Here at vape-ecigs.com, we only carry brands that have Food and Drug Administration (FDA) approvals pending or those that are already approved for sales and marketing. This is because we want to ensure that our customers have access to vape products that will available for years to come, and those that choose to follow the appropriate channels for sales and marketing. That said, let’s use this blog to break down the difference between the two FDA titles.
What does it mean when e-cig products have FDA approvals pending?
E-cig companies seeking to sell their products in the United States must first have them tested. The company must complete the appropriate paperwork, which includes a list of products and their ingredients, as well as their current marketing materials, and send it in as “evidence” to perform the tests to prove the products are safe and effective for their intended use—as a smoking cessation aid.
Applications for electronic nicotine delivery systems (ENDS) were required to be submitted to the FDA by September 9, 2020. Companies that failed to meet the deadline were not permitted to remain on the market.
All menthol e-cigs for sale are current examples of products that have FDA approvals pending.
What does it mean when e-cig products are FDA approved for sales and marketing?
A team of physicians, statisticians, chemists, pharmacologists, and other scientists will review the company’s submitted data and proposed labeling. If as a collective, they feel the product’s health benefits outweigh its known risks, it will be approved for sale and marketing.
Before the product(s) are tested with people, animal tests must be conducted. Then, a series of tests on people will begin to determine if the product(s) works well for its intended use. In this case, subjects who wish to quit smoking would be offered an opportunity to test e-cig products.
The approval process takes place within the following structured framework:
- Analysis of the target condition and available treatments: The FDA analyzes the condition for which the product(s) is intended and evaluates the current treatment landscape to weigh in the risks and benefits.
- Assessment of benefits and risks from clinical data: The FDA reviews clinical benefits and risk information submitted by the e-cig company, taking into consideration any uncertainties that may result from incomplete data.
While all menthol e-cigs for sale currently only have FDA approvals pending, the agency is working on the assessment of benefits ex-smokers have with access to these products. Especially if they once smoked menthol combustible cigarettes.
Do you follow the news to see if your favorite e-cig products get their well-deserved approval? Drop a comment below to let us know.
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