The Food and Drug Administration sent warning letters recently to an egg producer and two kratom distributors, citing various violations of federal law. Company officials have 15 working days from receipt of FDA warning letters to respond and provide the agency with details on specific measures they are taking to correct violations.
Samuel Zimmerman, shell egg farm
Inspectors from the FDA visited an egg farm in Penn Yan, NY, on March 22-23 and found multiple violations regarding detection and prevention of Salmonella Enteritidis (SE), according to a warning letter dated Sept. 5. Posted by FDA in recent days, the warning letter cites multiple violations of federal food safety laws regarding the production, storage and transportation of shell eggs.
The violations at the Zimmerman egg farm involve provisions of the Public Health Service Act and the Food, Drug, and Cosmetic Act. Failure to comply with the acts means the farm’s eggs are considered adulterated and “may have been rendered injurious to health,” according to the warning letter.
Zimmerman could not document that the pullets he buys are SE monitored or raised under SE monitored conditions. Also, inspectors found that his SE Plan, which he picked up from his former egg distributor, has only “general information which is not specific to the operations or procedures of your farm, and does not adequately address all the required SE preventive measures.”
Inspectors reported significant violations involving:
- Biosecurity program;
- Rodents, flies, and other pest control;
- Procedures for cleaning and disinfecting the poultry house; and
- Documenting compliance with the refrigeration requirements.
“Your farm failed to use appropriate rodent monitoring methods,” FDA told Zimmerman in the warning letter.
“Specifically, your rodent monitoring procedures include only visual observation to monitor for rodents. Your rodent monitoring procedures do not establish thresholds to determine acceptable or unacceptable rodent activity within a poultry house. Further, they do not detail what appropriate corrective actions are to be taken when rodent activity is deemed to be unacceptable to achieve satisfactory rodent control.”
The same violation details apply to the farm’s monitoring and control of flies, the letter states.
Zimmerman also failed to test his laying hens for Salmonella Enteritidis at the required age of 40 to 45 weeks. Infected birds can create conditions in which eggs can become contaminated.
Kratom distributors
FDA Commissioner Scott Gottlieb reported this past week that the agency Sept. 4 warning letters went to “unscrupulous” internet vendors Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims.
Those claims involve using kratom as a treatment for ailments including, but not limited to, diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety and alcoholism.
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