Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC have filed a law suit against the FDA on June 1, 2016. In this complaint, the Plaintiffs are suing in there official capacity, Defendant Robert Califf, M.D., Commissioner of Food and Drugs who is the senior official of the FDA, and Defendant Sylvia Mathews Burwell, Secretary of Health and Human Services, the official charged by law with administering the Act.
The complaint alleges that the Plaintiffs will suffer immediate financial harm to their business, since all of their cigar products were launched after February 15, 2007. The complaint further alleges that Regulatory Flexibility Act (RFA), 5 U.S.C. §601 et seq., requires federal agencies to consider the impact of their regulatory proposals on small entities, and inter alia, to analyze effective alternatives that minimize small entity impacts. The complaint alleges that the FDA failed to properly fulfill this obligation. Because of this, Plaintiffs will be adversely affected and aggrieved by the Deeming Rules, which constitute final agency action. Therefore, Plaintiffs are entitled to a judicial review of the FDA compliance with the requirements of sections 601, 604, 605(b), and 610 in accordance with [5 U.S.C §701, et seq.]. 5 U.S.C § 611(a)
You can read the complete filing here.
I am sure this is the only the start of such law suits against the FDA. As member of the industry we encourage all involved to continue the fight, in every way possible, against the FDA’s overreach into the premium cigar industry.