USA: D.C. Circuit upholds FDA cigar and pipe tobacco regulation, user fees

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(Reuters) – A federal appeals court has upheld U.S. Food and Drug Administration rules requiring pre-market approval for cigars and pipe tobacco and imposing user fees on their manufacturers and importers.

A unanimous panel of the D.C. Circuit Court of Appeals on Tuesday rejected a challenge by three industry groups, the Cigar Association of America, Cigar Rights of America and Premium Cigar Association, to aspects of the FDA’s so-called Deeming Rule subjecting cigars and pipe tobacco to the same regulatory framework as cigarettes.

Michael Edney of Steptoe & Johnson, a lawyer for the plaintiffs, did not immediately respond to a request for comment. The FDA declined to comment.

The FDA adopted the Deeming Rule in 2016, identifying a wide range of tobacco products including cigars and pipe tobacco to be subject to its regulatory authority under the Family Smoking Prevention and Tobacco Control Act of 2009.

The industry groups filed a lawsuit challenging the rule on multiple grounds in the District of Columbia. Some aspects of that challenge have been successful, as when the D.C. Circuit last year overturned a warning label requirement as arbitrary and capricious.

On Tuesday, however, the court upheld the FDA’s power to require cigar and pipe tobacco products to undergo premarket review, or for manufacturers to provide “substantial equivalence reports” showing that a product is equivalent to one already on the market before 2007 and thus “grandfathered.”

The cigar groups had challenged that rule on the grounds that the FDA failed to provide product-specific instructions on how to prepare substantial equivalence reports, violating the Tobacco Control Act’s provision that the reports must be provided “in such form and manner as the Secretary (of Health and Human Services) shall prescribe.”

Circuit Judge Judith Rogers wrote that it was not necessary to address whether the law required the FDA to provide the instructions, because the agency had said it would give companies 18 months to submit substantial equivalence reports. That meant that even if the FDA were required to provide instructions, it did not have to do so as part of the rule, but could do so later, meaning the rule could not be overturned on that basis, the judge said.

The judge also rejected the plaintiffs’ claim that the FDA failed to consider the costs and benefits of premarket review specifically for each industry or product, saying they had not cited any part of the law requiring it to do so.

Rogers further upheld the agency’s user fees on cigar and pipe tobacco manufacturers and importers. The plaintiffs had challenged the fees on the grounds that the agency did not impose similar fees on other newly deemed products like e-cigarettes.

Rogers said the Tobacco Control Act specifically gave the FDA authority to impose fees on cigarettes, cigars, snuff, chewing tobacco, pipe tobacco and roll-your-own tobacco, upholding its determination that it lacked authority to impose fees on any other products.

Source: Reuters