How to Submit Comments to the FDA on Tobacco Deeming Regulations

How to Submit Comments to the FDA on Tobacco Deeming Regulations

The Food and Drug Administration is accepting public comments regarding proposed tobacco regulations until August 8, 2014. Under one option, the FDA would extend its tobacco regulatory authority to all other categories of tobacco products including cigars (both domestic and premium), pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables. Under a second option, the FDA’s regulatory authority would be extended to all of the tobacco products under the first option, except premium cigars. All retailers, wholesalers and manufacturers who sell tobacco products should consider submitting comments to the FDA.

In addition, adult consumers who purchase and use tobacco products should also consider submitting their own comments to the FDA. The process to submit comments is simple and below is a link to step-by-step instructions and suggested comments for retailers, manufacturers and wholesalers to use and a separate link to step-by-step instructions and suggested comments for adult consumers to use. Comments can be submitted to the FDA by mail or on-line. The deadline to submit comments is August 8, 2014.

FDA Comment Instructions for Retailers, Manufacturers and Wholesalers

FDA Comment Instructions for Adult Consumers

State and Federal Legislative Update

Missouri: Missouri Governor Jay Nixon has vetoed Senate Bill 841, which would have prohibited the sale of e-cigarettes and vapor products to individuals under the age of 18 and exempted e-cigarettes and vapor nicotine products from the state’s excise tax on tobacco products.

Congressional Bill Seeks to Require Safety Caps on Nicotine Liquid Containers: A bill entitled the “Child Nicotine Poisoning Prevention Act of 2014 has been introduced in the U.S. Senate as Senate Bill Number S.2581. The legislation would require the Consumer Product Safety Commission to issue a rule under an expedited process that requires special child-resistant packaging for all liquid nicotine containers. The bill defines a “liquid nicotine container” as a consumer product that “has an opening that is accessible through normal and reasonably foreseeable use by a consumer” and “is used to hold liquid containing nicotine in any concentration.” At this time, there is no similar or companion bill pending in the U.S. House of Representatives. Senate Bill 2581

GAO Report Details Spending by Center for Tobacco Products

The federal government’s General Accounting Office just completed a study of how the FDA’s Center for Tobacco Products (CTP) has spent the $1.88 billion in tobacco user fees the agency has collected from tobacco manufacturers since fiscal year 2009.  From 2009 through March 31, 2014, the Center for Tobacco Products has spent $1.48 billion of the $1.88 billion in user fees as follows:

Retail Tobacco Inspections $123,000,000
Manufacturer/Importer Inspections and Enforcement $36,000,000
Promotion, Advertising and Labeling Surveillance $19,000,000
Outreach and Small Business Assistance $3,000,000
Public Education Campaigns (Youth and Retail Campaigns) $450,000,000
Communicating CTP’s Creation, Authority and Activities $58,000,000
Policy Research, Analysis and Liaison Activities $28,000,000
Issuance of Tobacco Regulation Guidance Documents $4,000,000
Issuance of Tobacco Regulations $14,000,000
Developing Tobacco Research Plan, Test Graphic Warnings,
Conduct Manufacturer Site Visits, Conduct Focus Groups,
and Fund Research to Better Understand Tobacco Products,
Health Effects, Use Patterns, and Risk Perceptions
Develop and Implement Tobacco Product Review Process
Including Substantial Equivalency (SE) Applications,
Pre-Market Tobacco Applications, and Process Adverse EventProblem Reports
Regulation and Guidance Support $5,000,000
Leadership and Management $16,000,000
Administrative Services $47,000,000