• Skip to primary navigation
  • Skip to main content
  • Skip to footer
Deibel Laboratories

Deibel Laboratories

Science you can trust from concept to consumer.

  • ABOUT US
    • MEET OUR STAFF
    • ACCREDITATION
    • TERMS AND CONDITIONS
  • SERVICES
    • TESTING SERVICES
      • MICROBIOLOGY
      • CHEMISTRY
      • BACTERIAL / FUNGAL IDENTIFICATION
      • ALLERGEN TESTING
      • NUTRIENT ANALYSES FOR LABELING AND CLAIMS
      • TOXIN TESTING
      • FDA DETENTION SAMPLING
      • PERSONAL CARE & COSMETICS
    • SPECIAL PROJECTS
      • CHALLENGE STUDIES
      • SHELF LIFE STUDIES
      • PROCESS VALIDATION
      • METHOD/MATRIX VALIDATION
    • ADVISORY SERVICES
    • ENVIRONMENTAL MONITORING SERVICES
    • BIOFUELS
    • DEIBEL COLAB 2.0
  • TRAINING AND EDUCATION
    • HACCP TRAINING
    • FSPCA PCQI TRAINING
    • SANITATION OPERATOR TRAINING
    • MICROBIOLOGY 101
    • FSPCA FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP) TRAINING FOR IMPORTERS OF FOODS FOR HUMAN AND ANIMALS
    • LABELING REQUIREMENTS FOR FOODS AND BEVERAGES
      MARKETED IN THE U.S.
    • GOOD MANUFACTURING PRACTICES
  • CONTACT US
  • Show Search
Hide Search

Test Category

Elevated Lead Levels Lead to Investigation of Cinnamon Used in Applesauce Pouches

Ryan Maus · December 1, 2023 ·

A recall and FDA public health alert has been issued for apple cinnamon fruit puree pouches after reports of acute lead exposure in children led to an investigation and finding of extremely high concentrations of lead in multiple product lots tested by health officials in North Carolina. An FDA investigation into how such high levels of lead contaminated the product is ongoing. However, since only products containing cinnamon had
elevated levels of lead, FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination. FDA is
currently trying to collect and test samples of the cinnamon sourced from Ecuador that was used in the recalled products as well as screen incoming shipments of cinnamon from multiple countries for lead contamination.


As of November 22, 2023, there are 52 reports of illness in children ages 1 to 4 years, with blood lead levels (BLLs) ranging from 4 to 29 micrograms per deciliter (µg/dL), potentially linked to recalled product. The FDA has found levels of lead in the recalled product as high as 2.18 ppm, 200 times higher than proposed action levels for similar products intended for babies and young children. Acute lead exposures are uncommon and have historically resulted from exposures to high concentrations of lead containing folk remedies, paint chips, or foreign bodies. Children exposed to large amounts of lead can develop gastrointestinal, hematological, and neurological effects. Symptoms include anemia, abdominal pain, weakness, and severe neurological sequelae (e.g., seizures, encephalopathy, and coma), which may result in brain damage. Elevated BLLs in children above 45 µg/dL may require hospital admission for monitoring and chelation therapy.


Lead is a naturally occurring heavy metal but also a man-made pollutant. According to the FDA and CDC, lead exposures related to food can involve:

  • water sourced from lead pipes, faucets, and plumbing fixtures;
  • fruits, vegetables, or grains grown in areas with lead containing soil, air, and water that resulted
    naturally or by contamination from human-activities such as pollution;
  • animals raised in high lead environments or that consumed lead contaminated feed;
  • leeching from lead contaminated food contact surfaces;
  • economically motivated adulteration – for example, lead-based dyes used to impact color have
    been found in spices such as chili powder, turmeric, and cumin.

While no level of lead exposure is safe for children, minimizing exposure from food is the focus of FDA’s Closer to Zero action plan. Draft guidance was issued in January 2023 proposing action levels for lead in food intended for babies and young children. It establishes the following action levels:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables),
    mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and singleingredient meats;
  • 20 ppb for root vegetables (single ingredient); and
  • 20 ppb for dry infant cereals.

Failure to Develop a Foreign Supplier Verification Program -Top FDA Citation for Fiscal Year 2023

Ryan Maus · November 14, 2023 ·

According to FDA’s Data Dashboard, the most frequently cited violation by FDA investigators in fiscal year 2023 (ending September 30th) was the failure to develop an FSVP. This encompassed about 35% of all form 483 citations issued. Additionally, nine warning letters were published in the past month alone when food importers failed to correct FSVP violations cited during FDA investigations. According to FDA data, warning letters issued for FSVP violations in 2023 increased in number from the previous year. Forty-eight importers were placed on import alert and only two were removed. Normally, FDA investigators will determine if foreign food is imported during routine investigations. Manufacturers that import food and lack FSVP documentation will be cited for not following the FSVP rule if no exemptions apply.

Warning letters published this past month cited inaction on developing, maintaining, and following an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for any of the foods they import. Generally a written response to a warning letter is required within 15 working days of notification. If the matter is not adequately addressed, the FDA may take further action including an FDA product hold, detention, and Import Alerts (e.g. Import Alert # 99-41). Removal from an Import Alert is a lengthy process. The importer is required to submit information to the FDA that adequately demonstrates resolution of the conditions that gave rise to the FSVP violation and provide assurance that FSVP requirements will be met for future imports.

Final guidance is available from FDA to help importers comply with the FSVP rule. U.S. importers who have responsibility for fulfilling FSMA FSVP requirements for foreign suppliers that manufacture, process, pack, or hold food intended for human or animal consumption in the U.S. must use a qualified individual to develop and perform FSVP activities. These activities include determining known or reasonably
foreseeable hazards associated with each type of food, evaluating risks posed by the supplier’s performance, approving suppliers, conducting appropriate supplier verification activities, and verifying corrective actions that provide assurance the food’s hazards have been significantly minimized or prevented. Detailed records documenting these activities are also required.

A course specifically designed to train FSVP qualified individuals was developed by the Food Safety Preventive Controls Alliance (FSPCA) that provides a standardized curriculum recognized by the FDA. The course is offered by Deibel Laboratories.

Recent Outbreaks Involving Natural Toxins

Ryan Maus · October 3, 2023 ·

By Ryan Maus
Ingredient hazard assessments often include an assessment of natural toxins. Of these, mycotoxins such as aflatoxin are often first to be assessed. However, other naturally occurring toxins exist and have caused foodborne outbreaks in the past few years. These outbreaks involved toxin containing raw morel mushrooms, undercooked kidney beans, and new ingredients such as tara powder. While consumer demands can inspire new food trends, it is important to remember the hazard that naturally occurring toxins present and the controls that can be put in place to reduce the risk of illness.

A recent article describes a 2018 incident in France where an outbreak of acute gastroenteritis occurred at a military base after 200 people ate at a dining facility and became ill. An investigation indicated that chili con carne was the likely source of illnesses. Further analysis indicated that a plant lectin, phytohaemagglutinin, was present in the chili at a level above what is considered a toxic dose. The source of the plant lectin was undercooked kidney beans, a toxin that is destroyed with proper cooking of the beans.


In 2022, numerous customer complaints were made to the manufacturer, the FDA, and the CFSAN Adverse Event Reporting System about illnesses associated with the consumption of Daily Harvest’s French Lentil and Leek Crumbles. The product was eventually recalled and an outbreak investigation undertaken to determine the cause of illnesses. Initially, 393 adverse illness events were reported, including 133 hospitalizations. Illnesses reported involved the gastrointestinal tract, liver, bile ducts, and/or gallbladder. An FDA investigation identified tara protein flour, an ingredient in the product implicated, as an ingredient of interest although non-specific toxin tests, mycotoxin tests, and microbial tests did not identify any results of public health significance. An investigation of the adverse event and the potential role tara protein played in causing illness was published in 2023. The authors found that the original product and tara protein powder ingredient were free from intentional, accidental, and economic adulteration, spiking with synthetics, and toxic compounds. However, three nonprotein amino acids were present at high levels. One of these, baikiain, was present at the highest level and produced a minor metabolite in vivo similar to acetaminophen. When tested using a mouse model at levels relative to consumer consumption, the mice exhibited liver and kidney symptoms similar to an overdose of acetaminophen. The presence of baikiain was theorized to have caused the adverse events seen in consumers, the severity of which depended on the dose of tara consumed and the susceptibility of the individual to the toxin.

In 2023, an outbreak at a sushi restaurant in Montana caused 51 illnesses involving diarrhea, nausea, vomiting, or abdominal pain; and two deaths. An investigation indicated that morel mushrooms were the likely cause of illness. Left over mushrooms tested were found to be true morels and not false morels that contain the toxin gyromitrin, and no significant levels of pesticides, heavy metals, toxins, or pathogens were found. However, documented cases of similar illnesses associated with consumption of raw or undercooked true morel mushrooms have been reported due to low levels of naturally occurring heatlabile hydrazinic toxins in the raw morels. Morels consumed at the restaurant were served raw or lightly cooked.

Food producers need to ensure that proper controls are in place to eliminate toxic hazards, such as cooking. Likewise, new ingredients incorporated into products should be FDA approved and have a history of being safe. More information on natural toxins is available from FDA, WHO, and other sources.

READY TO WORK TOGETHER?

Request a quote from one of our sales professionals. Contact Us

Footer

CONTACT US

Have a question? Contact our Sales team.

Request Info

Subscribe to our newsletter

Subscribe

“Science you can trust from concept to consumer -since 1967”

We are proud of our integral role in helping to ensure product safety and quality for all our clients.

  • Facebook
  • LinkedIn
  • Twitter

CAREERS

Deibel Laboratories is always seeking energetic individuals to fill positions at our rapidly growing corporation of food and pharma/cosmetic testing laboratories.

VIEW CAREERS

LOCATIONS

California, Idaho, Pennsylvania, Sarasota, Gainesville, Lakeland, Illinois, Minnesota, Missouri, Wisconsin, Kansas, Tennessee, Texas, Canada

SEE LOCATIONS

Copyright © 2025 Deibel Laboratories, All Rights Reserved.
PRIVACY NOTICE · COOKIE POLICY · TERMS AND CONDITIONS