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As all manufacturers and other vaping business owners have been sitting on the edge of their seats, waiting for the FDA’s deeming regulations to come into play, not knowing exactly how they will be affected. When asked the direct questions that are on everyone’s mind, the FDA responded with a 1300 words long ungraspable reply. An article published on Forbes on July 25th, quotes Professor Siegel who is attempting to solve this riddle.

As from next August, vaping products will be regulated as tobacco products in the US, with the reasoning that even though e-cigarettes do not contain tobacco, they deliver nicotine which is extracted from tobacco. However this is not always the case, as there are several nicotine-free liquids, and also vaping liquids containing synthetic nicotine, which has not been extracted from tobacco plants. Will all variations be classified as tobacco products?

Public Health Professor at Boston University Michael Siegel, who is pro-vaping, believing that e-cigarettes are a healthier alternative to tobacco smoking and an effective cessation aid, cited “someone” he is in touch with, who posed the following questions to the FDA :

  • ”Are e-cigs that do not contain nicotine ( or any other tobacco extracts ) also covered by the FDA deeming regulations?
  • If so, will they also require pre-market approval like products that do contain nicotine?”

An attempt to decipher the FDA’s cryptic response

In reply, this person received an essay of gibberish from the FDA that goes far from answering the questions that are on everyone’s mind in a clear and direct manner. The 10th paragraph in this “explanation” is the one that attempts to address the questions :

As it relates to e-liquids that contain zero nicotine, 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. This applies to closed and open system devices that contain zero-nicotine.

I have no clue what the heck the FDA is talking about.M. Siegel, Boston University

Siegel’s reaction to this answer goes as follows, “Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations,” Siegel writes, “I have no clue what the heck the FDA is talking about.”

He points out that he cannot comprehend how a nicotine-free liquid can be used with or for the human consumption of a tobacco product. He goes on to point out that this seems to referring to vaping equipment rather than liquids, which would mean that any equipment that could be used to deliver nicotine (even if that consumer chose nicotine-free refills) would be classified as a tobacco product. This could indicate that any products such as vaping systems that accept only nicotine free cartridges, or disposable nicotine-free e-cigarettes, may be exempt from classifying as a tobacco product.

What are vaping businesses facing?

Siegel’s argument  is concluded by pointing out that it will be tough for the vaping business to comply with these regulations since “these products will be evaluated on a case-by-case basis”.

This correspondence is a little taster of what awaits vaping businesses in the US, as not only will these regulations lead to a substantial financial loss, but even figuring out whether one is compliant with the regulations or not, would be a feat.

  • Esteban Garita

    Big tobacco wins again… Thank god at least one aspect of the US government is crystal clear, hypocrisy.