FDA recently revised its draft guidance on the “Use of Investigational Tobacco Products.” This draft guidance was originally issued in September 2015; however, after receiving numerous comments, FDA decided to revise the guidance to clarify certain information. FDA also regards the revision to be in furtherance of its commitments under the Agency’s comprehensive plan for tobacco and nicotine regulation.
Continue Reading

As the partial shutdown of the U.S. government reaches a month (the longest in U.S. history), and thousands of federal workers furloughed or working without pay, regulated industry and stakeholders are asking: How long will the shutdown continue? And, what is the impact of the shutdown on federal agencies and regulatory matters? In addressing the first question, there does not appear to be an immediate end in sight as President Trump’s standoff with Congress over a border wall continues.
Continue Reading

As we previously reported here, on September 5, 2018, 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 (six months sooner than FDA’s initial, estimated timeline of November 2021).
Continue Reading

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.
Continue Reading

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. 
Continue Reading

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.
Continue Reading

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).
Continue Reading

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.
Continue Reading

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.
Continue Reading