For agreeing not to challenge Natural American Spirit’s use of the word “Natural” in its product packaging and labeling, the U.S. Food and Drug Administration (“the FDA”) has been sued in the U.S. District Court for the Southern District of Florida. The case is Sproule v. U.S. Food & Drug Administration, et al., No. 9:17‑cv‑80709 (S.D. Fla.).


By way of background, the federal Family Smoking Prevention and Tobacco Control (“TCA”) bars firms from selling modified risk tobacco products (“MRTPs”) without an order from the FDA. An MRTP is “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” A product may be considered an MRTP if its labeling or advertising expresses or implies lower risk, less harm, or reduction or absence of any substance.

The issue traces back to an FDA warning letter dated August 27, 2015. The FDA took the novel position that use of terms such as “Natural” and “Additive Free” in labeling or advertising rendered such products MRTPs. The warning letter was resolved with the agreement that “Additive Free” would not be used in connection with Natural American Spirit. The word “Natural,” however, could continue to be used in Natural American Spirit’s brand names and trademarks.

Individual Plaintiff Sues the FDA

Plaintiff, a Floridian and self-professed smoker of Natural American Spirit cigarettes, asserts that “health descriptors like ‘Natural’ ‘Additive Free’ and ‘Organic’ are used to deceive consumers into thinking that [Natural American Spirit] cigarettes are safer or carry less risk of a tobacco-related disease than other cigarettes.”

So, why sue the FDA? According to Plaintiff, the agreement resolving the warning letter violated the federal Administrative Procedure Act (“APA”) insofar as the FDA effectively granted the right to sell MRTPs but without following relevant procedures.

Suing the FDA is not Plaintiff’s first bite at the apple. Plaintiff is also part of a class action against Natural American Spirit’s manufacturer, Santa Fe Natural Tobacco Co., and its parent company, Reynolds American, Inc., in the U.S. District Court for the District of New Mexico. That case is In re Santa Fe Natural Tobacco Co. Marketing & Sales Practices Litigation, No. 1:16-md-02695 (D.N.M.).

Plaintiff originally filed in the Southern District of Florida on September 30, 2015, but the case was transferred in connection with the multidistrict litigation. The Florida claims in the class action include

  • Florida Count I: Violation of Florida’s Unfair & Deceptive Trade Practices Act, Fla. Stat. § 501.201, et seq., on Behalf of the Florida Class and the Florida Menthol Subclass; and
  • Florida Count II: Unjust Enrichment on Behalf of the Florida Class and the Florida Menthol Subclass.

These claims stem from alleged deception and misrepresentation—according to Plaintiff, Natural American Spirit’s uses of the terms “Natural” and “Additive Free.”

What’s Next?

It remains to be seen how or when these cases will be brought to finality. There are significant pending issues, though.

In In re Santa Fe Natural Tobacco Co., Defendants have a Motion to Dismiss pending before the Court. An interesting link to the Sproule litigation (if not also its impetus), among the Motion’s grounds is a challenge to Florida Count I on the basis of federal “safe harboring” of the challenged descriptors.

As of this date, the Sproule case remains in its early stages, having only been filed on June 6, 2017. On July 14, 2017, the Judge ordered the parties to “jointly file written notice addressing (1) the relationship between this case and the case pending in the District of New Mexico and (2) the parties’ respective positions as to how to proceed with this case in light of that relationship, including but not limited to whether this case should be transferred to the District of New Mexico.” That response is due on July 21, 2017.

For that matter, it will also be interesting how the Judge addresses the jurisdictional issue of Plaintiff’s standing as his litigation against the FDA progresses. Cf., e.g., Sheller, P.C. v. U.S. Dep’t of Health & Human Servs., 663 F. App’x 150 (3d Cir. 2016) (holding that a plaintiff law firm lacked standing to sue the FDA over its not revoking approval of a drug that was the subject of litigation between the law firm’s clients and the drug’s manufacturer), cert. denied, 137 S. Ct. 2150 (2017).  Stay tuned for further developments.