R Street urges House Appropriations Committee to pass amendment changing predicate date for tobacco-related products
Dear Chairman Rogers and Members of the Committee on Appropriations,
R Street Institute is a free-market think tank focused on a pragmatic approach to public policy challenges. As advocates of limited, effective government who are deeply concerned about the public-health hazards of cigarette smoking, we urge you to support the amendment offered by Rep. Tom Cole, R-Okla. to the FY 2017 Agriculture Appropriations bill. This amendment would change the predicate date for tobacco-derived products in order to preserve a friendly and competitive environment for safer alternatives, like electronic cigarettes.
There is no question that cigarette smoking presents a real threat to public health. But research clearly indicates that some forms of tobacco and nicotine products are less harmful than others. E-cigarettes and related vapor products contain nicotine extracted from tobacco, but have no combustion, no tobacco and no tar. Although no form of nicotine delivery can be considered risk-free, research has shown that e-cigs present less than 5 percent of the health risks posed by cigarettes and are relied upon by thousands of Americans as a tool to help them quit smoking.
Without congressional action, the e-cigarette market will be effectively wiped out. Under current Food and Drug Administration (FDA) regulations, all tobacco or tobacco-related products entering the market after the established predicate date of Feb. 15, 2007 must undergo an extensive and costly approval process unless they can establish “substantial equivalence” to existing products grandfathered in before the predicate date.
Since virtually all electronic cigarette and vapor products entered the market after this deeming date, if the FDA’s current regulatory approach is implemented, producers would be required to submit expensive and burdensome applications for every single product. In order to preserve the products already on the market and allow continued innovation in the vapor-product industry, it is essential that Congress act to amend the predicate date. If not, millions of consumers across the country will be denied the option to use these safer alternatives. From the perspective of both public health and basic logic, we should be doing everything we can to steer smokers away from combustible tobacco and toward lower-risk alternatives—not enforcing an arbitrary regulatory regime that privileges the deadliest forms of nicotine delivery.
Opponents of e-cigarettes claim that the products will attract nonsmoking teens to nicotine addiction. Yet research shows that almost no e-cigarette users transition from vaping to cigarette smoking. Nearly all vapor-product use is by smokers and former smokers who use them as an alternative to combustible tobacco or as a steppingstone to quit nicotine consumption altogether.
It’s also important to note that amending the predicate date does not prevent the FDA from regulating electronic cigarettes in a wide range of ways to prevent teen use and ensure consumer safety. The FDA will still retain full authority to issue marketing restrictions, labeling requirements and other regulations to ensure standards in the vapor-product industry. In addition to moving the predicate date, the proposal also contains a number of new requirements designed to strengthen the FDA’s oversight and alleviate concerns about children accessing the products.
Amending the predicate date is a simple fix that will save electronic cigarettes from being wiped out through arbitrary regulations. From a public-health perspective, the case to preserve consumer access to vapor products as a lower-risk alternative to smoking is indisputable. Please act to push back the deeming date for tobacco and tobacco-related products to ensure that smokers and former smokers have access to life-saving nicotine-delivery alternatives.
Sincerely,
R Street Institute
