CRN regularly submits thoughtful and substantive comments to U.S. and international regulatory and scientific bodies on issues that impact the dietary supplement and functional food industry. Comments are listed below.
Amicus Brief Filings
CRN also engages in legal action as appropriate to its mission, including amici curiae "friend of the court" filings, recently catalogued on the site here.
CRN Comments and Court Filings
Comments are listed below in date order and in the side bar by regulatory authority. To search by topic, use the main search function (see upper right). 
October 24, 2024: New York State
August 30, 2024: Office of Dietary Supplements
CRN Comments on Draft ODS Strategic Plan 2025-2029
August 21, 2024: New York State
July 3, 2024: New York State
June 3, 2024: FDA
- CRN Comments on Guidance on New Dietary Ingredient Notification Procedures and Timeframes
- CRN Comments on Draft Guidance on New Dietary Ingredient Notification Master Files
May 25, 2024: Comments on Health-Canada Revised Consultation on proposed fees for natural health products
- Natural and Non-Prescription Health Products Directorate
- USMCA Non-Compliance Concerns Regarding Health Canada's Proposed Fees For Natural Health Products
May 1, 2024: U.S. House and Senate
April 3, 2024: New York State
CRN Files Preliminary Injunction Motion Seeking to Stop NY State Age-Restriction Law
March 13, 2024: New York State
CRN Files Lawsuit Challenging Unconstitutional Law That Restricts Access to Health Products
October 27, 2023: FDA
CRN submits comments on Modernizing Recalls of FDA-Regulated Commodities, Docket No. FDA-2023-N2393
September 26, 2023: FDA
September 21, 2023: Federal Trade Commission
CRN submits petition to FTC on itsHealth Products Compliance Guidance
August 17, 2023: Congressional Chairs and Ranking Members
CRN responds to a Congressional RFI seeking comprehensive information from key industry stakeholders on CBD
August 16, 2023: Government Accountability Office (GAO)
CRN responds to GAO inquiry on safety of prenatal supplements
July 10, 2023: FDA
May 10, 2023: FDA
May 4, 2023: FDA
CRN responds to FDA's review of the oral toxicity of cannabidiol in Food and Chemical Toxicology
April 24, 2023: FTC
April 13, 2023: FDA/USDA
March 9, 2023: FDA
February 16, 2023: FDA
CRN submits comments on FDA Proposed Rule: Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.” Docket No. FDA-2016-D-2335. See summary in our press release.
February 8, 2023: USPSTF
September 28, 2022: FDA
September 23, 2022: FDA
September 13, 2022: FDA
August 31, 2022: Comments to ODS
CRN submits comments on Office of Dietary Supplements (ODS) Five-Year Strategic Plan for 2022–2026
July 19, 2022: Comments to FDA
CRN submits comments to FDA on NDI Enforcement Discretion Draft Guidance
July 15, 2022:
CRN submits input for White House Conference on Hunger, Nutrition, and Health
May 16, 2022: Comments to HHS for Dietary Guidelines 2025–2030 development
Request for Comments on Scientific Questions To Be Examined To Support the Development of the Dietary Guidelines for Americans, 2025–2030. Docket ID: HHS-OASH-2022-0005. 87 FR 22540
January 4, 2022: Letter to FDA's, Deputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition
CRN Criticizes FDA’s ‘Nonresponsive’ Response to Citizen Petition on NAC
December 27, 2021: Submitted to the U.S. Department of Health and Human Services
November 22, 2021: Submitted to the European Commission regarding potential unintended public health consequences of restricting vitamin D3 imports
September 1, 2021: Submitted to Senators Schumer, Booker, and Wyden
June 1, 2021: FDA
CRN files Citizen Petition requesting FDA allow N-acetyl-L-cysteine (NAC) to be marketed as a dietary supplement + (Attachment A)
June 1, 2021: USPSTF
February 22, 2021: FDA
December 4, 2020: FDA
CRN urges FDA to reverse its recently adopted position on FDCA prohibition of marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements
Attachment:
Document acquired through a Freedom of Information Act (FOIA) request referenced in CRN's letter to FDA
December 4, 2020: HHS
November 23, 2020: Oregon Department of Justice
September 14, 2020
August 13, 2020
August 11, 2020
June 16, 2020
CRN submits Citizen Petition calling on FDA to regulate CBD as a legal dietary supplement
April 21, 2020
March 4, 2020
February 11, 2020
February 7, 2020
CRN comments on National Bioengineered Food Disclosure Standard: Validation of Refining Processes
(84 Fed. Reg. 68816-68817 (December 17, 2019). Docket ID: AMS_FRDOC_0001-1997 - PDF)
November 13, 2019: Oregon Department of Justice
October 31, 2019: Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)
CRN comments on paper on harmonized probiotic guidelines for use in food and dietary (PDF)
October 31, 2019: Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)
CRN comments on Codex project prioritization (PDF)
October 4, 2019: DGAC
CRN comments on 2020 Dietary Guidelines to Advisory Committee (Docket FNS-2019-001) (PDF)
July 16, 2019: FDA
July 15, 2019: FDA
July 11, 2019: DGAC
CRN's Haiuyen Nguyen delivers oral comments on 2020 Dietary Guidelines for Americans
May 31, 2019: FDA
CRN's Mister, Olsen deliver oral comments on CBD at FDA public hearing
November 19, 2018: USPSTF
USPSTF Draft Research Plan for Vitamin D Deficiency in Adults: Screening
October 10, 2018: FDA
FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments. 83 Fed. Reg. 30180-30182 (June 27, 2018). Docket No. FDA-2018-N-2381
September 7, 2018: EFSA
Public Consultation on Draft EFSA Statement “Genotoxicity Assessment of Chemical Mixtures”
July 3, 2018: USDA
Docket No. AMS-TM-17-0050. Proposed Rule: National Bioengineered Food Disclosure Standard. 83 FR 19860 (May 4, 2018)
May 25, 2018: FDA
Docket No. FDA-2017-D-5225; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Draft Guidance for Industry
April 5, 2018: FDA
Docket No. FDA-2017-P-6211; Citizen Petition from DSM Nutritional Products, LLC
March 30, 2018: USDA
Dietary Guidelines for Americans: Request for Comments on Topics and Questions. FNS-2018-0005. 83 Fed. Reg. 8649
March 19, 2018: FDA
Docket No. FDA-2017-N-0763 – Proposed rule to revoke the regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease
March 14, 2018: FDA
Docket No. FDA-2017-P-6245 – Pyridoxamine – Citizen Petition from ViGuard Health Inc.
February 5, 2018: FDA
Docket No. FDA-2017-N-5093 – Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration
November 14, 2017: Codex CCNFSDU
Proposed Draft NRV-NCD for Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Long Chain Omega-3 Fatty Acids
October 16, 2017: OEHHA
Request for Comments on Possible Listing of n-Hexane
October 4, 2017: FDA Docket No. FDA-2017-P-2229-0001; American Bakers Association Citizen Petition
October 2, 2017: OEHHA
Request for Comments on Possible Listing of Coumarin
September 14, 2017: U.S. International Trade Commission (ITC)
Public Interest Comments on Certain Synthetically Produced, Predominantly EPA Omega-3 Products in Ethyl Ester or Re-esterified Triglyceride Form, Docket No. 3247
September 14, 2017: U.S. International Trade Commission (ITC)
Non-institution of Investigation Based on Certain Synthetically Produced, Predominantly EPA Omega-3 Products in Ethyl Ester or Re-esterified Triglyceride Form, Docket No. 3247
August 25, 2017: USDA
USDA Seeks Input in Developing a Proposed Bioengineered Food Disclosure Rule
July 28, 2017: USP
F 43(2) Proposed Revision to USP-NF General Chapter <467> Residual Solvents
April 26, 2017: FDA
Docket No. FDA-2016-D-2335: Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period
March 31, 2017: Department of Commerce
Docket No. DOC-2017-0001: Impact of Federal Regulations on Domestic Manufacturing
March 7, 2017: FDA
Docket No. FDA-2016-P-3968; Citizen Petition from International Probiotics Association
February 21, 2017: FDA
Docket No. FDA-2016-D-2241; Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling
January 17, 2017: FDA
Docket No. FDA-2016-Q-3770; Qualified Health Claim Petition – Magnesium and Reduced Risk of High Blood Pressure (Hypertension)
December 12, 2016: FDA
Revised Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Docket No. FDA-2011-D-0376
November 28, 2016: Puerto Rico Department of Health
Proposed Regulations for Natural Products / Administrative Order 346 (REVISED)
November 7, 2016: FDA
Status of Vinpocetine - Docket No. FDA-2016–N–2523
October 23, 2016: Health Canada
Consulting Canadians on the Regulation of Self-Care Products in Canada
October 14, 2016: Congressional Task Force on Economic Growth in Puerto Rico
Puerto Rico Administrative Order 346
October 13, 2016: Codex Working Group
Proposed draft NRV-non-communicable disease (NCD) for EPA and DHA long chain omega-3 fatty acids (Document CX/NFSDU 16/38/8)
September 20, 2016: Codex Working Group
CCNFSDU EWG Australia - Draft Codex Nutrient Reference Value Requirement (NRV-R) for Vitamin E
September 28, 2016: USDA
Food packages available to recipients through the Special Supplemental Nutrition Program for Women, Infants and Children (WIC)
June 7, 2016: OEHHA
OEHHA modified proposed regulation on clear and reasonable warnings
May 12, 2016: FDA
Use of the Term “Natural” in the Labeling of Human Food Products
April 27, 2016: USPSTF
Draft Research Plan for Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Adults
April 26, 2016: OEHHA
Clear and reasonable warning requirements (CRN & coalition comments)
April 15, 2016: FDA
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
April 14, 2016: USDA
National Organic Standards Board sunset review process for carageenan
December 31, 2015: ODS
Dietary Supplement Label Database
December 29, 2015: FDA
Legal Status of Combination Dietary Ingredients
December 21, 2015: EPA
Proposed Management Standards For Hazardous Waste Pharmaceuticals
November 12, 2015: OEHHA
Pre-regulatory Prop 65 proposal for lead, arsenic levels
November 10, 2015: FSSAI
Comments to India Food Safety and Standards Authority of India
October 28, 2015: OEHHA
Proposed repeal of MADL for lead
September 10, 2015: Health Canada
Selenium
August 28, 2015: HHS and FDA
Support of Elevating the Division of Dietary Supplement Programs to an “Office” within CFSAN
June 12, 2015: Codex
CRN Comments to CCNFSDU EWG Chile and Russian Federation NRV-NCD DHA/EPA
June 5, 2015: EFSA
Magnesium - Dietary Reference Value
June 2, 2015: NTP
Support of AHPA’s Submission to the National Toxicology Program Regarding Board of Scientific Counselors Meeting
May 29, 2015: CODEX
Proposed Labelling Requirements
May 8, 2015: DGAC
Calcium and Vitamin D
May 8, 2015: FDA
Toxicological Principles for the Safety Assessment of Food Ingredients
May 8, 2015: DGAC
Consumer Understanding of Multivitamin and Calcium and/or Vitamin D Supplement Use
May 8, 2015: DGAC
Vitamins and Minerals and Key Nutrients Including Folate, Choline, Iodine, Iron and Vitamin B12
May 8, 2015: DGAC
Role of Biological Measures of Nutrient Status in Determining Nutrient Requirements
March 24, 2015: DGAC
Dietary Guidelines for Americans Committee
March 13, 2015: CODEX
CRN Comments to CCNFSDU EWG Australia NRV Vitamins
March 12, 2015: EFSA
Caffeine
March 10, 2015: FDA
Food and Cosmetic Export Certificate Application Process
March 8, 2015: Health Canada
Revised Monograph (Selenium) and the Selenium Monograph in the Natural Health Products Ingredients Database (NHPID)
March 6, 2015: ODS
2015-2030 Strategic Plan
November 17, 2014: FDA
Support of GOED's petition for EPA and DHA qualified health claim
September 22, 2014: CODEX
New Zealand Natural Health Product Supplement Bill
September 14, 2014: Health Canada
Nutrition Labelling
September 5, 2014: DGAC
Addressing Nutrient Shortfalls Through the Daily Intake of Multivitamin/Mineral Supplements When Nutrient Intake Cannot Be First Met Through Food
August 6, 2014: USPSTF
Folic Acid Supplementation for the Prevention of Neural Tube Defects
August 1, 2014: FDA
Proposed Revision of the Nutrition and Supplement Facts Labels
July 14, 2014: DGAC
Recommending Two Recently Published Scientific Articles
June 5, 2014: DGAC
Expert Recommendations for Multivitamin Use
May 8, 2014: NTP
Draft Technical Report on Green Tea Extract
February 3, 2014: DGAC
Multivitamins
February 3, 2014: DGAC
Vitamin D and Calcium
February 3, 2014: FTC
GeneLink, Inc. and foru™ International Corporation - Consent Agreement; File No. 112–3095
January 27, 2014: FDA
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
January 14, 2014: DGAC
Dietary Guidelines Advisory Committee Meeting
December 9, 2013: USPSTF
Draft Recommendation Statement on Vitamin, Mineral, and Multivitamin Supplements for the Primary Prevention of Cardiovascular Disease and Cancer
November 22, 2013: FDA
Docket No. FDA-2011-N-0920; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Proposed Rule
October 31, 2013: FDA
Docket No. FDA-2013-D-0880 Draft Guidance for Industry, Frequently Asked Questions About Medical Foods; Second Edition
September 4, 2013: DGAC
Nutrient Topic Areas
September 4, 2013: DGAC
2010 Report on Future Research Needs Related to Multivitamins
May 13, 2013: FDA
Docket No. FDA-2012-N-0711: Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds
December 4, 2012: FDA
CRN letter to FDA on its Response to CRN Comments on Synthetic Botanicals
October 22, 2012: FDA
CRN Calls on FDA to Reverse Its Current Position on Synthetic Botanicals
May 21, 2012: FDA
Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
January 5, 2012: FDA
Citizen Petition to Require Cautionary Statements On the Label of Dietary Supplements Containing St. John’s Wort
December 2, 2011
November 14, 2011: OGE
Federal Employees Attendance at Trade Association Events
October 25, 2011: FDA
Health Claims for Phytosterols and Risk of Coronary Heart Disease, Proposed Rule, Reopening of the Comment Period
September 19, 2011: OMB
Premarket Notification for a New Dietary Ingredient
August 1, 2011: FDA
Five Trade Associations Request Extension from FDA for Filing Comments on NDI Draft Guidance
July 25, 2011: FDA
Premarket Notification for a New Dietary Ingredient
July 25, 2011: FDA
Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
July 25, 2011: FDA
Criteria Used To Order Administrative Detention of Food For Human or Animal Consumption
July 25, 2011: FDA
Information Required in Prior Notice of Imported Food
June 29, 2011: FDA
Docket FDA-2009-P-0298 —Defining a "Dietary Ingredient"
May 4, 2011: FDA
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Label Statements Experimental Study
April 29, 2011: FDA
Food Safety Modernization Act: Title III – A New Paradigm for Importers
April 15, 2011: FDA
Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease
April 8, 2011: USDA
Organic Food Fortification Policy
February 4, 2011: Codex
Standard for Marine Oils
January 11, 2011: FDA
Draft Guidance for Industry on Investigational New Drug Applications