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WARNING LETTER
•Wild Arabic Herbs•May 1, 2026

Wild Arabic Herbs – FDA Warning Letter, May 1, 2026

Record Details

The U.S. Food and Drug Administration (FDA) issued a warning letter to Wild Arabic Herbs on June 17, 2026, following a review of the company’s website conducted in May 2026. The FDA determined that the firm is marketing a product named "Edral-17t" as an unapproved new drug, which violates the Federal Food, Drug, and Cosmetic Act. According to the letter, the company"s website promoted "Edral-17t" as a treatment for serious medical conditions, including prostate and testicular cancers. The marketing materials claimed the product possessed anticancer and anti-metastatic effects, such as inhibiting tumor cell growth and preventing the spread of malignant cells. Under federal law, products intended to treat or prevent disease must be proven safe and effective through an FDA approval process before they can be sold. Because "Edral-17t" lacks such approval, its distribution is considered a violation of federal safety standards. The FDA has instructed Wild Arabic Herbs to immediately address these violations and investigate the underlying causes of the non-compliance. The company must provide a written response within 15 business days detailing the specific steps taken to correct the issues and prevent their recurrence. Failure to comply with these requirements may lead to regulatory actions, such as the seizure of products or legal injunctions.

Company
Wild Arabic Herbs
Inspection date
May 1, 2026
Product type
drugs
Office
Office of Unapproved Drugs & Labeling Compliance
Person
  • Tina Smith (Director)
View Company Profile

ID · d05a4b1d-d90c-403f-8b83-d62cd2dead85

Violation Codes10
21 CFR 201.12821 U.S.C. 355FD&C Act 201(p)(1)FD&C Act 201(g)(1)FD&C Act 301(d) of the FD&C Act21 U.S.C. 331(e)FD&C Act 505FD&C Act 505(a)21 U.S.C. 321(p)21 U.S.C. 355(a)

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