LAKEVILLE, Minn. -- As a reminder, July 16 is the deadline for the public, including retailers that sell tobacco products, to submit comments to the U.S. Food and Drug Administration (FDA) on the Advance Notice of Proposed Rulemaking (ANPRM) issued by the agency about setting a maximum level of nicotine in cigarettes and possibly other tobacco products.
An ANPRM is a request by the FDA for information, data and studies on an issue and is not an actual proposed regulation. Rather, the agency is seeking information to determine whether a new regulation should be proposed in the future.
The process to submit comments to the FDA is simple, and this article provides easy-to-follow, step-by-step instructions.
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:
Docket No. FDA-2017-N-6189.
B. On the internet through www.regulations.gov:
- Click on the link below or type the address in your browser and press enter: Nicotine ANPRM: https://www.regulations.gov/comment?D=FDA-2017-N-6189-0001
- The www.regulations.gov web page will appear on your screen.
- Type your comments into the box beneath the word “Comment” or scroll down and upload your comments if you typed a letter on your computer.
- You may, but are not required to, fill in the boxes labeled “First Name” and “Last Name.”
- If you want to provide your ZIP code and email address, click on the box in front of “I want to provide my contact information” and then type in your ZIP code and email address in the appropriate boxes. Providing this information is optional.
- 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.”
- Then, click the blue “Continue” button, and you will be taken to “Your Preview” page. If all 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.”
- 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 list of suggested comment topics that retailers and wholesalers may consider including when submitting comments to the FDA:
Suggested Comments on the Nicotine ANPRM
- Setting a low level of nicotine in cigarettes and possibly other tobacco products could result in the creation of an illegal market for cigarettes and tobacco products that have a higher level of nicotine.
- Criminal elements that would sell tobacco products with a higher level of nicotine would not be concerned with verifying the legal age of individuals, which could allow underage youth to have more easy access to tobacco products.
- The FDA should not adopt a regulation that promotes the illegal sale of tobacco products in the marketplace. A government agency should work to minimize crime, not create an opportunity for individuals to engage in illegal tobacco sales.
- If an illegal market for higher nicotine cigarettes and other tobacco products occurs, retail sales will decrease along with a decline in sales of other products sold in stores. This decline in legal sales will reduce the amount of federal and state cigarette and tobacco product excise taxes plus decrease the amount of state sales tax collected.
- The FDA should study the potential consequences of lowering the level of nicotine in cigarettes and other tobacco products, including organized criminal activity, law enforcement resources needed to respond to illegal tobacco sales, easier access to tobacco products by underage youth, the potential reduction in legal sales of cigarettes and tobacco products, and the impact of reduced federal and state excise tax and state sales tax collections on federal and state budgets.
- One outcome of requiring lower nicotine cigarettes is that adult smokers might smoke more cigarettes than they currently do to obtain the same level of nicotine. Another outcome may be that adult smokers attempt to add nicotine to cigarettes or other tobacco products to increase the level of nicotine.