Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
Passage 2Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.
Passage 3the FDA has observed that your website offers the products “Beam Suwa Dharani,” “Sethsuwa ‘Suwa Dharani’ Immune Enhancing Medicinal Drink,” “Siddhalepa Lakpeyawa,” “Siddhalepa Ayurveda Herbal Balm,” “Siddhalepa Cough Syrup,” “Siddhalepa Sarshapadi Oil,” “Siddhalepa Natural Asamodagam Spirit,” “Siddhalepa Kolaselesma Oil,” “Siddhalepa Live Long Healthy Pack,” and “Ceylon Teas” for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19***1*** in people.
Passage 4“Beam Suwa Dharani . . . [A]pproved by the ayurvedic Department of Health, an immune-enhancing drink for the COVID-19 virus based on ancient indigenous prescription and treatment extracted from ancient ola leaf booklets.”
Passage 5“Sethsuwa ‘Suwa Dharani’ Immune Enhancing Medicinal Drink . . . [A]pproved by the ayurvedic Department of Health, an immune-enhancing drink for the COVID-19 virus based on ancient indigenous prescription and treatment extracted from ancient ola leaf booklets.”
Passage 6“Covid 19 immunity boosting with ayurvedic products . . . Drink Siddhalepa Lakpeyawa twice a day to boost your immunity . . . Buy Siddhalepa Herbal Balm . . . Siddhalepa Cough Syrup for dry cough . . . Siddhalepa & Sharshapadi oil for respiratory discomforts . . . Gargle your throat thrice daily with Siddhalepa Asamodagam Spirit which has natural thymol derived from asamodagam seeds. Anticeptic [sic], antibacterial and antifungal activities of thymol helps [sic] to treat sore throat and minor oral inflammations . . . If you have symptoms of sore throat or throat infections, apply Kolaselesma oil on the sides of your neck . . . Energy booster – Siddhalepa healthy pack.”
Passage 7“While still in its preliminary findings, it has been noted that according to the latest research, the presence of theaflavin, a polyphenolic compound in black tea is said to have a medicinal value; thus acting as an inhibitor against several viruses, from influenza A and B, hepatitis C and even SARS-related viruses like COVID-19 . . . Shop online from our range of Ceylon black teas to reap the health benefits of this natural beverage.”