We are happy to announce that Bidi Vapor has been granted a stay order by the FDA.
Which means all 11 flavors of the BIDI®️ Stick are now legal to market and distribute as the FDA is currently reviewing the previously released MDO.
MELBOURNE, Fla. — With compliance being a core company value, Bidi Vapor, LLC, announced its support of the state of Alabama and the publishing of a directory of compliant ENDS products legal for sale in the state. The Alabama Revenue Commission is scheduled to make that directory public as of May 1, 2022. After that date, any manufacturer not on the list that sells product in Alabama will be subject to daily fines.
“Alabama’s new directory will identify manufacturers who are following the regulatory processes set by the U.S. Food and Drug Administration,” said Niraj Patel, president and CEO of Bidi Vapor, Melbourne, Fla. “This list of manufacturers will remove players who are trying to circumvent the rules, including manufacturers pushing electronic nicotine delivery systems or ENDS with synthetic nicotine, which the state has separately banned. We encourage states to follow the path that Alabama has taken in creating a directory of compliant ENDS products so that retailers and distributors can know what they are permitted to sell.”
The directory is part of a larger measure designed to keep nicotine-delivery devices like e-cigarettes from minors. When signed by Gov. Kay Ivey in May of 2021, the new law raised the legal age to purchase tobacco and other nicotine products to 21, bringing state law in alignment with federal age restrictions. With the general purpose of preventing youth from vaping, the law puts restrictions on sponsorships of events where youth will be present, keeps vaping devices out of vending machines in establishments that permit minors, and prohibits manufacturers from labeling or marketing their products with candy, cake or pie flavors, as well as food brands or superheroes and other characters that appeal to children.
“The underlying goals of this Alabama law fully align with our vision,” Patel said. “We prioritize preventing youth use of vaping products, while providing adult smokers 21 and older with an alternative to combustible cigarettes. We believe our product and the way we go to market are appropriate for the protection of the public health.”
Also included in the law is a ban on products containing synthetic nicotine, unless the manufacturer obtains FDA authorization for sale as a drug, device, or combination product. Bidi Vapor has publicly stated its support for bans of these products, which Congress placed under FDA’s tobacco product authority this past March.
“We support ongoing Congressional efforts to place synthetic nicotine under the authority of the FDA,” Patel said. “Products in the vaping space should be developed and placed in the market under a high degree of supervision, with prime examples being the FDA’s PMTA and drug-approval processes.”
The Alabama law adds another layer of complexity to the category, especially regarding flavored ENDS products. As noted in a recent CSP podcast, the FDA eliminated over 90% of the applications for flavored ENDS this past September, in a series of swift and surprising Premarket Tobacco Product Application (PMTA) decisions.
Bidi Vapor submitted PMTAs for all 11 flavor varieties of its BIDI® Stick prior to the court-ordered September 9, 2020, PMTA deadline, despite considerable business and logistical challenges due to the COVID-19 pandemic. The detailed applications ran over 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health. Despite submitting scientifically rigorous PMTAs and keeping FDA informed about its ongoing clinical and behavioral studies, Bidi Vapor received a marketing denial order or MDO for its flavored BIDI® Sticks, along with nearly all other manufacturers of flavored ENDS, in early September 2021.
However, on February 1, 2022, the U.S. Court of Appeals in the Eleventh Circuit issued a judicial stay on that MDO. The court-ordered stay means that the MDO is not legally in force. Accordingly, Bidi Vapor anticipates being able to continue marketing and selling the flavored BIDI® Sticks, subject to the FDA’s enforcement discretion, while Bidi continues with its merits case challenging the legality of the MDO. FDA has indicated that it is prioritizing enforcement against companies that have either not submitted PMTAs, or whose PMTAs have been refused acceptance or filing by FDA, or whose PMTAs remain subject to MDOs.
Bidi Vapor remains committed to regulatory compliance and the premarket review process and is forging ahead with its planned studies to support its PMTAs. The Company’s behavioral studies show that the majority of BIDI® Stick consumers are older smokers who were either able to transition completely away from smoking or were able to significantly reduce the number of daily cigarettes smoked. This corresponds with the Bidi Vapor’s completed clinical pharmacokinetic (PK) study, which demonstrates that the BIDI® Sticks deliver nicotine to adult consumers comparable to their usual cigarette brand and also elicited similar subjective effects. In short, the behavioral studies and PK study demonstrate that the BIDI® Sticks may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.
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