Photo of Agustin Rodriguez

Agustin Rodriguez

Subscribe to Agustin Rodriguez's Posts

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing practices. A partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco and Cannabis law practices, he represents manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving federal or state governmental entities, mergers and acquisitions, commercial agreements, and taxation matters.

Contact:Read more about Agustin Rodriguez

On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the products), but also by retailers who would sell such products. As a result, more challenges to MDOs are likely to be brought before the U.S. Court of Appeals for the Fifth Circuit, where litigants have generally had greater success to date in challenging MDOs relative to other appellate courts.

Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The law, enacted through HB 916, creates separate directories for cigarettes, including roll-your-own (RYO) tobacco, and Electronic Nicotine Delivery Systems (ENDS) products, such as e-cigarettes and vapes.

We previously wrote about this case last January, here and here, when Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal district court against the Iowa Department of Revenue (the Department), challenging Iowa House File 2677 (HF 2677), a law imposing certification and directory requirements on vapor products sold in Iowa. On May 2, the court granted plaintiffs’ motion for preliminary injunction and enjoined the Department from implementing and enforcing HF 2677’s vapor product directory provisions. The court held that the Department could, however, continue to enforce the provisions of HF 2677 requiring nonresident vapor product manufacturers not registered to do business in the state as a foreign corporation or business entity to appoint and continually engage an agent for service of process. The parties have a status conference before the court scheduled for May 29.

Our colleagues recently wrote about 14 memoranda from the new U.S. Attorney General (AG) Pam Bondi to Department of Justice (DOJ) employees framing the DOJ’s current policies and enforcement priorities. In a memorandum addressing DOJ’s general charging, plea bargaining, and sentencing policy, the AG stated the following: “To free resources to address more pressing priorities, the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) shall shift resources from its Alcohol and Tobacco Enforcement Programs to focus on matters relating to the other priorities set forth herein. No resources shall be diverted from the ATF’s regulatory responsibilities, such as federal firearms licenses and background checks.”

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be revived under a future administration, the withdrawal ends both of the current rulemaking processes. The move also strongly indicates shifting FDA priorities under the second Trump administration. Amid these changes, industry may find the agency more receptive to its arguments — particularly those submitted in comments to proposed rulemaking.

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). As we have previously discussed here and here, FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium cigars to the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act (TCA). On January 24, the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit) issued an opinion agreeing[1] with (i) the district court’s ruling that FDA acted arbitrarily and capriciously when it sought to include premium cigars in its Deeming Rule and (ii) the district court’s vacatur of the Deeming Rule as applied to premium cigars, but it remanded the case to the district court to determine the appropriate definition of “premium cigar.” Now, the district court will reconsider the appropriate definition of “premium cigar,” which will ultimately determine the types of cigars that are not subject to the TCA and FDA’s Deeming Rule. In one potential setback for industry, the D.C. Circuit also stated that it understood the district court’s order as granting relief from user fees prospectively but that it does not read it as permitting the refunding of past user fee payments.

On January 7, the U.S. Court of Appeals for the Fourth Circuit found that Virginia’s hemp product restrictions do not violate federal law. The ruling is the latest defeat for the Virginia hemp industry’s efforts to overturn Virginia S.B. 903, a law intended to prohibit the sale of intoxicating hemp products like delta-8 and delta-10 tetrahydrocannabinol (THC) gummies and beverages in the Commonwealth.