As I pointed out, this is a dramatic change in its public position, as in the past, the FDA has always maintained that no cigarette on the market is any safer than any other cigarette, as small differences in additives or ingredients between brands do not confer any significant health protection. In fact, the FDA has always maintained that all tobacco products are equivalent in their health effects. Even today, the FDA continues to claim (in contradiction to its statement that small differences in additives make cigarettes more or less hazardous) that: "To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, or cause less harm than other tobacco products."
The FDA goes on to assert that anyone who implies that any cigarette brand is safer than any other cigarette brand is committing a "health fraud."
The FDA was joined in this abrupt change in position by the Campaign for Tobacco-Free Kids, which also argued last week that preventing minor changes in cigarette additives or ingredients is essential to protect the public's health.
Today, I found out that one of the foremost tobacco control researchers and advocates - Dr. Stan Glantz - has also abruptly changed positions and is now arguing that by preventing minor changes in cigarette additives, the FDA is serving the public's interest by substantially protecting the health of smokers. On his blog, Dr. Glantz writes: "This is an example of government doing its job to protect the public."
The Rest of the Story
Let's be very clear. Cigarettes are such an extremely hazardous product that minor changes in additives, ingredients, or packaging cannot possibly result in a substantially safer cigarette.
But this is precisely what the FDA, the Campaign for Tobacco-Free Kids, and Dr. Glantz are arguing. Their argument that the FDA is serving an important public health protection function by preventing minor changes in cigarette additives implies that such minor changes are relevant to the harmfulness of cigarettes. That is, they are implying that minor changes in additives can produce a substantially safer cigarette. Because by asserting that minor changes in additives can produce a more dangerous cigarette, the automatic corollary is that minor changes in additives can produce a safer cigarette.
Like the FDA prior to last Friday, and like most of the anti-smoking groups prior to their lobbying for the Tobacco Act, I reject this notion. It is my opinion that the FDA is spending countless time and resources squabbling about nothing. Most of the applications for substantial equivalence designations amount to minor changes that will have no substantial consequences for the health of smokers, and in my view, this effort is largely a waste of time.
Moreover, it diverts attention from where action is urgently needed: in replacing existing cigarettes with alternatives that are actually substantially safer. What is needed are not minor changes but major changes. Of course, one example would be trying to convince smokers to use electronic cigarettes as an alternative to the far more hazardous tobacco cigarettes. But the FDA and many of the same researchers and groups arguing that small changes in additives are critical will not even acknowledge that a major change - completely eliminating the tobacco - is a crucial public health advance.
Most importantly, this change in public position by the FDA and the anti-smoking groups sends exactly the wrong message to smokers. It suggests to smokers that minute differences in cigarette additives and ingredients can produce major changes in the health effects of smoking. This is not only incorrect but it is damaging because it takes the emphasis off the need to quit smoking and gives smokers hope that by merely changing brands, they can substantially lower their risk of disease.
Let's not forget that there are cigarettes on the market that contain no additives. Specifically, Winston cigarettes. In 1999, R.J. Reynolds Tobacco Company was forced by the FTC to change its labeling to indicate that "No additives in our tobacco does NOT mean a safer cigarette."
However, if the FDA, the Campaign for Tobacco-Free Kids, and Dr. Glantz are correct that additives can increase the toxicity of cigarettes, then R.J. Reynolds was - by definition - initially correct in its implication that the absence of additives confers less health risk. If the FDA's assertion is correct and if it is true that preventing changes in additives protects the public's health, then Winston cigarettes must be safer than cigarettes that contain certain additives. Are the health groups willing to admit this? Or are they bamboozling the public by claiming that the FDA is actually protecting smokers from more harmful products by not allowing additional additives?
The rest of the story is that this change in the anti-smoking groups' position on this issue was stimulated by the Campaign for Tobacco-Free Kids' propaganda campaign in support of the FDA tobacco legislation. The Campaign, in order to convince the anti-smoking groups that the legislation would actually accomplish something in terms of health protection, was able to blind much of the rest of the movement into falling into the previously scorned-upon belief that by regulating additives, the FDA could reduce the health hazards associated with smoking.
To be honest, I don't believe that the FDA is accomplishing any meaningful public health function by disallowing new products that are not precisely identical to existing products. I do not believe for a moment that the public's health would be any more at risk if the FDA took a liberal, rather than strict interpretation of the "substantial equivalence" clause.
In contrast, I do believe that the FDA is harming the public's health by discouraging the use of electronic cigarettes and by adopting a stringent construction of the evidentiary requirements for modified risk product claims.
If the FDA and the anti-smoking groups are being truthful in their claim that cigarette additives make cigarettes substantially more dangerous, are they willing to admit that Winston cigarettes do confer some degree of safety compared to some other cigarettes on the market? If not, then it seems to me that they are talking out of both sides of their mouths.
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