Implementing a “Quality by Design” Approach to Assure the Safety and Integrity of Botanical Dietary Supplements

Abstract

Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined.

Chicoric acid: chemistry, distribution, and production

“…the safest source of consuming chicoric acid is via food. Good review articles (Dufault et al, 2000; Cardellina II, 2002; Sanzini et al, 2011; Khan and Smille, 2012; Applequist and Miller, 2013) regarding these concerns and possible ways to improve our current US dietary supplement situation are available. Effective research and commercial use of plant derived chemicals requires well defined and validated chemical analyses (Lee, 2014).…”

Assessment of the Authenticity of Herbal Dietary Supplements: Comparison of Chemical and DNA Barcoding Methods

“…In some cases, these techniques may also be applicable to dried or processed plant material. However, under many circumstances, macroscopic or microscopic examinations will fail because a preparation consists of multicomponent powdered samples that have been processed beyond the ability to provide morphological characterizations [9]. Use of alternate techniques becomes necessary in order to identify and authenticate such complex samples.…”

Quality-by-Design (QbD) process evaluation for phytopharmaceuticals on the example of 10-deacetylbaccatin III from yew

“…Transferring the QbD-approach to botanicals the natural variability of plant material needs to be addressed, establishes a quality standard and offers increased process knowledge, three aspects with very high significance for herbal products [15].…”