Regulating Flavored Tobacco Products: What You Need to Know

    FDA regulations prohibiting menthol in cigarettes and characterizing flavors in cigars

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    Once the comment period ends, Step 7 requires the FDA to review each of the comments submitted and make any changes it deems appropriate to the proposed tobacco product standards. Then, in Step 8, the White House Office of Management and Budget will need to review the final regulations because they will have a significant impact on the U.S. economy. In the ninth and final step, the agency will publish a final version of the regulations and state a specific effective date that would be one year from the date the final regulations are published in the Federal Register.

    During this open public comment period, it is very important for retailers, their employees and even their customers to submit comments to the FDA. While comments can be mailed or delivered directly to the FDA, the federal government utilizes a website at www.regulations.gov to accept the submission of comments online.

    Following are step-by-step instructions for how to submit comments. Note that since there are two proposed regulations, comments should be submitted on each separate proposed regulation, which will require using the www.regulations.gov website comment submission process twice.

    1. Go to www.regulations.gov.
    2. In the “Search” box, for submitting a comment on the menthol cigarette regulation, type in FDA-2021-N-1349-0001 and click the “Search” button.
    3. In the “Search” box, for submitting a comment on flavored cigar regulation, type in FDA-2021-N-1309-0001 and click the “Search” button.
    4. On the next screen, below the title of the regulation, there will be a “Comment” box; click this “Comment” box.
    5. At the top of the next webpage, under the heading “Write a Comment,” you can manually type in your comment. If you plan to upload a file with your comments, see Step 7 below.
    6. Beneath the “Write a Comment” section, there is a “What is your comment about?” question. Click the small arrow to the right and select the choice titled “Private Industry.”
    7. To upload comments, scroll down the webpage to the box with the heading “Attach Files.” If you have already drafted comments in a Microsoft Word document, click the “Browse” button and select your file to upload.
    8. Below the document uploading box, you will need to fill in your email address, and then under the “Tell Us About Yourself” heading, click on the “An Individual” icon.
    9. Fill in your contact information, check the “I Am Not a Robot” box, and then click the “Submit Comments” button to file your comments.

    With these instructions to navigate the www.regulations.gov website, it is important to focus your comments on some key points, including the following:

    • Prohibition of legal tobacco products is not the answer. This country has tried prohibition of alcohol and it failed.
    • Retailers are responsible businesses who serve as the first line of defense in preventing the sale of tobacco to underage persons.
    • The underage use of tobacco is at historically low rates, with less than one percent or just over 1 percent of youth regularly using traditional tobacco products.
    • Explain that illicit sellers will come to supply the banned products through illegal means.
    • These regulations will trade licensed retailers for unregulated sellers who do not check IDs, do not pay any taxes and will sell to anyone, including youth who have cash.
    • Explain the impact of banning menthol cigarettes and flavored cigars on your business. Include information on how much business will be lost, where will your customers go and how many employees might be laid off.

    The time is now to let your voice be heard by the FDA, and the means to do that is through the public comment process.

    This story first appeared in the July/August 2022 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    – Photo: Adobe Stock.