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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.

In May, NOW Foods explained how to spot fake versions of their supplements on their website

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.

The Botanical Adulterants Prevention Bulletins are seriously detailed. This is an extract from the Saffron bulletin.

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.
Three classes of fraud in botanicals: fillers, undeclared marker compounds, removal of valuable components

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.

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Honey Fraud – Much Worse Than We Thought?

From the desk of Karen Constable, principal consultant at Food Fraud Advisors.

My daughter loves honey and eats a lot of it. She spent a few months in Europe last year – mostly in Spain –  and told me the honey there had no flavour.  She said it tasted like sugar water.

‘Honey’ that doesn’t taste like honey may have been diluted with water and adulterated with non-bee sugar syrups: food fraud.  Honey is one of the most fraud-affected foods on the planet, so perhaps it shouldn’t be surprising to hear that “honey in Europe just doesn’t taste like honey”.

But I was surprised. Europe takes its honey seriously.  And it takes food fraud seriously, too.  I wouldn’t have been surprised to hear about flavourless probable-fraud-affected ‘honey’ in other parts of the world, but I was surprised to hear my daughter say it was “everywhere” in Europe.

Listen to this post on YouTube by clicking the preview below.

 

The last time I saw Europe-wide honey fraud results they were quite good.  For example, a honey-checking operation that was part of the famous Europol/Interpol anti-food-fraud activity, Operation Opson X, in 2021, found that of the  495 honey samples tested, 93% were compliant.  Separately, a European honey fraud survey in 2015 – 2017 reported only 14% ‘suspicious’ samples.Seven percent, fourteen percent, as non-compliance rates, they are hardly fantastic but they don’t match my daughter’s claim that all the honey she tasted in Europe was affected.

But new results have just been published for a multi-year European anti-honey-fraud operation and they are pretty bad.  Of the 320 samples tested in the operation, almost half were suspected of being non-compliant with the provisions of the European honey standard (the Honey Directive).

What is going on here? Why are these results so much worse than past surveys?

Firstly the samples that were tested do not represent the European-wide honey market.  The sampling focussed only on imported honey and only on adulteration with sugar syrups.

Secondly, the methods used in this most recent round of testing are almost certainly different from previous European surveys.  The test methods are only suitable to identify “suspicions of fraud” by looking for chemical markers of extraneous sugars (presence/absence only) and they are different from the officially-approved honey test methods.

The European Joint Research Council (JRC) says these methods are “the most sophisticated methods” currently available but they have not been validated and they are not part of the regulatory framework.

For this enforcement activity, the analytical results were used only as a tool to decide whether further investigations were needed to uncover fraud in the honey supply chain.  Further investigations included on-site inspections, examination of documents, computers and phone records.

Investigators reported that fraudsters appear to be deliberately adjusting the levels of adulterants so that they can evade border control checks.  The European Union’s Food Safety Commission says that officially-approved honey authenticity test methods are not keeping up with the fraudsters, claiming that analytical methods used for border control checks “lack sufficient sensitivity to detect low and intermediate levels of sugar adulterations”.

Something is just not right with honey in Europe

The investigations began more than eighteen months ago, but it appears likely that there are still high levels of fraud-affected honeys in the European market now. More than sixty percent of importers were found to have imported at least one suspicious consignment.

In fact, the European Food Safety Commission, last week reported that “there is a strong suspicion that a large part of the honey imported from non-EU countries and found suspicious by the JRC of being adulterated remains present and undetected on the EU market” (source).

Takeaways

Honey fraud is difficult to detect and expensive for government agencies to investigate.  Fraud perpetrators have been shown to use sophisticated systems to evade detection, and these investigations appear to show that importers and exporters are working together to defraud customers and governments.

If your business purchases honey, food fraud mitigation activities must go beyond checking documents or relying on letters of guarantee.

As a consumer, it is impossible to tell whether honey is fraud-affected or not, but if you suspect honey of being fraudulent, contact the brand owner as a first step and share your concerns.

…. Or you could seek out incense honey, a premium mono-floral honey from the incense flower in Portugal, for which all samples in a recent analytical test were found to be authentic 😊.

🍏 Source: https://food.ec.europa.eu/safety/eu-agri-food-fraud-network/eu-coordinated-actions/honey-2021-2022_en 🍏

 

*** This post originally appeared in Issue #81 of The Rotten Apple Newsletter.  Subscribe to The Rotten Apple to get unique, helpful food safety and food fraud information direct to your inbox every Monday  ***

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Future and emerging threats of food fraud

Food fraud: you don’t want it.

  • If you are manufacturing, wholesaling or retailing food or beverages, fraudulent activities within your supply chain pose risks to your brand and to your customers.
  • Different food types vary in their susceptibility to food fraud.
  • The risks change over time.
  • Purchasers of food and food ingredients must remain vigilant about new and emerging risks.
  • The requirement to monitor emerging and predicted food fraud issues is a part of all major (GFSI) food safety standards.

Learn how to monitor food fraud threats here.

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Organic Food Fraud in 2020

Twelve million dollars buys a lot of raspberries. Even if they are organic. In August 2019, a $12m shipment of (supposedly) organic raspberries was intercepted at the Chilean border, as they were being exported to Canada. They were accompanied by fake organic declarations and fraudulent paperwork claiming they were grown in Chile.

It was an all too common occurrence; organic food fraud, committed by criminals to profit from the higher prices consumers will pay for organic, “clean” produce. The raspberries were not grown in Chile; they had been shipped all the way from China; imported to Chile so the fraudsters could pretend they were locally grown.

And they were not organic.

Organic berries are vulnerable to food fraud

 

Sales of organic food have increased since the global corona virus pandemic started. Sales in the USA were up 50% in March 2020. An Organic Trade Association poll of “likely organic shoppers” found 90% of respondents think buying organic has become more important because of the virus, presumably because of an increased focus on health and healthy eating.

Sales of organic food are increasing year on year. In 2019, American consumers bought $55.1 billion worth of organic food, up on the previous year by 4.6% .

As organic food becomes ever-more popular, frauds like the raspberry heist are becoming more common. It is impossible for a consumer to know whether food is authentically organic or not. This makes organic fraud easy for criminals to get away with. Organic foods are one of the food types most frequently affected by food fraud, according to the Decernis Food Fraud Database.

The good news for the USA is that after many years of criticism of its organic program, the Department of Agriculture (USDA) is making a visible effort to reduce fraud in the organic supply chain.  In fact, they are proposing new rules that aim to strengthen control systems, improve traceability for organic produce, and increase enforcement of the USDA organic regulations.

Organic peas vegetable pesticide
Organic foods and food fraud are like two (freshly picked) peas in a pod.

How to protect your business from organic fraud

If you have a food business that buys or sells organic food, you are at risk, now more than ever. Global supply chains have been disrupted by the pandemic and these disruptions mean many suppliers are struggling to deliver foods that meet specifications. It is tempting for wholesalers and distributors to substitute conventionally-grown produce for organic to make extra profits, or simply to allow them to fulfill customers’ orders.

Step 1: Become aware

Don’t be blind to the risks. Organic fraud happens more often than most people realise. Would you be able to tell the difference between an organic raspberry and a conventionally grown raspberry? Probably not. If criminals in Chile found it profitable to transport fake organic raspberries right across the globe before the pandemic, you can bet they are even more motivated to perpetrate fraud in the current economic climate.

Step 2: Educate yourself

If you own a food business, educate yourself about the risks. Learn about organic fraud; how it is perpetrated, what it looks like.

Michigan State University and the USA Organic Trade Association have published a free online course in Organic Fraud Prevention. It is US-centric but contains fraud detection and prevention strategies that can be applied anywhere.

Step 3: Assess your ingredients and products

Make a list of the organic food ingredients or food products that your business purchases. For each item on the list, ask yourself the question: “Can I be sure this is really organic?”.

Right now, you probably rely on verbal assurances from suppliers or pretty logos on packaging or invoices. That’s a fool’s game.

Instead, seek proper documentation from suppliers: request copies of organic certificates and cross-check them against invoices and labels. Or take a minute to research the certifications and logos on labels. All reputable organic certification bodies maintain a list of certified products or suppliers that you can check online. If the product or grower has a genuine organic certification, you will find it listed on the certification body’s website.

Unfortunately, it’s not uncommon for food companies to use organic logos without having the proper certifications.  Always check.

You can also check the list of fraudulent certificates on the USDA organic program website.

If your business operates a food safety program it should already have a food fraud vulnerability assessment.  Review that assessment.  All organic foods should be rated as “vulnerable” in the vulnerability assessment and they must have appropriate mitigation strategies applied to reduce the risks.

Step 4; Take steps to reduce the risk

If you can’t be sure of the authenticity of the ingredients or products you are buying (and selling) you only have two choices:

(i) change your supplier to one with a properly certified organic program, or

(ii) stop making organic claims about the products you sell.

To do anything else puts you at risk of inadvertently committing food fraud, which is a criminal offence.

Consumers are buying more organic foods than ever before.  At the same time, the unstable global economy makes fraud more tempting and supply chain disruptions provide extra opportunities for criminals.  Organic food fraud puts your business and brands at risk.

Now is not the time for complacency; stay alert and keep your brands safe.

 

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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.  

oregano adulteration
Source: Elliott, C. (2016) Addressing complex and critical food integrity issues using the latest analytical technologies

 

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: 

  1. Update your purchasing specifications to include authenticity requirements.
  2. Review your vendor approvals systems and revise questionnaires and requirements if required.  Consider implementing more stringent requirements for those suppliers that provide vulnerable materials.
  3. Request certificates of analysis (CofA) from suppliers of vulnerable materials
  4. Begin a testing regime for vulnerable materials
  5. Investigate the costs and benefits of supply chain audits, including whether ad-hoc, one-off visits to certain suppliers might be worthwhile
  6. Request tamper-evident packaging and bulk container tamper seals for vulnerable raw materials
  7. Ask suppliers of vulnerable materials to undertake a mass balance exercise at their facility or further upstream in the supply chain.
  8. 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.