Western Herb Products, Inc.
FDA issued a warning letter to Western Herb Products, Inc. (Index, WA) following a May 2021 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations including failures to establish adequate specifications, master manufacturing records, and batch production records for their Wormwood/Aloes dietary supplement capsules. Additionally, the product's labeling was found to be misbranded on multiple grounds, including incorrect plant part declarations, non-compliant Supplement Facts formatting, failure to declare common ingredient names, and use of 'approximately' in net quantity statements. FDA required a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.
Flagged claims (2)
Artemisia absinthium and Aloe ferox are not the standardized common names for these dietary ingredients.
This package contains approximately 300 "00" capsules.
Required actions (3)
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.
The plant part declared on the product label must be consistent with the actual plant part identity as indicated on the specification sheet.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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