Who remembers the Cole-Bishop amendment from 2016?
The Cole-Bishop amendment was on everyone’s lips in 2016.
It’s finally been passed through Congress but with some concerning edits.
It was a hope against hope that we could push back the predicate date for grandfathering in e cigarettes, from 2007 to 2016.
Had it succeeded, post FDA regulations, (currently due to be enforced in 2022) there would be a plenty of e-cigarettes left on the market, and manufacturers could have applied for substantial equivalence, instead of the rigorous Pre-Market Tobacco Application.
In 2016 the Cole-Bishop amendment was a ‘rider’, meaning it was: “an additional provision added to a bill, yet having little connection with the subject matter of the bill. Riders are usually created as a tactic to pass a controversial provision that would not pass as its own bill.”
This is why an e-cigarette amendment was placed into an Agricultural bill.
The Cole-Bishop amendment was put into the Agriculture Appropriations Committee for the 2017 budget, in an attempt to get it through congress.
The hope was that not only would the bill change the predicate date, it would also provide sensible standards for e-cigarettes.
It was the predicate date that was the all-important part.
Sadly, the first attempt to get this through failed, and it was removed altogether from the budget.
A further attempt was made, this time without it being a rider:
“The Cole-Bishop amendment was introduced again in 2017 as part of the FY 2018 Agricultural Appropriations bill. Unlike 2016, where the language was included as a rider to the bill, Cole-Bishop was part of the base appropriations bill which made it more difficult to simply strip out. Additionally, the battery standards language was clarified by providing a PMTA exemption for manufacturers that needed to make changes to their devices to be compliant. CASAA along with several industry stakeholders suggested these changes to representative Cole in 2016.”
Other stricter amendments were made to the bill, including standards for flavors, but again, the Cole-Bishop amendment was not included in the FY 2018 Agricultural Appropriations bill.
The bill was then re-introduced again, with even more amendments, but in March of this year there was talk, on twitter, that the Cole Bishop had yet again failed.
Indeed, The American Vaping Association tweeted
“We are disappointed that the #ColeBishop Amendment was not included in the FY 2018 omnibus appropriations bill.
We will continue to push both Congress and @SGottliebFDA to enact reasonable reforms to ensure that adult smokers are not denied access to harm reduction products.”
It was with interest then, that on May the 17th Congressman Bishop released a statement that it had been passed.
“I am also pleased that the committee passed my Cole-Bishop amendment that maintains the availability of harm reducing nicotine vapor products, while also keeping them out of the reach of children through robust advertising and labelling rules, enhanced shipment age-verification, battery standards, and FDA funding for education and outreach.”
Excellent you might be thinking! The predicate date has been moved – we are saved!
As CASAA have pointed out though, the Cole – Bishop amendment that we knew in 2016 is not the same as the one that has been passed and approved for the fiscal year 2019.
In this new bill, there is no mention of the predicate date.
This means that unless there are changes, come 2022, there will be no e-cigarettes on the market, as we know them now.
CASAA have detailed the new amendment, with the last point on it being downright scary – not too dissimilar to the post we wrote regarding Phillip Morris being able to spy on you with their Heat not Burn device.
Provisions affecting vapor products in the FY 2019 Cole-Bishop amendment:
• Directs the Secretary of Health and Human Services (HHS) to promulgate rules establishing standards for “characterizing flavors” and batteries
• Limits advertising of vapor products to adult-only publications
• Prohibits sales from vending machines (unless they are located in an adult-only establishment)
• Requires vapor product labelling to contain the messages “Keep Out of Reach of Children” and “Underage Sale Prohibited”
• Requires vapor retailers to register with the Secretary of HHS
• Amends the “Remote Sales” provision in the Food, Drugs, and Cosmetics Act (21 USC 387 f (d)(4)) to specifically require vapor retailers selling online to verify a purchaser’s age through the use of a commercially available database. (Currently, the code refers to “tobacco products” generally. This change would narrow that focus to solely vapor products.)
• Directs the Secretary of HHS to submit a report to Congress “that includes a plan of action with respect to the development and operation of the Youth Vapor Product Education, Prevention, and Enforcement Program”–the program is to be funded by $50,000,000 per year for the next four years from Center for Tobacco Products user fees.
• Directs the Secretary of HHS to conduct a study on preventing the use of vapor products by youth. (This section specifically directs the Secretary of HHS to include an analysis of using biometric security features during the purchase and use of vapor products. In other words, imagine having to scan your fingerprint every time you wanted to turn on or use your mod.)
In 2016, we had high hope for Cole-Bishop. It was going to be a cross party amendment and signal a new beginning for e-cigarette legislation.
Sadly, in 2018, Cole-Bishop has morphed into something that could have very easily been written by the FDA, and they want your data to boot.