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Talk to a SpecialistTalk to a SpecialistRelax Relief Rejuvenate Trading, LLC was cited for marketing EDP 7OH Mitragyna Speciosa Extract 50 mg shot, a dietary supplement containing 7-hydroxymitragynine (7-OH), which the FDA classified as a new dietary ingredient lacking adequate safety data. The company violated the Federal Food, Drug, and Cosmetic Act by introducing an adulterated dietary supplement into interstate commerce, as 7-OH had not been marketed as a dietary ingredient in the United States before October 15, 1994, and no adequate information existed to demonstrate it does not pose significant health risks. The FDA expressed serious safety concerns regarding 7-OH products generally, including opioid-like effects and adverse event reports associated with such products.