Regulation of Reduced Risk Products

A number of regulatory authorities and public health officials have recognized the need for regulation to address products marketed with claims that they reduce the risk of tobacco-related diseases. Today novel products, whether tobacco products, nicotine products (such as electronic cigarettes), or other items (such as herbal cigarettes) are often sold with claims that they are safer alternatives to conventional cigarettes, or are effective smoking cessation therapies. To our knowledge, none of these claims has been reviewed and approved by regulators.  

A few countries have enacted laws that specifically address products sold with claims that they reduce the risk of smoking-related diseases. One example is the United States, where Congress enacted legislation granting the Food and Drug Administration jurisdiction over tobacco products. The legislation  prohibits claims that a tobacco product reduces the risk of disease, except when authorized by the FDA. Another example is Greece, which passed legislation prohibiting manufacturers from claiming that a tobacco product reduces health risks without prior approval from the Ministry of Health.

The U.S. Congress explained the need for regulation of claims about reduced-risk tobacco products as follows:

“The dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk are so high that there is a compelling government interest in ensuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product.” [1]

Another perspective on the need for regulation of reduced-risk tobacco products was expressed in 2001 by the U.S. Institute of Medicine. The IOM’s External reference panel of experts stated that regulation of reduced-risk tobacco products was important because it could provide an “incentive to develop and market products that reduce exposure to tobacco toxicants and that have a reasonable prospect of reducing the risk of tobacco-related disease.” [2]

Our View

We believe regulation of reduced-risk products is a vital component of tobacco product regulation. As recognized by the U.S. Congress and others, regulations can prevent claims from being made without adequate scientific support. Regulations can also ensure that claims are made according to rigorous and uniform standards. 

Regulations for reduced-risk products should consist of four elements:

pre-market review: the claim must be approved by a regulator prior to marketing;

claim substantiation: the claim must be supported by valid scientific data;

approval of the claim’s content: the language of the claim must accurately convey the benefits and risks of the product; and

post-marketing monitoring: once on the market, the use of the product should be monitored to determine its impact on consumers and the population as a whole.

A reduced-risk claim should be substantiated by reliable scientific data establishing that, in comparison to conventional lit-end cigarettes, the product is reasonably likely to reduce the risk of one or more tobacco-related diseases. This is consistent with the U.S. Institute of Medicine’s 2001 recommendation that a reduced-risk claim be permitted if the product “can reasonably be expected to reduce the risk of one or more specific diseases or other adverse effects.” [3]

There is insufficient evidence today that simply reducing exposure to one or several smoke constituents will reduce the risk of disease. Therefore, we do not believe that reduced-risk claims should be permitted solely on the evidence that a product reduces a smoker’s exposure to selected smoke constituents.

Assessment of Reduced-Risk Products
Determining whether a new product will reduce the risk of smoking-related diseases poses substantial challenges. That is because most smoking-related diseases take many years to develop, and the specific mechanisms by which those diseases develop are not well understood. Development of modern scientific methodologies to assess whether a product has the potential to reduce the risk of smoking-related diseases is essential to substantiating reduced-risk claims. 

The ultimate test of whether a novel product reduces the risk of smoking-related diseases would be to conduct a long-term epidemiological study. As experts have agreed, requiring this kind of study before a product is marketed is not practical. Alternative methods for assessing reduced-risk product claims are needed. 

We believe that recent advances in scientific knowledge and technologies provide opportunities to develop rigorous and reliable methods that will be practical for the pre-marketing assessment of reduced-risk tobacco products.

Approving the Content of Claims
Regulations should also establish guidelines for the content of claims. They should require that consumers receive accurate information about the relative benefits and risks of a product, and that government substantiation of a claim is not an endorsement of a product. Importantly, claims should inform consumers that using a reduced-risk product will not eliminate risk (unless substantiated to do so), that it is not an alternative to quitting, and that the best way to reduce the risk of smoking-related diseases is to stop smoking.

Post-Marketing Monitoring
Post-marketing monitoring is an important component of regulation, which will permit regulators to confirm reduced-risk substantiation and track population harm. The specific system for post-marketing monitoring must be developed by regulators, taking into account the nature of the tobacco market.

[1]  HR 1256, IIIth Congress of the U.S.A., 2009
[2]  and [3] Clearing the Smoke: assessing the Science Base for Tobacco Harm Reduction, IOM Committee, 2001

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