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 Tobacco and E-Cigarette Legislative Overview

State Tobacco and E-Cigarette Legislative Overview

With only eight state legislatures still in session this year, a clearer picture of the outcome of tobacco and e-cigarette legislation is emerging.  So far this year very few tobacco and e-cigarette bills have been passed and enacted into law despite the fact that 25 state legislatures considered cigarette and/or tobacco tax rate increases, 16 states debated bills to assess a tax on e-cigarettes, and 14 states deliberated bills to restrict the use of e-cigarettes/vaping in public places.

Below is a summary of state legislative activity so far in 2014:

Cigarette and/or Tobacco Tax Increases

Tax increases on cigarettes and/or tobacco products were proposed but failed in Alabama, Florida, Hawaii, Kansas, Kentucky, Maine, Maryland, Mississippi, Missouri, Nebraska, Oklahoma, Oregon, Rhode Island, Tennessee, West Virginia, Wisconsin, and Wyoming.

Vermont enacted a tax increase on cigarettes/little cigars and smokeless tobacco effective July 1, 2014.  The cigarette/little cigar tax increase is $.13/pack for a new rate of $2.75 per pack.  The new law also raises the excise tax rate on moist snuff to $2.29 per ounce, or $2.75 per 1.2 oz. can or tin and changes the tax rate on other smokeless tobacco products to the greater of $2.29 per ounce or, if the package contains less than 1.2 ounces, $2.75 per package.  The original legislation proposed raising the cigarette tax by $1.30 per pack and assessing a 92% tax on the wholesale cost of e-cigarettes.

Those states with cigarette and/or tobacco product tax increase bills still pending are California ($2.00 per pack cigarette tax increase), Massachusetts (bill to increase the tax on other tobacco products to 45% designated for a revenue study), Michigan (bill to tax moist snuff at $.53 per ounce as opposed to the current 32% tax rate), New York ($1.65 per pack cigarette tax increase), Ohio ($.60 per pack cigarette tax increase over two years and 49% tax on other tobacco products over two years), and Pennsylvania (bill to allow the City of Philadelphia to assess a $2.00 per pack cigarette tax to fund the Philadelphia Public School District).

E-Cigarette Tax Proposals

Bills to assess a new tax on e-cigarettes were proposed but not enacted in Hawaii, Indiana, Kentucky, New Jersey, Oklahoma, Oregon, Rhode Island, South Carolina, Vermont, and Washington.

North Carolina enacted a tax on nicotine in a solution used for electronic vapor products at a rate of five cents per fluid milliliter of consumable nicotine solution product.

Those states with a proposed e-cigarette tax still pending include Michigan (a tax of $.15 per 1.5 milliliters on the nicotine solution in vapor products including electronic cigarettes), New York (a 75% tobacco products excise tax on e-cigarettes), and Ohio (a proposal to assess the $1.85 per pack cigarette tax on e-cigarettes).

Public Restrictions on E-Cigarette Use/Vaping

Bills to restrict the use of electronic cigarettes in public places were proposed but failed in Alaska, Hawaii, Kentucky, Louisiana, Maryland, New York, Oregon, South Carolina and Vermont.

Minnesota enacted a law prohibiting the use of e-cigarettes in government-owned buildings and schools.

Those states with e-cigarette/vaping use bills still pending are California, Delaware, Massachusetts, and Pennsylvania.

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
$449,000,000
Develop and Implement Tobacco Product Review Process
Including Substantial Equivalency (SE) Applications,
Pre-Market Tobacco Applications, and Process Adverse EventProblem Reports
$25,000,000
Regulation and Guidance Support $5,000,000
Leadership and Management $16,000,000
Administrative Services $47,000,000