Warning Letter — Aja Health and Wellness Inc.
The FDA issued a Warning Letter to Aja Health and Wellness Inc. following an evaluation by the Center for Drug Evaluation and Research (CDER).
This affects Aja Health and Wellness Inc., specifically their regulatory compliance, marketing, and quality departments responsible for product labeling and therapeutic claims.
While the source provides limited detail regarding specific product names, the involvement of CDER suggests the products are being marketed with claims that categorize them as drugs under the FD&C Act. For regulatory professionals, this underscores the FDA's continued scrutiny of the 'wellness' sector when it crosses into therapeutic or disease-related claims without proper drug approvals.
Review all digital marketing, social media, and product labeling to ensure health-related claims do not qualify the product as an unapproved new drug. Audit website copy for language that implies a product can treat, cure, or prevent disease.
FDA Warning Letter issued to: Aja Health and Wellness Inc.. 05/18/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aja-health-and-wellness-inc-729644-05182026
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