Edit
Tobacco

Steps and Suggestions for Submitting Comments to the FDA

Agency seeks input on nicotine levels, flavors and premium cigars
Jillwt from ThinkStock

MINNEAPOLIS -- Retailers are strongly encouraged to submit comments to the U.S. Food and Drug Administration (FDA) regarding three advance notices of proposed rulemaking (ANPRM) issued by the agency. They are setting a maximum level of nicotine in cigarettes and possibly other tobacco products, the role of flavors in tobacco products, and the premium-cigar category.

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.

Comments can be submitted to the FDA’s Center for Tobacco Products by mail or at www.regulations.gov. Comments are submitted separately for each of the three ANPMRs. The deadlines to submit comments are July 16 for the ANPMR on nicotine, July 19 for the ANPRM on flavors in tobacco, and July 25 for the ANPRM on premium cigars.

[Editor’s Note: This article was updated on June 7 to reflect revised FDA deadlines.]

Here are some steps and suggestions for submitting comments:

How to Submit Comments

By mail:

  • Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. At the top of the letter, type “Docket No. FDA-2017-N-6189.”

By web:

  1. Use the following links for each ANPRM.
    Nicotine: https://www.regulations.gov/comment?D=FDA-2017-N-6189-0001 
    Flavors: https://www.regulations.gov/comment?D=FDA-2017-N-6565-0001 
    Premium cigar: https://www.regulations.gov/comment?D=FDA-2017-N-6107-0001
  2. Type your comments into the box beneath the word “Comment,” or scroll down to upload an already-typed letter.
  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 email address, click on the box in front of “I want to provide my contact information” and then type in your information. This step is optional.
  5. The next box is titled “Category” and an answer must be selected. 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.”
  6. Click the “Continue” button to be taken to a “Your Preview” page. If all the information is correct, scroll down, read the filing statement and then click on the box in front of “I read and understand the statement above.”
  7. Finally, click the “Submit Comment” button to submit your comments. You will then be provided with a receipt of submission.

What Should You Say?

What follows is a list of suggested topics that retailers and wholesalers may consider including when submitting comments to the FDA.

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 and also 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 effect 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.

On the flavors ANPRM: 

  • Prohibiting all flavors in tobacco products will remove hundreds of tobacco product SKUs from retail store shelves.
  • An across-the-board ban on flavors in tobacco products will also eliminate entire categories of other flavored tobacco products, including cigars, electronic cigarettes, vapor products and hookah tobacco. The legislation that Congress passed and that the president signed into law granting the FDA the authority to regulate tobacco products specifically prohibits the FDA from banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products. Any FDA regulation that prohibits flavors and in turn eliminates an entire category of tobacco products would be contrary to the limitation placed on the agency by Congress.
  • Adult consumers prefer flavors in a variety of forms, including food products, soft drinks, alcohol and tobacco products. Flavoring is commonplace throughout many industries that produce consumable goods. The FDA should allow adult consumers to determine what kinds of tobacco products they purchase and not limit consumer choices.
  • Many adult tobacco users have transitioned to noncombustible tobacco products or electronic cigarettes and vapor products, which can represent a reduced harm compared to traditional combustible tobacco products. In addition, studies have found that adults have used e-cigarettes and vapor products to quit smoking altogether. One reason for this transition and use of e-cigarettes and vapor products is the availability of different flavored products. Restricting or prohibiting flavors may cause adults to continue to use, or return to using, other combustible tobacco products. 

On the premium cigars ANPRM:

The FDA is asking for the following information:

  • Based on information provided by my customers, the average age that my customers began smoking premium cigars is ____ years old.
  • The age range of my customers that currently smoke premium cigars is from ____ years old to ____ years old.
  • Generally, my customers started smoking premium cigars before (after) smoking or using other tobacco products.
  • Generally, my customers use (insert the other kinds of tobacco products used such as domestic cigars, cigarettes, electronic cigarettes, vapor products, pipe tobacco, smokeless tobacco, or hookah tobacco).
  • On average, my customers smoke _____ premium cigars per day, _____ premium cigars per week and _____ premium cigars per month.

Will Submitting Comments Make a Difference?

The most direct and simple answer to this question is yes. The FDA has indicated that FDA staff members read every comment that is submitted. It is very important that members of the tobacco industry, including retailers, wholesalers and manufacturers, and consumers, all submit comments to the FDA.


Thomas Briant is executive director of the National Association of Tobacco Outlets (NATO). Reach him at (866) 869-8888 or [email protected]

Trending

More from our partners