Breaking News: Changes to FDA Regulations in New House Bill

Questions about the legislation remain; it asks FDA to regulate flavors

flavor ban vaping

Someone has inserted language [see page 99] addressing the FDA’s deeming regulations into a House appropriations bill that will pass this fall — but no one is quite sure who did it. And advocates are uncertain whether it was done by a friend or a foe.

The language mandates that the FDA create product standards for regulating vapor products, rather than put all existing products through a premarket tobacco application (PMTA) system that has only the vague goal of proving each product is appropriate for the protection of the public health.

The “third rail” of vaping: flavors

flavor ban vaping

In addition to changing the predicate date to allow products that were on the market as of August 8, 2016, to remain available, the bill forces the FDA specifically to create standards for “characterizing flavors” and batteries. Some in the vaping industry are concerned that the flavor mandate is an invitation to the FDA to ban e-liquid flavors that are crucial to the survival of the industry. In fact, in a sense, flavors are the industry.

The House Agriculture Appropriations Bill is one of the major government funding vehicles that will become part of the larger budget for 2018. The bill just left the Appropriations Committee, which is where the language was added. All FDA funding is done through the agriculture bill, often called the ag bill.

(1) Notwithstanding any other provision of law, not later than 21 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a notice of proposed rulemaking to establish a product standard for vapor products pursuant to section 907 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g) to include but not limited to—
(A) characterizing flavors; and
(B) batteries.
(2) Notwithstanding any other provision of law, not later than 36 months after the effective date of this Act, the Secretary shall promulgate a final rule pursuant to such notice.

One of the major goals of vaping advocates and lobbyists this summer and fall was to include language in the bill — or as an amendment or rider to the bill — that would fix the predicate date in the deeming rule.

During the last budget negotiations, the language (adapted from the Cole-Bishop bill) that would have fixed the predicate date was included as a rider but then left out of the spending bill at the last minute as a concession to House Democrats. None of the Cole-Bishop legislation mandated that the FDA address flavors, though HR 1136 does address batteries.

In fact, the FDA originally included a prohibition on all flavors except tobacco and menthol in the deeming rule.

Whether you support or oppose the appropriations bill, keep in mind that the FDA already has the ability to ban flavors, or restrict them in any way. There is nothing to prevent the agency from exercising that option in the future. In fact, the FDA originally included a prohibition on all flavors except tobacco and menthol in the deeming rule. The White House Office of Management and Budget prevented that from becoming part of the final regulation.

The ag bill mandates that the FDA issue rules on flavors no later than three years after the passage of the bill. That gives current products probably a two- to three-year reprieve, and may give lobbying efforts a chance to pull off an update to the Tobacco Control Act (TCA) similar to Rep. Hunter’s bill, HR 2194. But it could also leave the industry with draconian flavor regulations, no change to the TCA, and the prospect of a less sympathetic administration around the corner.

Who wrote this thing anyway?

flavor ban vaping

The mystery of where the language came from is all part of the charm of this little surprise. Some speculate that it came from Democrats — either unfriendlies looking to ban flavors, or quietly sympathetic Dems trying to find a bipartisan way forward (there are two Cole-Bishop co-sponsors on the Appropriations Committee, including Sanford Bishop himself).

If the former, the idea may have come from the Campaign for Tobacco-Free Kids or the American Cancer Society, or other anti-nicotine groups with a strong lobbying presence in Washington.

Probably the best advice right now is to wait and see what happens.

Yet other vaping insiders describe two scenarios in which Republicans could have inserted the language in the ag bill. In the first, a sympathetic GOP member might believe that mandating product standards under the FDA leadership of known vape-sympathizer Scott Gottlieb is far preferable to hoping and praying for a difficult-to-pass rewrite of the TCA.

The second plot involves a legislator who, as one well-known advocate described to me, “just wants to get this over with and out of their hair.” Frankly, standing up for vapor can be trying for lawmakers sometimes. Imagine being called a tool of Big Tobacco when all you really want to do is support the thousands of small businesses the deeming rule will shutter.

The language could also have come from lobbyists from the tobacco industry, although multiple well-placed advocates told me they don’t believe that to be the case. However, Altria’s heat-not-burn product iQos would benefit by having suppressed competition from vaping flavors, and Reynolds American is about to be absorbed by British American Tobacco, the one major tobacco company that has a variety of flavored vapor products.

Should we support the ag bill?

Probably the best advice right now is to wait and see what happens. The vaping lobbyists in Washington and the groups they represent were blindsided by this, and aren’t sure what to make of it yet.

Is it written in stone? We’re not sure. Possibly the “characterizing flavors” line could be amended to be more broad. Then again, if it is changed, will it get support from necessary Democrats? Will it get support from them now? We just don’t know.

Finally, could the mandate to create flavor standards be an invitation for the FDA to simply ban everything but tobacco and menthol? Yes it could be. And they might do just that — in which case we’d be back fighting the same fight all over again, but without much desire from Republicans to help.

And even if Commissioner Gottlieb prevents the agency from banning flavors on his watch, the FDA could do it — with or without a mandate from Congress — during the next administration, which may be less sympathetic to both vapor and business in general. Which leaves us unsure of who’s on our side, who hates us, and who doesn’t care enough to help. Which ought to be very familiar to vapers.

Jim McDonald

I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.