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Agustin Rodriguez

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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.

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Over the past decade, at least five states and hundreds of localities have passed, or attempted to pass, laws banning flavored tobacco products. To date, litigants have brought many challenges to these laws, often arguing that such bans are preempted under the federal Family Smoking Prevention and Tobacco Control Act (TCA). This argument, however, has largely proven unsuccessful — a trend that continued in January when the U.S. Supreme Court declined to hear R.J. Reynolds Tobacco Company’s challenge to California’s ban on the sale of flavored tobacco products.

We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar bills have been introduced in Arizona, Hawaii, Iowa, Nebraska, New York, South Carolina, South Dakota, Vermont, Washington, and West Virginia. Additionally, a bill in Oklahoma would update the state’s existing directory framework to be consistent with the proposals of these recent bills. The directories would allow states to prohibit the sale of vapor products that are not authorized by the U.S. Food & Drug Administration (FDA) or subject to a pending premarket application. Like the proposals discussed in our previous coverage, these bills are intended to reduce the proliferation of illicit vapor products.

In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA) marketing denial order (MDO) of petitioner’s premarket tobacco applications (PMTAs) violated the Administrative Procedure Act (APA).

The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in the Commonwealth. The regulations are largely similar to those that existed under the Board of Pharmacy, but they bring the Commonwealth one step closer to opening applications for the state’s single unlicensed health service area (HSA).

Recently enacted Pennsylvania Senate Bill 773 (SB773) introduces several amendments intended to expand opportunities and increase competition among existing cannabis licensees in Pennsylvania. The bill seeks to support independent licensees in the state and is a response to the consolidation among licensees that many states have seen as state-legal marijuana operators struggle under the weight of federal prohibition and competition from the unregulated marketplace.

This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory bills would create a mechanism for states to bar the sale of products that are not FDA-authorized or subject to a pending premarket application. Like state cigarette directories implemented in connection with the tobacco Master Settlement Agreement, these directories would specify which vapor products are permitted to be sold in the state.

We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual regulation and policy guidance agenda, which “outlines rules and guidance documents that are in development or planned for development.” Below, we discuss CTP’s current priorities for new regulations. CTP’s policy agenda is important because it identifies the areas CTP views as most in need of regulation or guidance, and the key actions it plans to take in those areas.

The U.S. Department of Health and Human Services (HHS) has drawn criticism for heavily redacting a recommendation letter to the U.S. Drug Enforcement Administration (DEA) concerning the rescheduling of cannabis. HHS said the redactions were justified under Exemption 5 of the Freedom of Information Act (FOIA), which protects inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency. As Stephen C. Piepgrass, Agustin E. Rodriguez, Jean Smith-Gonnell, and Cole White noted in a recent article published by Law360, this has sparked debates about the balance between necessary secrecy and the public’s right to government information. Legal challenges to these redactions are expected. The deliberative process privilege, which safeguards deliberative discussions within government corridors, is often invoked in the context of FOIA.

In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent focus, the letters target unauthorized products, which FDA states are particularly appealing to youth — including Lost Mary, Funky Republic/Funky Lands, and Elf Bar/EB Design. These warning letters follow FDA’s recent issuance of civil money penalty complaints against 25 brick-and-mortar retailers for failing to comply with prior warning letters. Those civil money penalty complaints, which we previously discussed here, continued the agency’s approach of seeking the maximum penalty approved by law.

Despite the federal ban on the sale, use, and possession of cannabis in the U.S., in October, Georgia became the first U.S. state to allow pharmacies to sell low-dose tetrahydrocannabinol (THC) products. Pursuant to statutes passed by the Georgia General Assembly in 2019, certain Georgia pharmacies approved by the Georgia Board of Pharmacy, are permitted to sell low-dose THC products containing up to 5% THC, the intoxicating component found in the cannabis plant. The 5% cap is far lower than the allowable THC levels in most states.