Natural Relief Inc.
FDA issued a warning letter to Natural Relief Inc. (owner Omar Ashraf, Coshocton, OH) following a March–April 2023 facility inspection and June 2023 website review, finding that two products — Edema NatRelief 6 and BP NatRelief 11 — were marketed with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to extensive CGMP violations including absent specifications, inadequate quality control procedures, and deficient manufacturing records. FDA warned that failure to adequately address these violations may result in seizure and injunction, and required a written response within 15 working days.
Flagged claims (3)
Edema NatRelief…
Coriander seed have been actively investigated for their chemical composition and biological activities including antimicrobial, antioxidant, hypoglycemic, hypolipidemic, anxiolytic, analgesic, anti- inflammatory, anti-convulsant and anti-cancer activities *. The seeds of coriander also have a remarkable hypolipidemic action. The levels of total cholesterol and triglycerides decreased significantly….
Helps relieve mild joint inflammation and swelling
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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