Last week, during the mark-up of the FY17 Agriculture appropriations bill, Representative Debbie Wasserman Schultz (D-FL)--who is Chair of the Democratic National Committee--argued that passage of an amendment (the Cole amendment) that would prohibit the FDA from requiring pre-market applications for e-cigarettes that are currently on the market would "make it harder to regulate this product."
The proposed FDA deeming regulations would require every electronic cigarette product on the market to submit a pre-market application in order to remain on the market. Such an application, which would take an estimated 5000 hours to prepare and would cost more than $300,000 per product, is not only unduly burdensome but is virtually impossible for any small business to complete successfully. The effect of the regulations would be to decimate the e-cigarette industry, eliminating all but the largest of companies from remaining in the vaping business. This would have a chilling effect on the sales and growth of vaping products, and would protect a continuing stream of high cigarette sales.
The Cole amendment would remove this requirement for e-cigarettes currently on the market to submit a pre-market application, thus allowing current products to remain on the market and preventing the destruction of the vaping industry. It would also help maintain lower rates of smoking by ensuring that the hundreds of thousands of ex-smokers who quit using e-cigarettes will continue to have access to the products which helped them to quit. If the Cole amendment does not pass, then many former smokers will return to smoking as their favored products will be removed from the market and many smokers who would otherwise have quit smoking using vaping products will not do so because of the limited options that will be available.
The Rest of the Story
It is difficult to see how any Congressmember could oppose the Cole amendment on public health grounds. How could legislation that allows vaping products to challenge cigarette profits possibly represent a good thing for the public's health? Clearly, it is by allowing cigarettes to be challenged by the much safer electronic cigarettes that the public's health can best be protected. And, as explained above, in the absence of the Cole amendment, the FDA regulations will lead to higher rates of smoking. This is obviously not in the best interests of the public's health.
Not only do those opposing the Cole amendment fail to understand that they are actually protecting cigarette sales and harming the public's health, but they also are deceiving the public when they claim--like the DNC Chair--that the Cole amendment would make it harder for the FDA to regulate e-cigarettes.
This is complete nonsense. All the amendment would do is prevent the FDA from banning the overwhelming majority of vaping products currently on the market. It would have no impact on the FDA's ability to regulate these products. The FDA would still be free to regulate product safety. In fact, the FDA would be required to regulate product safety by setting safety standards, something that the FDA is not doing in its deeming regulations.
Although the Cole amendment represents a last-gasp attempt to prevent the FDA from creating a public health disaster by destroying the vaping industry, it still does not represent the ideal solution to the problem. After all, the Cole amendment would still allow the FDA to require pre-market applications for new products introduced after the effective date of the deeming regulations. This would stifle innovation in the vaping market, thus impairing the ability of new and potentially safer and more effective products to enter the market. In this way, the Cole amendment is simply the better of two evils.
The appropriate way to regulate vaping products is not to do so through pre-market applications, which do nothing to directly make these products safer, but by directly promulgating safety standards for vaping products. As the FDA has demonstrated a lack of interest in doing this, it may be far more beneficial to place e-cigarettes under the jurisdiction of another agency that is better prepared to regulate product safety. Alternatively, the Cole amendment could be revised so that it precludes the FDA from establishing any requirement for pre-market review of vaping products and instead, requires the agency to set product safety standards.