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

2
© 2018 USP
Common Concerns (and Issues)

Supplement containing Cynanchum wilfordii (백수오)

contaminated with Cynanchum auriculatum (이엽우피소)

 Utilized DNA method

Sources: The New York Times, Feb 3, 2015; The Korean Broadcasting System (KBS) Company News, Jun 24, 2015 3
© 2018 USP
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

4
© 2018 USP
Value of Public Quality Standards

 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

5
© 2018 USP
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://hmc.usp.org
6
https://online.uspdsc.com
© 2018 USP
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

7
© 2018 USP
Programs to Ensure DSHM Quality
USP Verification Services
 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
Adulteration of Dietary Supplements
 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)
8
© 2018 USP
Collaboration with Korea for Herbal Medicines

 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

9
© 2018 USP
Milestone with NIFDS HM

 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

10
© 2018 USP
Fingerprint of Danggui Species

A. gigas A. gigas A. gigas

A. sinensis
Standards Standard
A. acutiloba

 The differences between three Danggui species indicates the

possibility of needs for separate standards using harmonized
methods

Species Country
Angelica sinensis China
1. chlorogenic acid, 2. ferulic acid, 3. nodakenin, 4. decursinol, 5. Angelica gigas Korea
xanthotoxin, 6. coniferyl ferulate, 7. demethylsuberosin, 8. Z-ligustilide,
Angelica acutiloba Vietnam/Japan
9. decursin, 10. decursinol angelate, I.S. a-asarone
11
© 2018 USP
Potential Future Plans

 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

12
© 2018 USP
Call for Candidates

13
© 2018 USP