Judge rules that new packaging does not create a new product.

In 2015, the Big Three tobacco manufacturers filed a lawsuit against the U.S. Food and Drug Administration, claiming that the new tobacco guidelines introduced on Sept. 8, 2015 were too restrictive. Finally, on Tues., Aug. 16, 2016, a federal judge ruled partially in favor of the tobacco companies.

According to a report from The Winston-Salem Journal, the Big Three tobacco manufacturers – Altria Group Inc., Lorillard Inc. and Reynolds American – filed the suit to request a permanent injunction that would prevent the implementation of new packaging guidelines by the FDA. The guidelines introduced last year by the FDA mandated that the modification of a product’s packaging qualifies that product as a new product for regulatory purposes, meaning the product would be subject to the substantial equivalence review process under the Tobacco Control Act of 2009.

However, on Tues., Aug. 16, a federal judge ruled that modifying a product’s label does not make it a new product for regulatory purposes; therefore, label changes will not require FDA approval. The Winston-Salem Journal reported that judge Amit Mehta has since ordered the FDA to abandon the proposed guidance on label changes.

While the judge ruled in favor of the Big Three in this portion of the case, he ruled in favor of the FDA when it came to volume changes. Judge Mehta ruled that changing the volume of a tobacco product in new packaging does trigger the substantial equivalence review process, because it is no longer the same product.

Despite the ruling on volume changes, tobacco companies are counting this as a win, because it was the labeling issue that was the main focus of the lawsuit, The Winston-Salem Journal reported.