Congress has concluded its budget negotiations, and the vaping industry has again been left to twist in the wind. The Cole-Bishop language that we hoped would be included as a rider to the budget bill was opposed by Democratic negotiators, and for Republicans it wasn’t a big enough priority to fight for.
A rider is a piece of legislation that “rides along” with the larger bill, in this case the must-pass budget bill that keeps the government funded through this fiscal year, which ends in September. The inclusion of riders was negotiated by Congressional leadership, and many were left out to gain bipartisan support for the budget bill.
The failure means that the slow-motion demolition of the vaping industry by the deeming regulations continues. The two-year timeline that began last August is almost half complete. If the 2007 predicate date is not changed, every vaping product now on the market will be gone in 15 months, unless the manufacturers can afford millions of dollars to gamble on a premarket tobacco application (PMTA), and the application is approved by the FDA — both highly unlikely events.
It seems like a crushing defeat, and it is pretty painful. But really, the fight has a long way to go. We have other options to pursue, and there are things we can all be doing to advance them. The key is for those who have been fighting to stay committed and energized, and to find more help.
Where do we go from here?
We’re not in a worse position than we were a week ago, despite being shocked by coming close and falling short. Vaping advocates now have several other paths to changing the predicate date in the deeming regulations. None of them are going to be easy, but if we quit trying the result will be certain — and bad.
HR 1136 - the Cole-Bishop Bill
This bill remains the primary focus. The FDA Deeming Authority Clarification Act — HR 1136 — would change the predicate date from February 2007 to August 8, 2016 (the date the deeming rule went into effect). It would save the existing market by grandfathering current products and exempting them from undergoing the prohibitively expensive PMTA process.
Cole-Bishop was designed to gain bipartisan support by ceding a lot of authority to the FDA. The bill orders the agency to regulate batteries, and imposes product standards, labeling rules, advertising restrictions, and registration of retailers and manufacturers.
As of about a week ago, HR 1136 had 48 co-sponsors in the House of Representatives, including six Democrats, which is more than the bill’s predecessor had last year. To reach critical mass — to have enough support that the bill can be expected to comfortably pass in the House and have a fighting chance in the Senate — HR 1136 needs many more co-sponsors and supporters.
For vaping vendors, this should be a priority. Making an appointment to meet with your representative (or their staff) is not difficult for a local business owner. It is pressure from constituents — and especially businesses within the district — that will convince members to get behind the effort to save this industry.
If you own a vaping business but are uncertain how to go about this, please contact your trade association for help. Both SFATA and the VTA will assist you in planning a meeting. Greg Conley of the AVA is also willing to offer advice to those meeting members of Congress. Now is the time to make those connections; don’t wait until it’s too late!
It is possible that Dr. Scott Gottlieb, once he is approved as the new FDA commissioner, could change the agency’s course on the deeming regulations. This would probably require active support from the new Secretary of Health and Human Services, Dr. Tom Price, who would bear the lion’s share of the political heat for loosening what many people think are simple common-sense regulations to protect children.
“We must redouble our efforts, focusing on not only Congress, but also the executive branch,” AVA president Gregory Conley said in a press release Monday. “If Congress refuses to act, President Trump and Health & Human Services Secretary Tom Price must act to avert this oncoming disaster for public health and small businesses.”
Price and Gottlieb could act to suspend or delay one or more of the upcoming deadlines of the deeming regulations, most importantly the August 8, 2018, deadline for submitting PMTA’s. A two-year postponement of that execution date, for example, would give uncertain businesses something to hang onto while continuing to fight for a legislative solution.
Last week, a letter signed by more than 2,000 vaping manufacturers and vape shop owners was sent to Sec. Price, asking that he take action to help the small businesses that will be shut down by the FDA’s inappropriate regulation. The letter was a joint effort by the AVA, CASAA, SFATA, and the VTA. CASAA is also promising another member-driven campaign to persuade Sec. Price.
This section was written before the FDA announced a 90-day extension on all deeming deadlines last night. See our separate story posted today for more details.
The next budget battle
The budget battle for fiscal year 2018 will be fought in the months leading up to this September, and offers another opportunity for getting the Cole-Bishop language passed as a rider. The chance it will be included next time probably depends on how much support can be generated in the meantime for HR 1136, and perhaps how many Democrats are willing to buck their party’s allegiance to the powerful anti-nicotine lobby led by the Campaign for Tobacco-Free Kids.
It’s going to be a tough fight, and we’re basically starting from scratch. As it stands, the most prominent Democratic supporter of vaping is the Iowa Attorney General, Tom Miller. Needless to say, state officials have no power in Congress.
HR 2194 - the Hunter Bill
Then there is the recently introduced bill from California Republican Rep. Duncan Hunter. HR 2194 is a rewrite of the Family Smoking Prevention and Tobacco Control Act (TCA) that goes farther than any previous Congressional effort to separate vaping from tobacco regulation.
The problem is that the legislation is so ambitious, it’s hard to see it succeeding anytime soon. In an environment in which we have strong opposition to merely keeping existing products on the market (as Cole-Bishop does), how can we immediately leap past the opposition and slam dunk the ball? We can’t, and that’s why almost all advocates see the Hunter Bill as a good starting point for future efforts — but not till after the crucial step of changing the predicate date is taken.
The Nicopure/Right to be Smoke-Free Coalition lawsuit
U.S. District Court Judge Amy Berman Jackson has been considering the evidence presented by the vaping industry plaintiffs and the FDA for more than six months. She could decide any day on the united vaping legal challenge to the deeming rule — or she could take another six months.
If she rules in such a way that the deeming regulations are mortally wounded — which most observers think is an extreme longshot — it is possible that the Trump administration could choose to not actively pursue an appeal of the decision. This, however, is probably the most unlikely of all possible solutions to the deeming nightmare.
For those who depend on vaping — as a job, a business, an alternative to smoking, or even as a hobby — throwing up our hands and walking away isn’t an option. We need to stay strong, stay focused, and stay resolved to keep banging away at a solution until we score. We will eventually.