FDA WARNING_LETTER - Shreeji Homeo Clinic

On January 26, 2010, the FDA reviewed www.shreejihomeoclinic.com and determined the website offers unapproved products, "Swine Flu Drops" and "Immune Drops" (marketed as a combo pack), intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. This violates the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331 and 352.

The FDA cited claims such as "[I]t is homeopathy medicine for SWINE FLU," "[I]t is helpful in curing patients & helpful in prevention by improving immunity in natural way," and specific symptom relief claims for "SWINE FLU DROPS" and "IMMUNE DROPS."

Due to a nationwide H1N1 public health emergency, the FDA's enforcement discretion for homeopathic drugs under CPG 7132.15 does not apply to these unapproved products. The FDA requires immediate cessation of marketing these products. The firm must email FDAFLUTASKFORCECDER@fda.hhs.gov within 48 hours detailing corrective actions. Failure to comply may result in enforcement actions like seizure, injunction, or criminal prosecution. The firm will be added to a public list of non-compliant companies. Unapproved products offered for import into the U.S. are subject to detention.