Food Fraud Advisors

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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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Nutraceuticals; a growing risk

A nutraceutical is a food or food component that is designed to provide health benefits when ingested.  The term is derived from the words nutrition and pharmaceutical.  Nutraceuticals may claim to promote health, prevent and even treat disease.  Nutraceuticals are big business; their global sales volume is estimated to be more than $382 billion in 2019.  Demand for nutraceuticals is at an all time high and growing year on year as the idea of ‘nutrition for health’ becomes more popular.

Both consumers and businesses purchase nutraceuticals; consumers buy supplements to add to food or as stand-alone pills, powders and tonics.  Businesses purchase nutraceuticals to add to the food and beverage products that they manufacture.  Nutraceuticals are also used in personal care products like face creams and in animal feed.

Nutraceuticals are not regulated in the same way as pharmaceuticals, so their claimed benefits do not necessarily have to be proven.  In many countries, they are not covered by food laws either.  As a result, nutraceuticals receive minimal regulatory oversight in many countries, including the USA.

Nutraceuticals are big business with a large global market and fast-growing demand

Fraud in nutraceuticals

Nutraceuticals are a good target for food fraud because of their high prices and high demand.  They are manufactured from specialist agricultural commodities that are often only produced in one or two locations worldwide.  As a result their global supply chains can be complicated.

Fraud in pharmaceuticals can take the form of:

  • Adulteration or dilution
  • Counterfeiting
  • Diversion and grey market

Adulteration and dilution

Adulteration and dilution fraud occurs when the claimed active ingredient is not present in the quantities that are declared by the manufacturer.  Sometimes, the ‘correct’ ingredients are replaced with cheaper ingredients that do not have the functional properties of the genuine ingredients.

Adulteration fraud is thought to occur often in nutraceuticals.  A survey of raw botanical plant parts and powders in the USA found 53% of them contained plant material that did not match the label.   In a separate study, cranberry extracts were found to have been adulterated with cheaper and more abundant grape seed extracts.  A range of aloe vera products contained no evidence of aloe vera ingredients at all.

Adulteration also takes a more insidious form, when fraudsters add extra functional ingredients without declaring them on the label.  This can put consumers’ lives at risk.  The fraud is usually perpetrated to boost the efficacy of nutraceuticals that are claimed to be natural.  For example, grapefruit seed extract, a dietary supplement that is said to have natural antimicrobial properties has been found to contain undeclared added chemical biocides such as benzylkonium chloride, methyl paraben and triclosan.  The biocides are added to mimic or increase the antimicrobial properties of the grapefruit seed.

Adulteration with pharmaceutical drugs also occurs.  Supplements for body-building and weight loss have been spiked with drugs that enhance their effects.  In 2017, the US FDA warned consumers  that body building supplements sometimes contain undeclared and illegal selective androgen receptor modulators (SARMS), which mimic the effects of testosterone.  Liver injuries and other serious side-effects occurred in people who took the so-called ‘natural’ supplements.

A 2019 study conducted in The Netherlands found 64% of supplements contained pharmacologically active substances or plant toxins such as caffeine or ephedrine.

Counterfeiting

Counterfeiting is the copying of a product by an entity other than the brand owner, so that it appears exactly the same as the legitimate product.  Counterfeited supplements may be produced in unlicensed facilities under unhygienic conditions.  They may contain less of the functional ingredients than the authentic product, or perhaps none at all.

Diversion of nutraceuticals. 1. The manufacturer sells their product into multiple countries at different price points. 2. A wholesaler in a lower-price-tier country purchases bulk quantities. 3. The wholesaler diverts the product from authorised sales channels in their own country to sell the product into markets with higher prices.

Diversion and Grey Market Fraud

Diversion and grey market fraud occurs when goods are directed away from their expected supply chain, being sold to places unintended by the brand owner.  This can be profitable if, for example, a product is sold at a higher price in one country but a lower price in another.

Distributors or importers of a nutraceutical can participate in diversion if they purchase more than they expect to sell through legitimate channels, obtaining a bulk quantity discount in the process.  The excess stock can then be sold to discount outlets or individuals who sell it on the internet or other channels that have not been authorised by the brand owner.

Products that have been diverted may be expired (past ‘best before’) or may have been held in conditions such as hot warehouses that degrade the product, causing it to lose its potency.

 

Protection from fakes and diversions

Manufacturers can protect their brands from counterfeiting and grey market sales by adding anti-counterfeiting features to product packaging.  The features can be overt or convert. Often a combination of both overt and covert features is used.

Overt brand protection features are obvious to the consumers.  They include holograms, tamper-evident labels, seals and stickers.  Overt brand protection features are used to provide consumers with a sense of safety and trust in the brand. Unfortunately, counterfeiters can easily copy overt features.

QR codes and bar codes can be added to packages so that purchasers can check the authenticity of the product.  However, barcodes and QR codes can be copied by counterfeiters.  Unless the QR or bar code is unique to a single batch or single product, then anyone who checks a counterfeit product that carries a copied bar code or QR code will be fooled into thinking it is legitimate.

Covert brand protection features are designed to be invisible.  They often require special scanners for reading and verification.  They can include fluorescing inks that can be read only under invisible wavelengths of light.  Chemically unique inks can be customised for a single manufacturer so that they are difficult for counterfeiters to reverse engineer.  These are called ‘taggant inks’.

Covert features are most useful for brand owners when they need to investigate a problem with product; they reveal whether the problematic product is genuine or not. They can also be used to find counterfeit products in authorised sales outlets and trace products that have been diverted.

Unique, serialised product identification codes provide an extra layer of protection.  Each product or product batch carries a different code.  The codes can be scanned by distributors, retailers and consumers to provide assurance that the product is authentic.

Protection from counterfeits and diversions using digital authentication. The product is marked with a unique code that can be scanned by distributors, retailers and consumers.  The code is checked against digital product information to check its authenticity.

Digital authentication as a protection against nutraceutical fraud. The product is marked with a unique code that can be scanned by distributors, retailers and consumers. The code is checked against digital product information to check its authenticity.

 

When the unique identifier is scanned, the brand owner can find out where the product is geographically located.  If that does not match the expected location of that product within the authorised supply chain that could signal diversion.  Likewise, if a single ‘unique’ barcode or QR code is scanned by multiple consumers that would indicate fakes in the market; counterfeiters have copied one code and applied it to whole batches of product.

One company to have benefitted from such a system is Windmill, a well-known Dutch brand of potato starch.  The company claims that its products were affected ‘up to 50%’ by counterfeits and look-alikes in overseas markets until it implemented digital security features including a unique ID code on each pack.  The code allows the purchaser to confirm authenticity, while the act of checking provides the brand owner with “valuable data… which can be used to make the entire supply chain more transparent and to generate crucial market insights.”

Nutraceuticals are high value products with complex global supply chains, making them an attractive target for food fraud.  Brand owners have been caught manufacturing and supplying products that contain less than the amount of functional ingredients.  Other brands have been found to contain undeclared pharmacological components, which can be dangerous. Diversion and counterfeiting of legitimate product also affects nutraceuticals.  With growing global demand for nutraceuticals, consumers and businesses alike need to be on the look out for food fraud in this sector.

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Where’s my tricorder?

We would all love to have a magic machine that can tell us exactly what is in a food or a health supplement, but our current technology isn’t quite at the level of Star Trek yet.  Here’s a question asked recently on Reddit/foodscience . It follows a common theme for questions asked by entrepreneurs who are investigating food and supplement business opportunities.

Supplement testing

 

Question: How do I test supplements to make sure the ingredients are authentic and organic?

The Reddit poster explained that he had stumbled upon a mix of plant extracts that helped his acne and wants to make and sell a pill with those ingredients.  He writes:  “I sourced some plant extract manufacturers in china but I do want to test the plant extracts to check if they are actually what they are and if they are truly organic. Can someone please point me in the right direction as to how to do that?“.  A food manufacturing expert suggested that he seek a contract manufacturer to make the pills for him, which he said sounded like a good idea.  Then he asked “I’d feel a lot better if there was maybe a machine I could buy to check the composition of what was in there“.

Answer: I think you want a Star Trek Tricorder

I wish it was possible to buy a magic machine that will tell you what is in a product.  On the other hand I am a food/supplement fraud expert so if there was such a thing I wouldn’t have a job.

Organic testing is ‘simple’. Sort of.  To test for ‘organic’ status in a finished capsule supplement you can check that pesticide residues are absent.  There is no technology that allows you to put a pill into a machine and ask it to look for ‘anything’, so you need to ask the machine to look for specific pesticides.  The USDA perform this type of testing every year on fruit and vegetables.  Each sample is tested separately for around 200 different pesticides.  The USDA use a network of independent labs so it should be easy to find a lab that can test your finished product for pesticide.  More on the pesticide testing program here:  https://www.ams.usda.gov/datasets/pdp

Authenticity testing is not simple.

Herb-like ingredients can be tested for authenticity by an expert who looks at them under the microscope.  This only works if they are not ground up too small.

Liquid extracts and soluble powders can be tested using chromatographic methods, such as HPLC and GC.  In these methods the machine creates a chemical ‘fingerprint’ for the material and then compares that to the fingerprint of an authentic sample.  There are two things that make it difficult: firstly you need to find a lab that knows what an authentic sample fingerprint looks like for the material you want to test (they call this ‘having a database’); secondly, these methods are best suited to single ingredients.  Once you mix a whole bunch of ingredients together, if you test the mixture all the chemical fingerprints get mixed up and the machine can’t tell you which peak (which part of the ‘fingerprint’) comes from which ingredient.  There are ways around this but the methods are expensive as the databases are custom-made for each finished product that is to be tested.

Unfortunately it usually comes down to trust in your suppliers and a reliance on their systems and certifications.  Check all certifications to make sure they are not forged as unfortunately that is common in some countries.  Do this by contacting the certifier directly.

Reddit user: Karenconstable4

Want help with supplement authenticity?  Don’t know where to start?
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