Our Principal, Karen Constable, explains how high levels of lead may have got into applesauce (video audiogram).
For sources and a transcript, click here.
Fraud in Botanical Products and Dietary Supplements
Fraud in dietary supplements and herbal medicines is dangerous and costly
Fraud is estimated to affect around 10% of food products and dietary supplements are almost certainly affected at levels of at least 10% as well.
Supplement fraud surfaces often in my food fraud searches. Food supplements and additives were the second most seized food type, by quantity, after alcoholic beverages in Interpol’s annual food fraud operation, Operation Opson X in 2021.
Just last month, I shared the stories of how two supplement brands were working to prevent online counterfeits of their products after finding fake versions of their products in the market.
Fraud in supplements comes in at least eight different ‘flavours’
(1) Fraudulent, misleading or unsubstantiated claims of efficacy. For example, glucosamine, a supplement marketed as effective for reducing osteoarthritis, may work no better than a placebo. In fact, one study was halted because the group taking glucosamine reported worse joint pain than the placebo group! (source)
(2) False claims of potency and purity, such as listing more active ingredient on the label than is actually in the product. For example, a survey of curcumin supplements in France in 2022 found that less than half of the products contained as much active ingredient as was declared on the label. (source)
(3) The addition of materials to trick analytical tests, making an ingredient seem authentic when it is not. For example, pigments from black rice added to elderberry to boost the amount of anthocyanins (source);
(4) The use of undeclared fillers and bulking agents. This is sometimes legitimate and sometimes fraudulent, depending on the filler, product labelling and regulations.
(5) Adulteration with undeclared pharmacological ingredients such as sildenafil (Viagara) and stimulants. Weight loss products and sexual function products are most often affected. For example, a pre-workout booster supplement from the USA was found to contain DMBA by German authorities earlier this year. DMBA is a stimulant that is an unauthorised substance in Germany (source).
(6) Misrepresentation of synthetic ingredients as ‘natural’. For example, 70% of “all-natural” turmeric extract supplements purchased in the USA in 2021 contained curcumins from non-natural sources (source).
(7) Addition of unsafe or unauthorised colourants. For example, powdered turmeric is adulterated with unsafe colourants lead chromate, metanil yellow, acid orange 7 and Sudan Red G (source).
(8) Counterfeiting, in which an entity that is not the brand owner creates and sells products that resemble the brand’s products. For example, a review of supplements that contained insufficient active ingredients found that most of them carried ‘fake’ barcodes, that either belonged to fictitious, unregistered companies or to companies that do not supply supplements (source). In Hungary, forty percent of young people reported that they had encountered counterfeit dietary supplements (source).
Fraud in Botanicals
A ‘botanical’ is a part of a plant, extract or essential oil that is traded for its therapeutic properties, flavour(s), or aroma(s)
If you want to know about fraud in botanical ingredients like herbs and complementary medicines, there is a fabulous resource provided by the American Botanical Council’s Botanical Adulterants Prevention Bulletins (BAPP bulletins).
Each Botanical Adulterants Prevention Program (BAPP) bulletin provides detailed information about a single material. Take the saffron bulletin, for example. It is seventeen closely written pages about saffron, its adulteration and the detection of such, including the molecular structure of its most important chemical compounds, its common name in a multitude of languages, its geographical distribution, the size of the market and, most importantly, a deep dive into the known adulterants for saffron and the methods for detecting them.
Fighting Adulteration in Botanicals
Earlier this year, the team behind the BAPP bulletins published an ambitious paper that sought to combine all the knowledge from all the previously published bulletins into a single, peer-reviewed journal article, in the Journal of Natural Products.
It is a truly remarkable article, with thousands of words of detailed information about every reasonably foreseeable adulterant for dozens of botanical ingredients used in complementary medicines, food supplements, functional foods, and cosmetics.
I was delighted to get a chance to talk with its lead author, and Director of BAPP, Stefan Gafner, PhD about the paper and the program last month.
KC: Is the BAPP an independent program? How is it funded?
SG: BAPP is funded by direct financial support, predominantly from industry sponsor members of the American Botanical Council. Memberships and endorsements for the ABC come from not just manufacturers and suppliers but from analytical laboratories, law firms, research centres and media companies from about 80 countries worldwide.
KC: Can you tell me about your recently published Botanical Ingredients Forensics paper: why did you create it and who was it made for? What do you hope it will be used for?
SG: The inspiration for the paper was to combine the knowledge from multiple past [BAPP] bulletins so that all the information is in one place. We wanted to make the knowledge more accessible to a larger audience. The main target is QC people in industry labs.
The paper discusses three main adulteration types and how to test for them in dozens of botanicals:
- Bulking agents, such as undeclared starches or fillers;
- Addition of extra marker compounds to trick the analytical tests, such as pigments from black rice added to elder berry to boost the amount of anthocyanins;
- Removal of valuable constituents, such as ginger or cinnamon with the essential oils removed before being ground up and sold as ginger powder or cinnamon powder.
KC: Do you worry (like I do) that sharing too much information about adulteration and adulterants that can evade detection is helpful to the bad guys?
SG: I am concerned that BAPP work may provide some information on adulteration to bad actors. Some people tell me that I help unethical people learn how to adulterate, rather than how to prevent adulteration. But there are other ways for fraudsters to figure it out since most of the information we summarise is already publicly available. However, there is a risk that some of the less sophisticated adulterators could become more sophisticated; that’s my main concern.
I know that some of our documents have been translated into other languages, and I’ve been told they are available in Chinese via WeChat so I can imagine that other countries may have that information and may try to see how to get around [the tests].
But we know the BAPP information is making a positive impact. When we surveyed ABC members and asked if they had changed their quality control procedures, specifications or suppliers based on the information provided in BAPP, twenty to thirty percent said “Yes”, they did change specifications or suppliers based on the information, so the program has had a very good impact [in preventing fraud].
KC: How much fraud is occurring in botanical ingredients every day?
SG: We don’t know. There are too many unknowns. No one has done a comprehensive analysis of the market. While it is possible to summarise results from various papers there are many potential confounders. For example, you do end up counting duplicate samples this way and the sampling is often not designed to have been representative of the geographic market.
However, there have been two papers that attempted to get these figures, and came up with approximately 25% of samples being adulterated based on DNA with similar results for chemical analyses*. However, it is very variable between different products. For example, Gingko leaf extract could have an adulteration rate as high as 57% (this is from soon-to-be-published research reviewing tests of 533 samples).
Europe and North America had very similar results in the Gingko study, about 60% [of samples adulterated] for both.
We think there is less fraud in Europe in regulated herbal medicines, compared to food supplements which are less regulated.
KC: Wow so fraud in botanicals is a pretty big problem. How does the food supplement industry cope with fraud in botanical ingredients?
SG: Reputable suppliers are doing a good job of mitigating fraud. They know their own supply chain well, and some even grow their own ingredients. That is, they have vertically integrated supply chains. For example, during my time at Tom’s of Maine, a significant portion of the herbal ingredients, including echinacea, chamomile, thyme and calendula were grown at its farms in Vermont, USA.
Ingredient suppliers that grow their own botanicals are also less likely to supply fraudulent materials to their customers. Being vertically integrated obviously has its benefits.
However, there is more fraud when the supply chain is less well-controlled. An example is liquorice root, which is typically grown in small quantities on individual farms in China and India, and sold on to intermediate persons, aggregators and traders who grade and blend the root from all different places. This makes it impossible to really ‘map’ the supply chain or keep control of the quality or authenticity.
Another big problem is that consumers in the USA have been taught to expect to pay prices that are too low for quality herbal products. American consumers think about some herbal extracts like a medication like paracetamol (‘Tylenol’) or ibuprofen… they think it’s all the same and so it’s fine to just buy the cheapest. However, not all Echinaceas are the same. That is one of the biggest issues we have at the moment. The high-quality herbal supplements are usually more expensive.
KC: Are you seeing any new and worrying trends in fraud in botanicals? Any good news?
SG: The good news is the BAPP program has gained good support in its twelve years, with a substantial percentage of industry now supporting it, including from Europe, Asia and Australasia. The program is having real impact.
My biggest concern is the spiking of supplements with prescription drugs, followed by fortification with marker constituents, for example, ellagic acid added to pomegranate peel extracts (Punica granatum, Lythraceae) and synthetic curcumin used in place of genuine turmeric extract.
A new vulnerability is the increasing popularity of products containing mixtures of botanicals, say six or seven ingredients. These can include ingredients that are only present in sub-therapeutic doses, and that contain excipients instead of adequate levels of the labelled botanicals.
KC: Thank you Stefan, that was a fascinating insight into the industry and the important work you do to prevent adulteration in botanicals.
🍏🍏🍏🍏🍏
*Ichim, M.C. (2019). The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration. Frontiers in Pharmacology, [online] 10. doi: https://doi.org/10.3389/fphar.2019.01227 and Ichim, M.C. and Booker, A. (2021). Chemical Authentication of Botanical Ingredients: A Review of Commercial Herbal Products. Frontiers in Pharmacology, 12. doi: https://doi.org/10.3389/fphar.2021.666850.
Main source:
Gafner, S., Blumenthal, M., Foster, S., Cardellina, J.H., Khan, I.A. and Upton, R. (2023). Botanical Ingredient Forensics: Detection of Attempts to Deceive Commonly Used Analytical Methods for Authenticating Herbal Dietary and Food Ingredients and Supplements. Journal of Natural Products. doi: https://doi.org/10.1021/acs.jnatprod.2c00929.
Food Safety Hazards from Food Fraud (EMA)
Updated 28th June 2023
Are you confident in your FSMA preventive controls for hazards from food fraud?
This post is for you if your company manufactures food in the USA or exports food to the USA.
Food companies in the USA must comply with food safety regulations that require them to identify and address hazards from economically motivated adulteration (EMA), a type of food fraud.
In this post you can learn what EMA is and how to identify food safety hazards from EMA. You can also discover what type of preventive controls are best for EMA hazards.
Definitions
EMA is short for economically motivated adulteration which is a type of food fraud. Other types of food fraud include counterfeiting, making false claims (for example, fake ‘organic’ food) and species substitution (for example, selling cheap white fish labelled as snapper).
“Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value.” (US FDA)
FSMA denotes the Food Safety Modernization Act (USA). is a set of rules for food manufacturers. Under the rules, food manufacturers must assess food safety hazards and implement preventive controls. The US Food and Drug Administration (FDA) is responsible for the enforcement of the rules. If your company is outside the USA but exports to the USA, you must also comply with the FSMA rules.
Hazards are chemical, physical and biological agents that may be present in food and that are capable of causing harm to consumers of the food. (Find the official FDA definition here)
Preventive controls are procedures and systems that are designed to ensure that food safety hazards are prevented or minimized to an acceptable level.
Rules for food fraud (USA)
FSMA requires that preventive controls are implemented by food manufacturers to prevent hazards to human health. The relevant regulation is called the FSMA Final Rule for Preventive Controls for Human Food, and is commonly known as the Preventive Controls Rule.
The Preventive Controls Rule requires food manufacturers to identify and control hazards that could arise from:
- natural occurrences (for example, some raw meat products naturally contain certain human pathogens);
- unintentional contamination (for example food may be accidentally contaminated with a pesticide during a pest control treatment), and
- economically motivated adulteration (EMA).
After food manufacturers have identified the hazards, they must minimize or prevent the hazards by creating and implementing preventive controls in their food manufacturing operations. These are procedures and systems that are documented and that include monitoring, corrective actions systems and verification activities. The preventive controls form part of the food manufacturer’s food safety plan.
Learn more about the preventive controls rule on the FDA’s preventive controls guidance webpage.
A separate part of the FSMA rules also requires food manufacturers to create and implement systems to prevent intentional, malicious adulteration. The FDA calls this type of adulteration Intentional Adulteration (IA). It is different from economically motivated adulteration. Intentional adulteration prevention is also known as food defense. Click here to learn more about food defense.
Examples of hazards from economically motivated adulteration (EMA)
Economically motivated adulteration (EMA) is a subset of food fraud. Food fraud includes many types of deception carried out for the purposes of economic gain. It includes activities such as mislabeling (for example, making false claims about the geographical origin of a food product) and other fraudulent activities that do not involve the adulteration of food.
Economically motivated adulteration is a type of food fraud in which a person has added a substance to food to enhance its apparent value or profitability. Often the added substance will boost the apparent quality or appearance of the food, other times the substance will be a diluent, which dilutes or replaces the genuine material with a cheaper material, thereby increasing the profitability of the resulting mix.
Food businesses are required by law to
- understand food safety hazards that may be in their products;
- create and implement systems that will prevent, minimize or eliminate those hazards;
- systems for preventing, minizing and eliminating hazarsd must be documented in a food safety plan.
Economically motivated food fraud (EMA) happens when food fraud perpetrators add materials to increase the apparent value of the food or to extend its shelf life in an undeclared or unlawful manner. Materials that are added to make food or ingredients seem bigger, or heavier include water and other liquids, or fillers and bulking agents, such as starches, husks or sawdust. Adulterants that are added to make food look better include unauthorised colorants, glosses and glazes. Adulterants that extend shelf life include non-approved preservatives.
Food safety hazards can arise from EMA.
The food safety hazards from such adulterations include acute or chronic chemical poisoning, allergenic reactions, and microbial illnesses from pathogens introduced during the adulteration processes.
Example: Unauthorized color in turmeric
A significant proportion of powdered turmeric traded worldwide contains unsafe levels of lead. Researchers in Bangladesh have confirmed that the lead is added to the spice in the form of toxic lead chromate which has an intense yellow-gold color, the color favoured by turmeric traders and buyers as an indicator of freshness and quality. Curry powder, cumin and cinnamon have also been affected. A survey of more than 1496 samples of 50 spices from 41 countries found that 50% of the spice samples had detectable lead, and more than 30% had lead concentrations greater than 2 ppm, a level that is 200 times higher than the recommended maximum lead content of candy in the USA. Lead is a potent neurotoxin that damages organs including the brain.
Example: Undeclared peanuts in chopped hazelnuts
Peanuts are cheaper than most other nuts which makes them an attractive ‘filler’ or bulking agent in chopped nuts, powdered nuts and nut pastes. When a food fraud perpetrator adds peanuts to a tree nut product, they gain more profit than if they sold a pure paste or powder. In Germany in 2017, authorities found bulk quantities of chopped hazelnuts adulterated with 8% chopped peanuts. The chopped hazelnuts were sold as ‘pure’ hazelnuts and did not declare any peanut ingredients on the label. Because peanuts are a regulated human food allergen, their presence in the hazelnut product presented a serious food safety hazard.
How to identify hazards from economically motivated adulteration (EMA)
Follow the five steps below to identify hazards from EMA food fraud for your food manufacturing preventive controls plan.
- For each raw material that your company purchases to use in the food manufacturing process, investigate whether economically motivated adulteration is likely to occur within the supply chain. Ask yourself: could adulterants be present in the raw material when it is purchased? Learn how to investigate susceptibility to food fraud here.
- For each raw material and each finished product your company makes, also investigate whether economically motivated adulteration could occur inside your manufacturing facility or storage areas. This is sometimes known as ‘insider activity’.
- After you have understood whether adulteration is likely to occur for each raw material, make a list of adulterants that could be added to each of the susceptible foods. Historical records of past incidences of food fraud provide the best indication of the types of adulterants that can be expected in different foods and ingredients. This page has a list of databases you can use to find historical records. .
- For each possible adulterant, make a note of whether it could be hazardous to human health if present in the food. As an example, olive oil is commonly adulterated with (non-olive) vegetable oils. That type of adulteration is unlikely to be hazardous and as such it would not require a preventive control under the FSMA rules*. Document your decisions and justifications for such.
- Add the economically motivated hazards you have identified to your company’s food safety plan. Implement preventive controls for each hazard. Supplier approvals programs are commonly used for control of economically motivated hazards in incoming raw materials.
Need to learn more about food fraud prevention? Visit our online training school. Courses start at just US$59.
*Even if not strictly required under FSMA rules, it is always a good idea to prevent any type of food fraud from affecting your products. This will protect your company and brand as well as your consumers’ health.
Saffron Fraud (Everything You Ever Wanted to Know)
What is Saffron?
Saffron is a spice made from the dried stigma (part of the flower) of the saffron plant (Crocus sativus). You can see the red stigmas in the pictures.
Why is Saffron Vulnerable to Food Fraud?
Genuine saffron is harvested by hand, highly prized for its colour and flavour and very expensive. In fact, it is the most expensive spice and costs between USD $1,100 to $11,000 per kg. The international saffron market was worth US $430 million in 2018.
Saffron trade is complicated. Saffron’s most important growing areas are in Iran, Greece, Morocco and India. Afghanistan and Spain are also important sources of saffron. Saffron labelled Spanish is mostly grown in other countries but packed in Spain. Iran accounts for most global production at 90% – 93% but only accounts for 40% of direct global exports, according to the report (confusing!), apparently because the Iranian saffron is resold by other countries.
With so much of its production in one country, and with a short harvesting season, saffron supply is extremely vulnerable to weather events. For example, there was a tripling of prices from 2006 to 2009 because of heavy frost in Iran in 2007. Climate change is a threat, with increased moisture in some areas leading to more fungal plant diseases, and drought in other areas limiting yields.
Saffron Fraud
Saffron is one of the most frequently adulterated foods. Powdered saffron is more at risk than whole saffron.
The biggest food safety issue with saffron fraud is probably the use of synthetic dyes to boost the colour of fraudulent whole saffron and saffron powder. Sudan I-IV and Rhodamine B dyes have been found in saffron and are considered potentially genotoxic and carcinogenic.
Adulterants in Whole Saffron
Here are some of the things that are added to saffron to fraudulently increase its value.
- Parts of saffron flowers, including the yellow style and the white style.
- Filaments from other plants, including corn fibres, safflower stigmas, calendula stigmas, pomegranate fruit fibres
- Filaments from other sources including silk. Adulterant filaments may be dyed with plant dyes including beetroot, pomegranate, fruit peel.
- Liquids that are added to increase weight, including oils, glycerin and honey
- Dyes and aroma compounds as listed below
Adulterants in Saffron Powder
Here are some of the things that are added to saffron powder to fraudulently increase its value.
- Turmeric powder
- Paprika powder
- Ground seeds of sweet fennel, or annatto
- Dried marigold flowers
- Gardenia (Cape Jasmine) extract, for their crocetin esters which are also in saffron
- Natural dyes from flowers and roots
- Artificial dyes including erythrosine, ponceau 4R, tartrazine, Sudan dyes, magenta III and rhodamine B
- Safranal, which is a synthetic aroma compound
Also, there are historical reports of fillers added for increasing the product’s weight, including chalk, gypsum and heavy spar (barium sulfate)
Other Types of Fraud (Non-Adulteration-Type Food Frauds)
- Selling Philippine saffron or “saffron flowers” as if they are real saffron (C. sativus). They are instead safflower or kasubha.
- Exhausted saffron sold as whole saffron
- Coloured paper shreds sold as saffron
- Provenance fraud, in which the geographical origin of the saffron is misrepresented
Saffron testing
Testing is a challenge. Microscopic inspections can be done on powdered as well as whole saffron, but they are time-consuming and expensive. In addition, visual examinations won’t necessarily recognise adulteration with colourants or safranal.
Some DNA-based tests struggle to differentiate safflower from saffron, because they are closely related. DNA tests also don’t find safranal or dyes. Spectroscopic methods can be simple and quick but they are not very sensitive and won’t pick up all adulterants. There are many other authenticity test methods, each with its own challenges. It is recommended that a suite of complementary tests be used to cover all types of adulteration and fraud. Provenance testing has been successfully done using stable isotope methods.
This piece was orginially published in The Rotten Apple, a weekly newsletter about food safety, food fraud and sustainable supply chains.
Oregano Fraud; six things every food professional needs to know
1. What happened?
Testing was conducted by the Australian consumer group Choice, mirroring tests conducted in the UK and published by the UK Consumer Group Which? in 2015. A selection of packs of dried oregano were purchased from supermarkets (grocery stores), delis (specialty food stores) and grocers (produce stores) in three cities in Australia and a single sample of each was tested. Seven of the twelve samples, over fifty percent, were found to be inauthentic, with the inauthentic samples containing between 10% and 90% of ingredients other than oregano, including olive leaves and sumac leaves.
2. Why test oregano?
Herbs and spices are one of the rock-stars of food fraud; their complex cross-border supply chains, high price per kilogram and the fact that they are often sold in powder or particulate forms make them prime targets for adulteration, dilution and substitution with cheaper materials.
Why oregano in particular? Professor Elliott, Director of the Institute for Global Food Security, and an international authority on food fraud conducted testing on oregano in the UK in 2015, the results of which were published by the UK Consumer group Which?. It is possible that Prof Elliott used rapid evaporative ionization mass spectrometry (REIMS), a test method recently made available by Waters Corporation, although Which did not disclose the test method. REIMS makes use of a rapid sampling method that produces vapour which is analysed using time of flight mass spectrometry. Sophisticated software compares molecular markers in the resulting spectrum with those in known materials in a database, allowing a sample to be quickly identified as belonging to a particular product type or not. The method has huge potential for testing food authenticity, with one of the advantages being that unlike other tests for adulteration there is no need to specify which adulterants to seek. A downside is that many hundreds or thousands of tests must be performed and compared to traditional analytical methods to create a database before the method can be used with confidence to determine the authenticity of any given material.
Professor Elliott recently revealed that Waters Corporation and Queens University, Belfast worked together to build a database of oregano samples (Elliott, C. (2016) Addressing complex and critical food integrity issues using the latest analytical technologies). This means that oregano is one of the few materials that can currently benefit from accurate authenticity testing using the REIMS method.
3. Are the results unexpected?
Global food fraud commentators attribute the presence of significant concentrations of adulterants or diluents in dried herbs to economically motivated food fraud in most cases, as opposed to seafood mislabelling which sometimes occurs due to unintentional errors in species identification. Food fraud is estimated to cost the United Kingdom one billion pounds each year. It is thought to be very common among some food types, including herbs and spices.
4. Who is responsible?
It is highly unlikely that any of the brand owners named in the Choice report were aware that they were selling adulterated herbs. Most if not all of the brands included the Australian testing would have been sourced and packed under well-controlled systems that include vendor approval processes, formal specifications for incoming materials (such as bulk herbs) as well as certificates of analysis and declarations of conformity to specification. The fraudulent tampering probably occurred further up the supply chain during drying, bulk packing, shipping or storage. Interestingly, all seven adulterated samples contained olive leaves and two contained sumac leaves. It is possible that tampering occurred in two different points within the supply chain for some products; perhaps one fraudster added olive leaves to bulk lots of the herb at a location close to the oregano growing area and sumac leaves were added by someone else at a later date.
5. What are the legal and financial ramifications?
The sale of misrepresented products is a breach of Australian consumer law and ignorance cannot be used as a defense. The incidences were investigated by the Australian Competition and Consumer Commission (ACCC), an independent authority of the Australian government. One company was fined a substantial sum for selling product that contained only 50% oregano leaves. It is likely that other businesses that had been supplied with inauthentic herbs sought financial redress from their suppliers, either through purchasing contract penalties or through private legal action.
When a food business chooses to voluntarily recall or withdraw their products from the marketplace they may try to claim the costs against their business insurance. Insurance companies will seek to recover their costs from further up the food supply chain and this may have an impact on premiums in coming years.
6. What should food businesses do?
No food business is immune from economically motivated food fraud and preventing food fraud from affecting a business is a multi-functional task that should involve personnel from purchasing, finance and legal departments as well as food safety and quality personnel. In the short term however, there are some things that can be done by food safety and quality personnel to help prevent, deter and detect food fraud without a lot of investment from other parts of a food business:
- Update your purchasing specifications to include authenticity requirements.
- Review your vendor approvals systems and revise questionnaires and requirements if required. Consider implementing more stringent requirements for those suppliers that provide vulnerable materials.
- Request certificates of analysis (CofA) from suppliers of vulnerable materials
- Begin a testing regime for vulnerable materials
- Investigate the costs and benefits of supply chain audits, including whether ad-hoc, one-off visits to certain suppliers might be worthwhile
- Request tamper-evident packaging and bulk container tamper seals for vulnerable raw materials
- Ask suppliers of vulnerable materials to undertake a mass balance exercise at their facility or further upstream in the supply chain.
- Make a business case for switching suppliers of materials that prove to be consistently problematic and present it to your purchasing department.
Want to learn more about food fraud mitigation in the spice industry? This article in Food Safety Magazine provides an excellent insight.