Bella’s Nutri Shop Inc. – FDA Warning Letter, Oct 1, 2026
In a warning letter dated October 26, 2026, the U.S. Food and Drug Administration (FDA) notified Bella’s Nutri Shop Inc. of significant violations identified during a review of their website and product samples in August 2026. The agency’s investigation focused on the product "Tawon Liar," which was found to be an unapproved new drug and misbranded under the Federal Food, Drug, and Cosmetic Act.
Laboratory analysis revealed that "Tawon Liar" contains hidden, undeclared pharmaceutical ingredients: dexamethasone (a steroid), tapentadol (a controlled opioid), and meloxicam ( a non-steroidal anti-inflammatory drug). These substances pose serious health risks to consumers, including potential respiratory failure, addiction, and heart complications, especially as they are not disclosed on the label. Additionally, the company marketed the product with therapeutic claims to treat medical conditions like gout and high cholesterol without the required FDA approval.
The FDA requires Bella’s Nutri Shop Inc. to immediately address these violations to ensure compliance with federal safety regulations. The company must provide a written response within 15 business days outlining the specific steps taken to correct the issues, a root cause analysis, and a plan to prevent recurrence. Failure to take prompt corrective action may lead to regulatory consequences, including product seizure or legal injunctions.
ID · 96f45386-8d48-4145-b581-24e1855a3b61
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