How to Submit Comments To The FDA On The Tobacco Deeming Regulations

How to Submit Comments to the FDA on the Tobacco Deeming Regulations

The FDA has proposed two deeming regulatory options. Option 1 would extend the agency’s regulatory authority to all other categories of tobacco products including cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables, except accessories of a tobacco product. Exempt accessories would include such items as lighters, cigar cutters, humidors, cases, and hookah tobacco tongs, charcoal burners and holders. Under Option 2, the FDA’s regulatory authority would be extended to all of the tobacco products under Option 1, except premium cigars and accessories of a tobacco product.

Adult consumers who purchase and use tobacco products should consider submitting their own comments to the FDA’s Center for Tobacco Products. The process to submit comments to the FDA is simple and below are easy to follow step-by-step instructions on how to send in comments to the FDA. The deadline to submit comments is August 8, 2014.

Step 1: How to Submit Comments to the FDA

Comments can be submitted to the FDA’s Center for Tobacco Products either by mail or over the Internet on the www.regulations.gov website:

A. By Mail: Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Note: At the top of your letter, you need to type in the following line: RE: Docket No. FDA-2013-N-0189 and RIN 0910-AG38.

B. On the Internet (Click on the link below or type the address in your browser and press enter):

http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0189-20870

1. The www.regulations.gov webpage will appear on your screen and should state across the top “You are commenting on the Food and Drug Administration (FDA) Proposed Rule: Deeming Tobacco Products to be Subject to the Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.

2. Under Number 1, “Your Information”, you can either type or copy and paste your comments into the box beneath the word “Comment” or scroll down and upload your comments if you typed a letter on your computer. To upload your comments, click “Choose files”, a listing of the documents on your computer should appear on your screen, locate and then double click the letter that you want to upload. (Note: Please use your own words in typing your comments and see suggested points to make in your comments below under Step 2: What Should You Say in Your Comments).

3. You may, but are not required to, fill in the boxes labeled “First Name” and “Last Name”. So, you may remain anonymous.

4. If you want to provide your zip code and e-mail address, click on the box in front of “I want to provide my contact information” and then type in your zip code and e-mail address in the appropriate boxes. Providing this information is optional.

5. The next box is titled “Category” and an answer must be selected. Click on the down arrow box and then select “Individual Consumer”.

6. Then, click the blue “ Continue” button and you are taken to the “Your Preview” page. If all of the information is correct, scroll down, read the filing statement and then click on the small box in front of the phrase “I read and understand the statement above.”

7. Finally, click the blue “Submit Comment” button to submit your comments. You will then be provided a receipt for the submission of your comments.

Step 2: What Should You Say in Your Comments?

Below is a set of suggested comments on premium cigars, pipe tobacco, and electronic cigarettes. Select the comments that are most appropriate to you and consider changing the wording as well.

To assist you in submitting comments, consider the following example and suggested comments:

Dear FDA Representative:

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

I am writing to submit my comments on the proposed deeming tobacco product regulations. As a tobacco consumer, I have some concerns with the proposed deeming tobacco regulations.

I strongly oppose the proposed definition of premium cigars which includes a $10 dollar price minimum.  I purchase premium cigars which are below the $10 dollar limit and believe that setting an arbitrary price point as the definition of Premium vs Non-Premium is not an effective way to define what type of cigar it is.

The FDA should not ban the sampling of premium cigars in retail stores. Cigars are an adult product and I enjoy the ability to sample cigars before I decide to buy a new cigar. I support my local cigar retailer and appreciate the fact that I am able to sample cigars in the store.

I also oppose the FDA proposal to ban flavors in premium cigars. Premium cigars have many different sizes, shapes, tobacco blends, and flavors. The flavor is what makes a premium cigar unique. If flavors are banned in premium cigars, my local retailer will be financially impacted and I will be unable to purchase a legal tobacco product.

Thank you for considering my concerns.