Vaping eyes Altria lawsuit over FDA ‘substantial equivalence’ rules

The vaping industry will be watching a new lawsuit filed by a subsidiary of the Altria company as it travels through the U.S. District Court in Washington, D.C. in the coming months.  The U.S. Smokeless Tobacco Company (UST) alleges that the U.S. Food and Drug Administration (FDA) is unfairly applying the Not Substantially Equivalent (NSE) requirements in the rejection of one of its new tobacco product applications.  The U.S. Department of Health and Human Services (HHS), its Secretary Alex Azur, and the FDA Commissioner Scott Gottlieb are also named in the lawsuit.

According to the FDA deeming regulations, all new tobacco products must first be approved by the FDA before being released for sale to the general public.  This approval process can take place in a number of ways, either via a Pre-Market Tobacco Application (PMTA), an Substantial Equivalence (SE) Report, or an SE Report Exemption.  However, tobacco products introduced to the market prior to February 15, 2017 can be “grandfathered” in after completing the required paperwork.

FDA rejects UST SE Report

When the FDA rejected an SE Report for UST’s Copenhagen Bold Wintergreen Flavor Packs, the Altria subsidiary argued that the ruling flies in the face of the Tobacco Control Act (TCA) of which the FDA deeming regulations are fundamentally based.  In the official UST lawsuit, the plaintiffs call the FDA ruling “arbitrary, capricious, and contrary to the TCA.”

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For an SE Report to be approved by the FDA, the manufacturer must prove that the new product is the same or substantially comparable to a previously marketed predicate or grandfathered product.   The pertinent section of the FDA deeming regulations regarding substantial equivalency states the following.

“A ‘new’ tobacco product is a tobacco product that was either introduced to the U.S. market after February 15, 2007 (the ‘grandfather date’), or, if it was already on the market as of that date, had any modifications made other than to its labeling (e.g., a change in any design, component, part, constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient).”

The UST lawsuit alleges that the FDA rejection of the Copenhagen application is illegal.  The court documents explain that the product-in-question is a mint-flavored tobacco product utilizing essentially the very same packaging format and ingredients.  Based on this premise, the application should be automatically approved as per the grandfather clause of the FDA deeming regulations.

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However, the FDA may have rejected the Copenhagen SE Report because UST was acquiring their tobacco leaves from a different vendor, which in the eyes of the FDA, seemingly constitutes a “new product” that was technically not on the market prior to the February 15 grandfather clause.

UST argues that the definition of substantial equivalence (SE) as per the FDA deeming regulations requires that the new product cannot have any “modifications” to its original, pre-predicate date ingredients.  The Copenhagen product still contains mint-flavored tobacco leaves.  They just happen to come from a different source.  To remain legally compliant, UST asserts that it only has to show that the new product has the “same characteristics as the predicate tobacco product.”

Furthermore, the FDA rejection letter also states that agency officials will be conducting a broader inquiry into the “public health” impacts of the “new” Copenhagen product.  UST alleges that the FDA offered no explanation as to why this would be necessary since the only “change” was in the supplier of the tobacco leaves and an upgraded pouch design, which are characteristically comparable. 

What does this mean for vaping?

Any time that a tobacco retailer makes a change – no matter how small - to the packaging, ingredients, or additives of a particular product, the vendor must first notify the FDA by way of a PMTA, and SE Report, or an SE Exemption application.  Should the FDA be able to reject any one of these processes based simply on the fact that the vendor happened to change suppliers of one of the necessary ingredients?

If so, then every time an e-liquid manufacturer starts buying their propylene glycol from a less expensive supplier, they will be forced to yet again pay perhaps hundreds of thousands of dollars to submit another SE Report to the FDA.   The financial consequences to the American vaping industry as a whole could potentially be catastrophic, which is why all eyes are on the outcome of this new UST lawsuit.

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