White House Changes to FDA Proposal Benefited Premium Cigar Efforts

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While the premium cigar industry continues to lobby for support to protect itself from devastating proposed regulations by the U.S. Food and Drug Administration (FDA), new evidence suggests the biggest helping hand from one of the unlikeliest of sources, the White House.

As first noted by Reuters, new documents released yesterday indicate that the White House’s Office of Management and Budget (OMB) made crucial changes to the FDA’s proposed deeming regulations, including the establishment of a proposed exemption for premium cigars, otherwise known as Option 2, and clarifications to protect the internet sales of tobacco products.

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In April, FDA introduced its proposed deeming rule, which could apply significant regulations to cigars, e-cigarettes, pipe and shisa tobacco, chief among them, a crippling product approval process. At the moment, the agency is seeking public comment on the matter, including whether “premium cigars” should be exempt from regulation entirely, the only such product category to receive this option.

That provision came from OMB.

Under its original proposal, FDA would seek comment regarding premium cigars, and what defines a “premium cigar, “but only in an effort to create different sets of rules for premium cigars compared to other cigars. The agency was not considering an exemption, rather, minimal restrictions. This language was struck by OMB in favor of an option to remove FDA’s authority regarding premium cigars altogether.

Originally, the FDA proposed:

For example, in the health warning restrictions provisions of the proposed rule, we are proposing different rules for cigars, such as premium cigars, that are sold individually and not in a product package. If FDA were to adopt final regulations that further distinguish among types of cigars, we would need to define both the regulatory approach and what products would be subject to that approach. FDA is seeking comments on whether it would be appropriate to define a category of “premium cigars” which, because of their different characteristics, may have a different impact on public health than other cigars. If a definition of “premium cigars” were developed, such a definition might include such elements as how the cigars are made; what type of wrapper or tobacco is used in the cigars; price point for the cigars; or the cigars’ weight or diameter. We seek comment on how to define a category of “premium cigars.” (42)

Instead, OMB introduced new language:

FDA is also proposing a second option to deem only a subset of cigars (i.e., to exclude from the scope of this proposed rule certain cigars that we refer to as “premium cigars”). (9)

The idea of defining “premium cigars” was not a new one, even stricken language from FDA indicated how the agency was planning to define an exemption.

If a definition of “premium cigars” were developed, this definition could include such elements as how the cigars are made; what type of wrapper or tobacco is used in the cigars; price point; and the cigars’ weight or diameter. In addition, FDA would consider whether and how certain youth attracting flavors or other youth attracting characteristics should be taken into account with regard to the definition of premium cigars. (162)

This language is consistent with more detailed language, originally proposed by OMB, regarding what makes a “premium cigar.”

Furthermore, OMB removed some language describing the negative health impacts of cigars while introducing mentions of the efforts from the International Premium Cigar and Pipe Retailers Association (IPCPR) and its argument that cigars are a significantly reduce public health risk compared to cigarettes, a move that drew ire from organizations like the American Lung Association. This extended as far as recalculating the economic impact premium cigars have on public health.

“We are encouraged that the White House and OMB are taking a thoughtful approach to this issue,” said Kip Talley, senior director of federal legislative affairs for IPCPR. “Premium cigars are neither marketed to nor desired by America’s youth and IPCPR member stores are dedicated to complying with existing laws that prevent youth access to tobacco products. Moving forward, we will work with industry partners to continue our public education efforts and develop substantive comments for submission to the Food and Drug Administration.”

Elsewhere, OMB modified a provision that would have prohibited of non face-to-face sales of tobacco products.

It originally read

prohibition of non-face-to-face sales (e.g., vending machines), unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time (10-11)

OMB edits transformed it to:

prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time (10-11)

While the changes seem minor, OMB also added, “This prohibition on sales from electronic or mechanical devices is not intended to impact the sale of any tobacco product via the Internet.” The message is clear—internet sales of certain tobacco products, like premium cigars, were to not be affected. It’s unclear whether FDA truly wanted to attempt to ban such sales, or if it had the authority to do so.

Together, the changes paint a picture that suggests lobbying efforts by the premium cigar industry paid off and the White House, one of the unlikeliest of proponents, played arguably the largest role in creating more favorable language for the premium cigar industry.

Last week, FDA extended the comment period for an additional 30 days, meaning it currently will expire on Aug. 8. These proposed regulations could be the largest in the history of the cigar market and easily are the most substantial change to the cigar world since the Cuban embargo. Estaimtes from FDA themselves indicate that the regulations could cost the industry as much $300 million over the next two decades and remove half of the handmade cigars from the market.

You can view the changes made by OMB here. In addition, it also revised a document regarding the financial impact of the regulations, which can be viewed here.

For more information about the proposed regulation of premium cigars, click here.

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Charlie Minato
About the author

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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