Black Note is Here to Stay – FDA Receives Company’s PMTA Application
IRVINE, CA, September 11, 2020 /24-7PressRelease/ — The naturally extracted tobacco e-liquid company Black Note has officially had their pre-market tobacco product authorization (PMTA) submitted to the Food and Drug Administration (FDA), in line with the new regulations for vaping products. The acceptance comes after FDA’s careful review of data-gathering and planning requested from the company in a submission intended to show that Black Note’s products are “appropriate for the protection of public health.” The company’s full-line of tobacco e-liquids is included in the application.
The PMTA process is the main consequence of the FDA’s deeming regulation for vaping products. It requires manufacturers to submit documentation on the marketing of their products, safety data and documentation showing that the products won’t (for example) appeal to youths and other population-level concerns. The deadline for the submission was September 9th.
A PMTA is required for each product a company wants to remain on the market, and Black Note’s applications cover its complete line-up of products: Virginia Tobacco, Cuban Cigar Blend, Menthol Blend, Burley Tobacco, Cavendish Blend, Kentucky Tobacco and Latakia Tobacco, in 0, 3, 6, 12 and 18 mg/ml of nicotine. The fact that all of the flavors are tobacco and menthol-based immediately allays concerns that vaping products may appeal to youths and non-smokers. For Black Note, their focus on tobacco makes it clear that adult smokers and vapers are the primary intended market.
The submission of the PMTA application is an acknowledgment that it has been filed correctly and received; it is not a confirmation that the application will be accepted. This will only come as a result of the FDA’s analysis of the documentation provided.
Black Note is also fairly unique in terms of e-liquid companies. While other companies use artificial flavorings to imitate the taste of tobacco, Black Note steeps real tobacco leaves in the base ingredients of the e-liquid to draw out the authentic flavor. This produces a flavor customers love, but presents a unique decision for the FDA, who are at present dealing with applications for primarily “ordinary” e-liquids in a variety of flavors.
In any case, the company remains in business and has passed through the first step of the deeming regulation process and all of their products will remain available to customers.
Our Guiding Principles:
Since day one, we have steered clear from kid-friendly designs, names, marketing materials and characterizing flavors that stir up childhood nostalgia and appeal to the underage crowd.
These same practices are currently being discussed and implemented by the FDA and other governing bodies. That’s why we think the FDA and state lawmakers have been spying on us and are seeking to align the vaping industry with the same high standards Black Note has upheld since its inception.
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