October 6, 2016

Stanton A. Glantz, PhD

Court opens door to FDA authorizing “Teddy Bear” cigarettes

A federal court’s August 2016 ruling opened the door to FDA approving Teddy Bear cigarettes.  Here’s some background to explain why: The Family Smoking Prevention and Tobacco Control Act requires tobacco companies to obtain FDA approval before marketing new tobacco products.  This can be obtained by submitting a comprehensive new tobacco product premarket application, or by convincing the FDA that the new product is “substantially equivalent” to one already on the market.[1]  In September 2015 the FDA issued a guidance document saying that a change to a product’s label that makes it “distinct” from the labeling of the existing product creates a “new tobacco product” requiring FDA review before the product can be marketed.
FDA’s original position on labeling changes (in 2011[2]) was that the labeling and packaging of a tobacco product was a “part” of that product, and a change to any part of a tobacco product (including to its labeling) would render the product a “new tobacco product” that required FDA approval.  
The FDA did the right thing because it is consistent with how the industry itself thinks about labeling and packaging.  As we described in our paper, “Packaging colour research by tobacco companies: the pack as a product characteristic,” the tobacco companies use labeling and pack colors to manipulate consumers’ perceptions and experiences of the taste, strength, and health impacts of the cigarettes inside the packs.  In fact, they change labels and design new packs as a major factor in their marketing strategy, understanding that “a package change can create a ‘new’ product.”  Even seemingly small pack refinements such as increasing white space, reducing a red band, or lightening brown color tones are used to influence how consumers perceive the strength of the cigarette inside the pack.
In 2015, after the industry complained, FDA weakened this position, saying that if a product is new because of “distinct” labeling changes, but otherwise has the “same characteristics” as an existing product, the manufacturer may take the easier route of submitting a streamlined “Same Characteristics Substantial Equivalence Report” in lieu of submitting a full substantial equivalence report.  
Despite this lenient position (and the companies’ own internal practices), the tobacco companies sued FDA and, unfortunately, in August 2016 got a federal court to agree with them, ruling that label changes on tobacco products do not make them “new tobacco products” subject to substantial equivalence review.
So, according to this ruling, the FDA could authorize Marlboro cigarettes in Teddy Bear packages for sale (as substantially equivalent) as long as the cigarettes themselves were unchanged. 
The fact that kids and their parents might perceive Teddy Bear cigarettes as tasting milder and being less harmful than Marlboro full flavor in Philip Morris’ iconic red chevron pack is, according to the court, not relevant. 
The court’s ruling was wrong because it failed to consider scientific evidence about a label’s impact on public health.  As noted above, tobacco companies routinely use packaging and labeling – and in particular, colors – to create “new products,” making color an “ingredient” as much as the tobacco in the cigarettes.  Indeed, they use packaging changes as an alternative to changes in the physical product. 
The Tobacco Control Act’s foundational public health standard (section 906(d)) requires FDA to consider the risks and benefits of any regulation to current users, non-users, and potential users.  In particular, FDA must consider the increased or decreased likelihood that current users will stop using the tobacco products, and that non-users will start using the products.  Considering this essential standard, the court should have recognized that tobacco companies invest money in label changes to make their products more appealing to new and current smokers, and any change made to a tobacco product’s label increases the likelihood that current users will continue using the product, that non-users will start using the product, and that potential users will change brands, and decreases the likelihood that current smokers will quit.  
FDA should appeal the court’s ruling based on this evidence of how the companies actually use labels.
But the FDA does not have to wait for the legal process to grind forward.
The FDA has ample authority to act now to prohibit companies from introducing tobacco products into the marketplace that have new or changed labels that would harm the public health.  Tobacco Control Act section 902 gives FDA enforcement powers to deem as “adulterated” and order the removal of products that violate section 911 by making explicit or implicit modified risk claims.  In addition to the internal industry research and practice on this subject, Greg Connolly and Hillel Alpert demonstrated that using light colors on cigarette packs in lieu of the prohibited terms “light” and “mild” make “implicit” modified risk claims that should spark FDA action.  Section 903 provides that any tobacco product whose labeling is “false or misleading in any particular” shall be deemed “misbranded” by FDA, triggering enforcement action. 
Further, FDA can and should start a rulemaking (as suggested by the court) under section 903(b) to issue a new regulation requiring premarket review of all label changes, including those for which substantial equivalence reports are submitted.
[1] Under the Tobacco Control Act, a tobacco company can avoid the rigorous premarket new tobacco product application process and instead file a substantial equivalence report if it can demonstrate that the new product has the same “characteristics” as a product already on the market, or has different characteristics, but the product does not raise different questions of public health  (sections 910 and 905(j)).
[2] “FDA Center for Tobacco Products. Draft Guidance for Industry and Food and Drug Administration Staff.  Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. September 2011.”  Link no longer available – FDA took it down from website, replacing it with newer September 2015 guidance.
Lauren Lempert helped prepare this blog post.

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