FDA Commissioner Says Tobacco Act is Working to Reduce Youth Smoking; However, Not a Single Measure Cited is Effective

Last Thursday, FDA Commissioner Margaret Hamburg published a self-congratulatory op-ed which argued that the Tobacco Act is working and that the FDA's actions to date under the Act have been effective in helping to prevent youth smoking.

In this Reuter's op-ed column, Hamburg wrote: "Three years ago, President Obama signed the Family Smoking Prevention and Tobacco Control Act into law. ... Today, I am pleased to report that the law is working. In passing the Tobacco Control Act, Congress recognized that the linchpin of any successful strategy to reduce adult tobacco use must be to prevent young people from ever starting. ... Reversing this trend requires aggressive action on two fronts: reducing the attractiveness of tobacco products to children and ending their access to them. That's exactly what the FDA is doing."

Hamburg cites seven FDA actions that she claims have been effective.

"During our first 12 months of regulating tobacco, the FDA pulled candy and certain other flavored cigarettes off the market; issued tough new regulations to halt sales of cigarettes, cigarette tobacco, and smokeless tobacco to young people; banned brand-name sponsorship of sporting events and concerts; and implemented requirements for new warning labels for smokeless tobacco products. The FDA also has begun funding state authorities to assure vigorous enforcement of these new actions to protect our children. ... the FDA is enforcing the prohibition on misleading labeling and advertising claims, and ... tobacco companies are required to report the quantities of harmful or potentially harmful chemicals in the products they make. The FDA also is requiring graphic health warnings on cigarette packages and ads."

The op-ed concludes: "Much has been done since that day three years ago when the Tobacco Control Act was signed into law by the president in the White House Rose Garden. To the FDA, these achievements represent a solid foundation to build on."

The Rest of the Story

Let's analyze each of the seven actions that the FDA claims has been effective in reducing youth smoking or otherwise protecting the public's health. For each action, I'll grade it (on a scale of A-F) in terms of its effectiveness in protecting the public's health by either reducing youth smoking, promoting smoking cessation, or reducing the toxicity of cigarettes:

1. Pulling candy and certain other flavored cigarettes off the market.

What the FDA Commissioner did not tell us is that the so-called flavored cigarettes taken off the market represented only about 0.1% of the market, that almost no youth were smoking these types of cigarettes, and that not a single Big Tobacco brand was taken off the market as a result of the law. In fact, there is no evidence that the candy-flavored cigarette ban prevented a single youth from starting to smoke.

In contrast, the FDA's "action" spared menthol cigarettes, which are the one flavoring that actually is being smoked by youth. In fact, more than half of youths smoke menthol cigarettes. And although it has been more than a year since the expert panel issued its report to FDA concluding that a menthol ban would benefit the public's health, the FDA has taken no action.

This action has had no appreciable effect on youth smoking.

Grade: F

2. Issuing tough new regulations to halt sales of tobacco products to young people.

The scientific literature shows that youth access regulations have no effect on youth smoking. In fact, fewer than half of youth smokers obtain their cigarettes by purchasing them. So even if sales to minors were reduced to zero, it still would not prevent youth from smoking, as there are multiple other sources of cigarettes.

This action has had no appreciable effect on youth smoking.

Grade: F

3. Banning brand-name sponsorship of sporting events and concerts.

While this is a laudable action, the Master Settlement Agreement had already put substantial restrictions on sponsorships of sporting events and concerts. Thus, this restriction has had minimal effects on youth smoking.

Grade: C-

4. Funding state authorities to assure vigorous enforcement of youth access laws.

As above, the scientific literature shows that youth access regulations have no effect on youth smoking. In fact, fewer than half of youth smokers obtain their cigarettes by purchasing them. So even if sales to minors were reduced to zero, it still would not prevent youth from smoking, as there are multiple other sources of cigarettes.

This action has had no appreciable effect on youth smoking.

Grade: F

5. Enforcing the prohibition on misleading labeling and advertising claims.

The Department of Justice lawsuit had already resulted in a prohibition on misleading labeling and advertising claims. The FDA's actions add an enforcement component; however, only a handful of very small companies have violated this prohibition, so the effects of this action are minimal.

Grade: D

6. Requiring tobacco companies to report the quantities of harmful or potentially harmful chemicals in their products.

As I have argued previously, this requirement is a complete waste of time and does nothing to protect the public's health.

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.

So in my view, the Secretary of Health and Human Services is deceiving the American public when she states that: "Today’s actions [the issuing of guidances on modified risk tobacco products and harmful constituents] represent critical steps forward on providing Americans with the facts about the dangers of tobacco use and to stop children from smoking."

Neither of these actions will do anything to help provide Americans with the facts about the dangers of tobacco use, nor will they do anything to stop children from smoking.

That the Department of Health and Human Services and the FDA see these actions as representing "significant" actions to "address the tobacco epidemic" is gravely worrisome.

Grade: F

7. Requiring graphic health warnings on tobacco product packages and ads.

I have written extensively on why graphic warning labels will have only a minimal impact on smoking. There is a substantial body of evidence to suggest that these warnings will not be effective in deterring either youth or adults from smoking. Moreover, the FDA's proposed warnings likely violate the First Amendment by compelling manufacturers to urge their customers not to purchase their products. This goes beyond a factual warning and thus requires a higher level of scrutiny under the commercial free speech rulings of the Supreme Court, which this regulation cannot withstand.

Grade: D

Summary

Overall, not a single one of these actions has had, or will have any substantial effect on improving the public's health by either preventing youth smoking, promoting adult smoking cessation, or reducing the health risks of cigarettes. This is hardly a "solid foundation" to build on.

The rest of the story is that after three years, the Tobacco Act has accomplished nothing.

I do agree with the Commissioner on one point: The Tobacco Act is working. It is working as intended. And that intention was to make it look like the law would protect the public's health without actually taking any of the difficult actions necessary to really put a dent in cigarette sales. The law was intended to allow public health groups and politicians to be able to score political and financial points from their constituents by telling them that they were standing up to Big Tobacco, when in fact, they were actually standing shoulder-to-shoulder with Big Tobacco in crafting a law that would only have the appearance of protecting the public's health.

So after three years, the law is working precisely as intended.