FDA WARNING_LETTER - Meta Labs Pharmaceuticals LLC - December 18, 2025

Meta Labs Pharmaceuticals, LLC, located in Roswell, Georgia, received a formal warning letter from the FDA following an inspection conducted between December 8 and December 18, 2025. The agency identified several significant violations of the Federal Food, Drug, and Cosmetic Act regarding the company"s marketing and manufacturing practices.

The FDA determined that Meta Labs marketed several products—including Diabetic Advantage, Yacon Root Extract, Nattokinase Max, and Respiratory Response—with health claims that classify them as unapproved new drugs. These products were promoted for treating serious conditions such as diabetes, heart disease, and viral infections. Because these medical conditions require professional supervision, the products are considered misbranded as they lack adequate instructions for safe consumer use.

Furthermore, the inspection revealed serious failures in meeting manufacturing quality standards. The company failed to establish necessary specifications for finished products and raw ingredients, lacked complete manufacturing and batch production records, and failed to perform essential identity testing on ingredients. Additionally, the firm’s quality control processes were deemed inadequate because they relied on subjective comparisons rather than standardized laboratory testing.

The FDA requires Meta Labs Pharmaceuticals to respond within 15 working days. This response must detail the specific corrective actions taken to resolve these violations and provide documentation to ensure future compliance. Failure to address these concerns adequately may result in legal action, including product seizures or injunctions.