SILVER SPRING, Md. -- The U.S. Food and Drug Administration (FDA) announced its approval of two noncombustible tobacco products from R.J. Reynolds Tobacco Co.: Eclipse and Eclipse Menthol.
In its Aug. 13 newsletter, the agency said the substantial equivalence (SE) orders mark the first time the FDA has issued such orders for noncombusted cigarettes, and thereby represents a “viable pathway” for approval of such products for marketing and sale in the United States.
To receive an SE order, the FDA said manufacturers must demonstrate that the new tobacco product has the same characteristics as the “predicate tobacco product,” or a product that was commercially marketed in the United States on or before Feb. 15, 2007. Additionally, if the product has different characteristics than the predicate tobacco product, those differences do not cause the new tobacco product to raise different questions of public health.
Winston-Salem, N.C.-based Reynolds introduced the “heat-not-burn” device in the 1990s, but it struggled to gain traction with smokers, according to the Winston-Salem Journal. The news outlet reported that Reynolds entered an SE application for the Eclipse products with the FDA in July 2017.
Officials with Reynolds did not comment by posting time.