PMTA certification has reduced or eliminated odors, so it may not be necessary to go that long. Thousands of companies have submitted 67 million applications, but so far, only 23 have been approved. To my knowledge, several companies have submitted over 1 million applications themselves. Ironically, each approved is a large tobacco company, and they only account for a small portion of the entire e-cigarette market
The second irony beyond that is that those so-called approved products are what no one wants.
What is PMTA
PMTA, also known as Pre market Tobacco Application, refers to the pre market application for tobacco. This is a market access license developed by the U.S. Food and Drug Administration (FDA) for new tobacco products in the United States.
As the federal government's regulatory measures for e-cigarette products in the United States gradually upgrade and increase, PMTA (pre market application for tobacco) will be a barrier that domestic e-cigarette companies cannot bypass when entering the US market. They will either take advantage of the situation or withdraw and give up.
PMTA requires that the legitimate promotion of any new tobacco product must undergo FDA review and approval. The FDA needs to comprehensively consider whether this product is beneficial to public health (treating smokers and non-smokers as a whole). After passing the review, the FDA will issue a "Pre market Tobacco Product Marketing Orders" to the relevant product.
The United States, through the Family Smoking Prevention and Tobacco Control Act, has for the first time granted the FDA the authority to regulate traditional tobacco, but the scope of regulation is limited to cigarettes, cigarette tobacco, smokeless tobacco, and homemade cigarettes.
The FDA approved the first pre market tobacco application for PMTA, granting the Swedish MATCH North American company Snus the right to market smokeless tobacco products.
On May 10, 2016, the FDA released new rules for the Deeming Tobacco Products Regulation, which regulate all tobacco products, including e-cigarettes, cigars, hookahs, and pipe cigarettes, effective August 8, 2016. The new regulations officially include e-cigarettes in regulated tobacco products, meaning that e-cigarettes are fully included in PMTA. The terms of PMTA regarding e-cigarettes require that any ENDS (Electronic Nicotine Delivery System) after August 8, 2016 must first obtain PMTA in order to be sold in the US market, and all e-cigarette brands and manufacturers must submit applications before August 2022. If the product is launched before August 8, 2016, it must obtain PMTA certification before August 8, 2020 before it can continue to be sold.
From then on, the FDA can legally regulate the manufacturing, import, packaging, labeling, advertising, promotion, sales, and distribution of Electronic Nicotine Delivery Systems (ENDS). For example:
Manufacturers in the United States are required to register every tobacco production site with the FDA and report any harmful and potentially harmful substances. (Companies outside of the United States do not currently need to be registered, but they will also need to be registered in the near future)
American manufacturers are required to submit a list of tobacco products produced to the FDA.
ENDS manufacturers are required to submit a list of ingredients for each product to the FDA.
Dangerous modifiers such as light, low, and mill cannot be used to describe tobacco products.
Free samples considered as tobacco products (such as e-cigarettes) are not allowed for sale (excluding B2B), etc.
In July 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation, extending the deadline for submitting PMTA applications for ENDS (electronic cigarettes) until August 8, 2022.
On March 14, 2019, the FDA announced that it would recommend revising the current compliance policy for ENDS (Electronic Cigarettes) (July 2017 policy). The revised draft specifically targets flavored e-cigarettes, including: 1. Some flavored e-cigarette products will no longer be sold. 2. The PMTA deadline for flavored e-cigarettes will be advanced by one year to August 8, 2021. 3. Seasoned cigars will no longer be sold. 4. It is recommended that e-cigarettes, like traditional cigarettes, cannot be promoted through social media.
On June 11, 2019, the FDA finalized the "Pre Market Application (PMTA) process for electronic cigarette and related tobacco product manufacturers" guidelines, further clarifying the tobacco product pre market application (PMTA) process for electronic cigarette and related tobacco product manufacturers. This guide aims to assist individuals submitting pre market applications (PMTA) for tobacco products of electronic cigarettes (ENDS) in accordance with Article 910 of the FD&C Act (21 USC 387j). This guide explains what kind of product, when the PMTA process is required, and the general procedures for pre market application of tobacco products (ENDS); Including what information is required to be submitted in PMTA under the FD&C (Federal Food, Drug, and Cosmetics) Act; The FDA suggests that products that can be submitted can provide information that is beneficial to public health.
According to the FDA, the PMTA application is relatively complex and requires a large amount of information, including ingredients, product design, and potential health risks, which can cost hundreds of thousands of dollars. As of now, only IQOS and one Swedish company have passed PMTA.
The review project of PMTA includes nine aspects:
Apply for qualifications
Basic information
descriptive Information
Product samples
product labeling
Scientific research results
Product attributes and production process
In vivo toxicology research
HPHCS (harmful and potentially harmful components)
The cost of PMTA will take approximately two years from inception to approval, and the total project cost is expected to be between $117000 and $466000.
Which domestic enterprises have PMTA
At present, some strong domestic e-cigarette enterprises have started the PMTA plan.
RELX
Suorin, a brand under YouMe Group
SMOK
VAPORESSO, a brand under Simore
VOOPOO under Jier Technology
Heyuan Group
Sigelei
Boulder