Monday, April 15, 2013

FDA Boasts About "Accomplishments," But So Far Has Not Accomplished a Single Thing to Protect the Public's Health

In a promotional flyer on its web site, the FDA boasts about its timeline of accomplishments to protect the public's health under the Family Smoking Prevention and Tobacco Control Act.

Here is its list of its so-called accomplishments:

September 2009: Banned flavored cigarettes making them less appealing to kids
March 2010: Restricted youth access to tobacco products
June 2010: Banned misleading advertising to avoid misperception that products are safer
June 2010: Established new smokeless tobacco warnings to communicate health risks
June 2011: Issued new cigarette health warnings to highlight product dangers (under litigation)
March 2012: Established list of harmful and potentially harmful constituents
March 2012: Issued draft guidance on submitting a Modified Risk Tobacco Product Application

The Rest of the Story

None of these interventions has or will do anything substantial to protect the public's health. Here is my analysis of each of these actions:

September 2009: Banned flavored cigarettes making them less appealing to kids

The ban on flavored cigarettes did not affect a single cigarette brand produced by the Big Tobacco companies. The brands being smoked by more than 99% of youth are not brands which were eliminated by the FDA. Thus, this action had no significant effect on reducing youth smoking.

In fact, the one flavoring that FDA could have banned but chose instead to exempt from regulation was menthol, and menthol cigarettes make up about half of the youth market.

Thus, far from being an accomplishment, the regulation of flavored cigarettes by the FDA has been a dismal failure.

March 2010: Restricted youth access to tobacco products
The restrictions on youth access to tobacco products will have no effect on youth smoking. Multiple studies have shown that youth access restrictions do not work. There are many ways by which youth obtain cigarettes and purchasing them is the usual method for fewer than half of youth smokers. Several meta-analyses have demonstrated that youth access restrictions have no effect on youth smoking rates.

Thus, far from being an accomplishment, the restriction and enforcement of youth access to tobacco products has been a waste of resources.

June 2010: Banned misleading advertising to avoid misperception that products are safer
The ban on misleading advertising (terms such as "lights") had already been put into effect by Judge Kessler as part of the remedies in the Department of Justice's RICO suit against Big Tobacco. Moreover, the regulation has had little effect because cigarette companies simply used different color schemes to indicate which products were "regulars," "lights," etc.

While anti-smoking groups complained that tobacco companies were circumventing the law, I have explained that they were well within their rights under the law and that had the FDA not wanted companies to use color schemes, then it should have prohibited companies from doing so. It failed to take such an action. The blame must not be put on the cigarette companies, but on the politicians and health groups that crafted and supported the Tobacco Act and on the FDA itself.

Thus, far from being an accomplishment, the regulation of misleading descriptors by the FDA has been a demonstrated failure.

June 2010: Established new smokeless tobacco warnings to communicate health risks
Substantial research demonstrates that these warnings will have no effect in reducing the use of smokeless tobacco. If anything, smokeless tobacco use among youth has increased since the FDA took this action.

Far from being an accomplishment, this action had no effect whatsoever.

June 2011: Issued new cigarette health warnings to highlight product dangers (under litigation)
These warning labels never saw the light of day as the FDA crafted warnings that were unconstitutional, as they violated the First Amendment. Even had they been upheld by the courts, they would have had no more than a marginal effect on cigarette smoking. In fact, the lack of evidence that graphic warning labels have any substantial effect in stimulating smoking cessation was what doomed this regulation in the courts.

Far from being an accomplishment, the graphic warning regulation was a policy and legal failure.

March 2012: Established list of harmful and potentially harmful constituents
The list of harmful and potentially harmful constituents was an exercise in futility. It accomplished nothing.

There is nothing that will be learned from the exercise that will either:

(1) provide meaningful or helpful information to consumers; or

(2) provide critical information to the Agency to allow it to develop a strategy to produce substantially safer cigarettes.

If anything, this information is potentially deceptive, as:

1. These constituents represent only a small fraction of the chemicals present in tobacco smoke.

2. No one actually knows which constituents, and in what combinations or at what levels, are responsible for each of the many diseases caused by tobacco smoke.

3. Lowering levels of certain of these constituents may have no effect on overall health risks.

4. Products with lower levels of certain of these constituents may or may not be safer than other cigarettes.

It must be remembered that there are between 10,000 and 100,000 chemicals in tobacco smoke, most of which have not yet been identified. Most likely, the majority of hazardous chemical constituents of tobacco smoke have not yet been identified. It is naive to think that by controlling levels of certain of these 20 selected chemicals, one can control the level of risk posed by different brands of cigarettes.

The entire strategy makes no scientific sense, is not founded in any scientific evidence base, is misleading and deceptive at the core, and represents a tremendous waste of time and resources. This is regulation for regulation's sake, and there is no public health benefit of these regulations. If anything, it is a huge distraction from the types of public health efforts that are actually needed to effectively address the problem of tobacco-related morbidity and mortality.

Rather than representing an accomplishment, the list of harmful constituents was a useless exercise.

March 2012: Issued draft guidance on submitting a Modified Risk Tobacco Product Application

The FDA's guidance on modified risk products do nothing to protect the public's health. Instead, they actually harm the public's health by making it more difficult for truly reduced risk products to reach the market. This guidance serves to protect the existing high-risk products on the market from challenge by safer products. The FDA guidance on modified risk tobacco products: (1) makes it almost impossible for new reduced risk products to be successfully developed and marketed; (2) makes it extremely difficult for existing potentially-reduced risk products to successfully achieve a modified risk status; and (3) makes it extremely unattractive for existing potentially-reduced risk products to successfully achieve modified exposure status.

Far from being a public health accomplishment, the modified risk product guidance harms the public's health by ensuring that the most hazardous tobacco products will remain unchallenged by much safer ones.

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