What happened
Original notice title
Avalon Packaging MARCS-CMS 555500, November 08, 2018
From the archived source record
Based on the inspection and the samples collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Pathogen Findings During our inspection, FDA collected three raw kratom material samples intended to be used in your finished dietary supplement products containing kratom, which isolated several serotypes of Salmonella, a human pathogen. Based on the analytical results, these products are adulterated under section 402(a)(1) [21 U.S.C. § 342(a)(1)] of the Act, because they bear or contains a poisonous or deleterious substance which may render them injurious to health. Salmonella is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. FDA laboratory analysis of the three raw ingredient samples of kratom (Sample 1031137 of Red Maeng Da Kratom, 1031138 of White Maeng Da Kratom, and 1031139 of Green Maeng Da Kratom), collected on March 13, 2018, isolated several Salmonella spp in all three samples. Whole Genome Sequencing (WGS) analysis was conducted on the Salmonella spp isolates obtained from the three-raw ingredient kratom samples and WGS isolated thirteen (13) different strains of Salmonella in the three samples. WGS analysis of bacterial human pathogens provides high-resolution data, enabling links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. At this time, the comparison of WGS from the Salmonella isolates found in the raw ingredient kratom samples shows thirteen (13) strains of Salmonella present in the three samples: 1. Red Maeng Da Kratom: A Salmonella 14[5]12:b:- strain was isolated from your Red Maeng Da Kratom.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 936e9c84fd4d
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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