Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
This guidance clarifies how Complementary and Alternative Medicine (CAM) products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act (PHS Act). It emphasizes that CAM products are not exempt from FDA regulation and must comply with applicable requirements based on their intended use and product category (drug, device, biological product, food, dietary supplement, or cosmetic).
This is a draft guidance. Not for implementation.
Recommended Actions
- Determine the regulatory category of your CAM product based on intended use
- Review and comply with all applicable requirements for your product category:
- Premarket approval if required
- Quality system requirements
- Labeling requirements
- Post-market reporting obligations
- Ensure proper registration and listing of manufacturing facilities
- Implement appropriate quality controls and good manufacturing practices
- Maintain documentation of safety and, where required, effectiveness
- Review product claims to ensure they align with regulatory category
- Monitor and report adverse events according to applicable requirements
- Consult with FDA when uncertain about requirements or compliance approach
- Stay updated on regulatory changes affecting your product category
- Consider engaging regulatory experts for complex compliance issues
Key Considerations
Labelling
- Products must be labeled according to their regulatory category requirements (drug, device, dietary supplement, etc.)
- Claims made on labeling determine the regulatory category and requirements
- Health claims for foods require premarket review by FDA
Safety
- Food additives require premarket approval unless Generally Recognized as Safe (GRAS)
- Dietary supplements must meet safety requirements
- Cosmetics must not be adulterated or misbranded
- Biological products must meet safety standards and licensing requirements
Other considerations
- The intended use of a CAM product determines its regulatory category
- Products may fall under multiple regulatory categories based on intended uses
- Premarket approval requirements apply for drugs, devices, and biological products
- Manufacturing must comply with applicable quality system requirements
- Post-market reporting requirements apply based on product category
Relevant Guidances
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
Related references and norms
- 21 CFR 120: HACCP Systems for juice products
- 21 CFR 101.14: Health claims regulations
- 21 CFR 880.5580: Acupuncture needle requirements
- 21 CFR 882.5050: Biofeedback device requirements
Original guidance
- Regulatory Framework for Complementary and Alternative Medicine Products
- HTML / PDF
- Issue date: 2007-02-27
- Last changed date: 2024-10-01
- Status: DRAFT
- Official FDA topics: Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Food & Color Additives, Premarket, Biologics, Cosmetics, Administrative / Procedural
- ReguVirta summary file ID: 6ce505df0fad9b8f14e172b2c2b48e63
This post is licensed under CC BY 4.0 by the author.