On Aug. 18, the U.S. District Court for the Eastern District of Texas issued an order further postponing the effective date of the FDA’s graphic cigarette health warning rule by another 90 days from July 13, 2022, to Oct. 11, 2022. In addition, the order also states that “any other obligation to comply with a…
PMTA Progress Update
The Food and Drug Administration (FDA) is under a court order to review and either authorize or decline to authorize — by Sept. 9, 2021 — the marketing of new tobacco products for which manufacturers submitted Pre-Market Tobacco Applications (PMTAs). But with numerous applications waiting for review, FDA is unlikely to meet the deadline. Background…
What Are Modified Risk Tobacco Products?
The term ‘modified risk tobacco products’ came onto the scene after regulators became concerned that tobacco products marketed using words like “light” or “mild” might give consumers the impression that the products posed less of a health risk than other tobacco products. Consequently, the Family Smoking Prevention and Tobacco Control Act, enacted into law in…
What Is the Cigarette Corrective Statements Litigation?
A newly proposed rule by the U.S. Department of Justice (DOJ) would require corrective statements about cigarettes to be posted by manufacturers at the point of sale (POS) in stores where cigarettes are sold. Background In 1999, the U.S. government sued the major cigarette manufacturers, asserting claims under several federal statutes for conduct by the…
Navigating Tobacco Regulatory Hurdles for 2021
With the new year comes new challenges for retailers that sell tobacco products. Just like in 2020, key issues for retailers will encompass local, state and federal legislative and regulatory actions. Local Flavor Ban Ordinances In February 2020, the Food and Drug Administration (FDA) made most flavored cartridge- and pod-type vaping products illegal. Then, in…
Significant Tobacco Issues for 2021
With the New Year comes new challenges for retailers that sell tobacco products. Just like in 2020, key issues for retailers will encompass local, state and federal legislative and regulatory actions. Local Flavor Ban Ordinances In February 2020, the Food and Drug Administration (FDA) made most flavored cartridge- and pod-type vaping products illegal. Then, in…
FDA Marketing Application Deadline Passes: What Happens Now?
The Food and Drug Administration (FDA) set Sept. 9, 2020, as the deadline for manufacturers to submit a substantial equivalence application (SE) or a pre-market tobacco application (PMTA) for “deemed” tobacco products introduced into the marketplace between Feb. 15, 2007, and Aug. 8, 2016. Tobacco products subject to the PMTA requirements include cigars (except “premium…
Courts Extend FDA PMTA Application Deadline
As previously reported in CStore Decisions, the U.S. Department of Justice, on behalf of the Food and Drug Administration (FDA), submitted letters on March 30, 2020, to the U.S. District Court for the District of Maryland and the U.S. Circuit Court of Appeals for the Fourth Circuit with a request for a 120-day extension of…