On May 17th, 2018, Congressman Sanford Bishop (D-GA 02) released a statement on Facebook (here) stating that he was “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 labeling rules, enhanced shipment age-verification, battery standards, and FDA funding for education and outreach.”
Unfortunately, the Cole-Bishop Amendment (for 2019 fiscal year funding) does no such thing and bears little resemblance to the Cole-Bishop Amendment that vapers have been fighting for since early 2016. In fact, it reduces availability of harm reduction products to adult smokers.
The Cole-Bishop amendment to the Agricultural Appropriations Bill was first introduced in 2016 as a vehicle for language that would change the predicate date in the Tobacco Control Act (TCA) from February 15th, 2007 to the effective date of the deeming regulations (August 8th, 2016) for all newly deemed products. This change would have allowed for all vapor products currently on the market to remain on the market without being subject to the FDA’s burdensome and prohibitive premarket approval (PMTA) process.
The first CASAA Call to Action in support of Cole-Bishop, in April 2016, specifically targeted members of the House Agriculture Appropriations Committee, where including the amendment in budget language was being debated. The committee voted in favor of keeping the bipartisan legislation in the Agricultural Appropriations bill. Unfortunately, with no companion language in the senate and lack of support from congressional leadership, the Cole-Bishop amendment was, ultimately, stripped from the final budget package. While representatives Nita Lowey (D-NY) and Nancy Pelosi (D-CA) were quick to announce they had removed the language from the budget, intel from people on the ground on The Hill suggests it was not an easy fight. Reportedly, staffers were emerging from budget meetings saying that the vapor language was still being discussed.
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.
In addition to the necessary changes to the battery standards language, the Cole-Bishop proposal for FY 2018 included stricter regulation of advertising for vapor companies and prohibited self-service sales from vending machines. The authors also added a provision directing the FDA to promulgate a rule regarding standards for characterizing flavors–which the agency is currently doing without any direction from Congress. Despite these concessions, the Cole-Bishop language (Section 753) was not included in the final budget package. It is little consolation that, like during the FY 2017 budget negotiations, the effort to preserve consumer choice of low-risk vapor products was being considered until the last minute.
This year, representatives Cole and Bishop have reintroduced their amendment to the FY 2019 Agricultural Appropriations bill. Shockingly, the amendment only vaguely resembles previous versions.
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 labeling 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.)
All references to the predicate date for vapor products are conspicuously missing which means that every vapor product currently on the market will still need to go through the PMTA process. The remaining provisions regarding vapor products, points which CASAA previously tolerated solely because of the enormous benefit of the predicate date change, involve keeping devices out of the hands of youth — and likely make it harder to obtain by smoking adults.
All of the points about keeping out of the hands of youth are virtually meaningless, not only because there will hardly be any products on the market, but also because these same provisions have failed in every other area where they have been tried (e.g. sex, drugs, alcohol). While it’s possible that larger tobacco or vape companies might be able to navigate the premarket approval process, that will do little to help thousands of other companies who cannot afford the time and expense required, leaving consumers with fewer choices. Failure to change the predicate date most certainly will NOT maintain “the availability of harm reducing nicotine vapor products,” as Bishop claims.
While the authors of Cole-Bishop have essentially thrown vapers and cigarette smokers under the bus, there is still much consumers can do to keep the fight going!
– Vote with your wallet by supporting industry members who support advocacy through donations, participation in lawsuits, advocacy promotion (i.e. link to CASAA and other advocacy efforts) and/or membership in recognized trade organizations.
– Respond to and share CASAA Calls to Action on other issues being considered by the FDA, and make sure to participate in state- and local-level Calls to Action as well. .
– Get to know your local legislators by meeting with them during their campaigns or contacting their office and telling them how switching to vaping has made a difference. Let them know about any other smokers you’ve helped switch to vaping, too. Seeing constituents in person makes an incredible impact.
– Register vote and then get out and vote.
– Do your part to change public perception of vapor products. Have conversations with family, friends, neighbors and acquaintances about how vapor products have changed your life.
– Share your testimonial with CASAA’s testimonial project at casaa.org/_testimonials
– If you haven’t yet become a member of CASAA, JOIN TODAY at casaa.org/join-casaa. It’s FREE!