USP Dietary Supplements & Herbal Medicines
Transcript of USP Dietary Supplements & Herbal Medicines
Collaboration on Development of Standards to Improve Dietary Supplements & Herbal Medicines Quality
Nam-Cheol Kim, Ph.D.
Scientific Liaison
Dietary Supplements and Herbal Medicines
United States Pharmacopeia
Content
BDSHM Quality
USP DSHM Program
Collaboration and Opportunities
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Sources: The New York Times, Feb 3, 2015; The Korean Broadcasting System (KBS) Company News, Jun 24, 2015
Common Concerns (and Issues)
Supplement containing Cynanchum wilfordii (백수오) contaminated with Cynanchum auriculatum (이엽우피소)
Utilized DNA method
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What We Should Consider…
Standardized nomenclature is essential. DNA-based
identification methods may be used as one of the aids to
identify organisms
Use orthogonal chemical methods to complement the DNA-
based methods for establishing the identity and quality of the
ingredient
DNA-based methods help to support identification of botanical
articles
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Specifications and quality controls are required for registration and international commerce
Public standards
– Set by independent experts using a robust, transparent process that involves the evaluation and
incorporation of public comments
– Expertise drawn from diverse sectors, including academia, industry, and regulatory bodies
– Standards based on the development and submission of robust data
– Public standards intended to meet the need of different manufacturers, regulators, multiple suppliers,
practitioners and consumers
Availability of public specifications that can be freely adopted and/or adapted would facilitate public health
and safety
Value of Public Quality Standards
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https://hmc.usp.org
USP Dietary Supplements & Herbal Medicines Compendia
USP Dietary Supplements Compendium
75 new dietary supplement monographs--nearly 500 in
all--from USP 38-NF 33 through the First Supplement
27 new General Chapters
More than 175 excipient (NF) monographs
Over 200 Food Chemicals Codex (FCC) monographs
More than 40 new and revised DSC admission
evaluations
Includes over 150 added pages of color plates and
illustrations
https://online.uspdsc.com
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USP Reference Standards- A Benchmark for Quality
Trusted for quality control worldwide
Over 3,600 Reference Standards now
available
Support standards and tests in various
USP compendia
Highly pure, with purity values
provided for quantitative standards
Korea is high rank in USP RS sales
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USP Verification Services Adulteration of Dietary Supplements
Programs to Ensure DSHM Quality
Focus on categories of products marketed for
sexual enhancement, weight loss, and sport
bodybuilding
To develop screening methods for drugs as
adulterants for dietary supplements based on
the claimed benefits and similar drug effects
of such adulterants
USP Workshops on DS and Food Adulteration
(2011–2015)
USP Expert Panel on Adulteration (July 2013–
Present)
USP General Chapter <2251> “Screening for
Undeclared Drugs and Drug Analogues”
Roman Database (USP Adulteration
Database)
Annually evaluate quality of verified products through:
– Good Manufacturing Practice (GMP) facility audits
– Product quality control & manufacturing process evaluation
– Product testing
https://www.usp.org/services/verification-services
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USP’s HMC East Asia Expert Panel member (Professor Yeong Shik Kim, SNU)
Standard co-development with Herbal Medicines Research Division in NIFDS
Dialog with Health Functional Food Policy Division in MFDS
Invitation by Korean Health Supplements Association
Collaboration with Korea for Herbal Medicines
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USP and NIFDS has MOU since 2012 (renewed in 2015 and 2018)
Progress in Workplan
– Monograph and RS co-development underway for six Korean TM-based plants (including Angelica
gigas Root)
– Visiting Scientist through Executive Exchange Program
– Formed Working Group (April 2019)
Other ways of working with NIFDS HM through:
– Forum for Harmonization of Herbal Medicines (FHH): NIFDS (member) and USP (observer) jointly
proposed harmonized reference standard developments
– WHO/WPRO: USP was invited as an instructor in NIFDS funded HM training course in Vietnam
Milestone with NIFDS HM
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Fingerprint of Danggui Species
Standards
1. chlorogenic acid, 2. ferulic acid, 3. nodakenin, 4. decursinol, 5.
xanthotoxin, 6. coniferyl ferulate, 7. demethylsuberosin, 8. Z-ligustilide,
9. decursin, 10. decursinol angelate, I.S. a-asarone
A. gigas
A. sinensis
A. acutiloba
A. gigas A. gigas
Standard
The differences between three Danggui species indicates the possibility of needs for separate standards using harmonized methods
Species Country
Angelica sinensis China
Angelica gigas Korea
Angelica acutiloba Vietnam/Japan
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Prioritize Korean herbal materials for KP-USP standard co-development
(monographs and reference standards)
Research the gaps for potential harmonization including specifications and test
methods
Facilitate visiting program
Engage with more companies that are interested in and can contribute to HM
and BDS standard developments
Encourage participation in USP Expert Committees
Potential Future Plans
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