New Smokeless Oral Tobacco Products Cleared by FDA

On Tuesday, the U.S. Food and Drug Administration (FDA) announced it has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company, LLC under the brand name of Verve. The products were reviewed under the agency’s premarket tobacco product application (PMTA) process in which the agency must determine whether the marketing of the products would be consistent with the statutory standard, “appropriate for the protection of the public health.”

The Verve products are oral tobacco products that contain nicotine derived from tobacco, but they do not contain cut, ground, powdered, or leaf tobacco. The products are chewed and discarded and intended for adult tobacco users.

According to the FDA, research has shown a low likelihood that youth, nonsmokers, or former smokers would initiate or reinitiate tobacco use with the Verve products. Further, current users of Verve products and users who completely switch to Verve products are generally exposed to fewer harmful and potentially harmful constituents compared to cigarettes and other smokeless tobacco products.

Under the FDA’s decision, the four tobacco products can now be legally sold and distributed in the U.S. Notably, the FDA notes that their review does not mean the products are safe or “FDA approved,” as there are no safe tobacco products.

Additional information from the FDA is available here.