FDA WARNING_LETTER - Nutrishop

The FDA issued a Warning Letter to Joseph D' Arpa, owner of Nutrishop of Brick, Inc., regarding "Zi Xiu Tang Bee Pollen" sold through websites and retail stores. FDA analysis confirmed the product contains undeclared sibutramine and phenolphthalein. Sibutramine, an active ingredient in the withdrawn drug Meridia, poses risks of heart attack and stroke, while phenolphthalein is a potential carcinogen. The FDA determined the product is an unapproved new drug (21 U.S.C. §§ 355(a), 331(d)) and a misbranded drug (21 U.S.C. §§ 352, 331(a)). It is excluded from the dietary supplement definition (21 U.S.C. § 321(ff)(3)(B)(ii)) and is classified as a drug (21 U.S.C. § 321(g)(1)) due to its intended uses, including disease treatment and affecting body function, as evidenced by various health claims on its labeling. Furthermore, it is a new drug (21 U.S.C. § 321(p)) not generally recognized as safe and effective. The product is misbranded because its labeling lacks adequate directions for use (21 U.S.C. § 352(f)(1)), contains false/misleading safety statements, fails to reveal material facts (21 U.S.C. § 352(a)), lacks adequate warnings (21 U.S.C. § 352(f)(2)), and is dangerous to health (21 U.S.C. § 352(j)). The firm was aware of potential undeclared ingredients through prior import refusals. Nutrishop of Brick, Inc. must promptly correct all violations and respond within 15 working days, detailing corrective actions and providing documentation, to avoid potential enforcement actions like product seizure or injunctions.