What Is The Cole-Bishop Amendment, and Why Should You Care?
What Is The Cole-Bishop Amendment, and Why Should You Care?
In American politics there are few lawmakers who openly advocate for vapor, but two US Congressmen, Rep. Tom Cole (R-OK) and Rep. Sanford Bishop (D-GA) have made an erstwhile bipartisan effort for sensible policy reform. The representatives have repeatedly put forth their Cole-Bishop Amendment, otherwise known as the FDA Deeming Authority Clarification Act which proposed to retool the “Deeming Rule” by separating vapor products into their own category instead of grouping them in with products like combustible cigarettes.
In order to understand the Cole-Bishop Amendment, it’s helpful to look back on the Deeming Rule and see why it’s so unpopular with vapers. Then, look at what aspects of that rule the amendment tries to correct, and finally, we’ll look at the bill’s failure twice in Congress, despite support from both sides of the aisle.
If you're not already aware of this very important bit of legislation and how it could affect your right to vape going forward, it's time to get informed. Let's jump in...
One of the most controversial vapor regulations that currently threatens to restrict access to vapor products is the “Deeming Rule,” which was issued by the federal Food and Drug Administration and took effect in 2016. This rule reclassifies vapor makers as “tobacco product manufacturers” and set an August 8 deadline last year for vapor producers to register products introduced to market after February 15, 2007. This covers essentially 100% of vape gear and liquid currently being used, and any suppliers unable to comply may be forced to close their doors.
The problem is that the cost of compliance is estimated to run between a few hundred thousand and up to a million dollars - per product. At the upper end of this range, an e-liquid manufacturer offering five flavors in four nicotine strengths (say 0 mg, 1.5 mg, 3 mg, and 6 mg) would have to submit 20 applications costing as much as $20 million! Unless you're one of the handful of companies backed by Big Tobacco's billions, and most vape suppliers are small, independent businesses, chances are you're not going to be able to pony up.
Vapor companies and vape shops have strongly objected to this law by filing lawsuits against the FDA. Here at Breazy, we've reported on a few of these lawsuits. The first company was Nicopure Labs - makers of Halo E-Liquids. Nicopure Labs lost their initial lawsuit, but the company’s legal team filed for an appeal in March. In February, owners of the Michigan vape shop Moose Juice filed a lawsuit saying that their business would go under due to the cost of compliance.
With middling success trying to minimize the negative impact of the Deeming Rule by suiting the FDA head on, Cole-Bishop offers a potential legislative remedy for worried vapor makers and vape shop owners.
Cole Bishop Amendment
One aspect of the proposal is to classify vapor products in a category independent of other nicotine products that contain tobacco; this has been a demand from the vapor industry for as long as the government has been imposing regulations. The amendment would still allow vapor products to fall under the authority of an existing law giving the FDA the power to regulate vape liquids and gear as tobacco products, but would clarify that a different approach to regulation when regulating tobacco and vapor products.
Additionally, the bill proposes common-sense regulations that most of the vapor community can get behind: warning labels on products, a ban on sales to minors, a ban on advertising in outlets that target youth, and a requirement for all sales to be conducted in-person (with a carve-out for online sales, this means that e-cigarette vending machines will not replace the mostly phased-out cigarette machines).
Perhaps most important, though, is that it would change the "predicate date" grandfathering in existing products from the date the FDA first received authority to regulate tobacco to the August 2016 date when it actively began to do so. Without such a provision, the vapor industry in the US as we know it would vanish overnight, leaving consumers with no legal access to liquids or replacement parts for their hardware.
Unfortunately, the bill stalled in Congress, failing to receive votes to include it as a provision of massive "omnibus" spending bills from 2017 and 2018, to the chagrin of vapor companies and advocates. Gregory Conley, the President of the American Vaping Association, has argued that the Deeming Rules will hurt small businesses and took a partisan position on the failure of the bill in a statement after the bill failed to pass in 2017.
Regardless of why the Cole-Bishop Amendment failed to make it onto the yearly spending bills, the effects of the Deeming Rules still looms over Americans in the vapor industry. Sensible regulatory reform is an arduous process in any industry and in government, but the vapor industry is staring down the immediate changes to their industry when the Deeming Rules go into effect, which could have a major impact on small businesses and job creation.
Luckily, the industry received a temporary reprieve - the two-year compliance date originally issued by the FDA would have forced all vapor products not undergoing the costly approval process to be pulled from shelves by August 2018. Last July, FDA commissioner Scott Gottlieb granted a temporary reprieve when he pushed the compliance date out to August 2022. That grants some breathing room, but ultimately the spectre of complete and total annihilation of the vapor industry still looms unless a measure like Cole-Bishop saves us all.
Now that you know, take action! Join the Consumer Advocates for Smoke-free Alternatives Association (it's free!) or another vape advocacy group. Write your congresscritters, or call them. Let them know how vapor products have helped you quit smoking, and that you feel it's important that more smokers get the same opportunity to quit when they're ready. Only YOU can prevent tobacco fires!