The U.S. FDA Opens a New Front in Its Ongoing Crackdown on Vaping
The U.S. FDA has opened a new front in its vaping crackdown by classifying 19 common e-liquid chemicals as harmful or potentially harmful constituents.
The U.S. Food and Drug Administration (FDA) has announced a new ingredient classification, opening another front in its ongoing crackdown on vaping devices. Nineteen chemicals commonly found in e-liquid have been added to the list of “harmful and potentially harmful constituents (HPHCs).” This does not amount to an outright ban on these chemicals, but it does mean that e-liquid manufacturers will have more work to do—after already being hit hard by compliance with the FDA’s notorious “deeming rule.”
Some of the chemicals on the list have already been phased out by the vaping industry. For example, diacetyl, a buttery flavoring, was at one time linked to an incurable lung disease (although there is no evidence that the level of harm is comparable to the levels found in e-cigarette vapor); for example, glycidol is a thermal decomposition product of glycerin and has been found in e-cigarette vapor. The FDA claims that ethylene glycol is sometimes used as a solvent in e-liquid, but it is not, because it is toxic; diethylene glycol is also toxic, and it is on the list because the FDA is concerned that e-liquid could somehow become contaminated with it.
E-liquid manufacturers and importers must now provide the FDA with laboratory test results showing the amount of each newly designated HPHC in every product they sell. Combined with the enormous costs required to obtain premarket tobacco authorization, this will almost certainly drive many smaller e-liquid manufacturers out of business. Of course, that may well be the FDA’s goal.
Some of the chemicals on the list have already been phased out by the vaping industry. For example, diacetyl, a buttery flavoring, was at one time linked to an incurable lung disease (although there is no evidence that the level of harm is comparable to the levels found in e-cigarette vapor); for example, glycidol is a thermal decomposition product of glycerin and has been found in e-cigarette vapor. The FDA claims that ethylene glycol is sometimes used as a solvent in e-liquid, but it is not, because it is toxic; diethylene glycol is also toxic, and it is on the list because the FDA is concerned that e-liquid could somehow become contaminated with it.
E-liquid manufacturers and importers must now provide the FDA with laboratory test results showing the amount of each newly designated HPHC in every product they sell. Combined with the enormous costs required to obtain premarket tobacco authorization, this will almost certainly drive many smaller e-liquid manufacturers out of business. Of course, that may well be the FDA’s goal.
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