An Overview of Fraud in Botanical Products
Botanical supplements are ubiquitous in the United States: they are found in almost every grocery store, pharmacy, and household. Botanicals have active ingredients that the body metabolizes and impact consumer health, so it is important someone can read a label and know exactly what they are consuming. While most botanical products are accurately labeled, there is always a risk that a product is not what it seems. Fraud and adulteration are common issues within the botanical market with potentially harmful health and monetary effects. The first step in reducing the rate of fraud in the marketplace is understanding where it comes from. 
What are botanical products?
According to the NIH, botanicals are plants or plant parts that have therapeutic effects or a favorable scent or taste. These products are sold as fresh or dried materials, tinctures, extracts, tablets, capsules. In some cases, they are sold as the entire plant or a full profile extract, and in others they are sold as individual compounds isolated from a plant and formulated into a pill. Consumers turn to botanical products to relieve disease and illness symptoms, supplement their diet, support a healthy lifestyle, cultural reasons, or completely unknowingly.
Botanicals is a broad term, and botanical products can fall under a few different CFRs:
- 21 CFR 111: Current Good Manufacturing Practices (cGMP) for Dietary Supplements
- 21 CFR 101: Food Labeling, including botanicals used in food products
- 21CFR 201: Labeling requirements for prescription and OTC drugs
Each CFR has different requirements, so it is crucial to understand your product’s intended use.
The global botanical product market was valued at 164.4 billion dollars in 2022 and continues to grow. With increasing sales comes increasing cases fraud: intentional action to take advantage of consumers.
What is fraud?
Fraud, also called Economically Motivated Adulteration (EMA), is the act of deceiving the buyer through changing a botanical product for economic gain. While fraud primarily occurs with botanical supplements, it can also occur in food and feed products. Fraud comes in many forms, including:
- Substitution: Replacing the claimed botanical with another plant entirely. Often, an expensive plant is replaced with a cheaper look-a-like that lacks the desired therapeutic effects.
- Addition: Adding in a cheaper or lower-quality plant it increase product supply.
- Dilution: Diluting an extract or product with additional solvent or water to increase the overall quantity of the product available.
- Spiking: Adding an unlabeled or unapproved substance to change the products attributes, like color or therapeutic effects.
- Fraudulent labels: Intentionally mislabeling products to sell at a higher price point. This includes advertising a higher dose, claiming a product is organic, or writing the incorrect formulation.
Examples of fraud in botanical products:
- Dilution of essential oil with water or labeling a synthetic oil as natural
- Enhancement of spices, like paprika, with artificial dye to improve perceived quality
- Spiking a botanical product that claims to reduce appetite with illegal synthetic weight loss compounds
Some of the most common botanical supplements investigated for fraud include bilberry, black cohosh, cranberry, gingko, and St. John’s Wort. Supplement authentication and testing falls under 21 CFR 111 which outlines the requirements for identity, potency, purity, and composition analysis.
The difference between fraud and adulteration:
Another common term is adulteration. Adulteration is similar to fraud, but has a much broader scope. According to the FDA, adulteration is when a product is prepared, packed, or held under conditions that do not meet current Good Manufacturing Practices (cGMP). This definition includes intentional and unintentional substitution (via processing or harvesting cross-contamination), packaging issues, or storage problems that lead to non-compliance with cGMP guidelines and label claims
Dangers associated with botanical fraud:
The biggest concern associated with botanical fraud is danger to the consumer. This danger can appear in many ways:
- Unknown allergens: Failure to disclose all ingredients in a product can result in consumption of unknown allergens, leading to severe or fatal reactions.
- Toxic spiked compounds: Spiking products with illegal dyes or pharmaceutical compounds can lead to toxic effects.
- Loss of desired effect: Specific plants have specific effects, and replacing the labeled plant with an alternative may result in the loss of therapeutic outcomes. Dilution can reduce the amount of active ingredient, resulting in loss of activity.
- Unintended herb-drug interactions: Botanicals affect the human body because they have bioactive compounds metabolized that the body metabolizes. These compounds can block receptors and interfere with drug functions. If an unknown herb is in a product, there is potential for harmful interactions.
Beyond consumer safety, botanical fraud results in economic loss to manufacturers, brands, and consumers who are paying higher prices for lower-quality materials. Brands and manufacturers risk costly testing and investigations to determine the source of fraud as well as the risk of a damaged reputation if a customer has adverse effects.
How to prevent fraud:
Developing a fraud mitigation program is the first step in preventing botanical product fraud. There are two main steps:
- Vulnerability assessment: identify potential risks, including high risk ingredients and supply chain issues.
- Mitigation plan: regulate and reduce risk through critical evaluation and monitoring.
Below are several considerations for your fraud mitigation program:
Supplier Relationship
Knowing your suppliers is critical to understanding your risks. While reviewing your suppliers, consider their history, audit strategy, and testing frequency. All of these contribute to their risk rating and potential frauds that could be introduced into your system.
Supply Chain
Who supplies your suppliers? The entire chain back to the farm should be reviewed, since fraud is possible at any point in a botanical’s lifecycle. The longer the chain, the higher the risk.
Geopolitical Considerations
Climate, natural disasters, and political environments can change product safety. In 2011, Fukushima nuclear incident introduced radiation effects in the space that could cross-contaminate ingredients from the area.
Fraud History
Evaluating past recalls and exposures provides a great overview of what ingredients higher risk of fraud. Past data shows there has been a known fraud in industries such as spices, honey, seafood, oils, wine, juices, and others.
Economic Anomalies
Like all industries, supply and demand can impact the price and quality of botanicals. For example, many wild-cultivated herbs have a higher demand than suppliers can meet based on the amount growing in a given season, leading to substitution. If the price is too good to be true, there is reason to suspect fraudulent activity.
Environmental Considerations
Botanical products are highly influences by their environment. This infographic summarizes some key environmental factors that can alter botanicals' chemical profiles. This is not fraud, but is still an important consideration for botanical manufacturing and processing.
Testing for Adulteration in Botanical Products:
We asked one of our exerts, Dagney McCready, if testing for adulteration in botanicals is possible. Find out her answer with this video: https://www.youtube.com/watch?v=IHKoC6kfNaw
"Testing for adulteration in botanicals, has proven to be very challenging. Their differing components, differing levels of these components, and amount of processing done on the raw plant creates a very complex situation making testing both helpful, but not fully conclusive. Detecting any sort of adulteration is hard, but running more than one analytical test can help possibly detect. On a turmeric extract, for example, conducting HP-TLC can confirm if the material is turmeric, while UPLC can help verify if its active component, or Curcuminoids, are present. However, if an extract is 95% Curcuminoids, UPLC may be the only needed analysis. Rule of thumb is to test based of fit for purpose of your needs and our teams can help you determine just that." - Dagney McCready, Technical Leader of Eurofins Botanical Testing Laboratory in Brea, CA.
