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USP Symposium Explores New Standards for Functional Foods and Dietary Supplements
The choices for consumers are nearly endless, as are the promises: Improved bone health. Increased energy. Enhanced focus. Better digestion. So-called functional ingredients represent not just a passing fad, but a fast- (and by some accounts, the fastest-) growing segment of the food and dietary supplement industries as consumers increasingly seek products that they consider beneficial to their health, appearance, athletic performance and more. The science behind many popular ingredients, however, is still emerging, with little consensus on the validity of claims among industry, regulators, consumer representatives and other key parties. With this premise, more than 200 attendees gathered in Boston September 1820 for the 2012 USP Science and Standards Symposium, to consider opportunities and challenges posed by functional ingredientsand the future direction for public standards in this area. The symposium opened with an evening keynote address from Dr. Paul Coates, director of the Office of Dietary Supplements (ODS) at the (From left to right): Drs. Gorecki, Ebert, Buchanan and Susana Socolovsky of National Institutes of Health. Argentinas Pentachem answer audience questions during a plenary session. Dr. Coates explained the regulatory landscape governing dietary supplements in the United States as laid out in the 1994 Dietary Supplement Health and Education Act (DSHEA), in which dietary supplements are regulated as foods. Since DSHEAs passage, supplement sales rose from $8.6 billion in 1994 to $28.1 billion in 2010. Dr. Coates noted that roughly 50 percent of the domestic population uses these products. He spoke about ODS work on evidence-based reviews of dietary supplements such as ephedra (now banned in the U.S.), omega-3 fatty acids, soy, probiotics, vitamin D and calcium; concerns about and current limitations of research in this area; and other ODS initiatives, including its Analytical Reference Chemicals program with the National Institute of Standards and Technology and consumer education programs. In a morning plenary session on the second day of the symposium, Dr. Robert Buchanan of the University of Maryland and a member of the USP Board of Trustees spoke about the science behind regulation of functional foods. He explained three intersecting activities: science, science policy and food law. Dr. Buchanan presented dictionary definitions of a functional food, but noted that there is no current legal definition, nor is there likely to be. He said that the U.S. Food and
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In This Issue
CEO Column
2 Message from the CEO The Importance of Public Documentary Standards and Reference Materials
USP Science
4 5 6 USP Workshop Focuses on Excipient Performance USP Advancing Standards for Tablet Scoring General Chapter <1>Transformed to Focus on Product Quality Tests for Parenteral Medicines USP Releases Standards to Guide Content, Appearance of Prescription Container Labels Workshop Focuses on Quality of Global Heparin Supply
International
12 Global Pharmacopoeias Explore Potential Collaborations on Medicines Quality Standards 12 USP Welcomes Guests from the Jiangsu Province
Inside USP
16 USP Awards Recognize Volunteer Experts 17 USP Achieves Continued ISO 9001:2008 Certification
Q U A L I T Y S TA N DA R D S f o r M e d i c i n e s , D i e t a r y S u p p l e m e n t s , a n d F o o d I n g r e d i e n t s W O R L DW I D E
USP Headquarters Maryland, USA Europe/Middle East/Africa Basel, Switzerland USPIndia Private Ltd. Hyderabad, India USPChina Shanghai, China USPBrazil So Paulo, Brazil
In This Issue
USP Science
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Continued
10 New Monograph Naming Policy Brings Clarity, Consistency to Drug Names 11 USP Initiates Spectral Library Project 11 New Reference Material Offerings for Novel, Natural Sweeteners
International
13 WHOFIP Meeting Focuses on Future of International World of Pharmacopoeias 13 Brazil Conference Provides Opportunity to Educate on USP Food Standards
I have written before about the importance of science-based, widely available public standards to help ensure good-quality medicines, foods and their ingredients. I reprise this theme now, driven by the fragmented state of global public health measuresparticularly regarding compendial standards. To this end, USP posted public statements on its standards-setting activities at www.usp.org/about-usp/our-impact/statementsusp-standards. A more detailed vision is advanced in a Stimuli article to be published in Pharmacopeial Forum in January 2013. In this smaller space, I offer a brief overview. In the world of public monographs for drugs, foods and their reference materials, the policy elements and opportunities are clear. A USP article in Pharmaceutical Research explains: For medicines and foods, a national or regional or even global goal might be a comprehensive collection of public documentary and reference material standards that can be usedto test for quality. An even more ambitious goal might be a single collection of documentary standards and reference materials to support testing of medicines and foods. (1) Attempts at harmonization among world pharmacopoeias have moved slowly, but a new approach has emerged that offers a path forward. Again, from USPs Pharmaceutical Research article: With availability of monographs where multiple acceptable procedures might be allowed (and one reference procedure designated for purposes of compliance), coupled with certified reference materials (CRMs) and other reference materials as needed, it is possible to imagine that a full cohort of public procedures and reference materials may become availableto help ensure the quality and benefit of medicines and foods. The importance of this vision is underscored when one considers USPNF, the most comprehensive of the worlds pharmacopoeias. USP estimates there are a total of 11,477 medicines, excipients, dietary supplements, food ingredients and their components marketed in the U.S. Of this universe, half are missing from USP compendia. Despite the efforts of dedicated scientists, the growing demands of global public health need to be better served.
Inside USP
17 USP Granted Observer Status by Codex Alimentarius Commission 18 USP Receives National Recognition for Employee Benefits Program 18 Three Students Receive 20122013 Global Fellowship Awards from USP
terials have come from donations by manufacturers, and these are greatly valued. But too many times manufacturers concerns about intellectual property issues or perceived lack of cost/benefit justification prevent donations. Additionally, it is argued that there is no need for a public standard until generic entry, with multiple companies manufacturing a product. Recently, there also has been an increased focus on current Good Manufacturing Practices (cGMPs) approaches (e.g., Quality by Design) and a correspondingly decreased emphasis on end-product testing requiring monographs and reference materials.
reference materials in view of the challenges that face USPNF in having a full complement of current monographs with allied reference materials. USP had no expectation that the MC would solve the deficiencies of USPNF. It simply was a way to create standards for articles approved in any country. USPs experience since the MC launch in 2011 has provided compelling insights. For example, USP can create a monograph based on procedures (Reference Procedures), as well as allowing optimized, manufacturer-specific procedures to be recognized as Acceptable Procedures. This creates a reference procedure that theoretically can be a single global testing standard for all articles under the same name. Additionally, USP can independently identify impurity reference materials needed to support a monograph and can create these materials in USP laboratoriesa departure from USPNF s use of manufacturer-specific procedures.
The initial motivation for the USP Medicines Compendium (MC) was to expand the availability of public monographs and
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General Chapter <1>Transformed to Focus on Product Quality Tests for Parenteral Medicines
As part of a larger effort to develop overall product quality chapters based on the five routes of administration for medicines, USP recently proposed a revised General Chapter <1> Injections and Implanted Drug Products (Parenterals)Product Quality Tests. Parenteral drug products encompass both injections and implants, and allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues or lesions. USP groups all dosage forms based on five routes of administration: injection, oral, topical-transdermal, mucosal and inhalation. To support individual drug product monographs, USP has divided the tests of a monograph into two categories: product quality tests and product performance tests. Product quality tests assess product quality attributes, which for parenteral products include identification, sterility and particulate matter, among others. Product performance tests assess, for example, in vitro release of the drug substance (active pharmaceutical ingredient) from the drug product. For each route of administration, USP intends to or has created two general chaptersone that provides product quality tests and one that provides one or more product performance tests. The approach was detailed in a Stimuli article in Pharmacopeial Forum (PF) 29(5) [SeptemberOctober 2003]. Based on these considerations, General Chapter <1> has been completely revised. The revised general chapter groups tests into three categories. The first is universal tests, which apply to all parenteral dosage forms. These tests include description, identification, assay, impurities, foreign and particulate matter and sterility, among others. The next category of tests is specific tests, which may be considered on a case-by-case basis and are referenced in particular monographs. These include physiochemical properties, container content, water content and residual solvents. The third category is product quality tests for specific dosage forms. Dosage forms covered include sterile powders for injection, suspensions, in situ gels, implants, drugeluting stents and more. A new informational General Chapter <1001> Product Performance Tests for Injections and Implanted Drug Products, will be prepared to provide information on potential product performance tests. According to Dr. Desmond Hunt, senior scientific liaison for USP, We are looking at this general chapter as a road map for parenteral drug products. It provides the fundamentals to help ensure product quality, and then points the user to the appropriate locations within USPNF for more detail on the required testing. Since this is a major revision of a frequently referenced chapter, we encourage people to pay close attention to the structure, dosage form grouping and methodology, and provide comments. USP has already rolled out the product quality chapter model with General Chapter <3> Topical and Transdermal Drug Products: Quality Tests, which is already official, and this is similar. When finalized, we anticipate these general chapters will allow for clearer understanding of expectations regarding potential testing and specifications for these products. Standards previously in General Chapter <1> that do not pertain to product quality tests have been removed from the revised general chapter and relocated to other general chapters. This information falls into the areas of 1) nomenclature and definitions, 2) labeling and 3) container content and packaging and storage. References to this material remain in General Chapter <1> to minimize the impact that changes to this general chapter will have on previously submitted regulatory filings. No new tests have been incorporated into the revised general chapter for dosage forms currently in the pharmacopeia. Dosage forms for which monographs do not currently exist in USPNF (e.g., implants) have been added, clarifying compendial expectations for such products. Methods and procedures specific to these dosage forms but not yet established as compendial tests remain to be developed. The revised general chapter was published in PF 38(6) [NovemberDecember 2012], which is accessible at www.usp.org/uspnf/pharmacopeial-forum. u
Elements of the new standards, contained in General Chapter <17> Prescription Container Labeling, include: 4 Emphasize instructions and other information important to patients. Prominently display information that is critical for patients safe and effective use of the medicine. At the top of the label specify patient name, drug name (spell Dr. Thomas Reinders, chair of the USP Nomenclature, Safety and Labeling Expert Committee, explains the impetus for and aspects of the new standards. Lack of universal out full nonproprietary and brand Video with Dr. Reinders is available at www.youtube.com/uspharmacopeia. standards for labeling name) and strength, and clear direcon dispensed pretions for use in simple language. scription containers is a root cause for patient misunderstandLess critical information (e.g., pharmacy name, drug ing, non-adherence and medication errors, said Dr. Joanne quantity) should not supersede critical information and G. Schwartzberg, director, aging and community health for should be placed away from dosing instructions. the American Medical Association and a member of the USP 4 Improve readability. Labels should be designed and Nomenclature, Safety and Labeling Expert Committee, which is formatted so they are easy to read. Typography should be responsible for the new standard. With an aging and increasoptimized by using high-contrast print; adequate white ingly diverse population, and people utilizing a growing number space between lines of text (i.e., 2530 percent of the point of medications, the risks are more pronounced today than size); simple uncondensed familiar fonts (Times Roman ever. These USP standards will promote patient understanding or Arial are specifically recommended); and large font size of their medication instructions, which is absolutely essential (e.g., minimum 12-point Times Roman or 11-point Arial) to preventing potentially dangerous mistakes and helping to for critical information. Older adults, in particular, have ensure patient health and safety. difficulty reading small print. 4 Give explicit instructions. Instructions for use should Studies have found that 46 percent of patients misunderstood clearly separate the dose itself from the timing of each one or more dosage instructions on prescription labels. The dose. Do not use alphabetic characters for numbers. For problem is particularly troublesome in patients with marginal example, write, Take 2 tablets in the morning and 2 literacy, and in patients receiving multiple medications that tablets in the evening rather than Take 2 tablets twice are scheduled for administration using unnecessarily complex, daily. Dosing intervals such as twice daily, 3 times non-standardized time periods. However, even patients with Continued on page 9. See Labeling Standards4 adequate literacy often misunderstand common prescription directions and warnings.
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This consistency in drug product names ultimately will benefit manufacturers, regulators, practitioners and, most importantly, patients.
Dr. Roger L. Williams, chief executive officer, USP
The development of USPs Monograph Naming Policy is designed to provide concise and consistent names for drug products, said Dr. Roger L. Williams, chief executive officer of USP. This consistency in drug product names ultimately will benefit manufacturers, regulators, practitioners and, most importantly, patients. Under the Federal Food, Drug and Cosmetic Act, if there is a USP monograph for a drug product, the monograph title must be used as the nonproprietary name of that product. If a monograph does not exist at the time the product is approved, then FDA can designate an Interim name that may be used unless USP later designates a different name. USP monographs are often developed years after the product approval, which along with other factors has led at times to inconsistencies in naming, including mismatches of the name and strength of the drug product. The Monograph Naming Policy was posted to USPs website in 2007 as a revision to General Chapter <1121> Nomenclature,
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USP International
Pharmacopoeial officials from 11 countries participated in the Second Global Summit of the Pharmacopoeias.
Representatives of pharmacopoeias from around the world participated in the Second Global Summit of the Pharmacopoeias on September 7, 2012, in Xian, China. Hosted by the Chinese Pharmacopoeial Commission (ChP) and USP, the Global Summit is a forum for participating national, regional, and international pharmacopoeias to share information about their standards-setting activities and to discuss the potential for harmonized standards for medicines. At this years summit, pharmacopoeial representatives from 11 countries participated, including Brazil, China, Germany, Indonesia, Japan, Kazakhstan, Russian Federation, Thailand, the United Kingdom and the United States. We hope this Global Summit promotes understanding and provides a long-term platform for exchanges of mutual experiences and information in terms of standards for medicines, said Mr. Wang Lifeng, director general of the ChP, in his opening statement. Our shared mission is international collaboration that will ultimately benefit the health of patients in the world.
Dr. Roger L. Williams, USP chief executive officer, noted that USP is pleased to be a part of this important initiative. The globalization of medicines requires global solutions, he said. It is critical to learn and share experiences with each other and to pool our expertise to create globally harmonized standards. Because pharmacopoeial standards can differ from country to country, one aim of the Global Summit is to explore ways in which pharmacopoeial standards can be more broadly harmonized. An outcome from the first Global Summit was a proposal from the ChP to develop an index of pharmacopoeias, and the initial work was presented at this meeting. This index coalesces information about standards from seven pharmacopoeias, and shows the similarities and differences in those standards, said Mr. Wang Ping, deputy director general of the ChP. We hope this index becomes an important technical reference on the development and revision of drug standards to achieve more globally harmonized standards.
Continued on back cover. See Global Pharmacopoeias
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New PQM Initiative Looks to Build a Pool of Experts to Improve Regional Regulatory Enforcement
USPs Promoting the Quality of Medicines (PQM) program convened a regional meeting to kick off its new initiative, Building Regional Expertise in Medicines Regulation, Information-sharing, Joint Investigation and Enforcement (BREMERE). Held in Bangkok, Thailand, on August 2829, 2012, BREMERE aims to strengthen regional cooperation between and among the medicines regulatory authorities and law enforcement agencies in the Greater Mekong Subregion to improve the quality of medicines in the area. Representatives of the relevant authorities (medicines authorities, police, enforcement agencies and customs) from Cambodia, Laos, Thailand, Vietnam, Philippines and Indonesia as well as a wide range of international and scientific At the first BREMERE initiative meeting in Bangkok, groundwork was laid for future collaboration. organizations and academia participated in the and technical/financial support. In the long term, it will meeting. During two days of discussions, the group drafted the create a regional pool of experts who will share information Terms of Reference (TOR) that would encompass BREMEREs and expertise in medicines regulation, registration, postgovernance, coordination, implementation and complementary marketing surveillance and enforcement. In order to reach the activities with other similar efforts. By the end of the meeting, objectives included in the TOR, support and collaboration will participants successfully reached a consensus on the TOR need to be strengthened between political bodies in the field and leadership of the initiative, and prepared a timeline for of medicines quality and regulation, and improvements will future activities. need to be made in the processes among regulatory/technical agencies and other sectors, such as customs and INTERPOL, The BREMERE initiative aims to build capacity in all member at national and regional levels. u countries by sharing regional expertise, and providing training
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Inside USP
The Joint Expert Panel on General Chapter <1059> Excipient Performance, a collaboration between the General ChaptersPhysical Analysis and MonographsExcipients Expert Committees that is co-chaired by The Food Ingredients Expert ComDrs. Gregory Amidon and Eric mittee, chaired by Dr. Andrew Ebert, Schmitt, received the 2012 USP received the 2012 USP Award for Award for an Outstanding Conan Innovative Response to Public tribution to the Standards-setting Health Challenges. It was selected Process. Due to the Expert Panels for its outstanding work and leadefforts, General Chapter <1059> ership in transitioning the Food provides an overview of critical Chemicals Codex (FCC) from the material attributes for many excipiMs. Angela Long, with Drs. Williams and Duane Kirking, Institute of Medicine to USP (USP ent functional categories along with present USPs volunteer awards to Drs. Amidon (top) and acquired the compendium of food a toolbox of procedures that may be Ebert on behalf of their Expert Panel and Expert Committee, ingredients in 2006) as well as speuseful in evaluating and controlling respectively. cifically addressing the public health excipient critical material attributes challenge of food adulteration. The Expert Committee not only that are not typically included in compendial monographs. The provided its expertise and guidance for the transition of FCC to general chapter also provides a framework for applying Quality USP, but ensured its growth and continuity as an international by Design principles to excipient quality and performance. USP compendium of food ingredients standards. Further, the Expert Expert Panels are formed to provide additional expertise with Committee guided USP staff in a significant expansion of the advisory input on a particular scientific topic, thereby supplescope of FCC to include new and novel ingredients essential to menting Expert Committee expertise. keeping FCC relevant to parties worldwide. As detailed in the awards ceremony, this general chapter has As noted in the awards ceremony, the Expert Committee a long historywith talk about such a resource beginning faced serious challenges soon after it was formed by USP to more than 20 years ago at a USP-convened meeting in 1991 in work on FCC in 2006. As it was becoming acquainted with Orlando, Fla. At this meeting, the International Pharmaceutical USPs standards-setting processes and transitioning FCC to Excipients Council was formed, and discussions about the need a regular publication cycle of every two years with intervenfor standards focused on excipient functionality first took place. ing supplements, a number of food and drug crises occurred USP has advanced many general chapters addressing excipient worldwide and increased the urgency and broadened the scope quality in the intervening years, but General Chapter <1059> is of the Expert Committees work. Specific to foods, episodes the first focused on excipient function and performance. of economically motivated adulteration involving pet food (in which wheat gluten was replaced with melamine) and infant Video interviews with Drs. Ebert and Amidon may be viewed at formula and other milk powder products (in which melamine http://youtu.be/gyUMykO5h4M. u
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The Commissions main work is the development of international food standards, guidelines and codes of practice.
The Commission was established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) in 1963. Today, it has more than 180 members, and more than 200 inter-governmental and international non-governmental organizations are accredited as observers. The Commissions main work is the development of international food standards, guidelines and codes of practice. The Commission also promotes the coordination of all food
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Inside USP
Recipients of the 20122013 USP Global Fellowships are: Darash Desai, Ph.D. candidate, Boston University, Department of Biomedical Engineering. His area of research is Pharmacheck: Counterfeit and Substandard Drug Detector for the Developing World. Jose Napolitano Farina, Ph.D., University of Illinois at Chicago, College of Pharmacy, Department of Medicinal Chemistry and Pharmacognosy. His area of research is New Generation of 1H NMR Fingerprints for the Rapid Analysis of Pharmacopeial Reference Standards. Ting Wang, Ph.D. candidate, University of Maryland at Baltimore, School of Pharmacy. His area of research is Developing the Scientific Basis for the Application of Spectroscopic and Chemometric Methods to Excipient Identification and Adulteration Detection. u
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The Standard
Symposium Continued from front cover.
Drug Administration (FDA) simply considers these products food and not a separate entity. Dr. Buchanan explained that the lack of a legal definition means functional foods may be regulated under a variety of categories, depending on what a manufacturer is trying to claim and the group/population for which the product is intended. USP Chief Executive Officer Dr. Roger L. Williams offered USPs vision and strategy in the area of food ingredients and dietary supplements, and efforts to identify (and ultimately develop quality standards for) all articles moving in global commerce. He described USPs current offeringsthe Food Chemicals Codex (FCC) and USP Dietary Supplements Compendium (DSC)as textbooks of standards in these areas. Dr. Dennis Gorecki, chair of the USP Dietary Supplements Expert Committee, detailed various USP initiatives for dietary supplements, including new monograph development, monograph modernization, safety reviews of dietary supplements and a planned Herbal Medicines Compendium for ingredients used in Traditional Chinese Medicine, Ayurvedic medicine and more. Dr. Andrew Ebert, chair of the USP Food Ingredients Expert Committee, provided a corresponding overview of food standards initiatives and explained how USP has transformed FCC since acquiring the compendium from the Institute of Medicine in 2006. He also spoke specifically about USP efforts to help prevent economically motivated adulteration of food ingredients via its Food Fraud Database and other work. Providing attendees a glimpse into the future, Ms. Nirvana Chapman of the global market research firm Mintel discussed functional ingredients poised for growth, which fall in line with key consumer trends. These trends include an aging population seeking brain health, body health and cosmeceutical products, as well as a growing preference for natural products (with no artificial ingredients). From a consumer watchdog perspective, Mr. Chuck Bell of Consumers Union (publisher of Consumer Reports) presented concerns with these products and the claims they make, as well as questions they advise consumers to ask themselves: 1) should I be eating this? 2) how meaningful is the claim on this product? 3) do I need this additive (i.e., is my diet balanced enough without supplementation)? and 4) am I overdosing on a nutrient? Presenting on oversight and governance of an increasingly complex food-scape, Ms. Diane McColl of Hyman, Phelps & McNamara, P.C. and a member of the USP Food Ingredients Expert Committee provided more detail on legislation guiding the industry, including the Nutrition Labeling Education Act of 1990 and DSHEA. She also explained the Generally Recognized as Safe (GRAS) path to food ingredient use, noting that while this system has come under criticism of late for perceived lack of scientific rigor, the food safety problems that dominate today are related to foodborne pathogens. She stated that there have not been public health issues related to GRAS ingredients, and this is not a coincidence. From a food industry perspective, Dr. Janet Collins of DuPont and incoming president of the Institute of Food Technologists spoke about the challenges in meeting sometimes conflicting consumer preferences for foods that, on the one hand, do not contain long lists of additives (particularly ones they cant pronounce), but on the other, provide an increasing number of functional benefits. She described this as a catch-22 for industry. The remainder of the sessions fell into two break-out tracks, one focused on food ingredients and the other on dietary supplements. The function of food ingredients, and the degree to which function is tied to identity, were discussed in multiple food sessionsincluding one on functional assays. Topics included challenges and opportunities for Fourier Transform Infrared Spectroscopy to authenticate food ingredients and screen for adulteration; Nuclear Magnetic Resonance (NMR) for quantification and identification; a contract laboratory perspective on mistaken identity; and NMR to characterize reference materials. Other sessions looked at emerging ingredients from traditional sources. Topics included antioxidants in food: an evidencebased approach to understanding, sustaining and promoting benefits; functional oils; identity and authenticity testing of fruit juices; and more. On the dietary supplements side, multiple presentations addressed identity testing for these products, including orthogonal methods for identity; NMR; and DNA bar code techniques. Other sessions looked at standards supporting dietary ingredient structure/functional claims and quality initiatives from USP, including how USP standards can be utilized by industry in complying with current Good Manufacturing Practices and efforts regarding authenticating geo-authentic botanicals. Dr. Tieraona Low Dog of the University of Arizona and a member of the USP Dietary Supplements Expert Committee offered a unique viewpoint, presenting a clinicians perspective on dietary supplements. While personally supportive of their use, she laid out the complexities physicians face in counseling patients on these products. These include contradictory research on benefits/risks and inconsistent dosing recommendations. Throughout the meeting, many challenges regarding these ingredients were presented. Despite this, food and dietary supplement products incorporating these novel ingredients are currently in widespread use, and manufacturers are forging aheadpresenting a compelling need for public standards. Look to future issues of The Standard for updates on how this work is evolving. Interviews with some Symposium speakers are available at http://uspgo.to/Zulx2z. u
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