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.

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 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.

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.