Warning Letter — Momentum Health 360 dba Momentum Health
The FDA issued a warning letter to Momentum Health 360 dba Momentum Health following an evaluation by the Center for Drug Evaluation and Research (CDER). While specific product details are not fully detailed in the provided excerpt, the letter signifies documented violations of the Federal Food, Drug, and Cosmetic Act.
This affects Momentum Health 360 (dba Momentum Health) and internal departments responsible for drug marketing, labeling, and regulatory submissions.
The issuance of a CDER warning letter typically indicates that a firm is marketing products with therapeutic claims that lack substantiated safety and efficacy data or valid marketing authorization. This serves as a reminder that the FDA actively monitors firm operations and marketing claims even for entities that may not perceive themselves as traditional pharmaceutical manufacturers. Failure to remediate these issues can lead to secondary enforcement actions such as seizures or injunctions.
Regulatory and QA teams should conduct an immediate audit of all digital and physical marketing materials to ensure no unapproved claims are made that could reclassify a product as an unapproved new drug. Verification of current drug listing and registration status is essential for any products marketed for therapeutic use.
FDA Warning Letter issued to: Momentum Health 360 dba Momentum Health. 06/08/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/momentum-health-360-dba-momentum-health-728286-06082026
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