SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) recently denied premarket tobacco product applications (PMTAs) for several myblu electronic nicotine delivery system (ENDS) products. But ITG Brands is hoping to keep the devices on the market while an administrative appeal is ongoing.
The FDA issued marketing denial orders (MDOs) to Fontem U.S. LLC for myblu products because their PMTAs lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health, according to the agency. ITG Brands, Greensboro, N.C., is the U.S. affiliate of Fontem U.S., which sells blu electronic cigarettes.
“We are disappointed with the FDA’s decision and disagree with the scientific evaluation and conclusions they reached,” said Alexandra Wich, ITG Brands director of external communications. “We believe our products meet the regulatory requirements and plan to use the administrative appeals process to convince the agency that approval should be granted. Based on past practice, we expect the FDA will not seek to enforce the MDOs while this appeal remains ongoing, and we therefore expect the products to remain in the market during this period. We do not believe that there will be any short-term impact on the business.”
Products that received an MDO may not be sold, distributed or marketed in the United States, according to the FDA. But the agency has reversed or paused its decisions in at least 15 other cases.
CSP asked the FDA if it would refrain from enforcing MDOs while an administrative appeal is pending, and Alison Hunt, press officer at the agency, said the FDA makes enforcement decisions “on a case-by-case basis.”
“All new tobacco products without premarket authorization are marketed unlawfully and subject to enforcement at the FDA’s discretion, consistent with the priorities outlined by the FDA,” Hunt said. “Retailers can contact their suppliers for clarity on the current status of any particular tobacco product’s application or any product’s marketing authorization, including whether specific products are subject to a marketing denial order. The FDA intends to follow its usual enforcement practices and will send warning letters before taking enforcement action.”
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