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Assault Labs was cited for marketing Wild Thing Tropical Tornado flavor as a dietary supplement containing hordenine HCl and higenamine HCl, which do not qualify as valid dietary ingredients under the Federal Food, Drug, and Cosmetic Act. The FDA determined these substances are unapproved food additives that lack Generally Recognized as Safe (GRAS) status for their intended use, rendering the product adulterated and unsafe for interstate commerce. The company failed to establish that these ingredients met the statutory definition of dietary ingredients—which are limited to vitamins, minerals, amino acids, herbs, botanicals, or recognized dietary substances—or demonstrate premarket safety approval required for food additives.