Tobacco companies consider pack color an “ingredient” that creates “new” products; FDA should learn and reject SE claims

Lauren Lempert and I just published “Packaging colour research by tobacco companies: The pack as a product characteristic” in Tobacco Control.  This paper shows that the industry treats pack color as an “ingredient” interchangeably with the contents of the physical cigarette to create “new prodcuts.”  This evidence has important implications for FDA “substantial equivalence” determinations demonstrating that changes to packaging should not be considered substantially equivalent to existing products.
 
The main paper presents the relevant internal tobacco industry documents that prove this point.  There is also an extensive appendix with the legal analysis showing why, under the provisions of the Family Smoking Prevention and Tobacco Control Act the FDA should not consider products that have packaging changes “substantially equivalent.”
 
Here is the abstract:
 

Background Tobacco companies use colour on cigarette packaging and labelling to communicate brand imagery, diminish health concerns, and as a replacement for prohibited descriptive words (‘light’ and mild’) to make misleading claims about reduced risks.
 
Methods We analysed previously secret tobacco industry documents to identify additional ways in  which cigarette companies tested and manipulated pack colours to affect consumers’ perceptions of the cigarettes’ flavour and strength.
 
Results Cigarette companies’ approach to package design is based on ‘sensation transference’ in which consumers transfer sensations they derive from the packaging to the product itself. Companies  manipulate consumers’ perceptions of the taste and strength of cigarettes by changing the colour of the packaging. For example, even without changes to the tobacco blends, flavourings or additives,  consumers perceive the taste of cigarettes in packages with red and darker colours to be fuller flavoured and stronger, and cigarettes in packs with more white and lighter colours are perceived to taste lighter and be less harmful.
 
Conclusions Companies use pack colours to manipulate consumers’ perceptions of the taste, strength and health impacts of the cigarettes inside the packs, thereby altering their characteristics and ffectively creating new products. In countries that do not require standardised packaging, regulators should consider colour equivalently to other changes in cigarette characteristics (eg, physical characteristics, ingredients, additives and flavourings) when making determinations about whether or not to permit new products on the market.

 
The full citation is Lempert LK, Glantz S.  Packaging colour research by tobacco companies: The pack as a product characteristic.  Tob Control  2016; Published Online First: 2 June 2016 doi:10.1136/tobaccocontrol-2015-052656 and is available here.
 
The supplemental file containing a detailed legal analysis, Implications for FDA Review of New Tobacco Products, is available here.
 
The information in our paper, combined with the important recent paper “FDA’s misplaced priorities: Premarket review under the Family Smoking Prevention and Tobacco Control Act” by Desmond Jenson, Joelle Lester, and Micah Berman (also published in Tobacco Control) provides the information that the FDA needs to reject many of the pending substantial equivalent claims, which will allow it to stop prioritizing business over public health.