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Shaman Botanicals, LLC was cited for manufacturing and distributing two dietary supplement products (7OH + Pseudoindoxyl Green Vein Chewable Tablets and 7-OH White Vein Chewable Tablets) containing 7-hydroxymitragynine (7-OH) as a declared ingredient. The products violated the Federal Food, Drug, and Cosmetic Act because 7-OH is classified as a "new dietary ingredient" that was not marketed in the United States before October 15, 1994, and the company failed to provide adequate safety information to demonstrate that the ingredient does not present a significant or unreasonable risk of illness or injury. FDA expressed serious concerns about the ingredient's lack of safety evaluation, reported opioid-like effects, and adverse event reports associated with 7-OH products in the marketplace.