CRN Comments

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 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

Latest Comments

March 19: 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: FDA
Docket No. FDA-2017-P-6245 – Pyridoxamine – Citizen Petition from ViGuard Health Inc.

February 5: FDA
Docket No. FDA-2017-N-5093 – Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

December 4: 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

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