Food Supplements Aren’t Always Safe: What You Need to Know
Recently, an unhealthy enthusiasm for the use of herbal dietary supplements has been observed in society. Even seriously ill patients sometimes refuse treatment with conventional medications and demand “natural remedies” such as antibiotics, blood pressure-lowering agents, or digestive aids. Lithuanian and European Union legislation prohibits advertising dietary supplements by attributing therapeutic or preventive properties to them or their ingredients, except in cases where such claims have been approved by the European Commission. Unfortunately, dietary supplements are still sometimes presented as medicines. As a result, the number of consumers using herbal dietary supplements continues to grow, while specialists’ warnings about using dietary supplements for therapeutic purposes often remain unheard.
Due to advances in food technology, the market is rapidly expanding with products containing various active substances such as vitamins, bacteria, minerals, amino acids, and herbal components, which are presented to consumers as dietary supplements. These products are subject to food safety regulations and, from a legal perspective, are evaluated very differently from products regulated as medicinal preparations.
A dietary supplement is a food product intended to supplement the normal diet and which, alone or in combination with other substances, represents a concentrated source of nutrients or other substances with a nutritional or physiological effect. Dietary supplements are marketed in dosage forms such as capsules, lozenges, pills, tablets, powder sachets, ampoules, bottles with dropper dispensers, and other similar forms of liquids and powders intended to be consumed in small measured quantities.
According to legislation in force in the European Union and Lithuania, manufacturers who have obtained approval from the competent authorities and submitted applications to the European Food Safety Authority for authorization of health claims may directly or indirectly state or imply a relationship between a category of food, a food product, or one of its components and health. In other words, health claims such as “improves digestion” or “strengthens immunity” may be used when appropriately authorized.
It is not permitted to make claims suggesting that failure to consume a particular food product could adversely affect health, claims indicating how much or how quickly weight can be lost, or claims referring to recommendations from individual doctors or healthcare professionals. Health claims must be based on and supported by generally accepted scientific evidence. The advertiser of a dietary supplement must have sufficient evidence to substantiate the product’s health claims.
A product is classified as a medicinal product when it contains an active pharmaceutical ingredient or a combination of active substances that meets at least one of the following criteria:
- it has properties suitable for treating or preventing human diseases;
- due to its pharmacological, immunological, or metabolic effects, it can be used or prescribed to restore, correct, or modify physiological functions in humans or to diagnose human diseases.
The importance of the product’s pharmaceutical form in distinguishing medicines from dietary supplements has diminished, because forms previously associated only with medicines, such as capsules, lozenges, pills, and tablets, have become common in the dietary supplement market for convenience and practical reasons.
Therefore, because dietary supplements often resemble medicines in their form and are attributed various health-related properties, they may be advertised, purchased, and consumed as if they were medicinal products. This can mislead consumers, fail to meet their expectations, and may also pose risks to health.
Four types of adverse reactions caused by herbal preparations are distinguished:
Type A – pharmacologically predictable, dose-dependent reactions that can be prevented or reduced by lowering the dose;
Type B – idiosyncratic, pharmacologically unpredictable, toxic, dose-independent reactions that are often severe and potentially fatal;
Type C – reactions that develop after long-term use, are well known, but may still occur unexpectedly;
Type D – delayed effects, including carcinogenic and teratogenic effects.
Herbal preparations may also cause allergic, toxic, and mutagenic reactions, adverse effects related to their pharmacological action, and interactions with medications. These preparations may also be contaminated with various toxic substances or contain plants unsuitable for human consumption.
Despite numerous European Union and national regulations, the dietary supplement market remains insufficiently regulated and harmonized. Maximum permitted amounts of vitamins and minerals in dietary supplements have not been established, and there are no definitive lists of other substances, such as plant extracts and amino acids, that may be used in the manufacture of dietary supplements.
European Union legislation also lacks definitive lists of certain substances, including plant extracts, that may be used in dietary supplement production. Particular concern surrounds dietary supplements for which there is insufficient information about the safety of the plants used and their effects on the human body. These are often supplements originating from China or preparations used in Ayurvedic medicine.
Stable Market Growth
Recently, scientists have noticed an increase in the number of consumers of herbal food supplements, along with a decline in trust in traditional medicine. The World Health Organization provides data showing that the consumption of supplements made from plant materials has increased by 3% over the last decade, a trend observed worldwide. For example, in the United States, $60 billion is spent annually on herbal food supplements, while in Africa, they account for up to 80% of the products used in primary healthcare.
The belief that only “natural remedies can help and are safe” is alarming, especially since the consumers of herbal food supplements include the most vulnerable groups of patients—children, the elderly, and people suffering from serious illnesses. It is also concerning that some patients, particularly those with serious illnesses such as diabetes, heart diseases, asthma, cancer, multiple sclerosis, and hepatitis C, place greater trust in alternative medicine because conventional treatment does not meet their expectations.
Herbal Food Supplements – the “Heavy Artillery” of the Periodic Table
Herbal preparations used in traditional Chinese medicine and produced in exotic countries around the world are spreading globally. For example, patients with mental disorders may discontinue conventional treatment and start taking Ayurvedic food supplements, which can be rich in heavy metals and other toxic elements, such as arsenic and mercury, increasing the risk of intoxication. Heavy metals are also abundant in “slimming” preparations.
A study of 247 preparations used in traditional Chinese medicine found that arsenic contamination reached 5–15%, lead 5%, and mercury 65%. A study of 6,712 women aged 20 and older who took herbal food supplements revealed that their serum lead concentration was 10% higher than that of women who did not take supplements. In another study, serum lead concentration was found to be 24% higher among those taking Ayurvedic food supplements or traditional Chinese herbal medicine.
Contamination of herbal materials with mefenamic acid and cadmium can cause acute kidney failure, while phenylbutazone and dipyrone in food supplements can cause agranulocytosis.
Does the Label Really Reflect the Composition of the Food Supplement?
The quality control of herbal preparations is determined by the identity of the active substances—nomenclature (botanical source of the herbal medicinal product), purity (assessment of contamination), quantitative assessment of chemical compounds, and assessment of the qualitative and quantitative composition and contamination (heavy metals, pesticides, radioactive compounds, and microbial contamination) of the final herbal preparation.
Most often, when registering an herbal food supplement, the stability of the raw materials and active compounds is not assessed, and detailed information about individual production stages—from raw material collection and processing to preparation production—is not provided.
Due to violations during the production process, some herbal food supplements can be dangerous or even toxic, causing liver or kidney failure, interacting with drugs and altering their effects, or causing allergic or anaphylactic reactions. For example, food supplements made from fungi can trigger cross-allergic reactions in patients allergic to penicillin-group drugs.
The toxicity of herbal food supplements is determined by several factors: the use of unidentified plants, the selection of inappropriate parts of the plant, improper storage of herbal materials, contamination of herbal materials with microorganisms, chemicals, or heavy metals, falsification of food supplements, and improper labeling of the final product when the content of the food supplement does not match the information on the label or the quantity of active substances is not indicated.
Food supplements may contain banned substances, such as hormonal preparations—these supplements are particularly popular among athletes. When analyzing the composition of herbal food supplements, substances such as warfarin, diethylstilbestrol, indomethacin, caffeine, acetaminophen, hydrochlorothiazide, ephedrine, chlorpheniramine, methyltestosterone, prednisolone, and phenacetin have been found.
Increasing Cases of Liver Damage
Studies show that the consumption of herbal food supplements is leading to an increase in cases of liver damage. For example, plants containing pyrrolizidine alkaloids are hepatotoxic (Crotalaria—rattlebox, Senecio—ragwort, Heliotropium—heliotrope, Symphytum officinale—comfrey), as well as Teucrium chamaedrys—germander, Larrea tridentata—creosote bush, Cassia augustifolia (Senna)—senna, cinchona herbs, and Jin Bu Huan.
It is believed that the following may also be hepatotoxic: Viscum album—mistletoe, Scutellaria—skullcap, Valeriana officinalis—valerian, Teucrium polium—gray germander, Mentha pulegium—pennyroyal, Berberis vulgaris—common barberry, Hedeoma pulegioides—American pennyroyal, Azadirachza indica—neem tree, and Sassafras albidum—white sassafras.
Interaction With Prescription Drugs
Herbal supplements can interact with prescription drugs and alter their effects. The list of such plants includes St. John’s wort, ginseng, garlic, ginseng, valerian, and ephedra. These plants can worsen postoperative recovery in patients undergoing surgery, causing various complications: disrupting normal clotting (garlic, ginseng, ginseng), affecting the heart and circulatory system (ephedra), causing hypoglycemia (ginseng), and altering the effects of anesthetics (valerian).
Paid Health Advertising
Irresponsible manufacturers or advertisers of dietary supplements may attribute therapeutic properties to them that do not actually exist. A perfect example is the story of dietary supplements made from cinchona herbs that were sold online for weight loss. They contained a double dose of sibutramine—a drug that reduces appetite. Naturally, for some, this product helped them lose weight, while for others, it harmed their livers.
Therefore, dietary supplements containing herbs grown in exotic countries are often the most dangerous supplements for weight loss. Laima Misiūnaitė, chief specialist of the Food Department of the State Food and Veterinary Service (SFVS), states that more than 50 different dietary supplements for weight loss can be found in Lithuanian pharmacies, with slightly fewer available in online stores.
According to toxicologists, weight loss products may contain not only herbs but also toxic chemicals in doses exceeding permissible limits. Patients consult doctors with various complaints: they begin to feel dizzy and experience nausea and vomiting, which in some patients can lead to acute liver or other organ failure and cost lives.
Meeting Patient Needs or Ensuring Treatment Safety
Today, responsibility for the safety of a dietary supplement is limited to the manufacturer or supplier, raising doubts about whether a reasonable balance between business interests and the protection of human life and health is maintained in Lithuania. The trend of recent years shows that the Advertising Law is most often violated when dietary supplements are advertised by attributing therapeutic or disease-preventing properties to them.
According to Aušra Išarienė, Head of the Food Department of SFVS: “The trends in the advertising of dietary supplements are alarming, especially considering that the provisions of the law are often violated tendentiously, not due to lack of information or ignorance. It is worth remembering that illegal or misleading advertising not only incurs administrative liability but also tarnishes the company’s reputation, reduces consumer confidence in both the product and its seller. Therefore, correct advertising of dietary supplements should be a concern not only for SFVS but primarily for the entrepreneurs themselves. Of course, there are responsible companies that care about their reputation and customers, who often consult with our specialists to ensure that the advertising of dietary supplements is legally sound and accurate.”
The effectiveness, benefits, and side effects of drugs are consistently studied in multi-stage clinical trials, while these criteria are not applied to dietary supplements, so the production and sale of dietary supplements must be strictly regulated.
Therefore, when a patient asks for “something natural, made from plants,” healthcare professionals should not cater to the patient but treat them only with safe, scientifically and clinically proven drugs. When recommending herbal preparations, caution should be exercised or they should not be prescribed at all if the following drugs are being taken:
• anesthetics; • opioid analgesics; • drugs for treating diabetes; • anticonvulsants; • antihypertensive drugs; • benzodiazepines; • glucocorticoids; • immunosuppressants; • digoxin; • diuretics; • warfarin, platelet aggregation inhibitors; • NSAIDs; • proton pump inhibitors; • laxatives; • oral contraceptives; • antibiotics.
Clinical trials are necessary to confirm the safety of non-traditional herbal medicinal products, evaluating the intensity and frequency of side effects and the safety of product use for consumers at higher risk, such as pregnant women, nursing mothers, children, and the elderly.
Most often, herbal dietary supplements (but not herbal medicines!) are not subject to the same requirements as chemically synthesized preparations or herbal medicines. Therefore, caution should be exercised when giving dietary supplements made from herbal raw materials to children, pregnant or nursing women, people with allergies, and elderly patients, as well as in cases of kidney or liver insufficiency and before planned surgery. It is extremely dangerous to give herbal dietary supplements when taking multiple medications.
Dietary supplements should not be a lifeline for patients with incurable diseases—they should rely more on traditional medicine. Today, scientists actively debate the use of herbal preparations in the production of dietary supplements. The statement that what is natural is safe and healthy cannot be applied in this case.
“People imagine that their organism is like a plant that will grow beautifully and bloom quickly when fertilized—in this case, by taking dietary supplements. Remember that dietary supplements are not fertilizers used in agriculture, and they do not work miracles” (Prof. L. Kupčinskas).Literature
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Article from the journal "Farmacija ir laikas"
LT/Mez/2014/09
