The Dangers of Food Supplements: WHEN WILL WE SEE THE TRUTH?
Growing Popularity of Herbal Dietary Supplements
Lately, society has shown an unhealthy enthusiasm for consuming herbal dietary supplements. Often, even seriously ill patients refuse chemical drugs and demand "natural remedies," including antibiotics, blood pressure reducers, and digestive aids. Lithuanian and European Union legislation prohibit advertising dietary supplements by claiming their (or their constituent parts') therapeutic or prophylactic properties unless the European Commission approves them. Unfortunately, some dietary supplements are still presented as drugs. Consequently, the ranks of herbal dietary supplement consumers continue to grow while specialists' warnings about using dietary supplements for treatment purposes remain unheard.
Dietary Supplements vs. Drugs
Due to advances in food technologies, the market has rapidly increased products containing active substances like vitamins, bacteria, minerals, amino acids, and herbal components, presented to consumers as dietary supplements. These products are subject to food safety regulations and are evaluated differently than medicinal preparations. A dietary supplement is a food product intended to supplement the normal diet. The product can be a concentrated source of nutrients or other substances with a nutritional or physiological effect. Manufacturers market dietary supplements in dosage forms such as capsules, lozenges, pills, tablets, powder sachets, ampoules, and bottles with dropper dispensers.
EU and Lithuanian legislation allows manufacturers with approvals from their competent authorities to claim a connection between the food product (or its components) and health. For example, claims such as "improves digestion" or "strengthens immunity" are allowed. Claims implying that not consuming the product could impact health or indicating specific weight loss are prohibited. Health benefit claims must be based on universally recognized scientific evidence. Advertisers must have sufficient evidence to support these claims.
A product classifies as a drug when it contains an active pharmaceutical ingredient or a combination that meets at least one of the following criteria:
- Has properties suitable for treating or preventing human diseases.
- Due to pharmacological, immune, or metabolic effects, it can be used to restore, correct, or modify human physiological functions or diagnose human diseases.
The form of presentation of the product no longer distinctly differentiates between drugs and dietary supplements. Many dietary supplements now appear in forms previously characteristic only of drugs, such as capsules and pills. This similarity often misleads consumers to think dietary supplements are drugs, which can pose a health risk.
Adverse Reactions to Herbal Preparations
Researchers distinguish four types of adverse reactions caused by herbal preparations:
- Type A: Pharmacologically predictable, dose-dependent reactions avoidable by reducing doses.
- Type B: Idiosyncratic, pharmacologically unpredictable, toxic, dose-independent reactions, often severe and potentially fatal.
- Type C: Develop after long-term use, well-known but may still be unexpected.
- Type D: Delayed effects, such as carcinogenic or teratogenic reactions.
Herbal preparations can also cause allergic, toxic, and mutagenic reactions, adverse events related to pharmacological effects, and interactions with drugs. Often, these preparations are contaminated with toxic substances or plants unsuitable for consumption.
Regulatory ChallengesDespite many EU and national regulations, the dietary supplement market remains inadequately regulated and harmonized. Maximum amounts of vitamins and minerals in dietary supplements are not established. There are no definitive lists of other substances, such as plant extracts and amino acids, that may be used in dietary supplement production. This regulatory gap is particularly concerning for dietary supplements with insufficient safety information about the plants used, especially those from China or used in Ayurvedic medicine.
Watering the ranks of herbal food supplement consumers: is it safe
Stable market growth
Recently, scientists have noticed an increase in consumers of herbal food supplements, along with a decrease 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% in 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 make up to 80% of the products used in primary healthcare. The notion that only "natural remedies can help and are safe" is alarming. Especially since among consumers of herbal food supplements are the most vulnerable groups of patients - children, the elderly, and people suffering from serious illnesses. It is also concerning that some patients, especially those with serious illnesses (such as diabetes, heart diseases, asthma, cancer, multiple sclerosis, hepatitis C, etc.), have more 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 discontinue conventional treatment and start taking Ayurvedic food supplements, which are rich in heavy metals and other toxic elements (such as arsenic, mercury, etc.), 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%, mercury - 65%. A study of 6712 women aged twenty and older who took herbal food supplements revealed that their serum lead concentration was 10% higher than those who did not take supplements. In another study, it was found that the serum lead concentration was 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?
Quality Control Challenges
Quality control of herbal preparations hinges on the identity of the active substances. This includes 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 (e.g., 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. Additionally, detailed information about individual production stages (from raw material collection, processing, to preparation production) is not provided. Violations during the production process can make some herbal food supplements dangerous or even toxic. This can result in liver or kidney failure, interactions with drugs that distort their effects, and allergic or anaphylactic reactions. For instance, food supplements made from fungi can trigger cross-allergic reactions in patients allergic to penicillin group drugs.
Factors Contributing to Toxicity
Several factors determine the toxicity of herbal food supplements:
- Use of unidentified plants
- Selection of inappropriate parts of the plant
- Improper storage of herbal materials
- Contamination of herbal materials with microorganisms, chemicals, and heavy metals
- Falsification of food supplements
- Improper labeling of the final product, where the content 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, which are particularly popular among athletes. Analyses of herbal food supplements have found substances like warfarin, diethylstilbestrol, indomethacin, caffeine, acetaminophen, hydrochlorothiazide, ephedrine, chlorpheniramine, methyltestosterone, prednisolone, and phenacetin.
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, Jin Bu Huan. It is believed that the following may 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,
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 the postoperative recovery of operated patients, causing various complications: disrupting normal clotting (garlic, ginseng, ginseng), affecting the heart and circulatory system (ephedra), causing hypoglycemia (ginseng), as well as distorting the action 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 being 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, the chief specialist of the Food Department of the State Food and Veterinary Service (SFVS), states that in Lithuanian pharmacies, you can find more than 50 different dietary supplements for weight loss, slightly fewer of which are available in online stores. According to toxicologists, weight loss products may contain not only herbs but also toxic chemicals, doses of which exceed permissible limits. Patients consult doctors for various complaints: they start feeling dizzy, experience nausea, vomiting, which for 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 and human life and health protection interests is maintained in Lithuania. The trend of recent years shows that the Advertising Law is most often violated when advertising dietary supplements, 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.
Importance of Clinical Trials
Clinical trials are necessary to confirm the safety of non-traditional herbal medicinal products. These trials evaluate the intensity and frequency of side effects and the safety of product use for higher-risk consumers, 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 synthetic preparations or herbal medicines. Therefore, caution should be exercised when giving dietary supplements made from herbal raw materials to children, pregnant or nursing women, those with allergies, elderly patients, and individuals with kidney or liver insufficiency, or before planned surgery. It is extremely dangerous to combine herbal dietary supplements with multiple medications. Dietary supplements should not be seen as a lifeline for patients with incurable diseases—they should rely more on traditional treatments.
Debate Over Herbal Preparations
Today, scientists actively debate the use of herbal preparations in dietary supplement production. 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," says Prof. L. Kupčinskas.
Literature
1. Anastasi JK, Chang M, Capili B. Herbal supplements: Talking with your patients. Journal for Nurse Practitioners. In eMedicine. 2011. Available
at https://www.medscape. com/viewarticle/735530.
2. Barnes PM, Bloom B, Nahin RL. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. National Health Statistics Reports. Number 12, December 10, 2008. Available at https:// www.cdc.gov/nchs/ data/nhsr/nhsr012.pdf.
3. Barrueto F. Jr. Herb Poisoning. h t t p : / / e m e d i c i n e . m e d s c a p e . c o m / article/817427-overview.
4. Baxter K, Driver S, Williamson E. Stockley’s herbal medicines interactions. London, Pharmaceutical Press.2009.
5. Boullata JI, Nace AM. Safety issues with herbal medicine. Pharmacotherapy. In eMedicine.2000. Available at https://www.medscape. com/
viewarticle/409518. 6. Buettner C, Mukamal KJ, Gardiner P, Davis RB, Phillips RS, Mittleman MA. Herbal supplement use and blood lead levels of United States adults. J Gen Intern Med. Nov 2009;24(11):1175-82.
7. Centers for Disease Control and Prevention. Hepatitis temporally associated with an herbal supplement containing artemisinin - Washington, 2008. MMWR Morb Mortal Wkly Rep. Aug 14 2009;58(31):854-6.
8. Centers for Disease Control and Prevention. Self-treatment with herbal and other plant-derived remedies--rural Mississippi, 1993. MMWR Morb Mortal Wkly Rep. Mar 24 1995;44(11):204
9. Falloon J.The effect of garlic supplements on the pharmacokinetics of saquinavir. Clin Infect Dis. 2002 Aug 1;35(3):343.
10. Fetrow CW, Avila JR. Professional's handbook of complementary and alternative medicines. 3rd ed. Philadelphia (PA), Lippincott Williams & Wilkins. 2004.
11. Fox S. Chinese Herb Remains Health Threat Despite Widespread Bans. Medscape Medical News, March 18, 2013. Available at https:// www. medscape.com/viewarticle/780947.
Article from the journal "Farmacija ir laikas"
LT/Mez/2014/09
