R.J. Reynolds, a subsidiary of Reynolds American Inc., is the second largest tobacco company in the United States and has historically done well through the sale of its popular cigarettes such as Newport and Camel. Even with all of this success, recently smoking has been on the decline because of various things including increase in taxes on cigarettes, the increase in preventive messages sent towards the youth, and the realization of the true harm smoking can do to humans. Now, another shot at the R.J. Reynolds empire has been fired by none other than the Food and Drug Administration (“FDA”). The FDA on September 15, 2015 ordered that all stores carrying Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol, or Vantage Tech 13 must immediately stop the sale of those cigarettes and dispose of them within 30 days of the order or face severe financial penalties.
But how is it that the FDA has this much power to decide whether certain products (cigarettes) can be sold? How is it that consequently through this power the FDA can indirectly dictate whether those cigarettes likewise will be produced? In 2009, President Obama passed the Family Smoking Prevention and Tobacco Control Act that effectively gave the FDA the power to regulate the tobacco industry (previously it was up to the states to regulate tobacco) in an effort to aid in the protection of public health. The specific manner in which the FDA is prohibiting the sale of these products comes in its power to reject cigarettes or other tobacco products that its scientists believe pose a greater or different threat to public health than comparable products already for sale. In the past, cigarette companies could exchange existing products with new ones at will. It should also be noted that the order by the FDA does not necessarily mean that these products are more dangerous than other existing products, but simply that they are different and cause new health concerns.
The best and likely way R.J. Reynolds can fight this order is by offering its own scientific evidence to rebut this order by the FDA. R.J. Reynolds claims that “…. submissions to the agency on these brands were comprehensive and we believe we effectively demonstrated substantial equivalence.” In making this claim, R.J. Reynolds also has stated they are exploring their options at this moment and will likely file a legal injunction or pull the products and contest the findings. In all likelihood, if it came to a battle between what are accurate facts, R.J. Reynolds would probably lose barring some clear mistake by the FDA. Because of the Family Smoking Prevention and Tobacco Control Act, there may not be a wide range of legal actions R.J. Reynolds can use to block this action. Part of that may end up leading to a battle over the actual authority the FDA has and whether this goes too far. Even though there could be legal options for R.J. Reynolds to take, these four types of cigarettes only make up about 1 percent of cigarette sales for the company and therefore would not lead to a huge financial blow. What is more important is the fact that this is really the first action the FDA has taken against a major cigarette brand in Camel Crush Bold and is why legal action may end up being necessary for R.J. Reynolds. If no action is taken, there could be a flood of similar attacks by the FDA that could affect the long term success of the company. In making moves in the future, depending on what ends up resulting from this, companies like R.J. Reynolds may need to take closer control over their products to make sure that they avoid actions by the FDA that can lead to financial loss and a loss of goodwill.
* Alec Roberson is a third year law student at Wake Forest University School of Law and hopes to practice in sports, trust and estate planning, or tax law after graduation. He holds a Bachelor of Arts in Political Science and a Bachelor of Science in Accountancy from the University of North Carolina at Wilmington.