Will Non-nicotine E-liquids be Regulated by the FDA?

That is the question we submitted to the FDA’s contact page for information regarding the Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule). As expected, their answer is far from definitive and gives the FDA plenty of legal wiggle-room to regulate even products only tangentially related to tobacco products:

You have specifically asked regarding whether or not the law will apply to zero nicotine products, whether or not the law will apply depends. Generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation. These products will be evaluated on a case-by-case basis.

In short, to paraphrase what they stated, whether or not the law will apply to zero nicotine products depends. If they determine that it’s intended or can reasonably be expected to be used with or for consumption of a tobacco product or to alter the performance, composition, etc. of said product, they can regulate on a case-by-case basis. While such wording is pretty standard for government legal documents, it’s nevertheless worrying for the broad authority it provides regulatory enforcers who could potentially target businesses based on biases and subjective interpretation of the law.

Fortunately the FDA bill is being challenged by the Right to be Smoke-Free Coalition which filed a lawsuit on June 21. The coalition (which has the backing of trade groups such as CASAA, the Smoke-Free Alternatives Trade Association (SFATA), SEVIA USA, and Not Blowing Smoke (NBS) is putting on pressure to change some of the wording on various constitutional and administrative grounds (which we hope will include the FDA’s broad definition of “tobacco product”). The full document they drafted can be read here.

 

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One response to “Will Non-nicotine E-liquids be Regulated by the FDA?

  1. Pingback: Will Non-nicotine E-liquids be Regulated by the FDA? | Ecigvaporsonline·

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