The Cole-Bishop Amendment
March 22 is a very crucial deadline for what many vapers have come to know as the Cole-Bishop Amendment. Otherwise known as HR 1136, this proposed piece of legislation will effectively change the predicate date of the FDA deeming regulations from February 15, 2007, to August 8, 2016, should the bill pass congressional approval.
According to the current rules, any retailer or manufacturer of any vaping product placed on the market after February 15, 2007, will be forced to comply with the ultra-expensive Pre-Market Tobacco Application (PMTA). Each PMTA can potentially cost the vendor a million dollars or more per product. Since the majority of vaping companies are small businesses, economists estimate that nearly 99 percent of the American vaping industry is under threat of being regulated into bankruptcy by the FDA by the year 2022.
Why is March 22 so important?
March 22 just happens to be the cutoff date for Congress to finalize its two-year spending package. If the vaping industry wants to get a little financial support from Congress, then we only have a few days left to make it happen.
Since this seems unlikely, an alternative solution would be to urge our state representatives and senators to simply pass the Cole-Bishop Amendment instead. In doing so, the Appropriations Committee would be forced to change the predicate date in the 2018 budget automatically.
CASAA leads the way!
There are lots of different ways to connect with our elected officials. Thanks to the Internet, vapers can send tweets, write emails, or even call the White House with the click of a mouse. But if you want to contact lots of different politicians at the same time, CASAA shows you how.
Simply travel to the CASAA Call to Action webpage, type in your name and address, and the email addresses of your local congressperson and two state senators will automatically appear in a pre-written, CASAA-created message. The email will state the following, but you can also edit it or add to it if you like.
Please support the inclusion of Section 753 (aka the Cole-Bishop Amendment) in the House Agricultural Appropriations Bill in the final appropriations package for the 2018 US budget. This provision would modernize the 2007 predicate date that vapor products will be subject to once the FDA deeming rule takes full effect in 2022. If the predicate date is not changed, nearly all vapor products will be taken off the market as no one except a few large companies can afford the premarket application process.
Opponents to a predicate date change -- many of whom were instrumental in creating the original grandfather date that protected tobacco companies from certain collapse -- claim that changing the predicate date will take away FDA’s ability to regulate e-cigarettes, but that is simply not true. This will not impact the FDA's current authority to regulate these products, nor will it prevent the agency from implementing useful guidelines and regulations in the future.
The Cole-Bishop amendment makes a reasonable accommodation for products newly deemed to be tobacco to serve as predicate products based on the date they are brought under FDA’s jurisdiction. This simple clarification of FDA’s authority will allow millions of consumers continued access to a less harmful alternative to combustible tobacco and ensure that thousands of small businesses across the country will be able to continue to contribute to the economy.
As a vapor products consumer, it is vitally important to me that the diversity of quality products currently on the market is maintained. Millions of Americans like me have experienced remarkable and important health benefits by switching to these very low-risk, smoke-free products. (You can read thousands of testimonials here: testimonials.casaa.org.) It should be a public health priority that millions more have access to the same experience.
I look forward to your response on this issue. I, along with my fellow members of CASAA (Consumer Advocates for Smoke-free Alternatives Association), thank you for considering these comments and urge you to support including a provision to modernize the predicate date for vapor products in the final 2018 appropriations bill.”