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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.

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.

The principle of open government is foundational to a healthy democracy, and the availability of government records upon request from the public is one of its chief cornerstones. In the U.S., the primary mechanism by which the public gains access to government records is the Freedom of Information Act (FOIA).[1] FOIA serves as a pivotal tool for ensuring governmental transparency by allowing the public to make requests to governmental entities to access specific government records.

Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an (indirect) effort to force them to comply with federal and state laws. R.J. Reynolds Tobacco Company and R.J. Reynolds Vapor Company (collectively, RJR) also recently filed a complaint with the U.S. International Trade Commission (ITC) against more than 25 foreign and domestic manufacturers, distributors, and retailers (collectively, the respondents) that seeks to prevent the import and resale of certain tobacco products. These lawsuits serve as two examples of how industry is trying to take independent legal action to target allegedly noncompliant actors and force them to comply with applicable law.

On October 2, the Virginia Board of Pharmacy posted a general notice indicating that it had voted to rescind the request for applications (RFA) for a Pharmaceutical Processor license in Health Service Area I. The RFA will now be conducted by the Virginia Cannabis Control Authority (the CCA) sometime after it assumes oversight of the state’s medical cannabis program on January 1, 2024.

In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products. Notably, FDA’s most recent letters target several popular disposable flavored products, including Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech, which FDA states are particularly appealing to youth. FDA also sought civil money penalties against 22 retailers for failing to comply with prior warning letters and, for the first time, sought the maximum penalty allowed by law.

State attorneys general (AG) are continuing their push for cannabis banking reform, underscoring the need for action to promote public health and safety in legal cannabis markets. On Wednesday, a bipartisan group of 22 state AGs sent a letter to Congress urging passage of the Secure And Fair Enforcement Regulation (SAFER) Banking Act, coinciding

The Senate Banking Committee is scheduled to mark up a new version of the SAFE Banking Act, now known as the “Secure And Fair Enforcement Regulation Banking Act” or the SAFER Banking Act (SB 2860). The revised bill addresses concerns around potential bad actors, but also establishes guardrails in the case that federal regulators may want to put pressure on banks to not service certain customers, such as “marijuana-related businesses” or other high-risk industries.