FDA

CRA Statement

CRA Statement on Court Vacating Warning Label Requirements on Premium Cigars

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WASHINGTON, D.C. - Yesterday, Judge Amit P. Mehta issued an opinion that vacated FDA required warning labels on premium cigars.

In his findings, Judge Mehta found that FDA's approach was inadequate and stated that "FDA failed to articulate a reasoned basis for requiring warning labels for premium cigars."   And, that "By failing to analyze whether consumers are in fact misinformed or underinformed as to premium cigar health effects, the agency has failed to offer the rational connection between facts and judgment required to pass muster under the arbitrary and capricious standard."

Additionally, Mehta noted that FDA found that there were reasons to consider that premium cigars should either be regulated, or regulated differently than other deemed products but the agency didn't address this issue appropriately.

Glynn Loope, executive director of CRA, stated, "Today's decision demands a reasoned approach when addressing the regulation of premium cigars. For years, premium cigar manufacturers and retailers have been sounding the alarm that FDA's warning label requirements were among the regulatory requirements that would devastate the premium cigar industry."

Loope continued, "Judge Mehta's decision drew from evidence that was built into the administrative record by historic and diligent legislative and advocacy efforts, including CRA's comments in the rulemaking process. CRA is committed to continuing communications to Congress, the Trump Administration, and to numerous agencies within the federal government."

To read Judge Mehta's full decision, click here.

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