FDA WARNING_LETTER - Amrutam Life Care Pvt. Ltd.

The FDA issued a Warning Letter to Amrutam Life Care Pvt. Ltd. after reviewing their website, www.amrutamlifecare.com, for products "Diexi," "Zoom-Zooma-Zoom" ("Zoom"), "Arexi," "Allexi," "Cholexi," and "Obexi."

Laboratory analyses confirmed "Diexi" contains undeclared metformin (API in Glucophage, approved for type 2 diabetes) and "Zoom" contains undeclared sildenafil (API in Viagra, approved for erectile dysfunction). Since neither metformin nor sildenafil were marketed as dietary supplements or foods prior to their drug approvals, "Diexi" and "Zoom" are excluded from the dietary supplement definition. Labeling claims for "Diexi" and "Zoom" indicate they are drugs intended for disease treatment or affecting body function, making them unapproved new drugs and misbranded. They are also prescription drugs, requiring professional supervision, and lack adequate directions for lay use. The undeclared APIs pose serious health risks due to potential adverse effects and drug interactions (e.g., lactic acidosis with metformin, dangerous blood pressure drop with sildenafil and nitrates). Marketing these products as "all-natural" and "safe" without disclosing these APIs renders their labeling false and misleading, and misbranded due to lack of adequate warnings.

Additionally, "Arexi," "Allexi," "Cholexi," and "Obexi" are marketed