HQ Team
July 11, 2023: The FDA has told e-cigarette maker Fontem US, LLC, not to market or distribute its product myblu menthol in the US as it did not provide any “added benefits.”
Tobacco products covered under a marketing denial order cannot be legally introduced into interstate commerce in the US without risking FDA enforcement.
The regulatory body ensures that the manufacturer complies with the order, as with unauthorized products generally and the FDA intends to ensure compliance by distributors and retailers.
The company can resubmit a new application to address the deficiencies of the product subject to this order.
“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products.
‘Lacks scientific evidence’
“This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweighs the known risks.”
Last year, FDA issued MDOs to Fontem US for several other myblu products, which are the subject of ongoing litigation. Decisions on additional Fontem US e-cigarette products are pending.
FDA evaluates premarket tobacco product applications based on a public health standard that considers the impact of the product on the population as a whole, including benefits and risks.
After reviewing the company’s applications, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of public health.
This is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
‘Added benefit’
Among other deficiencies, the application did not present sufficient scientific evidence to show that menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.
Tobacco products that receive a marketing denial order may be removed from the market.
The current denial order is one of many the FDA took to ensure any tobacco products that are marketed in the US undergo science-based review and receive marketing authorizations from the agency.
To date, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
‘Considerable progress’
“FDA has made considerable progress on the unprecedented volume of applications received,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products.
“We’re committed to making determinations on the remaining applications as expeditiously as possible while ensuring the decisions are scientifically accurate, legally defensible, and aligned with the authorities granted by Congress.”
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, the only e-cigarettes that may be lawfully sold or distributed in the United States.
Tobacco kills more than eight million people every year. About seven million of those deaths are the result of direct tobacco use while around 1.2 million are the result of non-smokers being exposed to second-hand smoke, according to the WHO.
