By Jeffrey H. Brochin, J.D.
A private citizen’s lawsuit against the FDA alleging violations of the Administrative Procedures Act (APA) based on the FDA’s having entered into a Memorandum of Agreement with a tobacco manufacturer was dismissed by a federal district court in Florida due to lack of subject matter jurisdiction. Article III standing requires a showing of the elements of causation and redressability, neither of which were sufficiently alleged in the complaint, which relied upon mere speculation as to what the manufacturer would have done in response to an FDA Warning Letter if it had not entered into the Memorandum of Agreement (Sproule v. FDA, April 13, 2018, Rosenberg, R.).
Background. Santa Fe Natural Tobacco Company, Inc. (Santa Fe) manufactures and markets Natural American Spirit cigarettes which are labeled and advertised as "Natural," "Additive Free," "100% Additive Free," and "Organic," all terms that suggest the cigarettes carry health benefits and reduced risk. Santa Fe never submitted an application for a "modified risk tobacco product." In August, 2015, the FDA issued a Warning Letter to Santa Fe stating that the FDA had determined that the cigarettes were modified risk tobacco products and were being sold or distributed without FDA authorization.
In January 2017, the FDA and Santa Fe entered into a Memorandum of Agreement which provided that the FDA would not initiate an enforcement action as long as the cigarettes were not advertised as "natural" or "additive free," but that Santa Fe could continue to use the term "Natural" in the Natural American Spirit brand name and trademarks. The citizen’s complaint alleged that the FDA action effectively authorized Santa Fe to sell and distribute a modified risk tobacco product without going through any of the procedures mandated by the Family Smoking Prevention and Tobacco Control Act. For the reasons cited below, the court granted the FDA’s motion to dismiss.
Defining ‘modified risk tobacco products.’ The Family Smoking Prevention and Tobacco Control Act provides that the FDA is responsible for regulating the tobacco industry, including modified risk tobacco products. As defined by the Act, a modified risk tobacco product is any tobacco product that is sold or distributed for use to reduce the harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
Included in the definition is a tobacco product whose label, labeling, or advertising represents explicitly or implicitly that the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products. Based on the definition, the FDA determined that the cigarettes were modified risk tobacco products because the product labeling represented explicitly and/or implicitly that the products or their smoke did not contain, or were free of, a harmful substance and that the products presented a lower risk of tobacco-related disease or were less harmful than other cigarettes.
Requirement of FDA application. The court cited the portion of the Act which provides that "No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product" without first submitting an application to and obtaining authorization from the FDA. (21 U.S.C. § 387k(a)). The FDA may not provide authorization without first reviewing the application and making certain findings that the applicant has demonstrated that such product will: (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and, (B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
Causation and redressability. The court next examined the elements of Article III standing to sue with particular emphasis on ‘causation’ and redressability’. The citizen was required to show that: (1) he suffered an injury in fact that was (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical; (2) that the injury was fairly traceable to the challenged action of the FDA; and (3) it was likely, as opposed to merely speculative, that the injury would be redressed by a favorable decision.
Although the citizen argued that he had clearly pleaded sufficient facts to establish standing by alleging an injury in fact in the deprivation of information to which he, an interested member of the public, was entitled, the court determined that it was not necessary to decide whether his pleading sufficiently alleged an injury in fact because he had not sufficiently alleged either causation or redressability, and accordingly, lacked standing to sue.
Redress for the claimed injury. The element of redressability requires a substantial likelihood that the relief requested will redress the injury claimed. Therefore, the citizen needed to allege facts showing that, if the Memorandum of Agreement were to be set aside, there was a substantial likelihood that Santa Fe would submit a modified risk tobacco product application. However, the court found that although it was possible that Santa Fe might have submitted an application for a modified risk tobacco product, they might instead have changed their labeling and advertising to avoid the application process and to avoid penalties. Or, they might even have taken no action at all, in response to which the FDA may or may not have initiated an enforcement action or pursued other penalties.
In the absence of the elements of causation and redressability the court found that the citizen lacked standing to sue, and the FDA’s motion to dismiss was granted.
The case is No. 9:17-cv-80709-RLR.
Attorneys: Jonathan Gdanski (Sheldon J. Schlesinger PA) for Justin Sproule. Natalie N. Sanders, U.S. Department of Justice, for U.S. Food and Drug Administration and U.S. Department of Health and Human Services.
Companies: U.S. Food and Drug Administration; U.S. Department of Health and Human Services
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