CRN Comments & Legal Action

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).  search.png

June 3, 2024: FDA

May 25, 2024: Comments on Health-Canada Revised Consultation on proposed fees for natural health products 

May 1, 2024: U.S. House and Senate

Joint letter calling for funding for the U.S. Codex Office (USCO) in the Fiscal Year (FY) 2025 Agriculture-Food and Drug Administration Appropriations

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

CRN submits comments on Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry. Docket No. FDA-2023-D-1027 

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

CRN writes to FDA Commissioner Califf regarding the agency's 'Reorganization of the Human Foods Program -  Office of Dietary Supplement Programs' 

May 10, 2023: FDA

CRN submits Citizen Petition to FDA detailing drug preclusion clause interpretation's threat to innovation and consumer choice, health

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

CRN submits comments on Federal Trade Commission's Green Guides Review (16 C.F.R. Part 260) (Matter No. P952501) / Review of FTC's “Guides for the Use of Environmental Marketing Claims”

April 13, 2023: FDA/USDA

CRN and member company comments for the Codex Committee on Food Labelling (CCFL) regarding the Circular Letter request for comments on the discussion paper on sustainability labelling claims (CL 2023/16/OCS-FL).

March 9, 2023: FDA

CRN submits comments on Investigational New Drug Applications; Exemptions for Clinical Investigations To Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic. Docket No. FDA-2019-N-2650. 

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

CRN submits comments on U.S. Preventive Services Task Force (USPSTF) "Draft Research Plan for Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults: Preventive Medication"

September 28, 2022: FDA

CRN submits comments on Proposed Rule; Revocation of Methods of Analysis Regulation; FDA-2020-N-1383-0001

September 23, 2022: FDA

CRN submits comments on "Conducting Remote Regulatory Assessments, Questions and Answers, Draft Guidance for Industry" (Docket No. FDA-2022-D-0810)  

September 13, 2022: FDA

CRN provides feedback to FDA on the agency's "Supplement Your Knowledge" educational content and other dietary supplement information on its website

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

CRN submits comments on "Securing Updated and Necessary Statutory Evaluations Timely; Proposal To Withdraw or Repeal (October 29, 2021)" Docket No. HHS-OS-2020-0012

November 22, 2021: Submitted to the European Commission regarding potential unintended public health consequences of restricting vitamin D3 imports

CRN submits comments on EU Delegated Regulation 2019/625: Border controls for food – import conditions and border controls of trade samples and certain composite products, urging  the Commission to consider a proportionate and science-based risk management approach for vitamin D3

September 1, 2021: Submitted to Senators Schumer, Booker, and Wyden

CRN submits comments on Cannabis Administration and Opportunity Act Discussion Draft Section 505 relating to the regulation of hemp-derived cannabidiol (CBD)

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

CRN submits comments on U.S. Preventive Services Task Force (USPSTF) Draft Recommendation Statement: Vitamin, Mineral, and Multivitamin Supplements to Prevent Cardiovascular Disease and Cancer

February 22, 2021: FDA

CRN Comments on Requirements for Additional Traceability Records for Certain Foods—Proposed Rule, Docket No. FDA-2014-N-0053

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

Document acquired through a Freedom of Information Act (FOIA) request referenced in CRN's letter to FDA

December 4, 2020: HHS

Securing Updated and Necessary Statutory Evaluations Timely (Nov. 4, 2020), Docket No. HHS–OS–2020–0012 

 November 23, 2020: Oregon Department of Justice

Proposed Rulemaking – Permanent Adoption of OAR 137-020-0260  the “Novel-Infectious-Coronavirus-Related Representations Regarding Health Benefits of Goods” (adopted as a temporary rule on April 17, 2020) 

September 14, 2020

'Made in USA' (MUSA) Rulemaking, Matter No. P074204: Notice of Proposed Rulemaking for Unqualified U.S.-Origin Claims 

August 13, 2020

CRN submits comments on Scientific Report of the 2020 Dietary Guidelines Advisory Committee; Docket FNS-2020-0015 

August 11, 2020

CRN's Haiuyen Nguyen delivers oral comments to USDA/HHS on 2020 Dietary Guidelines Advisory Committee Scientific Report

June 16, 2020

CRN submits Citizen Petition calling on FDA to regulate CBD as a legal dietary supplement

April 21, 2020

CRN submits comments to the amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (HAD)

March 4, 2020

CRN signs on to FBIA Comments on Draft Instructions on Testing Methods: National Bioengineered Food Disclosure Standard (Doc. No. AMS-FRDOC-0001-2003)

February 11, 2020

CRN comments to USTR on Notice of Determination and Action Pursuant to Section 301: Enforcement of U.S. WTO Rights in Large Civil Aircraft Dispute; Review of Action: Enforcement of U.S. WTO Rights in Large Civil Aircraft Dispute (essential oils tariffs) 

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

CRN comments on proposed health benefit substantiation rule, with American Herbal Products Association (PDF)

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

CRN comments on FDA's Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments. 84 Fed. Reg. 12969 - 12975 (April 3, 2019). Docket No. FDA-2019-N-1482. (PDF) 

July 15, 2019: FDA

CRN comments on FDA's Responsible Innovation in Dietary Supplements; Public Meeting; Request for Comments. 84 Fed. Reg. 14660-14662 (April 11, 2019). Docket No. FDA-2019-N-1388. (PDF)

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

November 6, 2018: FDA
Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials: Draft Guidance for Industry. 83 Fed. Reg. 45454-45455 (September 7, 2018). Docket No. FDA-2018-D-3464

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”

September 6, 2018: USTR
Docket No. USTR-2018-0026 Request for Comments Concerning Proposed Modification of Action Pursuant to Section 301: China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation 

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

May 10, 2018: USTR
Docket No. USTR-2018-0005 Notice of Determination and Request for Public Comment Concerning Proposed Determination of Action Pursuant to Section 301: China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Proper

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

December 4, 2017: FDA
Docket No. FDA-2017-N-4625 – Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients; Public Meeting; Request for Comments (82 FR 42098 (September 6, 2017))

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

July 7, 2017: FDA
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” [Docket No. FDA−2015−N−2002]

June 12, 2017: HHS
FY 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System Proposed Rule, and Request for Information CMS-1677-P 

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

February 13, 2017: FDA
Docket No. FDA–2016–D–3401; Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry

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

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

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

April 7, 2014: FDA
Docket No. FDA-2010-D-0503. Guidance for Clinical Investigators,Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigation

March 7, 2014: FDA
Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information. Docket No. FDA-2013-N-1317 / 78 Fed. Reg. 67169

February 3, 2014: DGAC

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

October 25, 2013: USDA
Docket No. FNS-2011-0019: National School Lunch Program and School Breakfast Program: Nutrition Standards for All Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010; Interim Final Rule

September 4, 2013: DGAC
Nutrient Topic Areas

September 4, 2013: DGAC
2010 Report on Future Research Needs Related to Multivitamins

May 24, 2013: USDA
Docket No. AMS-NOP-11-0003: Proposed Rule: National Organic Program – 2013 Sunset (Expiration) of Allowances and Prohibitions Contained on the National List (Crops and Processing)

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

May 7, 2013: FDA
Docket No. FDA-2011-D-0376; Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications 76 Fed. Reg. 3911, by Steptoe & Johnson LLP

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

CRN/CHPA Comments to Docket No. FDA-2011-D-0376 76 Fed. Reg. 39111 (July 5, 2011) Draft Guidance for Industry—Dietary Supplements: New Dietary Ingredient Notifications and Related Issues


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 17, 2011: 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

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