Regulatory Purgatory: Tobacco Harm Reduction at Risk

I recently testified before the Kansas legislature in support of a resolution asking the state health department to review the scientific evidence for tobacco harm reduction and its potential benefits for smokers.  An American Cancer Society spokesperson opposed the resolution, saying that because the U.S. Food and Drug Administration (FDA) regulates tobacco, it is unnecessary and a waste of resources for any other agency to review tobacco harm reduction.

The FDA was authorized to regulate tobacco in 2009.  In March of this year, the agency released a 50-page draft document advising what information will be required for a product to be accepted by the agency as “modified [i.e. reduced] risk” (available here). 

The FDA’s “key areas of investigation” are listed after this post.  While decades of scientific investigation have established that smokeless tobacco use is at least 98% safer than smoking, this FDA guidance suggests that the agency will require dozens of new studies on minute product details and human effects. 

As many of the proponents of the 2009 bill intended, this new regulatory maze will condemn smokeless tobacco products, and therefore tobacco harm reduction, to purgatory.

FDA drug regulation is so burdensome that it takes up to $2 billion and 15 years to get a new drug approved, according to a study from the University of Texas M.D. Anderson Cancer Center and the Baylor College of Medicine (abstract here).  This study also showed that “regulatory fundamentalism” slows the development of new drugs, resulting in the loss of lives.

It is evident that FDA approval of a reduced risk claim for tobacco products will require similar resources and a similar time frame.  With this delay, cigarettes will continue to dominate the American tobacco market, and 440,000 more Americans will die every year. 

One thousand two hundred and five deaths.  Every.  Single.  Day. 

In the absence of rational FDA regulation, nicotine-addicted smokers should quit cigarettes and avail themselves of the many smoke-free harm reduction products that are currently on the market.  The roster of highly credible research and policy experts endorsing tobacco harm reduction continues to grow, providing more science-based support for smokers to switch. 

The FDA should abandon regulatory fundamentalism that condemns safer product development to a purgatory of red tape.

Following are the FDA’s five “key areas of investigation” for a modified risk tobacco product:

1.       1. Health risks of the tobacco product

a.       Human studies that show the product’s use will result in a significant reduction in harm and the risk of tobacco-related disease to individual tobacco users.

b.      The health risks associated with use of the product as compared to using other tobacco products on the market, including tobacco products within the same class of products;

c.       The changes in health risks to users who switch from using another tobacco product to using the product, including tobacco products within the same class of products;

d.      The health risks associated with switching to the product as compared to quitting the use of tobacco products;

e.       The health risks associated with using the product in conjunction with other tobacco products;

f.       The health risks associated with switching to the product as compared to using an FDA-approved tobacco cessation medication; and

g.      The health risks associated with initiating use of the product as compared to never using tobacco products.

2.      2. The effect the tobacco product and its marketing may have on tobacco use behavior among current tobacco users

a.       Nonclinical and/or human studies to assess the abuse liability and the potential for misuse of the product as compared to other tobacco products on the market; and

b.      Human studies regarding actual use of the product and consumer perception of the product, including its labeling, marketing and advertising.

c.       The likelihood that current tobacco product users will start using the product;

d.      The likelihood that tobacco users who adopt the product will switch to or switch back to other tobacco products that present higher levels of individual health risk;

e.       The likelihood that consumers will use the product in conjunction with other tobacco products;

3.      3. The effect the tobacco product and its marketing may have on tobacco use initiation among non-users (both never users and former users)

a.       Human studies that evaluate consumer perception of the product, including its 774 labeling, marketing and advertising.

b.      The likelihood that consumers who have never used tobacco products, particularly youth and young adults, will initiate use of the tobacco product;

c.       The likelihood that non-users who adopt the tobacco product will switch to other tobacco products that present higher levels of individual health risk; and

d.      The likelihood that former users of tobacco products will re-initiate use with the tobacco product.

4.      4. The effect of the tobacco product’s marketing on consumer understanding and perceptions

a.       Human studies regarding consumer understanding of the product, including its labeling, marketing and advertising;

b.      The ability of consumers to understand the modified risk claims and the significance of the information in the context of one’s health;

c.       Consumers’ beliefs about the health risks of using the product relative to other tobacco products, including those within the same class of products;

d.      Consumer beliefs about the health risks of using the product relative to cessation aids; and

e.       Consumer beliefs about the risks of using the product relative to quitting all tobacco use.

5.      5. The effect the tobacco product and its marketing may have on the population as a whole

a.       Quantitative estimates of the effect the marketing of the product, as proposed, may have on the health of the population as a whole;

b.      Tobacco users who switch from other commercially marketed tobacco products to the proposed product;

c.       Tobacco users and non-users who, after adopting the proposed product, switch to or switch back to other tobacco products that may present higher levels of individual health risk;

d.      Tobacco users who opt to use the proposed product rather than cease tobacco use altogether;

e.       Tobacco users who opt to use the proposed product rather than an FDA­ approved tobacco cessation medication;

f.       Non-users who initiate tobacco use with the proposed product, such as youth, never users, former users;

g.      Tobacco users who use the product in conjunction with other tobacco products; and

h.      Non-users who experience health risks from the product.