NATO Requests Comment Extension on FDA Guidance

Association hoping to give public more time with modifications for flavored e-cigarettes, cigars
Photograph: Shutterstock

LAKEVILLE, Minn.  NATO recently submitted a letter to the U.S. Food and Drug Administration (FDA) formally requesting that the agency expand the comment period on its recently announced modifications to compliance policy affecting flavored electronic-cigarette and nicotine-vapor products as well as flavored cigars.

The effect of the proposed modifications to the industry—on retailers, manufacturers and adult consumers—is likely to be significant. Upon the publication of the proposed draft guidance on March 14, NATO began an immediate review and analysis of the guidance document to fully understand the potential impact of the proposed changes.  

As a national trade association with members representing more than 60,000 retail stores across the United States, NATO is creating a step-by-step process to make it as easy as possible for our members to comment on the proposed changes. Some of the changes that FDA is proposing—such as removing numerous electronic cigarette and vapor products from certain retail locations or potentially requiring retailers to undertake expensive and challenging remodeling of stores—could dramatically affect the bottom lines of retailers across the country, even putting some locations out of business altogether.

It is crucial for retailers (and manufacturers) to submit constructive and informed comments on the proposed changes. It is also of critical importance that tens of thousands of affected businesses be afforded the time necessary to reach out to experts in order to properly evaluate proposed changes or highlight ambiguities that need clarification. Ultimately, the more effectively that regulated businesses can communicate with regulators, the better opportunity regulators have to draft appropriate regulations. That should be the end desired by both sides of the equation.

In the past, the FDA has listened and granted requests for extensions. Most recently, the FDA granted requests to extend the comment period 60 days on proposed restrictions related to menthol cigarettes. Additionally, the FDA granted requests for a 90-day extension on a proposed product standard related to smokeless tobacco products, and a 30-day extension regarding the FDA’s advance notice of proposed rulemaking (ANPRM) related to flavors in tobacco products. This proposed guidance will affect the manufacturers of numerous legal tobacco products currently being sold, tens of thousands of retailers who responsibly sell these products and millions of adult consumers.

The most important thing that cigar and e-cigarette retailers and manufacturers can do now is constructively be a part of the comment process by submitting comments (and requesting an extension of the comment period). To do so, click here and follow the instructions on how to submit a comment. At the same time, NATO is hopeful that the FDA takes the association’s request for an extension seriously, and it recommends that all affected businesses otherwise submit official comments on the public docket by April 15, 2019.

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