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Contents
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Industry Information and Regulations
Proposed and Final Regulations and Related Information
(The section below is a compilation of the principal regulations that govern
the labeling and claims for dietary supplements. Other related information can
be found elsewhere on this site.)
- Regulatory Strategy for the Further
Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
(Federal Register Notice of Availability November 9, 2004)
- Dietary Supplement Labeling
- http://www.cfsan.fda.gov/~dms/ds-labl.html
Requirements and guidance for labeling and making claims for supplements
(e.g. qualified and structure/function claims).
- Dietary Supplement Rules Published (Talk
Paper, September 23, 1997)
- Nutrition Labeling, Statement of Identity and Ingredient Labeling. Final Rule:
Food Labeling; Statement of Identity, Nutrition
Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide,
Revocation (Federal Register, September 23, 1997)
(also available in PDF, 300KB)
- Sample Labels (available in PDF)
- Nutrient Content and Health Claims, Comparative Percentage Claims, and Mandatory
Structure/Function Claim Disclaimer. Final Rule:
Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements
of Nutritional Support for Dietary Supplements (Federal Register, September
23, 1997)
- Requirements to Use the Nutrient Content Claims "High Potency" and
"Antioxidants". Final Rule: Food Labeling;
Nutrient Content Claims: Definition for "High Potency" and Definition of "Antioxidant"
for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods
(Federal Register, September 23, 1997)
- Botanical Ingredients - Food Labeling: Ingredient Labeling of Dietary Supplements That
Contain Botanicals, (Federal Register, August 28, 2003)
- Defining Structure/Function Claims That Can Be Used for Dietary Supplements.
Final Rule: Statements Made for Dietary Supplements
Concerning the Effect of a Product on the Structure or Function of the Body
(Federal Register, January 6, 2000)
- Mandatory Warning Statement for Iron-containing Supplements and Special Packaging
Requirements for High-Potency Iron Supplements. Final Rule:
Iron-Containing Supplements and Drugs: Label Warning
Statements and Unit-Dose Packaging Requirements
(Federal Register, January 15, 1997)
- Labeling on a "Per Day" Basis. Proposed Rule: Food
Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day" Basis (Federal
Register, January 12, 1999)
- Notification Procedures for Structure/Function Claims (30 Day Notifications).
Final Rule: Food Labeling; Notification Procedures
for Statements on Dietary Supplements (Federal Register, September 23, 1997)
- Information related to qualified health claims
(includes explanation, regulations, FDA letters, public meetings and other information).
- Other Labeling Information can be found on the Food Labeling Website at: http://www.cfsan.fda.gov/label.html
- Fact Sheet about FDA's New Interim Rule and Proposed Rule on Prohibited Cattle Materials in Food and Cosmetics July 9, 2004
- Current Good Manufacturing Practices (CGMPs)
- New Dietary Ingredients
- Special Issues
- BSE ("Mad Cow Disease")
- Ephedrine Alkaloids
- Warnings and Safety Information
Correspondence Related to Policy
Compliance Actions: Cyber and Warning Letters and Related Information
- "Cyber"
Letters
FDA's Center for Food Safety and Applied Nutrition (CFSAN) issues cyber letters
to firms that market dietary supplement products on the Internet, advising them
that the therapeutic claims, e.g., to diagnose, mitigate, treat, cure, or prevent
a specific disease or diseases, on their Web site, establish that the products
are drugs. Examples of products addressed in these cyber letters include: "colloidal
silver," "red thyme," flaxseed oil," and "colostrum."
- FDA Warning Letters
Includes CFSAN warning letters. This is a search page for warning letters
issued by FDA. You can browse warning letters by the most recent, company, subject,
issuing office or date.
- FDA Grants
Citizen's Petition Seeking Unapproved Drug Classification for
"Nicotine Water" (July 2, 2002)
Additional Dietary Supplement Industry Information
- Laws & Guidance Documents
- Contracts and Agreements
- Other
General Compliance and Inspection Information for Industry
- Imports and Exports (Procedures, Compliance
Programs, Import Alerts, Detentions)
- Inspections, Compliance, Enforcement and Recalls
- FDA Federal Register Documents, Code of Federal Regulations
& Food, Drug, and Cosmetic Act includes:
- How to Obtain Federal Register Documents and the Code of Federal Regulations
- Dockets Management Home Page
- Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking
- HACCP
- Interacting with the Center for Food Safety
and Applied Nutrition
- Information Materials for the Food and Cosmetics Industries
(How to reach FDA small business representatives, FDA field offices, and FDA import
and domestic compliance offices; and information materials for industry, e.g.,
publications and other materials)
CFSAN Adverse Event Reporting System
Codex Activities
FDA-DSFL Electronic Newsletter
*PDF Readers are available for free from the
Adobe Acrobat
web site.
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