Warning Letter — Naveh Pharma LTD/Bigdam Inc.
The FDA issued a warning letter to Naveh Pharma LTD and Bigdam Inc. regarding the marketing of products that the agency considers unapproved new drugs and misbranded.
This affects the named entities, their distribution partners, and companies marketing similar products who must ensure compliance with FDA drug registration and labeling requirements.
The issuance of a warning letter by CDER indicates that the FDA has identified significant violations regarding how products are represented to consumers. For industry, this suggests a continued focus on enforcement against products marketed with therapeutic claims that lack formal FDA approval or clearance. Regulatory teams should interpret this as a signal that the agency is monitoring digital and physical labeling for deviations from established drug definitions.
Conduct a comprehensive audit of all product listings and marketing claims to ensure they align with approved indications. Verify that any product marketed as a drug has a valid National Drug Code (NDC) and meets all CGMP and labeling requirements.
FDA Warning Letter issued to: Naveh Pharma LTD/Bigdam Inc.. 05/04/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naveh-pharma-ltdbigdam-inc-724669-05042026
Open in openFDA / FDA.gov