A1 Top World Products LLC – FDA Warning Letter, Sep 24, 2018

The FDA issued a Warning Letter to A1 Top World Products, LLC, following a September 2018 inspection and review of product labels and website. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act. Several products, including Doctor’s Hawaiian Noni Once A Day and Doctor’s SuperBone, are deemed unapproved new drugs due to therapeutic claims on the company's website, indicating intent for disease treatment or prevention. Introducing these without FDA approval violates sections 201(g)(1)(B), 201(p), 301(d), and 505(a) of the Act. The firm's dietary supplements are also adulterated under section 402(g)(1) due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111), specifically failing to establish label specifications (21 CFR 111.70(d)) and lacking written procedures for holding and distributing operations (21 CFR 111.453). The FDA emphasized the firm's ultimate responsibility for CGMP compliance. Furthermore, numerous dietary supplement products are misbranded under section 403 of the Act, failing to meet 21 CFR Part 101 labeling requirements. Deficiencies include missing manufacturer information, absent iron warning statements, incomplete bilingual labeling, undeclared common ingredient names, non-compliant nutrition information, incorrect serving sizes, unidentified botanical plant parts, and missing disclaimers for structure/function claims. Additional labeling issues like improper statement of identity formatting and ingredient misspellings were also cited. The FDA requires prompt corrective action and a written response within fifteen working days, detailing steps taken and preventative measures. Non-compliance could result in legal action, including seizure and injunction, and re-inspection fees.