Warning Letter — Maximus Health, Inc. dba Maximus
The FDA issued a warning letter to Maximus Health, Inc. dba Maximus following an evaluation by the Center for Drug Evaluation and Research (CDER).
This action affects Maximus Health, Inc., its regulatory and compliance departments, and potentially other firms engaged in the distribution of products making medicinal or therapeutic claims.
The involvement of CDER suggests concerns regarding the marketing of unapproved new drugs or misbranded products. This enforcement action indicates that the company's product positioning likely crossed the threshold from general wellness into regulated drug territory without necessary agency oversight. Regulatory teams should interpret this as a signal of continued FDA scrutiny over digital health and wellness platforms that facilitate access to therapeutic interventions.
Review all digital marketing materials and product listings for unapproved therapeutic claims. Ensure that any drug products distributed have been subject to the appropriate FDA approval process and listing requirements.
FDA Warning Letter issued to: Maximus Health, Inc. dba Maximus. 06/08/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maximus-health-inc-dba-maximus-730095-06082026
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