Responding to outcry from tobacco control groups, a bill has been introduced in the U.S. House of Representatives to regulate products made with synthetic nicotine. The Clarifying Authority Over Nicotine Act, HR 6286, would give the FDA Center for Tobacco Products regulatory authority over consumer products containing nicotine from any source.
The sponsor of the bill, New Jersey Democrat Mikie Sherrill, issued a press release claiming the legislation would close “a loophole allowing bad actors in the vaping industry to evade [FDA] regulations and sell nicotine products targeted at children.”
The bill comes after months of kvetching by tobacco control groups about the supposed switch to synthetic nicotine by c-store bad boys Puff Bar, and later about some small manufacturers reformulating products with synthetic nicotine after receiving Marketing Denial Orders (MDOs) from the FDA.
The bill is co-sponsored by Utah Republican Chris Stewart and Illinois Democrat Raja Krishnamoorthi. Rep. Krishnamoorthi announced last month that he was investigating synthetic nicotine, and had sent letters to Next Generation Labs (maker of Tobacco-Free Nicotine, or TFN) and Puff Bar.
Krishnamoorthi is a strong ally of the Campaign for Tobacco-Free Kids, which is the most powerful influence on tobacco, nicotine and vaping legislation in Congress and state legislatures. TFK has led the outcry about the “threat” of synthetic nicotine, sending a letter in September to FDA Acting Commissioner Janet Woodcock demanding the agency regulate synthetic nicotine as a drug. However, regulating nicotine in consumer products as a drug would likely open the FDA to risky legal challenges.
The new bill takes the alternate route of modifying the Tobacco Control Act to give the FDA Center for Tobacco Products authority over all forms of nicotine in consumer “tobacco products” (but not in FDA-approved drug products). Tobacco control activists are concerned that this pathway opens the Tobacco Control Act to modification, which could lead to unwelcome (from their point of view) amendments as the bill winds its way through Congress.
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 HR 6286 passes and becomes law, 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.)
The bill also includes a provision clarifying 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 tobacco products. (Nicotine occurs naturally in plants from the nightshade family, but only tobacco plants contain enough nicotine naturally to make extraction viable. There is no current commercial nicotine extraction from GM eggplants or tomatoes, but the possibility has been discussed.)
The bill has been assigned to the House Energy and Commerce Committee, but no hearings have yet been scheduled. The House is likely to take it up early next year.
Some states—including Alabama, Connecticut, Minnesota, Oklahoma, Pennsylvania and Wyoming—already have laws restricting synthetic nicotine, or regulating nicotine products without respect to the drug’s source.