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News: Final FDA Regulations on Cigars Expected Before End of 2015

21 Oct 2015

FDA-cigars-large

Yesterday both Cigar Rights of America (CRA) and the International Premium Cigar and Pipe Retailers Association (IPCPR) issued email alerts announcing that the pending FDA cigar regulations took another step towards final implementation. As we’ve covered previously, such regulations could be devastating to the thriving handmade premium cigar industry, even though there is no indication that such regulations would have any impact on youth smoking or public health.

According to the reports, the FDA has officially sent the latest version of the deeming rule on cigars to the Office of Management and Budget (OMB) at the White House for economic review. The controversial rules not only would subject cigars and pipes to FDA regulation, but also the growing line up of e-cigarette and vaping products.

OMB has 90 days from receiving the proposed rule to conduct its review before it goes to final implementation. According to CRA, the OMB may have received the rule from FDA up to a month ago, meaning that the 90-day maximum time period could end before 2016.

CRA and IPCPR will both now direct lobbying efforts to OMB, which is charged with examining the economic impact of proposed FDA rules. The groups and their lobbyists will attempt to show the potentially devastating economic impact that the proposed regulations would have on cigars, including costing jobs both in the U.S. and abroad.

In its initial proposed rule, the FDA offered two options for regulating cigars: option 1 (which covers all cigars) and option 2 (which exempts handmade cigars over $10). Although the proposed rules transmitted to the OMB presumably include the agency’s decision on that important issue, it is unlikely the OMB will make public the agency’s intentions on the issue of a possible exemption.

While the OMB review may seem like a formality, those familiar with the creation of the initial proposed rule say the OMB was critical in advancing the option of an exemption for some cigars. If the OMB feels the FDA’s final version insufficiently addressed its previous concerns, it could request further revisions.

Also, although unlikely, with such a hot-button topic, if the modifications requested by OMB are significant enough, they may not go to final review, but could instead be sent back to the FDA. Experts familiar with the federal rule-making process indicate that if the revisions are large enough, it could even trigger a second round of public commenting before returning to the OMB for another final review, which could delay the process significantly.

Patrick S

photo credits: Stogie Guys

 

Drew Estate

3 Responses to “News: Final FDA Regulations on Cigars Expected Before End of 2015”

  1. Mike Thursday, October 22, 2015 at 12:01 pm #

    Don’t forget there could be lawsuits over the regulations or their implementation, which could also delay any impact.

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