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Why Juul's PMTA was rejected by the FDA

Time: 2022-06-27

Views: 51

If you keep the taste, it will be rejected by the FDA; if you change the taste, it will be abandoned by the market!

The rejection of JUUL caused wild speculation in the industry. What everyone is most puzzled about is how could JUUL be issued an MDO (marketing refusal order) by the FDA for such obvious technical reasons? Is this the FDA's use of technical means to achieve its political goals, or the inability of the JUUL reporting team! If it is the FDA's problem, where is its credibility! How will you play in the future? If it's JUUL's problem, how could such a big company make such a low-level mistake! Is it bad money or bad! It's really baffling.

I am here to do a technical analysis, just for everyone to discuss. If the deviation is too far, civilization is welcome.

First of all, as I said in my last article, I believe that the two technical deficiencies given by the FDA are clear, otherwise JUUL will stand up in court when appealing, and JUUL’s technical staff cannot be refuted, and the FDA’s credibility will be lost. , lose face. So, the FDA will be 100% sure.

So, doesn't JUUL know that he can't do it himself? Such a big company can't find a master, or is it reluctant to spend money on experiments! Certainly not. If I were the PMTA person in charge of JUUL, with the support of the company's huge resources, I would be perfect! Except for one situation: there is a dead end that I can't handle in this declaration! I'll talk about what this dead end is in a moment. If there is this unsolvable dead situation, then I will give the company a suggestion: at present, the application should be made according to the existing information. If the FDA does not find this problem, it is our luck. We supplement the information, but we know that we cannot supplement it in this case, or can not supplement it in the short term. Therefore, the FDA will definitely issue an MDO in the end. If he issues an MDO, we will appeal to make the MDO invalid. Then, on the one hand, we can continue to sell in the U.S. market, and on the other hand, try to extend the lawsuit as much as possible. All time to solve this dead end! So, if you follow this line of thinking, then the story will be directed and acted by JUUL, and they still control the situation.

So what is this dead end? Let's take a look at the original words of the FDA:

The FDA stated that after reviewing the data of JUUL, it was found that its toxicological evidence was insufficient, especially the toxicological research on genotoxicology and potentially harmful chemicals extracted from e-liquid was insufficient or even contradictory data, so it could not be judged. its security. Then he said:

To date, we have received no relevant clinical information from JUUL regarding the "immediate hazards of using its products". Therefore, in general, we cannot assess the toxicological risks of using JUUL; nor can we know the potential harm of wild-type pods or pods combined with JUUL products.

In other words, you didn't make it clear in terms of toxicology, at least your clinical evidence should prove the safety of your product! It's a pity you didn't either, so you can't blame me!

Therefore, I personally think that the main source of JUUL being MDO is still in the first part, toxicology. Especially when it comes to genotoxicology, why is genotoxicology problematic? Why is this a dead end? I'm guessing this is due to JUUL's unique formula. As we all know, JUUL is the inventor of nicotine salt. Its unique taste must have its own unique formula, and a certain ingredient in this formula or the extract of e-liquid is very likely to have genotoxicity. If you change the formula, it will directly affect its taste. You must know that many people like JUUL because they like his taste. The change of taste will lead to strong opposition from users. Therefore, the dead end is "if you keep the taste, it will be rejected by the FDA; change The taste is abandoned by the market!”

If I were the person in charge of JUUL, in order to keep my market and my brand, and at the same time to meet the requirements of the FDA, I would definitely devote all my resources and strength to adjusting the formula so that it could not only meet the requirements of the FDA, but also meet the requirements of the FDA. The original taste is similar, but it takes time, so I choose the former, I can file a lawsuit, but I can't lose the "smoker's heart".

This may be the main reason why JUUL was rejected. As for the wildcard risk, it is easy to explain and solve. This is definitely not the main reason for rejection, so I will not discuss it here. Of course, the above analysis is just my guess from the technical level. On the one hand, I believe in the FDA's review ability, and on the other hand, I also believe in the strength and consistent attitude of JUUL. From this, what I want to say is:

1. The FDA will fight this lawsuit with JUUL that both parties can understand, and it will not affect everyone's feelings.

2. JUUL will do its best to upgrade the formula, then supplement the information and increase investment. In any case, it must pass the PMTA to keep the market and the stock price.

3. It can be seen from this case that the FDA is basically right things and not people, professionals are for professionals, and honest people will always be rewarded.

4. For the newly established PMTA, we must find out whether there is a dead end, otherwise the consequences will be unimaginable.

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