Court Dismisses Lawsuit over FDA’s Ban of Flavored Rolling PapersDecember 13, 2009
By Ricardo Carvajal –
FDA has prevailed on summary judgment in a lawsuit brought by BBK Tobacco & Foods, LLP ("BBK") which sought a declaration that separately sold flavored rolling papers are not tobacco products subject to regulation under the FDCA. Previously, FDA issued a draft guidance document and sent a letter to industry stating the agency’s belief that flavored rolling papers are banned by the FDCA as amended by the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"). BBK challenged FDA’s interpretation of the statute, and alleged that FDA’s actions had caused customers to stop buying BBK’s products.
The court ruled that the issues presented by BBK were not ripe for judicial review because FDA’s actions were not final agency action. The court noted that no legal consequences flow from FDA’s publication of guidance. Further, the court found that the hardship suffered by BBK had been largely the result of its own voluntary decision to stop distributing its products on the effective date of the Tobacco Act, and of BBK customers’ voluntary decisions to return BBK products. FDA had taken no action that specifically targeted BBK or its products. The court further ruled that BBK had failed to exhaust its administrative remedies because it had not filed a citizen petition with FDA seeking a “formal determination of whether the Tobacco Act applies to BBK’s products.”
The moral of the story? If an FDA draft guidance suggests that your product is unlawful, you'll need to file a citizen petition and/or face a warning letter or injunction before you can get judicial relief.