The European Commission’s Rapid Alert System for Food and Feed (RASFF) Portal shows a notification about the use of olive leaves in oregano in Turkey. Addition of cheaper bulking agents to herbs and spices is a common way of achieving a higher profit margin for pricier herbs. The olive leaves were classified as an unauthorized novel ingredient; however, they are known to be used for the adulteration of oregano. An investigation of commercial oregano samples showed that one quarter of samples were adulterated with other plant leaves, and two of the samples didn’t even contain any oregano.
Remember the 2015 Listeria outbreak linked to Blue Bell Creameries? The outbreak led to three deaths and 10 illnesses between January 2010 and January 2015. On Thursday the Department of Justice ordered the company to pay $17.25 million in criminal penalties for shipping contaminated products linked to that outbreak. The sentence, enforced by U.S. District Judge Robert Pitman (Austin, Texas), is the largest fine and forfeiture ever imposed in a conviction involving a food safety case.
“American consumers must be able to trust that the foods they purchase are safe to eat,” stated – Acting Assistant Attorney General Jeffrey Bossert Clark, Justice Department’s Civil Division in an agency news release. “The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers.”
In May 2020 Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream. The following is an excerpt from the Department of Justice news release:
“The plea agreement and criminal information filed against Blue Bell allege that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the Food, Drug and Cosmetic Act. According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems. Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination. Two weeks after receiving notification of the first positive Listeria tests, Texas state officials informed Blue Bell that additional state-led testing confirmed Listeria in a third product. Blue Bell again chose not to issue any formal notification to customers regarding the positive tests. Blue Bell’s customers included military installations.”
Inspector Meerkat checking in with this week’s food fraud investigation: While scanning the Food Fraud Database, I found that coconut oil was recently added to the site. There have been six reported incidents of fraud in coconut oil since 2013, with the most recent incident reported May 2019. Five of the incidents involved coconut oils produced in India, and one incident involved products from the Philippines. Reasons for adulteration include fraudulent labeling claims, dilution or substitution with an alternate ingredient, and misrepresentation of botanical origin.
Due to health benefits, grape seed extract has become more and more popular. Cheaper plant extracts, for example peanut skin extract, show very similar results with chromatographic methods, and therefore adulteration of grape seed extract may remain undetected. The American Botanical Council’s Botanical Adulterants Prevention Program released a laboratory guidance document that reviews analytical methods for detecting adulteration of grape seed extract with proanthocyanidin-rich extracts from other botanical sources.
Turkish delight, baklava, halva, biscotti, mortadella, ice cream and many more delicious foods from around the world contain pistachios, which are pricey and therefore a popular target for food fraud. A recent article describes a method to detect spinach and green peas that often are used as a pistachio replacement due to their color and low price. The technique combines NIR (near infrared) spectroscopy and chemometric analysis and provides a method that is precise, fast and non-destructive.
Botanical ingredients are important to the food and beverage industries as well as the dietary supplements industry. Botanicals are plants or specific plant parts (leaves, roots, bark, berries, etc.) that are used for particular properties. These properties can be therapeutic or related to color, flavor or other attributes. Botanicals include extracts such as Ginkgo biloba, saw palmetto, and elderberry as well as herbs and spices used in cooking, essential oils, pomegranate juice and extracts, and olive oil. There is a substantial overlap between botanical products used in the herb and supplement industries and those used in foods and beverages. Many “conventional” foods and beverages include botanical extracts or other ingredients to advertise a therapeutic effect.
In 2014, FDA issued a final guidance for industry related to labeling of liquid dietary supplements (vs. beverages). FDA noted, in their rationale for the guidance, two trends:
“First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods. Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement…and must meet the regulatory requirements that apply to conventional foods.
Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts. Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use. Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.”
The American Botanical Council (ABC) has been publishing information on the safe, responsible and effective use of botanicals since 1988, including the quarterly journal HerbalGram and a book of herb monographs The ABC Clinical Guide to Herbs. In order to help combat the increasing problem of adulteration in the industry, the Botanical Adulterants Prevention Program (BAPP) was launched in 2010 by ABC along with the American Herbal Pharmacopeia and the University of Mississippi National Center for Natural Products Research. The goal of BAPP is to educate members of the herbal and dietary supplement industry about ingredient and product adulteration through the publication of documents such as adulteration bulletins and laboratory guidance documents. The information in these documents helps ensure the identity, authenticity and safety of botanicals along the supply chain.
Karen Everstine will be discussing food fraud during the 2020 Food Safety Consortium Virtual Conference Series | An example of the Botanical Adulterants Prevention Bulletin for cranberry is seen in Figure 1. It includes a description of the species that can be labeled as cranberry in the United States, a brief description of the marketplace, information on potential adulterants in cranberry fruit extract and other cranberry products, and guidance on analytical methods to test cranberry products for adulteration.
Decernis has been working with the Botanical Adulterants Prevention Program (BAPP) to integrate links to their expert content into the Food Fraud Database (FFD). This will ensure our users can better develop ingredient specifications, manage risk, and protect their consumers by leveraging this content for food fraud and herbal ingredient fraud prevention. We are currently incorporating three types of BAPP documents into FFD:
Adulterants Bulletins. Information and links to these documents will be entered as Inference records in FFD. We are extracting ingredient and adulterant names (including Latin names as synonyms) from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
Adulteration Reports. Information and links to these documents will also be entered as Inference records in FFD. We are extracting ingredient and adulterant names from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
Laboratory Guidance documents. Information and links to these documents will be entered as both method record and inference records in FFD. We are extracting ingredient and adulterant names from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
Decernis analysts are currently integrating this content into FFD, which will be uploaded to the system between now and early September.
Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.
Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.
Safeguarding Food Quality to Meet Industry Standards
Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.
Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.
In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.
The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.
To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.
From Hazard Analysis to Record-Keeping: A Data-Led Approach
Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.
The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.
The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:
Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.
As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.
How LIMS Enable Clear Compliance and Optimal Control
Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.
The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.
Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.
Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.
Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.
Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.
LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.
With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.
To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.
With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.
Sulfites and sulfur dioxide can make meats look fresher than they truly are, and therefore are banned by the FDA The Australia New Zealand Food Standards Code also prohibits the addition of sulfites to raw meat. Not only is there a risk of meat past its prime getting into the food supply, sulfites may also pose a danger to allergy and asthma sufferers. More than 23 tons of ground beef were freshened up illegally with sulfites and sold in New Zealand to consumers. The manufacturer was recently sentenced to a fine in this two-year old case.
Fraudulent olive oil made its way into the retail market in Brazil. More than 1300 bottles of product labeled extra virgin olive oil were seized, the oil was analyzed and found to be fraudulent. An investigation about the source of the adulteration and whether the fraud happened at the producer or in retail is still ongoing.
This kind of lead must weigh heavily on the minds of food and beverage fraudsters. The quantity of lead isotopes and elemental lead can be used to determine the geographic origin and vintage of a wine and therefore determine whether the wine is from a specific location. The isotopic profiles of genuine Bordeaux wines were compared to suspicious bottling. The fake wines were clearly identified to be from different locations and vintages than claimed on the labels.
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