Warning Letter — Public Health Solution LLC dba DrMedHealth
The FDA issued a warning letter to Public Health Solution LLC (dba DrMedHealth) on June 8, 2026, regarding the marketing of products that the agency classifies as unapproved new drugs.
The warning letter affects Public Health Solution LLC (dba DrMedHealth) and its regulatory, quality assurance, and marketing departments responsible for product claims and distribution.
This action indicates that the FDA's Center for Drug Evaluation and Research is actively monitoring online retailers and healthcare solution providers for therapeutic claims that bypass the formal drug approval process. For regulatory professionals, this underscores the risk of 'doing business as' (dba) entities being targeted for enforcement when their promotional language suggests a product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease without an approved NDA or ANDA.
Review all digital marketing materials and product listings for unauthorized health claims that may categorize a product as an unapproved new drug. Ensure that any product marketed for a therapeutic benefit has the requisite FDA approval or conforms to an applicable monograph.
FDA Warning Letter issued to: Public Health Solution LLC dba DrMedHealth. 06/08/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/public-health-solution-llc-dba-drmedhealth-728278-06082026
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