUFACTURING RECORD
- A. Requirement to Establish a Master Manufacturing Record
- B. Information Required in the Master Manufacturing Record
- C. Record keeping and Records Access
- X. BATCH PRODUCTION RECORD
- A. Requirement to Prepare a Batch Production Record
- B. Information Required in Batch Production Record
- C. Record Keeping and Records Access
- XI. LABORATORY OPERATIONS
- A. Written Procedures
- B. Laboratory Facilities
- C. Laboratory Control Processes
- D. Laboratory Methods
- E. Record Keeping and Records Access
- XII. MANUFACTURING OPERATIONS
- A. Written Procedures
- B. Design Requirements
- C. Sanitation Requirements
- D. Rejected Dietary Supplements
- E. Record Keeping and Records Access
- XIII. PACKAGING AND LABELING OPERATIONS
- A. Written Procedures
- B. Packaging and Labels
- C. Filling, Assembling, Packaging, Labeling and Related Operations
- D. Repackaging and Relabeling
- E. Rejected Dietary Supplements
- F. Record Keeping and Records Access
- XIV. HOLDING AND DISTRIBUTING
- A. Written Procedures
- B. Holding Components, Dietary Supplements, Packaging and Labels
- C. In-process Materials
- D. Reserve Samples
- E. Distribution
- F. Record Keeping and Records Access
- XV. RETURNED DIETARY SUPPLEMENTS
- A. Written Procedures
- B. Receipt of Returned Dietary Supplements
- C. Disposal of Returned Dietary Supplements
- D. Salvage of Returned Dietary Supplements
- E. Reprocessing Returned Dietary Supplements
- F. Investigating Manufacturing Processes and Other Batches
- G. Record keeping and Records Access
- XVI. PRODUCT COMPLAINTS
- A. Written Procedures
- B. Review and Investigation
- C. Record Keeping and Records Access
- XVII. RECORDS AND RECORD KEEPING
- A. Record Keeping Requirements
- B. FDA Records Access
- XVIII. PETITION TO REQUEST AN EXEMPTION
- Chapter 7: FDA INSPECTION AND ENFORCEMENT
- I. FDA INSPECTION AUTHORITY
- A. FD&C Act
- B. Scope of Inspection
- C. Refusal to Allow Inspection
- II. REASONS FOR AN FDA INSPECTION
- A. Routine Compliance Inspections
- B. Complaint Follow-Up Inspections
- C. Recall Follow-Up Inspections
- D. FDA Surveys
- E. Government-Wide Quality Assurance Program
- F. Office of Criminal Investigations
- III. FDA’S RECORDS ACCESS AUTHORITY
- A. FDA’s General Records Access Authority
- B. FDA Access to CGMP Records
- C. FDA Access to Records of Adverse Events
- D. FDA Records Access under the Bioterrorism Act
- IV. THE FDA INSPECTION
- A. Pre-Inspection Conference and Inspection
- B. Reportable Observations
- C. Post-Inspection Conference with FDA
- D. Response to Form FDA-483
- E. Establishment Inspection Report
- V. FDA ENFORCEMENT OPTIONS
- VI. FDA ENFORCEMENT OPTIONS
- A. Warning Letter
- B. Recall Request
- C. Administrative Detention
- D. Seizure
- E. Injunction
- F. Criminal Prosecution
- G. States’ Enforcement Powers
- Chapter 8: IMPORTS
- I. OVERVIEW
- II. IMPORT PROCEDURES
- III. IMPORT FOR EXPORT
- IV. ENFORCEMENT
- A. Admissibility Standard
- B. FDA Inspection Authority
- C. FDA Enforcement
- Chapter 9: BIOTERRORISM ACT REQUIREMENTS
- IREGISTRATION OF FOOD FACILITIES
- A. Definitions
- B. Exemptions
- C. How to Register
- D. Foreign Facilities
- E. Compliance
- II. PRIOR NOTICE OF FOOD IMPORTS
- A. Definitions
- B. Exemptions
- C. How to Submit Prior Notice
- D. Timeframes for Submitting Prior Notice
- E. Information in the Prior Notice
- F. Compliance
- III. RECORDKEEPING/RECORDS ACCESS
- A. Definitions
- B. Exemptions
- C. Required Records
- D. Form, Location, and Retention
- E. Records Access
- F. Compliance
- IV. OTHER BIOTERRORISM ACT PROVISIONS
- A. Prohibition Against Port Shopping
- B. Import for Export
- C. Debarment for Import Violations
- D. 24-Hour Hold on Imported Food
- E. Notification to States
- F. Marking of Food Refused Admission into U.S.
- V. FOOD SECURITY PREVENTIVE MEASURES
- CHAPTER 10: ADVERSE EVENT REPORTING
- I. DIETARY SUPPLEMENT AND NON-PRESCRIPTION DRUG CONSUMER PROTECTION ACT
- II. MANDATORY REPORTING OF SERIOUS ADVERSE EVENTS
- A. Basic Reporting Requirement
- B. Relationship to FDA Reportable Food Registry
- C. How to Report
- D. When to Submit Reports
- E. Effect of Reporting
- III. LABELING REQUIREMENTS
- A. Domestic Address or Phone Number
- B. Additional Information
- C. Effective Date
- IV. MAINTENANCE AND INSPECTION OF RECORDS
- V. IMPACT ON IMPORTED DIETARY SUPPLEMENTS
- Chapter 11: ADVERTISING
- I. OVERVIEW OF ADVERTISING REQUIREMENTS
- A. Legal Framework
- B. Consistency with FDA Labeling Requirements
- C. Industry Self-Regulation
- II. TRUTHFUL AND NONMISLEADING ADVERTISING
- A. Identifying Express and Implied Claims
- B. Disclosing Qualifying Information
- C. Presenting Disclosures Clearly and Conspicuously
- III. SUBSTANTIATING ADVERTISING CLAIMS
- A. Reasonable Basis for Objective Advertising Claims
- B. “Competent and Reliable Scientific Evidence”
- C. Establishment Claims
- D. Comparative Claims
- E. Testimonial and Expert Endorsement Claims
- F. Traditional Use Claims
- G. “Doctor Recommended” Claims
- H. Weight Loss Claims
- I. “Green” Claims
- IV. NUTRIENT CONTENT CLAIMS IN ADVERTISING
- A. Emphatic Nutrient Content Claims
- B. Comparative Nutrient Content Claims
- C. Synonyms for Nutrient Content Claims
- D. Implied Nutrient Content Claims
- E. Nutrient Content Claim Disclosures
- V. HEALTH CLAIMS IN ADVERTISING
- A. Substantiating Health Claims
- B. Disqualifying Levels of Risk-Increasing Nutrients
- C. Wording of Health Claims
- VI. FTC ENFORCEMENT POWERS AND REMEDIES
- A. Investigative and Enforcement Authority
- B. Remedies
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