FDA WARNING_LETTER - Golden Lab LLC - November 10, 2021

The FDA conducted an inspection of Doctors Optimal Formula's facility in Jacksonville, Florida, in November 2021, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. Three products (DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule) are deemed unapproved new drugs due to disease treatment claims, violating 21 U.S.C. §§ 321(p), 331(d), and 355(a). Two of these are also misbranded as they lack adequate directions for use for conditions requiring professional supervision, violating 21 U.S.C. §§ 352(f)(1) and 331(a).

Additionally, the firm committed significant dietary supplement cGMP violations (21 CFR Part 111), rendering their dietary supplements adulterated (21 U.S.C. §342(g)(1)). Deficiencies included failure to establish finished product specifications (21 CFR 111.70(e)), failure to establish component specifications (21 CFR 111.70(b)(2)), and incomplete batch production records (21 CFR 111.255(b), 111.260). The company's responses to these observations were found insufficient. Furthermore, Hourzzz Sublingual Drops are misclassified as dietary supplements because sublingual products are not intended for ingestion (21 U.S.C. § 321(ff)(2)(A)(i)). The FDA requires a written response within 15 working days detailing corrective actions and prevention measures, warning that failure to comply may result in legal action, including seizure and injunction.