March 9 update
The House is expected to vote today on the spending bill that includes the synthetic nicotine law. But, while the Senate may vote as scheduled on Friday, it now looks possible that vote may not happen until early next week, according to Roll Call.
It’s crucial that vapers and harm reduction advocates message their senators and ask that the language be stripped from the bill. The result is not a “done deal,” as some have reported. The nicotine language can be removed at any point before the final Senate vote is taken.
With major tobacco companies and Juul Labs lined up in favor of the legislation, its only real opposition comes from nicotine consumers and small vaping businesses. The language will not be removed from the bill without a huge response from the people who will be hurt by the law. Vapers have responded before and helped stop anti-vaping laws—the nicotine tax last December, for example—and it can be done again.
Congress is likely to vote this week on a synthetic nicotine ban, if a bipartisan group of House members and senators have their way. Since the ban is part of the must-pass omnibus spending bill, it will become law unless the language is stripped from the final bill before the vote.
The House is not scheduled to be in session this week after Wednesday, so the bill could get its first vote as early as today. The Senate is scheduled to take it up Friday. Either body could remove the language between now and Friday, but the bill must pass by Friday or the government will partially shut down.
CASAA has issued a call to action, making it quick and easy for vapers to message their members of Congress, requesting them to ask leadership to remove the synthetic nicotine language from the bill. It’s important to act quickly, since the House is likely to vote today.
The synthetic nicotine language in the omnibus bill is mostly copied from HR 6286, New Jersey Representative Mikie Sherrill’s bill that gives the FDA authority over synthetic nicotine by amending the Tobacco Control Act.
If the language remains in the bill, it will become law 30 days after the bill’s passage. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a Premarket Tobacco Application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (in which case the manufacturer would be subject to enforcement when the law takes effect in 30 days).
The goal of the language is to punish Puff Bar and other disposable vape manufacturers widely sold in convenience stores. Those products are supposedly popular among youth. But the law would equally punish small e-liquid manufacturers that have converted to using synthetic nicotine after the FDA’s confusing and unfair regulatory process forced most flavored products that used tobacco-derived nicotine off the market.
The bill is purportedly backed by Juul Labs and British American Tobacco’s U.S. subsidiary Reynolds American (RAI—the former RJ Reynolds), both of which face competition from Puff Bar and from e-liquid sold in vape shops and online. According to Alex Norcia of Filter, Juul Labs has been a driving force in recently introduced state bills that would ban synthetic nicotine.
The current definition of a tobacco product in the Food, Drug & Cosmetic Act (of which the 2009 Tobacco Control Act is a part) reads: “The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”
If the omnibus spending bill passes as it currently reads, the Tobacco Control Act language will change to: “The term ‘tobacco product’ means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” (Change to language emphasized in bold type.)
Also like the Sherrill bill, the omnibus language clarifies that foods containing “naturally occurring” nicotine in trace amounts are not considered tobacco products. In other words, plants genetically modified to produce nicotine for extraction would be considered tobacco products. (Nicotine occurs naturally in plants from the nightshade family, but only tobacco plants naturally contain enough nicotine to make extraction viable. The possibility of genetically modifying eggplants or tomatoes to produce high quantities of extractable nicotine has been discussed, but has never been done commercially.)
Inclusion of the synthetic ban language in the spending bill was promoted by long-time Democratic vaping opponents Rep. Frank Pallone (NJ) and Sens. Dick Durbin (IL) and Patty Murray (WA), along with pro-tobacco industry Republican Sen. Richard Burr (NC), according to Bloomberg.
“At a time when the FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” American Vapor Manufacturers Association (AVM) President Amanda Wheeler said in a statement.