FDA WARNING_LETTER - Ar-Rahman Pharm LLC - September 09, 2021

The FDA issued a Warning Letter to Ar-Rahmah Pharm after reviewing their website and social media in August 2021, determining their "Diabetes Support" product is an unapproved and misbranded new drug. The product is marketed with claims such as "assists in keeping blood sugar at an optimum level" and "helps to balance blood glucose levels," which establish its intent for disease treatment, making it a drug under 21 U.S.C. 321(g)(1)(B).

Since the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" (21 U.S.C. 321(p)) and requires prior FDA approval, which it lacks, violating 21 U.S.C. 331(d) and 355(a). Furthermore, the product is misbranded under 21 U.S.C. 352(f)(1) because it lacks adequate directions for use by a layperson, as diabetes treatment requires professional supervision. This misbranding violates 21 U.S.C. 331(a).

The company must respond within 15 working days, detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and injunction. The Federal Trade Commission (FTC) also issued a cease and desist demand, stating that advertising claims must