Naturally complex: Perspectives and challenges associated with Botanical Dietary Supplement Safety assessment

Shipkowski, Kelly A.; Betz, Joseph M.; Birnbaum, Linda S.; Bucher, John R.; Coates, Paul M.; Hopp, D. Craig; MacKay, Duffy; Oketch-Rabah, Hellen A.; Walker, Nigel J.; Welch, Cara; Rider, Cynthia V.

doi:10.1016/j.fct.2018.04.007

Cited by 52 publications

(32 citation statements)

References 72 publications

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“…In addition, contaminants may occur in finished products during the manufacturing and preparation processes and they can include undeclared synthetic substances (pharmaceutical products and related compounds) and metals. Intentional adulteration of botanical products with chemical pharmaceutical substances is a significant concern worldwide (Shipkowski et al, 2018). This issue was also discused in the forum, the lack of monitoring of product quality being the reason why non-compliant products appear on the market.…”

Section: Resultsmentioning

confidence: 99%

“…As the market volume and the product variety increases, better product characterization and risk assessment are needed (Rietjens et al, 2008). The complexity and the variability of these products make it difficult to assess quality and safety (Shipkowski et al, 2018). from medicinal and aromatic plants: botanical supplements, vegetal extracts, natural cosmetics, essential oils, etc.…”

Section: Introductionmentioning

confidence: 99%

“…In the '80s local medicinal plants were exported to 20 countries, Romania being also on The actors involved in the value chain of the products obtained from medicinal and aromatic plants (consumers, suppliers, manufacturers, regulation authorities, medical services providers, researchers) recognize the importance of ensuring the quality and the safety of these products at all stages of the technological process of obtaining, from harvesting the raw material to the storage of the final product ( Fig. 2) (Shipkowski et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy Assessment of Medicinal and Aromatic Plants Derived Products. A Qualitative Research

Cadar

Pocol

2020

BUASVMCN-HORT

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The complexity of medicinal and aromatic plants products makes difficult to asses their safety and efficacy. A qualitative research method, called hybrid forum has been used in order to better understand the risks and benefits of those products, from the perspective of three key components: the manufacturing process, from raw material to the finished product, safety and quality assurance, consumers’ perception and biomedical context. The discussion forum took place in November 2019 in Cluj-Napoca and it was organized in two parts: the first addressed to researchers and actors in the field (14 stakeholders) and the second to the general public (23 participants). Critical points and limitations in the field of products obtained from medicinal and aromatic plants have been identified by both the specialists (poor cooperation between actors; lack of monitoring of product quality; increase self-medication), and the general public (difficulties in making informed choices; reluctance to pharmacists’ advice).

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy Assessment of Medicinal and Aromatic Plants Derived Products. A Qualitative Research

Cadar

Pocol

2020

BUASVMCN-HORT

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“…Researchers need to understand the pharmacokinetics (PK) of the natural product if absorption is necessary for its biologic activity. Studying the PK of botanicals is more complicated because of the numerous chemical constituents within a botanical extract (Shipkowski et al, 2018), and new methods for examining polypharmacokentics have been developed to examine the impact of multiple constituents (Li et al, 2018). If the active constituents with the botanical are unknown, additional preclinical work may be needed before PK studies can be conducted.…”

Section: Clinical Trial Designmentioning

confidence: 99%

National Center for Complementary and Integrative Health Perspectives on Clinical Research Involving Natural Products

Weber

Hopp

2020

Drug Metab Dispos

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The sales of dietary supplements continue to increase year after year. Despite their use by a large percentage of Americans, there is little evidence for the vast majority of products regarding their safety or efficacy. National Center for Complementary and Integrative Health supports a broad range of research on dietary supplements, including clinical trials. Our experience with these trials has shaped our current policies and priorities for clinical research. This perspective outlines those policies and priorities that are shaping our investments going forward. SIGNIFICANCE STATEMENT The sales of dietary supplements continue to increase year after year. Despite their use by a large percentage of Americans, there is little evidence for the vast majority of products regarding their safety or efficacy. National Center for Complementary and Integrative Health supports a broad range of research on dietary supplements, including clinical trials. Our experience with these trials has shaped our current policies and priorities for clinical research. This perspective outlines those policies and priorities that are shaping our investments going forward.

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“…Assessing the safety of BDS presents many unique challenges (4). The two most important challenges are also interrelated - the natural complexity and variability in BDS products and the relatively lenient regulatory structure for BDS in the U.S. BDS are complex mixtures containing hundreds of constituents, often with a large fraction of the botanical material consisting of unknown constituents.…”

Section: Challengesmentioning

confidence: 99%

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

Rider

Walker

Waidyanatha

2018

Clin Pharma and Therapeutics

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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.

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Naturally complex: Perspectives and challenges associated with Botanical Dietary Supplement Safety assessment

Cited by 52 publications

References 72 publications

Safety and Efficacy Assessment of Medicinal and Aromatic Plants Derived Products. A Qualitative Research

Safety and Efficacy Assessment of Medicinal and Aromatic Plants Derived Products. A Qualitative Research

National Center for Complementary and Integrative Health Perspectives on Clinical Research Involving Natural Products

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

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