FDA Tobacco Deeming Regulation | Citizens Against Government Waste

FDA Tobacco Deeming Regulation

Letters to Officials

June 14, 2017

The Honorable Scott Gottlieb, M.D.
The Food and Drug Administration
White Oak Building One
10903 New Hampshire Avenue, Room 2217
Silver Spring, MD  20993

Dear Commissioner Gottlieb:

Congratulations on your appointment as commissioner of the Food and Drug Administration (FDA).  Citizens Against Government Waste (CAGW) is familiar with your excellent published policy analyses and has referenced them in many of our publications.  As someone with a medical degree and a bachelor’s degree in economics, and as a former cancer patient, you understand healthcare policy and the importance of getting lifesaving products into the marketplace quickly and safely as possible.  Your background, including serving in prior leadership positions at the FDA, will make you an effective commissioner.

CAGW is interested in many issues within the purview of the FDA, particularly the need to implement policies contained in the 21st Century Cures Act to modernize and speed up drug approvals, and the reauthorization of the Generic Drug User Fee Amendments of 2017, which should reduce the backlog of abbreviated new drug applications.

However, a more pressing issue is the FDA tobacco product deeming rule and the deleterious effect it will have on small vaping manufacturers, vape shops, and ultimately, public health.  As you know, on May 10, 2016, the FDA finalized a proposed rule to deem all products meeting the statutory definition of a tobacco product to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act or TCA).  The TCA provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and all other tobacco products that the agency deems to be subject to the law.  This includes electronic nicotine delivery systems (ENDS), also referred to as e-cigarettes or vaping devices.

While the rule has some positive provisions, such as banning sales of vaping products to anyone under age 18 and requiring warning labels, it also placed extremely burdensome and expensive requirements on the vaping industry, particularly small manufacturers and vape shops.  Since the rule defines a predicate product as any tobacco product that was commercially marketed on or prior to February 15, 2007, a manufacturer is required to submit a premarket tobacco application (PMTA), unless it can demonstrate that its product is substantially equivalent to a predicate product.  Almost no ENDS products were commercially available in the U.S. until the end of 2007; therefore, manufacturers are required to submit a PMTA.

While the rule took effect on August 8, 2016, the FDA gave ENDS manufacturers two years to comply, but they had to register and list their products with the FDA by June 30, 2017, which has now been extended by only three months, to September 30, 2017.  While the extension is appreciated, it will not help most vape manufacturers and shops remain in business in the long run.

A May 5, 2016 Wall Street Journal article reported that the regulatory consulting firm SciLucent LLC estimated that vaping manufacturers and vape shops could spend between $2 million to $10 million per vaping item to get marketing approval.  The FDA disputes these figures, claiming that a PMTA will “only” cost between $117,000 to $466,000.  It does not matter who is correct.  These price tags will effectively ban most vaping products because a majority of ENDS manufacturers will not be able to afford to comply with the law and FDA rules.  They will simply go out of business.

We respectfully ask that, under your authority as the FDA commissioner, you provide an additional extension of two years for ENDS manufacturers so that Congress has the time to change the predicate date by law.  Legislation introduced by Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.), H.R. 1136, The FDA Deeming Authority Clarification Act, would change the predicate date so that vaping products already on the market will not have to comply with the arduous PMTA process.  The predicate date of February 15, 2007 would be changed to the effective date of the final rule, August 8, 2016.  The legislation would also restrict youth access to vaping products, demand ingredient disclosure, require the FDA to issue standards for e-cigarette batteries, and call for additional labeling requirements.

If a manufacturer should come up with a new but similar vaping product, it would have to provide a less onerous “substantial equivalence” application that shows the new product is substantially equivalent to a product that was on the market prior to the newly established predicate date.  This change would also free up the FDA from reviewing thousands of pages of a PMTA and focus on other issues, such as making sure ENDS manufacturers and distributors comply with good manufacturing practices and are marketing their products correctly.

Delaying compliance would be in line with your May 15, 2017 remarks to FDA employees when you said that among the many opportunities the agency has to improve and protect public health, “there’s probably no single intervention, or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking.  We need to redouble efforts to help more smokers become tobacco-free.  And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether.  At all times, we must protect kids from the dangers of tobacco use.”

It is important that e-cigarettes stay on the market because there is growing evidence vaping is a safer alternative to smoking cigarettes.  For example, an August 2015 study by the Health & Wellbeing Directorate of Public Health England found that e-cigarettes have become England’s most popular smoking quitting aid and that e-cigarette use is around 95 percent less harmful to health than smoking.

An April 2016 Royal College of Physicians report concluded that e-cigarettes appear to be effective as an aid to quitting smoking; that any health hazard arising from vapor inhalation is unlikely to exceed 5 percent of the harm from smoking tobacco; that evidence available today indicates that e-cigarettes are being used almost exclusively as a safer alternative to smoking; and that in the interest of public health, it is important to promote the use of e-cigarettes.

A June 27, 2016 Reason Magazine article by Jacob Sullum discussed a European Union survey published in Addiction that found 6 million Europeans have quit smoking and 9 million have cut back on smoking because of e-cigarettes.  According to Sullum, the lead researcher on the project stated, “the European data show that use of electronic cigarettes seems to have a positive impact on public health for two main reasons:  1) High smoking cessation and reduction rates are observed, and 2) electronic cigarette use is largely confined to smokers (current and former), with minimal use by nonsmokers."

On February 7, 2017, the British National Health Service reported on a study published in the Annals of Internal Medicine that looked at long-term vaping outcomes of real-world users.  Researchers found that there were significantly lower levels of toxic chemicals and cancer-causing substances in former smokers that used e-cigarettes.  This study showed similar results as the Public Health England August 2015 report.

The May 2016 final regulation states, “FDA is taking this action to reduce the death and disease from tobacco products.  Deeming all ‘tobacco products’ (including components and parts but excluding accessories of the newly deemed products) to be subject to the FD&C Act will result in significant benefits for public health.”  Unfortunately, it will do the exact opposite.

Vaping has proved to be a safer and more effective way to quit smoking.  If nothing is done to change the predicate date and extend the regulatory deadline by two years or more, most vaping manufacturers will go out of business and many vapers will return to smoking.  That will not benefit public health or taxpayers.

CAGW urges you to implement a two-year additional extension for ENDS manufacturers so that Congress has the time to change the predicate date by law and for you to work with Congress in implementing that law.  To do otherwise would force many individuals to return to smoking cigarettes, clearly an unhealthy alternative. 

Health officials and researchers overseas understand the benefits of e-cigarettes.  The FDA should do so as well.


Thomas Schatz

cc:       The Honorable Tom Price, M.D.
            Secretary of Health and Human Services

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