The Supreme Court held that retailers who would sell a new tobacco product if not for the FDA's denial order may seek judicial review of that order under 21 U.S.C. §387l(a)(1). The Court affirmed the Fifth Circuit's denial of the FDA's motion to dismiss or transfer the case for lack of venue, finding that retailers are "adversely affected" by a denial order and are therefore proper petitioners under the statute.

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The law often draws fine lines that can mean the difference between freedom and prison, and the Supreme Court just drew one of those lines in a case called Esteras versus United States. The ruling doesn't create technical traps for judges but ensures they apply the law as Congress intended, with appropriate review by appellate courts when mistakes occur.

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The heart of this decision turns on a fine line in federal drug rules—does simply handing out samples count as selling drugs to a non-patient? A group of chiropractors, who received free medicine samples to give directly to their patients, said “no.” The FDA’s rule says drug distributors must register and meet certain safety steps if they sell to anyone other than the patient. But these clinics never bought or sold the drugs at all. They only received samples from drug companies.

music for the podcast provided by ⁠⁠⁠⁠⁠⁠ Dimitry Taras