FDA Blocks Four New Cigarette Brands from the Makers of Camel®
[Posted on: Thursday, September 17, 2015]

Since the passage of Tobacco Control Act in 2009, the FDA has slowly built rules to regulate all forms or tobacco products, from ethnic Bidis to electronic cigarettes. FDA has released 16 rules to date that cover in details the current regulations. Under the Tobacco Control Act, FDA was given seemingly limited powers to assure that the tobacco industry is transparent on the quality of its products, it is visible and vocal about the risk of smoking, and it does its best to avoid tobacco use by youth. One rule, called the “substantially equivalence” rule requires that any new tobacco product introduced in the US market after 15 February 2007 meet either of two requirements; it be substantially equivalent to a previous product (predicate), or file a Premarket Tobacco Product application justifying that it is not more risky that previous products. Some products were granted exemption from the substantially equivalence rule. Under this rule in the last 2 years, FDA has blocked 113 new tobacco products because they were deemed not substantially equivalent to a predicate tobacco product. The most recent entries to the rejected products are four new cigarette brands proposed by R. J. Reynolds, the makers of Camel® and other popular brand of cigarettes. FDA does not approve cigarettes and other tobacco products because it believes all tobacco products are bad and should not be marketed, however, it has authority to reject products under limited conditions. And it does use its power aggressively. The reasons for rejection of the four products were diverse; not substantially equivalent to predicate products, increased level of potentially harmful constituents, manufacturer not disclosing all constituents, and even changed consumer “perception” about a product due to addition of menthol in the filter. This shows what great lengths FDA can go to reject a product. So far, FDA has rejected about 30% of the new tobacco products it was presented and the trends seems to stay for the near and far future. But does it have the intended effect, namely, reduced smoking rates, is not known. The last statistics from CDC in 2013, showed that about 1 in 5 adults smokes, with both male and female, and adults from 18-65 smoking at similar rates. That is 4 years after the Tobacco Control Act was passed. It would be interesting to see what the current rates are.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research