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Nefeteri Wellness was warned for marketing two unapproved drug products—"LOTUS FRESH™ intimate/flora gel" and "LOTUS FRESH™ v-gel moisturize & balance"—without FDA approval in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made drug claims on its website and product labeling indicating the gels were intended to treat yeast infections, bacterial vaginosis, and pH imbalance through antimicrobial properties, thereby establishing them as drugs requiring pre-market approval rather than cosmetics or dietary supplements. The products were being sold directly to consumers without a prescription through the website thelotusfreshline.com, and the FDA's Office of Unapproved Drugs and Labeling Compliance determined the company had introduced these unapproved new drugs into interstate commerce.