The Food and Drug Administration (FDA) gave e-cig manufacturers a timeline to submit ingredient and product documentation to be reviewed, giving their organization over 2.5 years to analyze said data and determine which brands and products would be approved for marketing and resale as smoking cessation aids. The agency has been overwhelmed with submitted requests and had extended its deadline, which has allowed many manufacturers to remain on the market with pending FDA approvals. All considered e-cig enthusiasts and vendors are left wondering if their favorite products will survive future vaping regulations. The review of e-cig products that will be allowed to continue to be sold in the United States has no new deadline, so all involved must know what is allowing these approvals to extend on for so long.
The FDA must put the interest of public health and safety first by determining if products are effective in helping smokers quit
While this consideration might seem a little black and white before a conclusion can be made on a singular product, let alone an entire lineup, there must first be an in-depth analysis conducted. Since an analysis can include the examination of various data, medical reviews, and documents, alongside studies and/or testimonials, it’s easy to see where delays can happen. Not to mention if at the end the evidence shows mixed results, further time will need to be spent to ensure the products are helping people to quit rather than jeopardizing their health and/or safety.
Here is a quick run-down of the review process:
- Preclinical animal testing is done before making it to human testing
- There is a rigorous evaluation process where elements such as side effects and manufacturing conditions are analyzed
- Clinical research must be conducted by the FDA in conjunction with a panel of scientists and research institutes specializing in quit smoking aids
Click here for more information on the FDA process.
What does this mean for Vape-ecigs?
At Vape-ecigs, we only sell products that possess pending FDA approvals, including Vuse tobacco products that as of this past October, have been fully approved—a first for the e-cig industry. We also comply with all federal and state laws according to the PACT Act. We stand with our chosen brands, which have supported vapers choosing nicotine replacement therapy over returning to combustible cigarettes. Their pending FDA approval indicated the commitment they have to remain on the market for transitioning ex-smokers and long-term vapers.
Although it’s the job of the FDA to determine how effective a smoking cessation aid is before the agency will give a stamp of approval, many e-cig manufacturers believe that the bar is set very high with harsh and unattainable vaping regulations that are nowhere near close to those mandated on tobacco products.
What do you think? Do you believe that e-cig manufacturers have to jump through more hoops than big tobacco companies?
The post Why are pending FDA approvals on e-cigs taking so long? appeared first on Blog Vape-Ecigs.
