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

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
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


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
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


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


 

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