Botanical Products

Even for a particular class of product, a variety of terms may be used. Botanical drug products also may be known as herbal products or nutriceuticals. Botanical drug products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations of these. These products may be available in a variety of forms, including a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection. By distinction, fermentation products (e.g., alcohol) and highly purified or chemically modified botanical substances are not considered botanical drug products.¹⁰

Dietary Supplements

The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines a dietary supplement as a product (other than tobacco) taken in addition to a normal diet. More on this key legislation is mentioned below. Further, dietary supplements must contain one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances such as enzymes, organ tissues, glandular materials, and metabolites). The U.S. Food and Drug Administration (FDA) oversees supplement use and regulation. The FDA characterizes and regulates botanicals and dietary supplements according to their use, not according to their composition. If the intended use is to “promote health,” the agent is viewed as a dietary supplement. By contrast if the intended application of a product is to treat or prevent a disease, the agent is considered to be a drug. To meet labeling requirements, a dietary supplement must be intended to be taken by mouth as a pill, capsule, tablet, or liquid.¹¹

Herbs

An herb is the above-ground part of a nonwoody plant that does not persist through the winter. It also is known commonly as a crude drug, or as a flavoring used in cooking.¹² Other terms are used synonymously for herbs or herbal products, including botanicals, nutriceuticals, and phytopharmaceuticals.

Functional Foods

Functional foods are defined broadly as foods that provide more than simple nutrition. They supply additional physiological benefit to the consumer, through properties that promote health and/or disease prevention. Many, if not most, vegetables can be considered functional foods because they deliver benefits beyond basic nutrition. Tomatoes, for example, provide lycopene, a phytochemical with powerful antioxidant properties.

Probiotics

Probiotics are bacteria-containing foods, such as milk and milk solids, yogurt, and kefir, which may favorably alter the floral composition of the gut through competition of one type of culture with another.

Prebiotics

Prebiotics are biologically based therapies used to alter the bacterial composition of the intestines, not by adding bacteria, but by changing the type of substrate provided to the existing mixture.¹³

Special Diets

Special diets, such as those advocated by Atkins, Ornish, Weil, and others, purport to prevent or mitigate the symptoms of illness and/or to promote wellness. Orthomolecular therapies include the use of specific types of ingredients, such as minerals, or high-dose vitamins to prevent or treat illness, or to enhance wellness.¹⁴

Safety

Unlike a pharmaceutical product DSHEA does not require that research establish an herb or dietary supplement’s safety for consumers before its release in the market.

Effectiveness

Manufacturers do not have to prove that an herb or dietary supplement is effective. Rather, the manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”¹⁵

Quality

A manufacturer does not have to prove an herb or dietary supplement’s purity or caliber. The FDA is not required to analyze the content of herbal or dietary supplement products. Manufacturers who want to demonstrate a commitment to the quality of their products can voluntarily follow the FDA’s stricter—but optional—Good Manufacturing Practices or GMPs for drugs.¹⁵ The designation “GMP” on a supplement’s label ensures product quality, although it does not indicate safety or efficacy.

The Federal Trade Commission (FTC) also oversees advertising of herbs and dietary supplements. It requires that all information about supplements be truthful and without misleading information. However, limited enforcement resources and manpower, and the explosion of information outlets on the Internet and in the media blunt the impact of these efforts. Given the multitude of avenues through which vendors can disseminate claims and advertising, the enforcement resources of the FDA are underequipped for the task. Removal of problematic or unsafe biologically based therapies, as in the case of the dietary supplement ephedra, does occur. However, the number of products removed has been relatively limited. Given limited government oversight of biologically based therapies in the United States, consumers may have limited information regarding the risks or effectiveness of a variety of products. It is a caveat emptor scenario for clinicians and consumers.

Adverse Events and Reactions

The MedWatch system of the FDA allows health care professionals and consumers to report serious adverse events, potential and actual product use errors, and product quality problems associated with FDA-regulated drugs, biologicals (including human cells, tissues, and cellular and tissue-based products), medical devices (including in vitro diagnostics), special nutritional products, and cosmetics. Reporting instructions and forms can be accessed at http://www.fda.gov/medwatch/how.htm

The MedWatch system has been used in limited fashion for adverse event reporting for herb/dietary supplement use since 2004.¹⁶ Websites for the Office of Dietary Supplements at the NIH¹⁷ contain searchable information on warnings and safety postings from the FDA and false advertising claims from the FTC. Other surveillance systems include information on biologically based therapies such as the American Association of Poison Control Centers (AAPCC) incident database known as the Toxic Exposure Surveillance System (TESS).¹⁸

The reporting of adverse events, toxicity, or contamination in botanical or biological products is an issue of public health and safety. To address this on a national scale, the TESS database monitors, identifies, and responds to emerging contaminations or poisonings. This effort is a partnering of multiple agencies, including the Centers for Disease Control and Prevention, and the AAPCC, with 62 regional and local poison control centers (PCCs).

As described on the CDC website, the TESS database is a flexible and adaptable system that can be used by government and health agencies to do the following:

As such, the TESS database serves as a portal for the reporting of suspected cases for concern by consumers or clinicians. TESS is not intended to function as a searchable database for an individual in practice, however. Individuals in the United States can contact the PCC in their area by calling 800-222-1222, where they will be referred directly to their local or regional center.

Research

In laboratory settings, plant extracts have been shown to have a variety of physiological effects and act like pharmacological agents. These effects include antiinflammation vasodilation and antimicrobial, anticonvulsant, sedative, and antipyretic effects. However, because of limited research on the biological therapies, the mechanism of action of many herbs, and dietary supplements, biological therapies remains unknown or incompletely understood.

A number of issues have influenced the dissemination of information regarding the effectiveness and safety of biologically based therapies. The efficacies of herbal medicines that have been tested in clinical trials are of varying methodological quality. Fortunately or unfortunately, the gold standard of allopathic medicine for measuring the effectiveness of a therapy is the randomized controlled trial (RCT), yet RCTs on biologically based therapies are relatively limited in number. Despite an increased interest in biologically based therapies, research funding in this area is limited when compared with the budgets of the pharmaceutical sector. Even if many more RCTs on biologically based therapies were conducted, generalizing the data may be difficult because investigations may use several different botanical features and preparations to determine efficacy.¹⁹

As Ernst and others noted, analysis of the evidence for recent overviews of rigorous trials of herbal medicines has had mixed results: of 23 systematic reviews of herbal therapies, 11 came to a positive conclusion, nine yielded promising but not convincing results, and three were negative.²⁰ Despite these inconsistencies, sensible recommendations can be made based on appraisal of the existing literature and rational risk-benefit analysis.

Commission E Monographs

In 1978 the German Ministry of Health established Commission E, a panel of experts charged with evaluation of the safety and efficacy of the herbs available in pharmacies for general use. The Commission reviewed more than 300 herbal drugs. This collection is known as the Commission E Monographs. The monographs are intended to provide guidelines for the general public, health practitioners, and companies applying for registration of herbal drugs. In general, they do not contain standards for assaying the quality and purity of herbal drugs, and they differ from North American and British publications in that some of their outcome measures do not use RCTs. For some clinicians and investigators, this may limit their use as a resource. Following the Commission E Monograph in Germany, the European Scientific Cooperative on Phytotherapy (ESCOP) evolved in Europe over the 1990s and reviews the therapeutic uses of herbal medicinal products. In all, 60 ESCOP monographs were published.²¹

National Center for Complementary and Alternative Medicine

In North America, the largest source of funding remains the NCCAM at the National Institutes of Health. NCCAM has declared that its future research portfolio will have an increased emphasis on studies of the mechanisms underlying CAM approaches, including biologically based therapies.²² For the busy clinician, the NCCAM web-site gives an overview of the government funded research in CAM (Box 10-1) and general information regarding and summaries of different forms of complementary therapies. For the health care provider or consumer, this Internet resource can be a helpful starting point to access general yet accurate and timely information about vitamins, minerals, herbs, and dietary supplements.

ConsumerLab.com

Health care providers concerned with the quality and safety of commercially prepared biologically based products may want to investigate ConsumerLab.com (CL), a private certification organization that evaluates products related to health, wellness, and nutrition, including herbal products, vitamins, minerals, functional foods, and dietary supplements. Companies can have their products tested through CL’s Product Reviews and Voluntary Certification Program. Products that “pass” the products review and certification program are eligible to carry the CL seal of approval. Health care providers and consumers who see the CL seal of approval on the label or packaging of an herbal product, vitamins, minerals, or dietary supplements are ensured that the product has undergone unbiased testing and has met standards of safety and quality. However, consumers should note that the manufacturer incurs the expense of the voluntary submission and testing. So, if a product does not have a CL seal of approval, a consumer does not know if a manufacturer has chosen not to submit the product for testing, or if the product has failed to meet the standards for the CL seal. To obtain the test results of product reviews, including pass/fail lists and a list of products that have achieved the CL seal of approval, a consumer or health care provider must purchase a subscription through ConsumerLab.com.

Natural Standard

Natural Standard, which can be accessed, online at http://www.naturalstandard.com/, is an international, multidisciplinary collaboration of clinicians and researchers founded to provide high-quality, evidenced-based information about complementary and alternative therapies. Natural Standard has developed several databases including Herbs & Supplements, Interactions, Brand Names, Condition Center, Complementary Practices, and Dictionary. For each therapy or botanical product included in the databases, an impartial research team has systematically gathered scientific data and expert opinions. Then, using a validated rating scale, the quality of the evidence is evaluated. Monographs written by the research team are then peer-reviewed before inclusion in the databases. The databases are organized so that a subscriber can read a comprehensive evidenced-based systematic review that provides details of efficacy, adverse effects, interactions, dosing, and more, or a simple “flashcard.” The flashcard has been adapted from a comprehensive review and provides a quick look- up and easy reading that can be used as a client handout. Another feature of Natural Standard’s databases is the “Condition Center-Comparative Efficacy Chart.” For these charts, medical conditions are cross-referenced across the evidence-based monographs and the interventions are arranged hierarchically by level of evidence for efficacy. Although Natural Standard appears to a valuable resource for user-friendly and highly credible information on complementary and alternative therapies, individual subscriptions to the databases are currently not available. According to the website, all database access and content licensing agreements need to be made between an organization, institution, or corporation.