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Regulation

Update: Blu's response to FDA's Marketing Denial Order

As part of the marketing regulations for all vapor products in the United States, the US Food and Drug Administration (FDA) required manufacturers to file applications by September 2020. Since that time, the agency has been conducting scientific reviews of those applications. The FDA has been issuing its decisions regarding these products on a rolling basis since late last year. On April 8, the FDA issued marketing denial orders (MDOs) for a number of ITG Brands myblu pod-based vapor products.

We are disappointed with the FDA’s decision and disagree with the scientific evaluation and conclusions they reached. 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.