The FDA was asked a simple question and this is how they responded…
This entry was posted on 26th July 2016 by twus.
Dr. Michael Siegel shared this on the Tobaccoanalysis blog spot.
Here is the question, “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 not contain nicotine?”
Pretty simple question don’t you think? It should have been answered with a simple “yes” or “no”. As Dr. Siegel points out, “if e-cigarettes do not contain nicotine then there is no basis for the FDA to assert jurisdiction over them as tobacco products. Therefore, these nicotine-free e-liquids would not be subject to the pre-market approval requirements.”
A simple answer of "no" would have, and should have sufficed.
However the FDA gave a long and convoluted twenty paragraph response, with one which actually addressed the question. The answer actually is convoluted, ridiculous and nonsensical.
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.
Siegel continues – “Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations, I have no clue what the heck the FDA is talking about. I can't even imagine a scenario where a nicotine-free e-liquid would be incorporated into a "tobacco product," but if it were, it would only be a tobacco product if it was mixed with nicotine-containing e-liquid, in which case the manufacturer or retailer is not selling a nicotine-free e-liquid. Of course that would be considered a tobacco product.
"The answer appears to be no. But the FDA hides this answer"
The question here was much simpler. If I produce a finished e-liquid that is nicotine-free, is my product regulated and if so, do I have to submit a pre-market application? The answer appears to be no. But the FDA hides this answer in such a stream of incomprehensible jibberish that the poor small business owner (or even the large business owner) is more confused after having asked the question than they were before.”
This entry was posted on 26th July 2016 by twus.
Dr. Michael Siegel shared this on the Tobaccoanalysis blog spot.
Here is the question, “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 not contain nicotine?”
Pretty simple question don’t you think? It should have been answered with a simple “yes” or “no”. As Dr. Siegel points out, “if e-cigarettes do not contain nicotine then there is no basis for the FDA to assert jurisdiction over them as tobacco products. Therefore, these nicotine-free e-liquids would not be subject to the pre-market approval requirements.”
A simple answer of "no" would have, and should have sufficed.
However the FDA gave a long and convoluted twenty paragraph response, with one which actually addressed the question. The answer actually is convoluted, ridiculous and nonsensical.
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.
Siegel continues – “Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations, I have no clue what the heck the FDA is talking about. I can't even imagine a scenario where a nicotine-free e-liquid would be incorporated into a "tobacco product," but if it were, it would only be a tobacco product if it was mixed with nicotine-containing e-liquid, in which case the manufacturer or retailer is not selling a nicotine-free e-liquid. Of course that would be considered a tobacco product.
"The answer appears to be no. But the FDA hides this answer"
The question here was much simpler. If I produce a finished e-liquid that is nicotine-free, is my product regulated and if so, do I have to submit a pre-market application? The answer appears to be no. But the FDA hides this answer in such a stream of incomprehensible jibberish that the poor small business owner (or even the large business owner) is more confused after having asked the question than they were before.”
