See the attached link (http://bit.ly/2C9ZESO) regarding an FDA announcement made yesterday (2/20/18) about a potential Salmonella outbreak related to kratom (Mitragyna speciosa) products. ...
This announcement concerns a multistate foodborne outbreak potentially related to a product that has been marketed and sold as a dietary supplement.
There are very serious Food Safety Modernization Act (FSMA) implications that we want you to be aware of.
This outbreak was posted to the CBS news website (http://cbsn.ws/2GxUPBb) at 3:15 pm MST yesterday and therefore it may also make it to the evening news and other media outlets in the days ahead.
The story was reported by the Washington Post this morning (http://wapo.st/2EG7QIk ) with the headline “CDC warns about salmonella infections traced to kratom”. Within the article the WP reporter writes:
“The Centers for Disease Control and Prevention, the Food and Drug Administration and several states are investigating an outbreak of salmonella illness linked to kratom, an unregulated herbal supplement that is sometimes used for pain, anxiety and opioid-withdrawal symptoms, the CDC said Tuesday.”
As a reminder, in an ongoing effort to support the sale of safe and responsible products, UNPA enacted a trade policy as a condition of membership, effective May 1, 2014, that states UNPA members will not engage in the sale, distribution or marketing of any products that contain kratom for human use or consumption.
This food outbreak investigation appears to include 20 states with 28 people infected to date. Eleven of those who became ill were hospitalized. Eight of the 11 (73%) of those interviewed by FDA report taking a product containing kratom in the form of pills, capsules, powder or tea prior to the onset of symptoms. No specific brand has been identified at this time. Whole genomic sequencing is being used in this investigation, and it appears a rare form of Salmonella is common among these consumers.
FDA currently prohibits the use of kratom in a dietary supplement. Per its web page titled, “FDA and Kratom” (http://bit.ly/2E5DsXj):
“There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom.”
However, since this ingredient is of botanical origin, the investigation has a deeper impact on safety of dietary supplement products than the use of a prohibited ingredient alone. This may signify a microbiological hazard reasonably likely to occur in a botanical ingredient and therefore in a finished good.
As a part of FSMA, the Preventive Controls for Human Food rule requires a manufacturer to evaluate the hazards reasonably likely to occur. Hazards may be introduced from the raw materials, during the manufacturing process and from exposure to the environment and employees.
With this news today, a Preventive Control Qualified Individual (PCCQI) might consider this biological hazard (Salmonella) when building a Food Safety Plan for a botanical ingredient or finished product.
This could be a meaningful consideration for dietary supplement ingredient suppliers and manufacturers when developing a Food Safety Plan. A written hazard analysis is required under the FSMA Preventive Control for Human Food rule (21 CFR Part 117). If a hazard is identified, a Food Safety Plan is required to be written, implemented, and monitored by a PCQI to reduce or eliminate the hazard.
Salmonella can survive in dry environments and in powders. Once ingested it can cause the symptoms of salmonellosis, including fever, abdominal cramps and diarrhea.
This outbreak investigation is ongoing.
If you have any questions or concerns, please feel free to contact me.