SILVER SPRING, Md. — Convenience-store retailers can now comment on the U.S. Food and Drug Administration’s proposed rules on banning menthol as a characterizing flavor in cigarettes and all flavors in cigars, and the FDA has some tips on what it’s looking for.
Comments are due by July 5; however, organizations like the National Association of Tobacco Outlets (NATO) have asked for an extension of this deadline.
At a February webinar held by the FDA, May Nelson, director of the FDA’s Center for Tobacco Products office of regulations, gave tips on how to submit effective comments on a proposed new product standard.
To start, retailers, or any member of the public, can visit www.regulations.gov and search for “FDA-2021-N-1349-0001” to find the menthol cigarette rule and “FDA-2021-N-1309-0001” for the flavored cigar rule. One each page there is a “write a comment” section where anyone can voice their opinions.
As reviewers evaluate comments, they are looking for those that have logic and are supported by studies, data and other information, Nelson said.
“A constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision-making than a comment that simply states its support or dissent for a particular issue or proposed rule,” she said.
Some other highlights from Nelson’s tips include:
- Read and understand the proposed rule before submitting a comment.
- Include only necessary information and support any claims. While it’s good to be concise, there is no minimum or maximum length for a comment.
- Base justifications on sound reasoning and scientific evidence. “Our reviewers are looking to see if your comments are supported with substantive data, facts and or expert opinions,” Nelson said. “You can also include considering how you will be affected by the rule, whether it’s negative or positive.”
- Commenters can also consider other viewpoints and explain them.
- The comment process is not a vote. “A substantive comment that is well supported may have more influences than thousands of standard form letters that do not provide new information,” she said.
“The comment process is an essential part of any rule we develop,” Nelson said. “Hearing form our stakeholders gives us the chance to make the rule stronger, and it enhances our understanding of the issue and helps us determine the best solution to a problem.”
The agency could get anywhere from a handful to thousands of comments, so it can be a lengthy process to review comments, she said. The Administrative Procedure Act requires the FDA to consider all relevant comments and respond to those in a final rule.
Once the FDA has finished considering comments and finalize the rule, it would go through another review and clearance process before being published in the Federal Register.
If the rule is finalized, the tobacco control act specifically states that product standards must have an effective date of at least one year after the date of its publication, she said.
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