On May 4, 2022, the U.S. Food and Drug Administration (FDA) published two new proposed tobacco product standard regulations in the Federal Register. A tobacco product standard regulation is a power granted to the FDA under the Family Smoking Prevention and Tobacco Control Act to reduce or eliminate an ingredient in a tobacco product or a constituent in tobacco smoke.
One of the proposed tobacco product standards would provide that a cigarette or any of its components or parts (i.e., cigarette roll-your-own tobacco, cigarette filters, cigarette wrappers and cigarette rolling papers) shall not contain menthol as either an ingredient or a smoke constituent.
The second proposed tobacco product standard would prohibit an artificial or natural characterizing flavor (other than tobacco flavor) in cigars, cigar components and parts (i.e., cigar tobacco, filter or wrapper). Specifically, the flavors that would be banned include, but are not limited to, an herb or spice, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, menthol and mint. It is important to note that the proposed regulation would apply to premium cigars, which means that premium cigars could only have a characterizing flavor of tobacco.
If these proposed tobacco product standards are finalized and implemented, FDA enforcement will only apply to manufacturers, distributors, wholesalers, importers and retailers who manufacture, distribute, or sell cigarettes and cigars within the U.S. That is, these proposed tobacco product standards do not include a prohibition on individual consumer possession or use nor would the FDA take enforcement action against individual adult consumers.
The FDA is proposing that these regulations, when and if finalized, become effective one year after the date of the publication of the final rule. Prior to the regulations becoming effective, there are several more steps in the federal regulatory process. While there are a total of nine steps in this process, the FDA proposed regulations are currently on Step No. 6.
The sixth step allows for the public to submit comments to the FDA on the proposed regulations. Currently, the FDA is allowing the public to submit comments for 60 days which runs through July 5, 2022.
Once the comment period ends, Step No. 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 which 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 on-line.
Below are step-by-step instructions on 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.
- Go to www.regulations.gov.
- In the search box, for submitting a comment on the menthol cigarette regulation, type FDA-2021-N-1349-0001 and click the “Search” button.
- In the search box, for submitting a comment on flavored cigar regulation, type in FDA-2021-N-1309-0001 and click the “Search” button.
- On the next screen, below the title of the regulation, there will be a “Comment” box; click this “Comment” box.
- 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.
- 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.”
- To upload comments, scroll down the webpage to the box with the heading “Attach Files.” If you have already drafted comments in a Word document, click the Browse button and select your file to upload.
- Below the document uploading box, you need to fill in your e-mail address and then under the “Tell Us About Yourself” heading, click on the “An Individual” icon.
- Fill in your contact information, check the “I am not a robot” box, and finally 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 historic low rates with less than 1% or just over 1% of youth regularly using traditional tobacco products.
- Explain that illicit sellers will come 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.