Call for Crackdown on Synthetic Nicotine

A coalition of more than 30 U.S. attorneys general have called on the U.S. Food and Drug Administration to reject marketing authorization for all nontobacco nicotine products, which they say are currently being sold without regulation of their contents, manufacturing, health effects, required warning labels or marketing claims.

In a letter directed to FDA Commissioner Robert Califf, the coalition argues that these products currently don’t meet the FDA’s public health standard, and that the health of residents—especially young people—should not be gambled on the unknown effects of these products.

The letter specifically calls for the FDA to reject a request by product manufacturers to grant marketing authorization for nontobacco nicotine products. The letter also insists that if the agency does grant marketing authorizations for these products, it imposes the same restrictions required of tobacco-derived nicotine products including a ban on all products with a flavor other than tobacco and strict regulatory requirements regarding their contents, manufacturing, and effect on users’ health.

Products should carry warnings concerning their addictiveness, and manufacturers should be required to validate health claims made about their products, including claims that a product is safer than tobacco, according to the attorneys general.

“The lack of regulation on non-tobacco nicotine products has created an unlevel playing field, as manufacturers of one category of nicotine products have evaded regulatory burdens and restrictions, while manufacturers of tobacco-derived nicotine products must undertake the expense and effort required to conform to FDA requirements,” wrote Massachusetts Attorney General Maura Healey in a statement.