The FDA Keeps Us Guessing About the Scope of Its E-Cigarette Regulations

Editor’s Note: See, Is the Internet a Tobacco Product?

From: Reason.com

Are nicotine-free e-liquids covered? Maybe. What about synthetic nicotine? Dunno.

Next Generation Labs, which makes synthetic nicotine for e-cigar­ettes, argues that a recent statement by the Food and Drug Administration shows the agency does not plan to regulate e-liquids as tobacco products unless they contain ingredients derived from tobacco. I don’t think the statement shows anything of the kind, but I can’t be sure. Like the FDA’s other pronouncements on the subject of what is covered by its potentially ruinous e-cigarette regulations, the statement cheered by Next Generation Labs is hard to decipher.

Here is what the FDA said last month in response to Nicopure v. FDA, a lawsuit by a company that sells e-liquids and vaporizers:

Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a “component or part”—that is, if it is “intended or reasonably expected” either “(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.”…An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a “component or part.”

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