In a Joint Status Report filed in federal court on December 13, Plaintiffs Cigar Association of America, Cigar Rights of America, and International Premium Cigar and Pipe Retailers Association requested the extension of the Food and Drug Administration’s harmful and potentially harmful constituent (HPHC) reporting deadline. The Plaintiffs have already obtained a delay of the cigar and pipe tobacco warning labeling requirements until after the resolution of the lawsuit. Now, Plaintiffs seek an extension of the approaching November 8, 2019 deadline for HPHC reporting for cigar and pipe tobacco products.
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On November 29, the Food and Drug Administration issued a warning letter to an e-liquid company for allegedly selling products with labeling and advertising causing the products to resemble kid-friendly products, including cereal and candy.  The products are alleged to be misbranded under Section 903 of the Food, Drug and Cosmetic Act because their labeling and/or advertising are false and misleading. 
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On December 5, 2018, FDA will hold a public hearing to discuss its efforts to eliminate youth e-cigarette and other tobacco product use. One of the objectives of the hearing is to obtain the public’s perspectives on whether there is a need for drug therapies to support youth e-cigarette cessation. In particular, FDA seeks to explore the appropriate methods and study designs impacting the development of such therapies, as well as safety and efficacy issues.
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Last month, the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes, as set forth in the 2009 Tobacco Control Act. The Court ordered FDA to provide an accelerated timeline for the completion of its rulemaking. On October 5, 2018, FDA provided the Court an accelerated schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021 (i.e., six months sooner than FDA’s initial estimated timeline of November 2021).
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The FDA has submitted a proposed, expedited schedule for the issuance of a final graphic warnings rule for cigarettes. Last month, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings after finding that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings as mandated by the 2009 Tobacco Control Act. On October 5, 2018, FDA provided the Court an accelerated schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021.
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As a follow-up to our earlier blog post on this topic, the FDA now has until October 5, 2018 to provide an expedited schedule for the issuance of a final graphic warnings rule in accordance with the Tobacco Control Act. As readers may recall, earlier this month, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings after finding that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings.
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The Troutman Sanders Tobacco Team will attend the FDLI Tobacco and Nicotine Products Regulation and Policy Conference on October 24-26, 2018.  The conference will feature a diverse group of stakeholders – manufacturers, governmental agencies, researchers, public health advocates and attorneys – discussing the effective regulation of tobacco and nicotine products in the U.S. and globally.  The FDA’s Center for Tobacco Products Director Mitch Zeller will speak about the latest updates on regulations, guidance and other initiatives.    
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This week, in a rare instance of a court directing a federal agency to take action, the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings. The order comes after the Court concluded that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act.

The Tobacco Control Act requires FDA to issue regulations requiring color graphics depicting the health consequences of smoking on product labeling within 24 months after the date of enactment of the Act, or by June 22, 2011. According to FDA, however, the final rule is now expected to be completed in November 2021. Calling this an “extraordinary delay,” the Court stated that FDA’s duty to issue the graphic warnings rule by June of 2011 was “nondiscretionary.” Accordingly, the Court concluded that the statute and deadlines set forth by Congress continue to apply to the FDA — despite the D.C. Circuit’s vacatur and remand back to the agency in R.J. Reynolds Tobacco Co. v. Food & Drug Administration in 2012 based on First Amendment challenges. In coming to this conclusion, U.S. District Judge Indira Talwani stated that “it cannot be the case that the FDA has freed itself from Congressional mandates and may now take the opportunity to promulgate this rule at whatever pace it chooses. While the vacatur may reset the two-year clock, it does not negate the FDA’s continuing obligation to comply with Congress’ deadlines.”

The Court did not accept FDA’s argument that the Agency had competing priorities because FDA failed to identify any single, specific competing priority. The Court also rejected any notion of FDA suffering from limited resources since CTP operations are funded by user fees and the amount of user fees collected in FY 2018 alone was $672,000,000 (even though FDA did not allege that limited resources were at issue in this case). Thus, in light of the original June 2011 timeline set forth by Congress, FDA’s current estimated timeline (and lack of progress in recent years), and the lack of competing priorities outlined in FDA’s brief, the Court found that FDA failed to convincingly show that it did not “unreasonably delay” promulgation of the final graphic health warnings rule for cigarette packs. As such, the court declined to defer to the Agency’s timeline. Instead, the Court has now given FDA a deadline of September 26, 2018 to provide the following:

  • an expedited schedule for the completion of outstanding studies for the graphic warnings;
  • the publication of the proposed graphic warnings rule for public comment;
  • review of public comments, and
  • issuance of a final graphic warnings rule.

According to FDA’s own
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To mark the nine-year anniversary of the Family Smoking Prevention and Tobacco Control Act and the one-year anniversary of FDA’s Comprehensive Plan for Nicotine, FDA recently provided updates on efforts to improve its tobacco regulatory programs. In addition, FDA announced new initiatives that are designed to help industry have a better understanding of what is needed to submit complete and robust tobacco product applications. The stated objective of these efforts is to improve the transparency and efficiency of the premarket review process.
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