Tobacco Giants Score Partial Victory Over FDA

     WASHINGTON (CN) — Phillip Morris and other Tobacco industry giants have scored a partial victory in their challenge to the U.S. Food and Drug Administration’s authority over their products.
     The D.C. District Court on Tuesday determined the tobacco companies could forego aspects of the approval and review process laid out by Congress in the 2009 Tobacco Control Act if they sought only to minimally modify the labels of their goods.
     Drastic changes to a label’s color or logo would constitute the goods as “new” and as a result, would trigger a formal round of strict scrutiny via traditional approval and review processes by the FDA, U.S. District Judge Amit Mehta said.
     But in his ruling, Mehta held that minimal changes to a label should not elicit regulatory approval, and moreover, such changes were never intended to do so.
     “The court must presume that that omission [in TCA regarding minor label modifications] was purposeful,” the judge wrote.
     Modifications to the quantities found in tobacco products however, will still fall under the agency’s final purview, Mehta said.
     Changing the gross total of a tobacco product, or the “number of portioned parts per package or a change in the weight of a product,” also “entails a change in the amount of constituent ingredients and additives,” the ruling stated.
     Typically, the review process for modified products, as described in the Tobacco Control Act, is two pronged. A tobacco company must either obtain a “sponsor of a new tobacco product [which] can show that its new product is ‘substantially equivalent’ to [an existing product],” or the sponsor can submit an approval application which demands not just a sample of the new product, but an extensive report which details information about the wares including health risk posed to the consumer, the physical makeup of the product and the manufacturing process implemented, the ruling said.
     FDA spokesman Michael Felberbaum declined to comment on Mehta’s ruling on Thursday.
     Despite multiple attempts by phone and email, Representatives of Phillip Morris and the other tobacco company plaintiffs could not be reached.
     A complaint over FDA guidelines was filed in 2015 by subsidiaries Imperial Brands, Reynolds American Inc. and Altria Group. That suit also challenged the regulations set out in the 2009 Tobacco Control Act.
     The Family Smoking Prevention and Tobacco Control Act established that only Congress and the Food and Drug Administration retained the “primary federal regulatory authority” over the manufacture, marketing and distribution of tobacco products.”
     Congress passed the TCA after it was determined that “federal and state governments … lacked the legal and regulatory authority and resources needed to comprehensively address the public health and societal problems caused by the use of tobacco products.”
     Congress also explained the necessity of TCA as one that arose from the failure of “past efforts to restrict advertising and marketing of tobacco products” to teenagers. The ultimate aim of TCA was to collaborate with the FDA to “set national standards regarding tobacco,” the ruling said.
     In addition to Phillip Morris USA Inc., the plaintiffs also include U.S. Smokeless Tobacco Company LLC, R.J. Reynolds Tobacco Company, American Snuff Company LLC, Santa Fe Natural Tobacco Company Inc. and ITG Brands LLC.

%d bloggers like this: