Safety Of Botanical Dietary Supplements Research Articles

Follow that botanical: Challenges and recommendations for assessing absorption, distribution, metabolism and excretion of botanical dietary supplements

Botanical dietary supplements are complex mixtures containing one or more botanical ingredient(s), each containing numerous constituents potentially responsible for its purported biological activity. Absorption, distribution, metabolism, and excretion (ADME) data are critical to understand the safety of botanical dietary supplements, including their potential for pharmacokinetic botanical-drug or botanical-botanical interactions. However, ADME data for botanical dietary supplements are rarely available and frequently inadequate to characterize their fate in vivo. Based on an assessment of the current status of botanical dietary supplements ADME research, the following key areas are identified that require robust data for human safety assessment: 1) phytochemical characterization including contaminant analysis and botanical authentication; 2) in vitro and/or in vivo data for identifying potential botanical-botanical or botanical-drug interactions and active/marker constituents; 3) robust ADME study design to include systemic exposure data on active/marker constituents using traditional or novel analytical chemistry and statistical approaches such as poly-pharmacokinetics; and 4) investigation of human relevance. A case study with Ginkgo biloba extract is used to highlight the challenges and proposed approaches in using ADME data for human safety assessment of botanical dietary supplements.

Getting to the Root of the Matter: Challenges and Recommendations for Assessing the Safety of Botanical Dietary Supplements.

The National Toxicology Program's (NTP) mission is "to evaluate agents of public health concern, by developing and applying the tools of modern toxicology and molecular biology." Botanical dietary supplements (BDS) represent agents of public health concern due to widespread exposure to high doses, a lack of safety data for most products, variable quality, and reports of adverse events. This commentary will address lessons learned in NTP testing activities with BDS and recommendations for moving forward.

New approaches addressing the challenge of evaluating safety of botanical dietary supplements

New approaches addressing the challenge of evaluating safety of botanical dietary supplements

In silico approach to safety of botanical dietary supplements utilizing constituent-level characterization of materials

In silico approach to safety of botanical dietary supplements utilizing constituent-level characterization of materials

Should there be concern about the safety of botanical dietary supplements?

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization whose mission is to improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines, dietary supplements (DS), and foods. To this end USP developes written quality standards and reference materials for medicines, dietary supplements (DS), and foods. DS monograph development is preceded by an evaluation of the safety of the article for which a monograph is sought. The purpose of the evaluation is not to determine intrinsic safety of the article but to determine whether or not it can be admitted for monograph development.

Safety of botanical dietary supplements used by menopausal women: In vitro investigations of drug-botanical interactions

Safety of botanical dietary supplements used by menopausal women: In vitro investigations of drug-botanical interactions

In silico approach to safety of botanical dietary supplements utilizing constituent-level characterization of materials

Hazard assessment of botanical ingredients, used in the dietary supplement industry, can result in toxicology endpoint gaps related to history of use, and conflicting safety data. Moreover, traditional toxicological studies used to generate safety data are expensive, time consuming and often require the use of animals. Alternatively, we developed an in silico approach to fill safety data gaps by assessing the composition of botanicals. Subsequent to full analytical characterization of the constituents, the composition of each sample is (1) systematically evaluated for potential structure-activity relationship with toxicity data of structurally similar chemicals, and/or (2) benchmarked against components of commonly consumed foods. Finally, as necessary quantitative data was used to estimate potential human exposure values and weighed against established thresholds of toxicological concern. Results demonstrate a novel approach in the supplement industry to identify hazards and establish safe human use for botanicals, which is cost efficient, informative, and minimal in its use of animals.

Safety Evaluation of Botanical Dietary Supplement: A Systematic Review of the Literature

Concerns on the safety of botanical dietary supplements have been raised by healthcare professionals and regulatory agencies as consumer interest in these products has increased. These concerns include the relative safety of individual herbs, the potential for drug interactions, and the safety of use in pregnant and nursing women. A scientific evidence-base is required for sound clinical and regulatory decision making. A recently completed systematic review of the literature on the safety of approximately 550 botanical dietary supplements provides an understanding of safety through organization of data available from clinical trials, pharmacological and toxicological studies, case reports, and historical texts. Many of the findings support empirical data from the traditional use of herbs, and also alleviate many of the newer concerns regarding herb-drug interactions. This review provides assurance for the safety of many botanicals while also highlighting the need for research in a number of areas from basic pre-clinical data through clinical trials. Acknowledgements: Support for this research has been generously provided by the Office of Dietary Supplements and members of the American Herbal Products Association.

A Comprehensive Approach to Identifying and Authenticating Botanical Products

Whether they are being taken as dietary supplements by the general public or being evaluated in a clinical study, the authenticity of botanical products is a matter of paramount concern. Botanical specimens and the dietary supplements derived from them can vary in quality and in chemical constituent profiles because of a number of factors. Subtle variations in botanical specimens are known to have profound effects on the quality, efficacy, and safety of botanical dietary supplements and can potentially alter the results of clinical studies that rely on these materials. A complete array of authentication and evaluation tools can be utilized to provide a well-rounded scientific approach to the authentication of botanical products. It is vital that the authenticity of botanical supplements be established using appropriate analysis tools regardless of whether the end products are being considered for evaluation in clinical studies or are being developed for the consumer market.

The Role of Quality Assurance and Standardization in the Safety of Botanical Dietary Supplements

The importance of complementary and alternative therapies such as botanical dietary supplements continues to increase throughout the world (1). The World Health Organization (WHO) has estimated that the majority of people in developing countries depend on traditional and herbal medicines as their primary source of health care (2). In the United States, 42% of the population have reported using complementary and alternative medicines, especially botanical dietary supplements (3), costing an estimated $5.1 billion per year (4). The marketing and use of dietary supplements has grown rapidly in the United States following the passage of the ‘Dietary Supplement and Health Education Act’ in 1994, which exempts dietary supplements from regulation as drugs providing that they are not marketed for the diagnosis, treatment, cure, or prevention of disease (5). Although the use of botanical dietary supplements has increased substantially during the last two decades, evidence for their efficacy and safety has not been well documented. In the United States for example, botanical dietary supplements are currently exempt from good manufacturing practice, do not require proof of efficacy, and do not require pre-marketing approval by the FDA unless drug-like claims are made. The safety of botanical dietary supplements is the responsibility of the manufacturers, and the role of the FDA in safety assurance is limited to post-marketing monitoring of adverse effects. Since no disease treatment or prevention benefits may be claimed for dietary supplements, they are exempt from FDA regulation, and efficacy studies for these products are relatively rare. Therefore, the safety and efficacy of most botanical dietary supplements lack documentation, which concerns many health care providers and consumers. Possible problems with botanical dietary supplements include contamination with pesticides, herbicides and heavy metals, contamination or adulteration with pharmacologically active medications, use of the incorrect part of the plants (for example, leaves instead of roots), and even misidentification of the plant species incorporated into the product. Since no toxicology studies are required for botanical dietary supplements, there is also concern that interaction might occur between botanicals and conventional pharmaceuticals or that metabolic activation of constituents in the botanical dietary supplement might result in the formation of toxic metabolites. The possibility of overdose is also an issue, since studies to establish maximum tolerated dosages and safe long-term chronic dosages are not required and are rarely carried out. Since botanical dietary supplements may be marketed until proven unsafe through the documentation of adverse effects, the safety of these products is determined primarily through self-regulation by manufacturers. Since consumers expect a consistent and safe product, the agricultural and herbal industries should work together to produce safe products of reproducible quality using basic principles of botany, chemistry and pharmacology. This review addresses basic safety issues concerning botanical dietary supplements. Specific problems that have occurred with respect to safety are described, and solutions to these safety issues are proposed.