Passage of the Family Smoking Prevention and Tobacco Control Act (TCA) in June 2009 gave the Food and Drug Administration (FDA) regulatory control over tobacco products.  The purpose of the TCA, as stated in the bill’s report language, was to permit the FDA “to restrict the sale and distribution of tobacco products, including advertising and promotion” and to “take specified actions, including public notification and recall, against unreasonably harmful products.”  The law also required the FDA “to establish tobacco product standards to protect the public health” but prohibited the agency from "banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products," or "requiring the reduction of nicotine yields of a tobacco product to zero."  Notably, the law also set forth standards for the sale of "modified-risk tobacco products.”

The FDA’s March 2012 draft guidance for companies that wish to submit a Modified Risk Tobacco Product Application (MRTPA) stated the following:  “The modified risk tobacco product provisions of the FD&C Act may be valuable tools in the effort to promote public health by reducing the morbidity and mortality associated with tobacco use, particularly if companies take advantage of these provisions by making bold, innovative product changes that substantially reduce, or even eliminate altogether, either the toxicity or addictiveness of tobacco products, or both.” 

For a manufacturer to make a claim that its tobacco product reduces the harm or the risk of tobacco-related associated diseases, it must submit the MRTPA and scientific evidence that the claim is accurate.  A manufacturer must also submit a pre-marketing tobacco application (PMTA) to the FDA if it wants to market a new, innovative tobacco product that was not on the U.S. market prior to February 15, 2007.

But, recent FDA actions demonstrate that the agency is really not interested in all harm reducing tobacco products remaining in or even entering the marketplace.  An April 2017 WasteWatcher article highlighted problems that manufacturers and distributors of vaping devices or electronic nicotine delivery systems (ENDS) are having with a FDA regulation.  Often called e-cigarettes, vaping devices heat a liquid containing glycerin, propylene glycol, flavorings, and nicotine (although not always) to generate an aerosol.  A May 5, 2016 final rule deemed ENDS products to be under the FDA’s authority.  Since vaping products were not sold in the U.S prior to 2007, manufacturers must now submit an onerous and costly PMTA to the FDA to sell their products. 

While the FDA gave ENDS manufacturers two years to comply with the law, it is highly unlikely that most vaping manufacturers, which are small businesses, will have the financial resources to submit a PMTA, with costs reaching as high as $10 million according to some estimates.  Most ENDS manufacturers will go out of business, causing millions of Americans to return to smoking.  This would be a shame, because numerous studies have shown e-cigarettes are a safer product to use.  It has been argued under the TCA, the FDA had the flexible authority to allow ENDS manufacturers to avoid submitting a PMTA, but the agency disagrees.

Meanwhile, Congress is attempting to pass legislation that will change the predicate date from 2007 to 2016, thus saving most of the vaping industry and allowing consumers to continue to have access to a safer product.

Another smokeless product is snus, which has been around since the 1400s and originated from snuff.  It is moist, ground-up tobacco, which is tucked under the upper lip and can be sold loose or wrapped in a small teabag-like paper pouch.  It began to grow in popularity in the late 1960s as people begin to look to alternatives to cigarettes, and research has shown snus is safer than smoking.  Sweden, where snus is very popular, has one of the highest rates of tobacco use in Europe but the lowest in smoking-related deaths, such as lung cancer.

Tobacco company Swedish Match submitted the first MRTPA to the FDA on June 11, 2014 for its eight snus products, seeking a risk modification order that would allow the company to change the warning label statements that are required for smokeless tobacco products.  The company had requested that two smokeless tobacco warnings be removed from the packages: that the products can cause gum disease and tooth loss, and mouth cancer.  The company also wanted a label change from snus is “not a safe alternative to cigarettes” to “no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”  The application was more than 100,000 pages and cited “an abundance of Swedish and international evidence on the health effects of snus – evidence that stretches over three decades and includes governmental cohort studies and clinical trial results.”

Although the FDA stated in its MRTPA guidance it intended to act on applications within 360 days of receipt, the decision on the Swedish Match products did not come until 918 days later, on December 14, 2016.  In spite of 30 years’ worth of scientific and consumer data, the FDA denied Swedish Match’s labeling request to remove gum disease and tooth loss.  For the cancer warning and the wording change, the FDA is deferring a final decision on these issues by two years, giving the company the opportunity to modify its application.

The delay for the decision on the cancer warning and the label change frustrated harm-reduction advocates such as University of Louisville Professor Brad Rodu, who has spent years studying the effects of smokeless tobacco.  He said, “Smokeless tobacco has risks so low that they can’t be measured with any precision.  This opportunity is being squandered.  It’s very frustrating.”  In March, 2017, Swedish Match’s CEO said the FDA requested to meet with company representatives to further discuss and decide the next steps to getting a MRTPA decision on the cancer warning and label change.

On December 5, 2016, Phillip Morris International became the second company to have its MRTPA accepted for review by the FDA in order to market its tobacco product as one that will substantially reduce, or even eliminate altogether, toxicity and/or addictiveness.  PMI’s innovative product, the Tobacco Heating System (THS), heats tobacco but does not burn it.  The product is called IQOS, for “I Quit Ordinary Smoking,” and is already available in Japan and test markets in several countries, including Italy, Switzerland, and the United Kingdom.  According to PMI, more than 2 million adults have switched from cigarettes to IQOS.

On March 31, 2017, PMI also submitted a PMTA to the FDA to market IQOS in the U.S.  If the FDA approves the PMTA, PMI will be able to market the product in the U.S.; but only an affirmative MRTPA will allow the company to state that use of the product is safer than smoking.

The IQOS consists of a tobacco stick or plug that is made from tobacco powder, a holder that heats the stick, and a charger.  According to PMI, the lit end of a cigarette can reach 1600°F; these high temperatures cause the tobacco to release toxic chemicals that are harmful, leading to cancer and other health problems associated with smoking.  But PMI’s product heats tobacco to a temperature of approximately 600°F.  Instead of smoke, an aerosol is created, composed mainly of water and glycerol.  Since there is no combustion, the harmful chemicals are not released, but the user feels the same effects as smoking.

The FDA began its scientific review of the PMI’s MRTPA on May 24, 2017.  On June 15, the FDA announced the docket to accept public comments on the PMI application until December 12, 2017.  The FDA has also posted an executive summary and the research supporting the PMI application.

PMI has also posted a summary of the 2 million-page application on the website PMIScienceUSA.com.  The website makes available scientific information that demonstrates the THS product is safer than smoking.  For example, it reduces exposure of harmful and potentially harmful constituents such as benzene and carbon monoxide to levels that are comparable to someone that has ceased smoking.

Hopefully, the FDA will not take more than two years to review PMI’s MRTPA.  Unless the FDA allows PMI to market its product, including as a safer alternative to smoking, there will be fewer tobacco harm-reduction products available to Americans and more people who will continue to smoke cigarettes.

Meanwhile, other countries are seeing the benefit of harm-reducing tobacco products.  England’s Department of Health just announced on July 18, its long-awaited tobacco control plan to cut smoking rates.  Part of their plan will include an emphasis the important role e-cigarettes and similar devices can play in smoking cessation and reducing harm.