A U.S. District Court in Washington has said a label change does not constitute a new tobacco product. It’s a ruling that will help the cigar industry, but its one that comes from an unlikely source – the cigarette industry. The decision was handed down by U.S. Court District Judge Amit P. Mehta on August 16th, 2016 in response to a lawsuit filed by Altria. Lorillard, and Reynolds American against the U.S. Food and Drug Administration (FDA).
The decision is a positive one for the premium cigar industry – where labeling changes are quite common. Prior to the ruling, a change in logo or color would require FDA approval through the Substantial Equivalence (SE) path.
On the other hand, the court did uphold that changes to product quantity in packaging does constitute a new tobacco product. For example, if a cigar company wants to change from 20 count to 10 count boxes, it would require FDA approval through Substantial Equivalence.
In the ruling, the court concluded that “..under the TCA (Family Smoking Prevention and Tobacco Control Act), a modification to an existing product’s label does not result in a ‘new tobacco product’ and therefore such a label change does not give rise to the Act’s substantial equivalence review process. Accordingly, the FDA’s Guidance as it relates to labeling changes is contrary to the law and cannot stand. On the other hand, the court concludes that a change to an existing product’s quantity does result in a “new tobacco product” and therefore does trigger the Act’s substantial equivalence review process. The court further finds that the FDA’s Guidance is not a legislative rule and thus was not subject to the demands of notice-and-comment rulemaking. Accordingly, in regards to quantity change, the court concludes that the Guidance need not be vacated.”
The lawsuit was filed by the Altria, Lorillard Inc. and Reynolds American prior to the FDA implementing the Deeming Regulations for premium tobacco. The lawsuit was originally filed by the three companies back in April, 2015 which challenged the FDA’s stand on labeling and packaging changes constituting new products. It appeared this was not going to court as the three companies announced in June 2015 that they were dropping the lawsuit after the FDA said it would not enforce the labeling changing. Two months later, the lawsuit was resurrected after it a revised policy would enforce similar regulations.
The ruling impacts the premium cigar industry because the Deeming Regulations extended the FDA’s control to all tobacco products and not just cigarettes, loose tobacco, roll your own tobacco, and smokeless tobacco