December 13, 2012

Stanton A. Glantz, PhD

FDA is acting prudently in not rushing to accept tobacco companies' claims of "substantial equivalence"

Today the Associated Press published a long story headlined "FDA review of tobacco products grinds to a halt" reporting that the FDA has not acted on "nearly 3500" product applications and quoted several industry executives complaining about the delay as well as Matt Myers from Tobacco Free Kids saying, "They [the tobacco companies] have the burden of demonstrating that new products and product changes won't increase youth tobacco use, won't increase toxicity and won't wrongly deter people from quitting." 

The AP also reported that Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products, said the agency is working with companies to get more information about products and hopes the industry will be more transparent about its reasoning that product changes don't affect public health.  Deyton noted that small changes in ingredients or additives can make a cigarette more addictive or harmful, continuing. "Though cigarettes seem like a very simple product - chopped-up tobacco rolled in paper ... we know that cigarettes are highly engineered. They're technologically incredibly sophisticated." 

As the AP reported, the tobacco companies have filed thousands of applications claiming that the new products are "substantially equivalent" to existing products.   The problem is, as Myers and Deyton correctly observe, seemingly small changes in the packaging (which affects consumer perceptions) and the design of tobacco products can have major effects on use patterns and subsequent health effects.  The cigarette companies also have a history of clever manipulations of the information they present in order to obscure changes to their products that can increase toxicity.  (See, for example, our paper on Philip Morris' Project Mix as well as the correspondence back and forth with Philip Morris.) 

Because of the industry's continuing efforts to obscure the true effects of their products, it is completely appropriate for the FDA to not allow itself to be stampeded into premature action on these applications.  (The FDA also needs to take cognizance of the fact that the companies are racketeers who are likely to be continuing the defraud the public.)   Absent convincing evidence (including adequately powered studies demonstrating equivalence) that the new products are "substantially equivalent," the FDA should deny these applications and require the companies to put in full applications for new products. 

An appropriate standard for “adequately powered studies” would be that used by the National Toxicology Program ( The National Toxicology Program uses a standard protocol to evaluate carcinogenicity with mice and rats that involves a 2 year exposure of several hundred animals.  NTP conducts 90 day “Pre-chronic” studies to evaluate general toxicity and as a range-finding exercise for the 2 year study (they don’t want to make the animals too sick when testing for carcinogenic potential).  In contrast, the cigarette companies (such as in Project Mix and other similar studies) have typically used a 90 day exposure of a small number (8-10) of animals.  This is neither an adequate number of animal or an adequate exposure duration to warrant a conclusion of no effect (in this case, “substantial equivalence").

Substantial equivalence should also be required to be demonstrated in terms of cardiovascular effects and also issues around product perception that relate to marketing (package color, product descriptions, use of specific words and images).

This is also not something where the FDA should "split the difference" and allow some fraction of these applications through just because there are so many of them.  This kind of effort to overwhelm government with thousands of submissions is a well-established industry tactic to avoid scrutiny and get its way.

This is not an example of government dragging its feet.  This is an example of government doing its job to protect the public.

Indeed, if the information that the tobacco companies is so obscure or incomplete (another common trick) that the FDA cannot make a sensible decision based on the information that was submitted, the FDA should start  rejecting applications for failure to meet the burden. 

That will clear out the backlog and help train the companies about the scientific standards that are necessary to secure approval.

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