2020 IECIE eCig Expo

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We are pharmaceutical companies, but we do not want e-cigarettes to fall into medical supervision

 Judging from the voting results, most participants accounting to 73% thought that e-cigarettes should be classified as brand new harm reduction products, but at the same time, 21% of them thought they should be classified as tobacco products and 6% thought they should be classified as medical supplies. .


What if e-cigarettes are classified as pharmaceuticals?


The Zhengqixinshili consulted a relevant person in a pharmaceutical industry on this issue.

Based on the technology of biological fermentation broth, a pharmaceutical company has made major breakthroughs in the field of e-liquids, and at the same time has a medical background, so the opinions are of great reference value.


The followings are the conversation during the interview.


Z stands for Zhengqixinshili, P stands for the interviewee from the pharmaceutical company.


Z: Do you have any relevant analysis on the future development and supervision of e-cigarettes?


P: Nicotine is the soul of tobacco and is the most important constituent. No matter what the regulatory policy of e-cigarettes is in the future, this is definitely a trend for the control of nicotine. At the same time, high taxes are imposed on nicotine.

At present, we analyze that the possibility of e-cigarettes being regulated by tobacco accounts for 90%, because the current resources of the Food and Drug Administration are limited, and the routine work is already very heavy. It is difficult to shoulder the burden of supervision of e-cigarettes.

Therefore, the possibility of categorizing it as tobacco regulation is still very high. It is reasonable to say that e-cigarettes should also be an extension of tobacco.


P: However, various policies and regulatory measures introduced by the United States, the largest consumer market of electronic cigarettes, have a tendency to regulate electronic cigarettes as pharmaceutical products, and the United Kingdom has also included electronic cigarettes in pharmaceutical supervision. Will this affect What about China's related policies?


P: Although the United States, Britain and other countries have this tendency, after all, there are great differences in national conditions and regulatory systems. The regulatory systems in western countries are horizontal, while China is more vertical.

If it really falls under the supervision of medicine, it will be very strict, and any kind of active ingredient must be clearly defined.

For example, e-liquid is similar to traditional Chinese medicine, and the effective ingredients of traditional Chinese medicine are currently difficult to fully define, but each Chinese medicine must be "fingerprinted" before it is marketed.

The peak value of each effective component must be identified. After each substance is analyzed, the structure of each component must be confirmed, and a series of related analytical processes such as hydrogen spectrum and mass spectrum nuclear magnetic resonance must be performed. Each raw material has very detailed quality standards.

.At the same time, many aspects such as acute toxicity, chronic toxicity, chronic toxicity, abnormal toxicity, blood pressure, irritation, and cytotoxicity should be tested.

In addition to ingredients, cost and cycle time are also very important factors. At this stage, the cost of approving a single-component new drug can reach up to 1 billion. Of course, in addition to various experimental costs, it also includes clinical costs.After the whole process is completed, the cycle is very long, and it cannot be done in 15 years.Therefore, the domestic classification of e-cigarettes into pharmaceutical supervision may be the worst result.


Z: How does a pharmaceutical company adjust to respond to the current situation?


P: In fact, the fundamental problem of e-cigarettes for so many years is the "controversy of nicotine." Although e-cigarettes have relied on nicotine to achieve great development before, they are now more and more constrained by the problem of nicotine.

The root of our company is the biological fermentation broth technology. Electronic cigarettes are just a branch of many applications. In addition to electronic cigarettes, we have been developing more application fields around the biological fermentation broth technology.

For example, the recent "spraying" is a "fragrant aerosolized product" using a fermentation broth, which enables users to inhale active ingredients in an atomized form, does not contain nicotine, and has a wider target user group.

In today's tightening global e-cigarette policy, relevant companies should be rational, analyze what their main advantages are, focus on maximizing their advantages, and avoid blind expansion.