Pharmacognosy with Basics of Plant Biochemistry - Kovalyov V. M. 2004

Special Section
Biologically Active Dietary Supplements
Dietary Supplements from Medicinal Plant Raw Materials

History shows that the commercialization of herbal medicinal products under the guise of dietary supplements first originated in the United States, followed later by the creation of a theoretical framework to justify their use.

Legal relations in the food sector are regulated by the Federal Food, Drug, and Cosmetic Act of 1938. In October 1962, the Kefauver-Harris Amendment was enacted, requiring all medicinal products to be tested for safety and efficacy by 1983. This marked the beginning of a new era in pharmacy. To implement the amendment, the U.S. Food and Drug Administration (FDA) contracted the National Academy of Sciences Research Council to evaluate the efficacy of drugs that had been approved prior to 1938 solely on The basis of their safety. Manufacturers were required to submit reports to the FDA on adverse drug reactions. Beginning in 1972, finished pharmaceutical products began undergoing evaluation according to these criteria.

"Obsolete" drugs that did not require proof of safety and were used to treat morbid states rather than pathologies were withdrawn from the market. This primarily affected herbal remedies, as clinical data rarely supported their approval. The pharmaceutical industry was reluctant to fund additional research for an in-depth Study of the efficacy of herbal products, leading to a situation where almost all herbal medicines disappeared from pharmacies. Consumer demand was met by stores and mail-order companies selling "dietary supplements" in the form of teas, herbs, health foods, and food products. Labels bore only the product name without any indication of its efficacy. Sellers naturally avoided giving usage recommendations to prevent being accused of practicing medicine without a license.

The answer to why natural remedies are not distributed through conventional channels globally lies in the economic mechanisms of drug development. A potential manufacturer or entrepreneur must invest substantial capital (sometimes hundreds of millions of dollars) to conduct all necessary tests and research. Since patent protection for natural products is difficult or entirely impossible, firms are reluctant to invest in their development. This is deeply regrettable, as investigating "old" medicines using modern methodologies could uncover new beneficial properties of active substances.

Even more regrettable from an economic, scientific, and professional standpoint is the charlatanism that accompanies recommendations by unqualified individuals regarding The Use of dietary supplements by seriously ill patients who have found no relief in conventional medicine and have resorted to self-medication. Therefore, a qualified pharmacist or provisore must be well-informed about special-purpose dietary supplements, particularly biologically active supplements authorized for sale in pharmacies. Specialists are obligated to inform and warn the public, patients, and their families against using unknown, foreign dietary supplements out of desperation or ignorance, especially those not approved by the Ministry of Health of Ukraine. At the same time, they must closely monitor the Introduction of newly registered dietary supplements, maintain professional expertise to build customer trust, avoid categorical judgments such as "this is outdated" or "this is worthless," show genuine care for the patient, and gently guide them toward traditional Treatment.

In the European Community, the legislative acts governing foods, cosmetics, and drugs are EU Directives. However, situations often arise where it is impossible to classify a product definitively. The exact same product might be considered a pharmaceutical in Germany while holding the status of a dietary Supplement in the Netherlands. The term "nutraceutical" is now widely used to designate products possessing characteristics of both foods and drugs, yet the EU still lacks legislative documents regulating this category of products. According to European legal norms, a product may fall under either the food industry or the pharmaceutical industry, but not both simultaneously.

The harmonization of EU member states' pharmaceutical legislation began with Directive 65/65/EEC of January 26, 1965. Article 1 defines a "medicinal product" as: "Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical Diagnosis or to restoring, correcting or modifying physiological Functions in human beings or in animals is also considered a medicinal product." Despite this precise formulation, companies find ways to market dietary supplements, for instance, as having a "positive effect on The Heart," a "carefully selected combination of lipotropic fat-burning ingredients," "hormone precursor tablets," "Blood sugar stabilizers," or agents that "help maintain normal body Water balance," among others.

Difficulties in product Classification often arise when a food product is manufactured in a pharmaceutical dosage form (tablets, capsules, granules). Certain products containing Vitamins AND MINERALS are classified as medicinal products and require a dispensing license because their instructions state they are used to treat conditions caused by vitamin deficiencies and contain these substances in high doses. In the absence of such therapeutic claims, the product may be marketed as a dietary supplement (subject to appropriate authorization).

In August 1999, the Ministry of Health of Ukraine approved the Regulation on State Control over the Quality and Safety of Special Food Products, Biologically Active Dietary Supplements, and Food Additives.

For the first time, these Regulations introduced terminology defining biologically active supplements as substances or mixtures thereof used to impart special therapeutic or prophylactic properties to the human diet.

Special food products comprise therapeutic, dietary, prophylactic, and biologically active food supplements, as well as infant formula and sports Nutrition.

Currently, the importation, distribution, and use of food additives, dietary supplements, and special food products in Ukraine are permitted only after state expert evaluation of the products and their regulatory documentation, followed by registration in the State Registers of Food Additives, Dietary Supplements, and Special Food Products.

Safety and Efficacy of Dietary Supplements

Abroad, natural products that showed little to no therapeutic value during testing were reclassified as "dietary supplements." Furthermore, certain products that are harmful with prolonged use remain on the market. Chemical analysis has revealed that some contain substances with carcinogenic, mutagenic, and allergenic properties.

Despite this, people pay exorbitant prices for them and continue consuming them. This can be explained, firstly, by the fact that in many cases a positive effect stems from the so-called placebo effect, while the therapeutic action depends little or not at all on the active ingredients of the preparation. The placebo effect operates through psychological mechanisms. Experiments by Western scientists have demonstrated that the placebo effect occurs in individuals given placebos depending on their psychological state. It is believed that this positive effect manifests toward the end of treatment and is caused by behavioral changes, subjective sensations, or responses from the Endocrine System or internal regulatory mechanisms. Most patients take herbal preparations and dietary supplements in the hope of feeling better, and clearly, they sometimes achieve this. Confidence is also a key factor in successful therapy or medical Procedures. The choice of raw herbal Materials, phytopreparations, and special dietary supplements is often based on familial or folk traditions, advice from friends, or persistent distributors. The latter is extremely dangerous—suffering the harmful consequences of the uncontrolled use of the "infamous" Herbalife or vitamins serves as a clear reminder.

Secondly, herbal raw materials, phytopreparations, and plant-based foods contain a highly complex mixture of compounds. Some of these are essential to meet basic vital needs, while others possess physiological activity. Small doses of active substances induce positive Biochemical changes in the macroorganism slowly; therefore, only prolonged use, cumulative effects, polyvalent action, manufacturing technologies that prolong the action of active substances, adherence to lifestyle and dietary modifications, and recovery from a pre-disease state can ultimately improve human well-being.

Finally, the super-profits generated by manufacturers and distributors of various dietary supplements incentivize them to invest massive amounts of money into product advertising or training multi-level marketing (MLM) distributors. Consumers are artificially conditioned to believe in the extraordinary benefits of dietary supplements. MLM strategies rely on building trust in the distributor, leveraging their personal authority, and influencing family, friends, and acquaintances, thereby artificially shaping public opinion. While these product distribution techniques are recognized worldwide as highly effective, the path to success is slow.