FDA WARNING_LETTER - Kosher Vitamin Express - January 31, 2013

The FDA and FTC reviewed www.koshervitamins.com in January 2013, identifying products marketed as dietary supplements intended to diagnose, mitigate, prevent, treat, or cure the Flu Virus. These products, "Zahlers Kosher Abreve Advanced Cold & Flu Formula," "Sunshine Health Kosher Cold & Flu Support," and "Nutri-Supreme Research Kosher Cold & Flu Plus with Olive Leaf, Garlic and Oregano Extract," are unapproved/uncleared by the FDA for these uses.

Violations include marketing unapproved new drugs under 21 U.S.C. § 321(p) and 355(a), as they are not generally recognized as safe and effective for their claimed uses. Additionally, the products are misbranded under 21 U.S.C. § 352(f)(1) because they are offered for conditions not amenable to self-diagnosis/treatment, thus lacking adequate directions for layperson use. The introduction of misbranded drugs into interstate commerce violates 21 U.S.C. § 331(a).

The FDA requires immediate cessation of marketing these unapproved/uncleared products. The firm must respond within 15 working days via email (FDAFLUTASKFORCECFSAN@fda.hhs.gov) detailing corrective actions. Failure to comply may result in enforcement actions like seizure, injunction, or criminal prosecution. Imported