Council for Responsible Nutrition

Legislation

DSHEA Summary and Analysis

Before and After DSHEA

Regulation

Food and Drug Administration (FDA)

Federal Trade Commission (FTC)

Self-Regulation

Regulations at a Glance

CRN Comments

Federal Register Watch

International Policy

CRN International (CRN-I) Comments

TransAtlantic Business Dialogue (TABD)

CODEX

CRN Comments to FDA back to index

The dietary supplement industry is regulated by the Food and Drug Administration and the Federal Trade Commission as well as by government agencies in each of the 50 states.

• CRN Submits Comments to FDA on Citizen Petition to Require Cautionary Statements On the Label of Dietary Supplements Containing St. John’s Wort (PDF) 01.05.12
• CRN Submits Comments to FDA on New Dietary Ingredient Draft Guidance (PDF) 12.02.11
• CRN Submits Comments to FDA on Health Claims for Phytosterols and Risk of Coronary Heart Disease, Proposed Rule, Reopening of the Comment Period (PDF) 10.25.11
• CRN Submits Comments to FDA, Docket No. FDA-2011-N-0238: Agency Information Collection Activities; Proposed Collection; Comment Request; Preventive Controls for Registered Human Food and Animal Food/Feed Facilities (PDF) 08.17.11
• Five Trade Associations Request Extension from FDA for Filing Comments on NDI Draft Guidance (PDF) 08.01.11
• CRN Submits Comments to FDA, Docket FDA-2011-N-0410, on Premarket Notification for a New Dietary Ingredient (PDF) 07.25.11
• CRN Submits Comments to FDA, Docket FDA-2011-N-0403, on Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act (PDF) 07.25.11
• CRN Submits Comments to FDA, Docket FDA-2011-N-0197, on Criteria Used To Order Administrative Detention of Food For Human or Animal Consumption (PDF) 07.25.11
• CRN Submits Comments to FDA, Docket FDA-2011-N-0179, on Information Required in Prior Notice of Imported Food (PDF) 07.25.11
• CRN Submits Comments to FDA, Docket FDA-2009-P-0298 —Defining a "Dietary Ingredient" (PDF) 06.29.11
• CRN, With Coalition, Submits Comments to Docket No. FDA-2011-N-0098: Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Label Statements Experimental Study (PDF) 05.04.11
• SIDI Working Group Comments to FDA on Food Safety Modernization Act: Title III – A New Paradigm for Importers (PDF) 04.29.11
• Comments to FDA’s Proposed Rule on Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease (PDF)
• CRN comments on Docket No. FDA-2010-D-0503. FDA on Draft Guidance for Industry on Investigational New Drug Applications (PDF)
• CRN comments on Docket No. FDA-2009-N-0247. FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration
• CRN Comments on Docket No. FDA-2009-D-0542. Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods (PDF) 02.02.10
• CRN Comments on Docket No. FDA–2009–N–0247. Food and Drug Administration Transparency Task Force (PDF) 08.06.09
• CRN Comments on Docket No. FDA–2009–N–0166. Economically Motivated Adulteration (PDF) 07.31.09
• CRN Comments on Docket No. FDA-2008-N-0389: Food and Drug Administration Amendments Act of 2007 Prohibition Against Food to Which Drugs or Biological Products Have Been Added (PDF) 11.25.08
• CRN Comments on Docket No. FDA-2008-P-0248: Citizen Petition Requesting FDA to Treat Weight Loss Claims for Dietary Supplements as Disease Claims (PDF) 07.29.08
• CRN Comments to FDA on Docket No. 2006N-0168 Food Labeling: Revision of Reference Values and Mandatory Nutrients; Advance Notice of Proposed Rulemaking (PDF) 04.30.08
• CRN Comments to FDA on Docket No. FDA-2008-N-0077, Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program (PDF) 04.15.08
• CRN Comments to FDA on Docket No. Docket No. 2007D-0491, CFSAN 200755. Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (PDF) 03.03.08
• CRN Comments to FDA on Docket No. 2007N-0464, Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation; Opportunity for Public Comment FR Doc. E7-24813 (PDF) 02.19.08
• CRN Comments to FDA on Docket No. 2006N-0168, Food Labeling: Revision of Reference Values and Mandatory Nutrients; Advance Notice of Proposed Rulemaking (PDF) 12.20.07
• CRN Comments to FDA on GMP Interim Final Rule: Docket No. 2007N-0186, CFSAN 200736 Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (PDF) 10.24.07
• CRN Comments to FDA on Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims; Availability (PDF) 08.29.07
• CRN Comments to FDA on Program Priorities in the Center for Food Safety and Applied Nutrition, FY 2008 (PDF) 08.29.07
• CRN Comments to FDA on Draft Guidance for CAM, Docket # 2006D–0480 (PDF) 05.02.07 Position Statement: FDA Seeks Clarity on Complementary & Alternative Products: Misinterpretation of DRAFT GUIDANCE Causes Unwarranted Concerns; DSHEA is Safe (PDF)
• CRN Comments to FDA for Public Hearing on Functional Foods (PDF) 12.05.06
• CRN Comments to FDA's Center for Food Safety and Applied Nutrition (CFSAN) on FY 2007 Program Priorities Docket # 1998N-0359 (formerly 98N-0359) (PDF) 08.09.06
• CRN Comments to FDA Docket # 2005P-0305 and Comment requested on Pyridoxamine—Citizen Petition (PDF) 03.07.06
• CRN Comments to FDA Docket # 2005P-0305 and Comment requested on Pyridoxamine—Citizen Petition (PDF) 12.16.05
• Joint letter from CRN, AHPA and NNFA to FDA on the Utah ephedra ruling (PDF) 05.17.05
• CRN Comments to FDA Docket # 2004N-0454: Premarket Notification for New Dietary Ingredients (PDF) 02.01.05
• CRN Comments to FDA Docket # 2004D-0466: Substantiation for Dietary Supplement Claims (Statements of Nutritional Support, Structure/Function Claims) (PDF) 01.11.05
• CRN Comments to FDA Docket # 2004N-0454: On Six Major Topics Outlined by FDA on New Dietary Ingredients (PDF) 11.15.04
• CRN President Annette Dickinson's Presentation from the FDA public meeting on New Dietary Ingredients (PPT) 11.15.04
• Peter Barton Hutt (CRN Counsel, Covington & Burling) Comments to FDA Docket # 2004N-0454: On Six Major Topics Outlined by FDA on New Dietary Ingredients (PDF) 11.15.04
• CRN Comments to FDA Docket # 2003N-0496 Food Labeling: Health Claims and Dietary Guidance (PDF) 02.25.04
• Joint Comments to FDA Docket # 96N-0417 on GMPs (CRN, AHPA and NNFA) 01.30.04
• CRN Comments to FDA Docket # 96N-0417 on GMPs 08.11.03 + CRN Comments on Economic Impact of GMPS submitted 9.10.03
• CRN Comments to FDA on GMPs with 4-way Comparison (PDF) 07.08.03
• CRN Comments to FDA on Recordkeeping Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDF) 07.08.03
• CRN Comments to FDA on Administrative Detention Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDF) 07.08.03
• CRN Comments to FDA on Consumer Health Information for Better Nutrition (PDF) 05.27.03
• CRN/CHPA Comments to FDA on Consumer Health Information for Better Nutrition (PDF) 05.27.03
• CRN Letter to FDA and FTA on Coral Calcium (PDF) 05.15.03
• CRN Comments to FDA on Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 04.04.03
• CRN Comments to FDA on Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 04.04.03
• CRN Comments to FDA on Ephedra 04.03.03
• CRN Comments to FDA on First Amendment/Health Claims 10.30.02 (PDF)
• CRN Comments to FDA on the Implementation of the Bioterrorism Act of 2002 08.30.02
• CRN Comments to FDA on CFSAN Priorities for 2003 08.20.02 (PDF)
• CRN Comments to FDA on Ephedra 12.20.00

1828 L Street, NW, Suite 510 • Washington, DC, 20036-5114 • (202) 204-7700 fax (202) 204-7701 • e-mail webmaster@crnusa.org