FDA WARNING_LETTER - Natural Relief Inc. - April 14, 2023

The FDA inspected NatRelief's facility from March 14 to April 14, 2023, and reviewed their website, identifying serious violations. The products Edema NatRelief 6 and BP NatRelief 11 are deemed unapproved new drugs and misbranded. Claims on the website establish them as drugs intended for disease treatment, making them "new drugs" requiring FDA approval, which they lack. BP NatRelief 11 is also misbranded as it lacks adequate directions for layperson use, being a prescription-only drug.

Furthermore, even if not unapproved drugs, these products are adulterated dietary supplements due to serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111. Violations include failure to establish specifications for components (identity, purity, strength, contamination limits), in-process specifications (e.g., particle size), and finished product specifications. The company also failed to establish and follow written procedures for quality control operations, master manufacturing records, batch production records, holding and distribution, returned dietary supplements, and equipment cleaning/sanitizing.

Additionally, Edema NatRelief 6 and BP NatRelief 11 are misbranded dietary supplements under section 403 of the Act due to incorrect serving sizes and improper nutrition information presentation on labels. The FDA noted the company's May 5, 2023, response was insufficient as it lacked