FDA Guidance on Reporting of Harmful Constituents in Tobacco Products Amounts to a Complete Waste of Time

Last week, the FDA released a draft guidance for tobacco companies on how to report the levels of 20 harmful constituents in tobacco smoke. The FDA has identified a total of 93 hazardous or potentially hazardous constituents, but will not require tobacco companies to report on the levels of all 93 chemicals at this time. Instead, FDA will allow the companies to focus on 20 selected harmful constituents.

The constituents that need to be reported for each brand of tobacco product are as follows (the first column is for cigarettes, the second column is for smokeless tobacco, and the third column is for roll your own tobacco):

Acetaldehyde	Acetaldehyde	Ammonia
Acrolein	Arsenic	Arsenic
Acrylonitrile	Benzo[a]pyrene	Cadmium
4-Aminobiphenyl	Cadmium	Nicotine (total)
1-Aminonaphthalene	Crotonaldehyde	NNK*
2-Aminonaphthalene	Formaldehyde	NNN**
Ammonia	Nicotine (total and free)
Benzene	NNK*
Benzo[a]pyrene	NNN**
1,3-Butadiene
Carbon monoxide
Crotonaldehyde
Formaldehyde
Isoprene
Nicotine (total)
NNK*
NNN**
Toluene

The Rest of the Story

This entire exercise is a huge waste of time. 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.

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.