NATO News Bulletin: How to Submit Comments to the FDA on Menthol in Cigarettes
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. While the FDA has extended the deadline to submit comments to November 22, 2013, the time to submit comments is now and the information below will help you do just that.
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
A. By Mail:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Note: In your letter, between the FDA’s address and “Dear FDA Representative”, you need to type in the following line: RE: Docket No. FDA-2013-N-0521
B. On the Internet (Click on the link below or type the address in your browser and press enter):
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: Menthol in Cigarettes, Tobacco Products: Request for Comments."
2. Under Number 1, “Your Information”, you can either type or copy and paste your comments in 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 3)
3. You may, but are not required to, fill in the boxes labeled “First Name” and “Last Name”.
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. If you are submitting comments for someone else (for example, your attorney is drafting comments to submit on behalf of your company), the person submitting the comments will need to check the box in front of “I am submitting on behalf of a third party” and type in his/her name and your company’s name. However, if you are submitting your own comments, do not check the box.
6. The next box is titled “Category” and an answer must be selected. Click on the down arrow box and then select “Private Industry” if the comments are being submitted by you as a retailer, wholesaler or manufacturer. If you or your customers desire to submit your own individual comments, click “Individual Consumer”
7. 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.
8. 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 Kind of Information Does the FDA Want in Comments?
It is important to understand that the FDA is not required to regulate menthol in cigarettes, nor has the agency made a final decision on whether menthol will be regulated. When the FDA issued its request for additional public comments on the use of menthol in cigarettes, the agency provided a list of questions to serve as a guide for the kind of information the agency was seeking. The relevant questions for retailers and wholesalers to respond to include the following:
A. Should FDA consider establishing a tobacco product standard to regulate menthol in cigarettes? If so, what allowable level of menthol (e.g., maximum or minimum) would be appropriate for the protection of the public health?
B. Should the FDA consider establishing restrictions on the sale and/or distribution of menthol cigarettes?
C. If menthol cigarettes could no longer be legally sold, is there evidence that illicit trade in menthol cigarettes would become a significant problem? If so what would be the impact of any such illicit trade on public health? How would any such illicit trade compare to the existing illicit trade in cigarettes?
Step 3: What Should You Say in Your Comments?
Below is a list of suggested statements to make in your comments. You can choose which of the statements you would like to include in your comments, but remember to put the statements into your own words. These statements will help you respond to the questions that the FDA has posed in seeking additional information about menthol.
A. Begin your letter or comments with “Dear FDA Staff”, “Dear FDA Representative” or “To Whom It May Concern”. Remember, if you are mailing a letter to the FDA, include “RE: Docket No. FDA-2013-N-0521” beneath the address.
B. Provide some background information such as your company’s name (unless you want to remain anonymous), number of stores or warehouses you operate, and the number of people you employ.
C. Retailers: Include a statement that you and your employees responsibly sell tobacco products to adult customers and work diligently to comply with state and federal laws regarding the sale of tobacco.
D. In passing the Smoking Prevention and Tobacco Control Act, the law that authorized the FDA to regulate tobacco products, Congress specifically allowed menthol to be used in cigarettes. Since this federal law regulates all cigarettes, there is no need to issue additional regulations that would ban or restrict the use of menthol in cigarettes. The current federal regulations that apply to all cigarettes, including menthol cigarettes, are sufficient.
E. Additional regulations on the sale and distribution of menthol cigarettes are not necessary. The current FDA regulations that retailers must comply with to sell cigarettes apply equally to non-menthol and menthol cigarettes.
F. If the sale of menthol cigarettes was banned in the United States, a black market will emerge for menthol cigarettes. Illicit trade in lower taxed or untaxed cigarettes already exists from state to state and a ban on menthol cigarettes will only provide a similar opportunity for criminal elements to establish a black market for menthol cigarettes. Fostering the illicit sale of menthol cigarettes will put the public at risk due to more illegal activity. Rather than protecting the public health, a black market in menthol cigarettes puts the public in harms way as a result of more widespread organized crime.
G. While retailers are on the front lines of preventing the sale of cigarettes to minors, the black market does not operate within the law or any sense of public responsibility. Instead of menthol cigarette sales taking place in licensed and regulated retail stores, a ban on menthol cigarettes will lead to smuggled menthol cigarettes being sold on the streets without black market profiteers being concerned with checking someone’s identification to ensure that they are of legal age.
H. Illegal sales of menthol cigarettes on the black market will undermine the FDA’s goal of protecting the public health. Rather than further the progress that retailers have made in preventing cigarette sales to underage youth, the availability of menthol cigarettes on the black market will provide minors a source for cigarettes that is easily accessible. This result is contradictory to the FDA’s goal of reducing youth access to tobacco products.
I. How can the FDA reconcile proposing a potential ban on the sale of menthol cigarettes to protect the public health when the agency’s own preliminary scientific evaluation of menthol cigarettes released in July of this year concludes: “From the available studies, the weight of evidence supports the conclusion that menthol in cigarettes is not associated with an increase in disease risk to the user compared to non-menthol cigarette smokers.” Based on this conclusion, banning menthol cigarettes would only force adults who purchase menthol cigarettes to seek out illegal menthol cigarettes on the contraband market.
J. Overly restrictive regulations or a ban on the sale of menthol cigarettes will have a severe negative impact on retailers and wholesalers. A ban on menthol cigarette sales will result in a significant drop in legal cigarette sales due to customers seeking out black market menthol cigarettes. This will put more jobs at risk and even the prospect of business closures. The result is lost jobs, lost cigarette tax revenue to state governments and the federal government, and greater expenditures by law enforcement officials to combat what will be a widespread black market in menthol cigarettes.
K. Banning menthol will trade good paying, legal jobs with illegal jobs created by a rampant black market with no resulting benefit to the public health.
Will Submitting Comments to the FDA Make a Difference?
The most direct and simple answer to this question is “yes”. The FDA is required to seek public comments on proposed regulations just like it is doing now on the question of using menthol in cigarettes. Moreover, FDA staff members have indicated to NATO and publicly that they read every comment that is submitted. With anti-tobacco advocates submitting comments, it is very important that members of the tobacco industry, including retailers, wholesalers and manufacturers, also submit comments to the FDA.