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.