June 2014

The ATS asks all members to send comments supporting the U.S. Food and Drug Administration proposal to regulate all tobacco products. Comments must be submitted online by July 9, 2014.

Background

The FDA has issued proposed rules to regulate all tobacco products including cigars and e-cigarettes. The FDA is currently accepting public comments on the proposed rule and will use information gathered from the public comment period to issue a final rule later in 2014.

FDA's proposal takes a number of welcome actions to more appropriately regulate all tobacco products, including:

• Prohibiting sales of tobacco products to anyone under the age of 18.
• Prohibiting vending machine sales (except in places where only adults have access).
• Registration by all manufactures with FDA, including a list of all tobacco products they sell.
• Disclosure of ingredients by manufacturers to FDA.
• Eliminating free sampling of all tobacco products.
• Good manufacturing practice requirements.
• Premarket review for any "new" tobacco product.
• Premarket review of any product wishing to make a "modified risk or harm" claim.
• User fees for all newly deemed products.

While the ATS supports the above proposed actions, we are concerned the proposal is weak in other areas. Most notably, the proposed rule does not:

• Ban sweetened or candy-flavored tobacco products.
• Require childproof e-cigarette cartridges.
• Ban internet sales of tobacco products.

Most concerning, the proposed rule seeks comment on whether "premium cigars"—defined as hand-rolled whole leaf cigars costing more than $10—should be exempt from any FDA regulations. The ATS strongly opposes this proposal.

Instructions for Submitting Comments

1. Please click here to submit prepared comments on this proposed rule.
2. Cut and paste the prepared comments below into the comment section of the online form.
3. Complete any necessary fields with your contact information and required information.
4. Click "Continue."

Prepared Comments:

Docket No. FDA-2013-N-0189 and RIN 0910-AG38

As a health care provider, I know the cost of diseases caused by tobacco. I see it in my patients every day, in the needless addiction, disease and death caused by tobacco use. That is why I support the Food and Drug Administration moving forward with strong regulations for all tobacco products. Specifically, I support FDA's proposals to require:

• Registration by all manufactures with FDA, including a list of all tobacco products they sell.
• Disclosure of ingredients by manufacturers to FDA.
• Prohibiting sales of tobacco products to anyone under the age of 18.
• Eliminating free sampling of all tobacco products.
• Good manufacturing practice requirements.
• Premarket review for any "new" tobacco product.

While I support these policies, I am concerned the proposed rule did not go far enough. I urge FDA to consider:

• Banning sweetened or candy-flavored tobacco products.
• Requiring childproof e-cigarette cartridges.
• Banning internet sales of tobacco products.

And under no circumstances should FDA exempt "premium cigars" from FDA regulations. While the health risks of cigars are different than those of cigarettes, cigars still cause disease and premature death. FDA should regulate cigars and all other tobacco products.

Despite the progress we as a nation have taken in reducing tobacco use, tobacco is still the single largest cause of preventable death in the U.S., killing more than 1,300 people each day. We look forward to FDA moving forward with rules to reduce the addiction, disease and death caused by tobacco.