USP Global Public Policy Position

Ensuring the Quality of Dietary Supplements

Position: The United States Pharmacopeial
Convention (USP)4 supports a comprehensive
public policy framework to ensure the quality of
dietary supplements. The framework should focus
on education, investment in the public agencies
responsible for consumer protection, public quality
standards, and surveillance.
ISSUE: While dietary supplement use is increasing
around the world, there have been quality and safety Key elements of a holistic public policy framework to ensure
issues with some products. New approaches are needed dietary supplement safety and quality include the following:
to help ensure the integrity of these products, restore
confidence, and protect public health. Empower consumers and healthcare professionals.
The use of dietary supplements among consumers is rapidly 1. Increase education campaigns on the importance of
growing: the global market for these products is projected to dietary supplement quality.
reach almost $180 billion by 2020.1 In the United States (U.S.),
• Public health agencies, enforcement officials, associations,
dietary supplements are used by 80% of adults.2 Drivers include
industry, and other organizations should invest in education
an aging population, more emphasis on wellness, and a desire
campaigns that provide guidance on selecting quality dietary
by some consumers to economize and exercise control in
supplements and outline potential risks from products whose
healthcare choices.
identity and quality has not been independently assured.
A recently renewed focus on dietary supplement quality • Consumers should be made aware that independent third-
and safety has generated discussion around public health party verification programs can help establish that products
implications surrounding these products while also prompting and ingredients are what they are represented to be.
enhanced regulatory interest and enforcement. Concerns have
• Awareness campaigns should focus on segments of the
included too little of an active ingredient in a supplement,
consumer population that are most vulnerable or likely to
extraneous material, substitution of a synthetic substance for
experience the most potentially serious physiological
a claimed naturally derived material, and products adulterated
effects from poor quality products (e.g., seniors, pregnant
with drugs or drug analogs. There have been reported cases of
women, children, and military/armed forces).5
supplements causing adverse events, including injury to young
adults taking products for weight loss or energy.3 Objections
have been expressed that dietary supplements can be unsafe or Advance consumer protection.
of unknown origin and that the industry needs more oversight. 2. Make adequate public investment in the agencies
In the midst of this expanding conversation, there is a growing
responsible for ensuring the quality of dietary
consensus that new approaches are needed to ensure quality
supplements.
and public trust in dietary supplements and ingredients. • Protecting consumers by ensuring quality in dietary
supplements is a shared responsibility across different
agencies at the federal and state/provincial levels.
• Agencies such as FDA and state health departments
in the U.S. should be provided with the resources they
need to carry out these responsibilities.

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Safeguard the consistency and quality of dietary supplements.

Why Should We Be Concerned About
Supplement Quality?
3. Ensure that all dietary supplement products adhere
As the globalization of manufacturing and distribution
to science-based public standards for identity, continues, the need for stronger systems to assess and ensure
strength, quality, and purity. quality in dietary supplements becomes more pressing. Many
Using public standards to ensure quality6 creates certainty dietary supplements and ingredients are made in countries
for consumers and regulators, advances transparency and around the world and may be of unknown provenance or may
fairness within the industry, and also helps keep dietary even be mislabeled, problems that can have serious health
supplements that are tainted with drugs and drug analogs consequences. For example, Chinese star anise (either as a food
off the market. ingredient, supplement, or medicinal product) is prized for its
reputed health benefits, while Japanese star anise is toxic and
Promote greater transparency for consumers and regulators. can kill a consumer if passed off as the former.10

4. Establish “public registries”7 that link supplements In the U.S., clinical and other research studies are not required
to public standards and communicate to consumers for dietary supplements; consumers are therefore largely on their
those that are verified to meet them. own when these products hit store shelves. Adverse reactions,
although rare, can be life threatening or even lethal. A lack of
• Registries should utilize a uniform nonproprietary name,
understanding of the interactions of dietary supplements with
linked to a science-based public standard, to provide
prescription and over-the-counter medicines—as well as with
assurance a product with a certain name is that product
other dietary supplements and foods—may also contribute
and has specified characteristics.
to products being non-efficacious or even toxic to patients.
Healthcare practitioners can be equally disadvantaged in
Report quality and safety issues. the absence of clinical data and instruction surrounding
these products.
5. Enhance surveillance programs, giving
policymakers and regulators more information According to FDA, the federal agency that oversees the quality
and ensuring more complete tracking of reported of dietary supplements in the U.S., “the choice to use a dietary
adverse events from dietary supplements. supplement can be a wise decision that provides health benefits.
However, under certain circumstances, these products may be
• Enhanced tracking programs can protect consumer unnecessary for good health or they may even create unexpected
safety and help regulators and policymakers determine risks.”11 FDA notes that people choosing to supplement their diet
whether voluntary standards are effective and point with herbals, vitamins, minerals, or other substances may want
to the potential need for an enhanced regulatory to know more about the products they choose so they can make
framework for quality. informed decisions. The agency provides helpful tips for dietary
supplement users, including for seniors.12
In the U.S. in early 2015, concerns about the quality and safety
of dietary supplements resulted in an investigation by the New
Background York State Attorney General’s Office into herbal supplement
manufacturers and sellers. The investigation spread to several
What Are Dietary Supplements? other states and generated calls by industry and some lawmakers
A dietary supplement is a product taken by mouth and intended for greater application of existing federal law—and ultimately
to supplement the diet—for example vitamins, minerals, herbs, or saw a multiagency federal enforcement action. The enhanced
other botanicals.8 While not always called as such, supplements regulatory attention also prompted efforts by industry to show
and other botanical or herbal preparations in various forms have greater responsiveness and accountability, including advancing
been around for a long time. For example, the Egyptians and proposals for heightened public information (“registries”)13
Chinese used botanicals over 3,000 years ago for their reputed about dietary supplements and ingredients. Incidents also
benefits.9 While in some countries dietary supplements are generated retailer interest in learning how to ensure the quality
regulated as drugs or as some intermediate category, in other of supplement products on their shelves.
countries, like the U.S., they are regulated as foods.

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Outside the U.S., a number of countries, including India and botanical, amino acid, or a concentrate, metabolite, constituent,
China, have been separately seeking to update and expand extract, or combination of any of these ingredients).
regulation of dietary supplements. Under DSHEA, dietary supplement manufacturers are responsible
to establish the safety and quality of a product, but are not
How Are Dietary Supplements Regulated required to share that information with FDA before the product
for Quality? enters the market unless it contains a new dietary ingredient,
defined as a dietary ingredient that was not marketed in the
Global Situation U.S. in a dietary supplement before October 15, 1994.16 To date,
Around the world, dietary supplements may be regulated as FDA has not issued final guidance on what constitutes new
foods or drugs, or sometimes a hybrid. For example, CoQ10, dietary ingredients, although it has issued final guidance on
considered a dietary supplement in the U.S., is included in distinguishing liquid dietary supplements from beverages.17
the Japanese Pharmacopoeia and regulated as a drug; similarly,
the European Pharmacopoeia has monographs for Echinacea
Special Challenges for FDA
as a drug, while it is treated as a supplement in the U.S.
At the same time, many countries have an intermediate While FDA has the authority under DSHEA to remove a
category of “traditional medicines” with different requirements product from the marketplace if it presents “significant or
for registration than those required for drugs. unreasonable risk of illness or injury,” FDA is first charged with
the responsibility to prove that the product presents such a
Some countries have recently determined that there is a need to
risk to public health. Because FDA has limited resources in
create a new regulatory framework for dietary supplements (and
ascertaining harm, and many of these products also have an
such similar products). In some cases, international agencies
inherently high threshold for safety, products of unknown quality
are creating regulations similar to those found in the U.S., but
and unestablished safety can de facto be marketed in the U.S.
generally they are more stringent.
without any oversight.
Examples of international regulatory requirements for dietary
The U.S. Government Accountability Office (GAO)18 has called on
supplements that are not mandatory in the U.S. include
FDA to do a better job in tracking serious adverse events related
§§ Registration, to dietary supplements, including utilizing data from poison
§§ Premarketing approval of chemical and manufacturing centers, in addition to its present sources (industry reports). At
controls, and least one Congressional committee has called for clarification of
whether retailers feel they are obligated under DSHEA to report
§§ Premarketing review of safety and benefit claims.
adverse incidents, noting this as a possible weak link in the
adverse reporting chain.19
Examples of recent international proposals include India’s draft
FDA is able to catch noncompliant facilities on inspection—in
regulation on “Food or Health Supplements, Nutraceuticals,
fact, more than 50% of inspections lead to agency observations/
Foods for Special Dietary Uses, Foods for Special Medical
warning letters. But finding offending products can be a
Purpose, Functional Foods, and Novel Foods,”14 which seeks to
resource-intensive activity. The agency needs more resources to
improve labeling requirements for food and supplements and
ascertain compliance and undertake enforcement.
references various nations’ compendia and other sources, and
China’s final revision of its 2009 Food Safety Law specifying Although identity testing is required by FDA regulations,20
registration and notification requirements governing special manufacturers can develop and/or choose the standards to which
foods such as health foods (i.e., dietary supplements).15 they test. Because there are few uniform requirements21 and no
FDA premarketing oversight, many of these testing standards
The United States remain private and unknown to the public. This makes it difficult
In the U.S., the Dietary Supplement Health and Education Act for a consumer or other concerned party to compare the “same”
(DSHEA; Public Law 103-417, October 25, 1994) provides a product (e.g., Echinacea) made by two different manufacturers.
regulatory framework for manufacturing and marketing dietary In fact, the quality of dietary supplements may vary significantly
supplements that are intended to supplement the diet and from one manufacturer to another, or even within a single
contain dietary ingredients (vitamin, mineral, herb or other brand—without uniform standards it is hard to know for sure.

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Opportunities for Manufacturers and China uses the category “health food,” classified as food,
Regulators dietary supplement, or Traditional Chinese Medicine (TCM)
on a case-by-case basis. All health food products sold within
§§ USP’s compendial quality standards are published in the
China must be approved and registered with the China Food
United States Pharmacopeia–National Formulary (USP–NF),
and Drug Administration (CFDA), which will assess and examine
an official compendium of the U.S.
the security, effectiveness, and quality control and labeling of
• USP–NF’s drug quality standards are legally enforceable products. A health food can promote only its approved health
by FDA for over-the-counter and prescription drugs under function(s) on its label and advertisement (e.g., enhancing
the adulteration and misbranding provisions of the Federal immune functions, assisting blood lipids reduction, assisting
Food, Drug, and Cosmetic Act. blood sugar reduction, assisting memory improvement).28

• USP–NF’s dietary supplement and dietary ingredient The European Union uses the category “food supplements,”
standards are legally enforceable by FDA for products classified as foods. Food supplements are concentrated
that are voluntarily labeled as meeting “USP.” In that sources of nutrients or other substances with a nutritional or
respect, USP–NF is also an official compendium for dietary physiological effect whose purpose is to supplement the normal
supplements in the U.S., although it is not recognized for diet. They are marketed “in dose” form (i.e., as pills, capsules,
dietary supplements in the same way as for drugs. liquids in measured doses per ESFA definition). Registration is
not required, but for harmonization purposes, there is a list of
§§ Following USP compendial quality standards for dietary
permitted vitamin or mineral preparations that may be added for
supplements can help manufacturers establish adherence
specific nutritional purposes in food supplements; the marketing
to Good Manufacturing Practices (GMPs) and provide
of products containing vitamins and minerals not listed is
assurance that ingredients they use are of good quality.
prohibited. Functional claims are allowed.29
§§ Testing to science-based public quality standards can help
India uses the category “foods for special dietary uses,” with the
ensure that manufacturers and regulators are comparing
subcategories “functional food,” “nutraceutical supplement,” or
products to a standard of quality.
“health supplement.” The product cannot claim to mitigate
§§ Voluntary verification programs22 based on public standards or cure any specific disease but certain health benefit claims
can help ensure that what’s on the label is in the bottle in the are permitted.30
right purity and strength.
Japan uses the categories “foods for specific health use”
(FOSHU) or “food and nutrient functional claims” (FNFC) based
on their product claims. No government approval is required for
APPENDIX I: Regulation of Dietary FNFC claims, because they are standardized and preapproved.
Supplements Outside the U.S.23 FOSHU claims must provide evidence to the government of the
product’s physiological effect, quality control processes, and
Argentina requires registration of dietary supplements prior to
safety prior to marketing. Standardized and approved claims are
marketing; therapeutic claims not scientifically supported are not
permitted for FNFC products. FOSHU claims are permitted after
allowed.24
government approval.31
Australia uses the category of “complementary medicines,”
Jordan uses the categories “herbal medicines,” “herbal food
essentially classified as drugs, with categories based on health
products,” “vitamin and mineral products,” “food supplement,”
risk. Manufacturers are required to hold a manufacturing
or “herbal medicine product,” and the product is considered a
license.25
drug or food depending on how it is classified. Herbal medicines,
Brazil uses the category of “vitamin or mineral supplement.” herbal products, and vitamins and minerals products require
Registration is required, subject to the same registration registration. Medical, health, nutrient content, and structure/
requirements as food. Claims to prevent, alleviate, or treat a function claims are allowed.32
disease are prohibited.26
Mexico uses the category “nutritional supplements,” and they
Canada uses the category “natural health products,” classified are classified as foods. Registration is not required. Claims are
like drugs as Therapeutic Products. Registration is required, not permitted to be used on food supplement products. Its only
but premarketing is allowed prior to approval. Health claims are intended use is to increase total dietary intake; complement
acceptable provided the product is registered.27 it or replace any component; or treat a disease, symptom, or
condition.33

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New Zealand uses the categories “natural health products,” USP standards help limit the introduction of potential adulterants
“complementary medicines,” and “dietary supplements.” New and contaminants and serve as a widely acknowledged quality
Zealand is currently working jointly with Australia to implement a benchmark in the buying and selling of dietary supplement
scheme to regulate “complementary medicines,” with the intent products and their ingredients.
to create a national registry for these products.34 The United States Pharmacopeia–National Formulary (USP–NF) is
Nigeria uses the category “herbal medicines,” classified as an official compendium of the United States for drugs and dietary
dietary supplements, health foods, functional foods, or as an supplements. USP’s compendial quality standards are set through
independent regulatory category. Herbal medicines are required leading scientific expert volunteers, with participation of U.S.
to be registered and are sold without restriction by licensed government liaisons from FDA.
practitioners. Claims that may be made about herbal medicines The USP Catalog features more than 3,600 items, including
include health, nutrient content, and structure/function claims.35 more than 800 dietary-supplement-related monographs and
Russia uses the category “biologically active food approximately 200 Reference Standards for dietary supplements
supplements” (BAFS). Food is divided into nutraceuticals and (e.g., amino acids, botanicals, vitamins and minerals, and fish oils).
parapharmaceuticals but cannot contain psychotropic or narcotic
substances. Advertisement of BAFS is strictly controlled, and no Independent Verification Services
claims to treat or cure diseases are allowed.36 In addition to its standards-setting work, USP offers the industry
South Africa uses the categories “traditional and complementary voluntary, independent, third-party verification services for dietary
medicines,” classified as foods or drugs. Registration is supplement finished products and dietary ingredients.40
required. Claims are allowed and classified into two categories: The USP Verified Mark is a symbol awarded by
1) high: treat cure/manages disease disorder; or 2) low: health USP to dietary supplement products that meet
maintenance and enhancement, including nutritional support not the stringent criteria of its Dietary Supplement
related to specific disease claim.37 Verification program (aligned to USP compendial
Turkey uses the category “herbal pharmaceutical product” but standards). The Mark has appeared on more than 400 million
is in the process of harmonizing with an European Commission supplement labels since the program’s start in 2002—helping
Directive and renaming these substances as food supplements. ensure that what’s on the label is in the bottle in the right purity
They are classified as Non-prescription medicinal, and include and strength.
phytopharmaceuticals, nutraceuticals, cosmeceuticals, and herbal USP also has a new GMP Facility
teas. Registration is required. Recommended use claims are Audit Program for dietary
allowed but inclusion of statements like “prevents or cures disease” supplement and dietary ingredient
on labels is prohibited.38 manufacturers. The program helps ensure that manufacturers
41

have good quality systems and may also help mitigate regulatory
risks by preparing manufacturers for GMP inspection.

APPENDIX II: How USP Works With Industry Meetings, Courses, Workshops, and Roundtables
to Promote the Use of Quality Standards USP meetings, courses,42 workshops, and roundtables bring
and Help Safeguard Dietary Supplements together the world’s leading scientific, regulatory, and healthcare
USP offers tools to help manufacturers and suppliers safeguard experts to share knowledge, lead discussions, and provide insight
the dietary supplement supply in the global marketplace for the effective development and application of standards. USP
and determine the identity and quality of supplements offers various dietary-supplement-related educational programs
and ingredients. for industry, practitioners, and others,43 including online and
classroom training.44 USP’s offerings have featured a course
USP Standards on food fraud mitigation, including USP guidance in this area;
To assist industry in the development and testing of dietary a workshop on adulteration, making available the expertise of
supplements, USP offers documentary standards (written authorities drawn from government and other sources;45 and an
monographs that describe specifications and tests for identity, Expert Panel roundtable meeting on adulteration.46
strength, quality, and purity) and Reference Standards39 (highly
characterized substances intended for use in conducting the
quality control tests and analytical procedures associated with
documentary standards).
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Stakeholder Forums and User Forums http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm

11

12
http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110493.
USP hosts Dietary Supplement Stakeholder Forums and User htm
13
See footnote 7.
Forums—offering manufacturers, organizations, service providers,
14
http://fssai.gov.in/Portals/0/Pdf/Draft_Regulation_on_Nutraceuticals_
and other interested parties who work with dietary supplements WTO_23 _ 07 _ 2015.pdf
the opportunity to share perspectives, provide direct feedback on 15
https://www.cov.com/~/media/files/corporate/publications/2015/05/china_issues_
revised_food_safety_law.ashx
priority standards issues,47 and learn about USP initiatives and 16
Federal Food, Drug, and Cosmetic Act, 413(d).
how to use USP resources.48 17
Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages, http://
www.fda.gov/Food/GuidanceRegulation/GuidanceDocuments RegulatoryInformation/
E-Newsletters DietarySupplements/ucm381189.htm
18
GAO, DIETARY SUPPLEMENTS, FDA May Have Opportunities to Expand Its Use of Reported
USP sends out via email periodic news about dietary supplement Health Problems to Oversee Products, GAO 13-244, March 18, 2013.
standards, as well as industry hot topics with links to upcoming 19
Letter from Ranking Member Claire McCaskill, Senate Special Committee on Aging to
retailers, June 2015.
meetings and events.49 Individuals are welcome to sign up for this 20
21 CFR 111.70, 111.75.
free service. 21
FDA’s Dietary Supplement GMPs: Standards Without Standardization, 63 Food and Drug
Law Journal, 929–942, 2008.
Food Fraud Database 22
See, e.g., http://www.usp.org/usp-verification-services
23
Condensed from USP internal research, current as of October 17, 2014.
USP offers a Food Fraud Database as a resource to industry, 24
ANMAT, http://www.anmat.gov.ar/principal_en.asp
government, academia, and consumers.50 Beyond listing food 25
TGA, http://www.tga.gov.au/overview-regulation-complementary-medicines-australia
fraud adulterants, the database provides a baseline understanding 26
ANVISA

of the susceptibility or vulnerability of individual ingredients to

27
Health Canada, http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/
28
CFDA, http://eng.sfda.gov.cn/WS03/CL0755/
fraud. In addition, it can be useful for those managing the risk of 29
EFSA, http://ec.europa.eu/food/safety/labelling_nutrition/supplements/index_en.htm
food fraud by providing a library of detection methods reported 30
www.fssai.gov.in/GazettedNotifications.aspx#regulations2011
in peer-reviewed scientific journals. Because an ingredient can 31
http://www.mhlw.go.jp/english/topics/foodsafety/fhc/02.html; http://www.mhlw.go.jp/
variously be a food ingredient, dietary ingredient, or excipient, english/topics/foodsafety/fhc/01.html
32
JFDA
the database can be a helpful resource to those interested in 33
http://www.cofepris.gob.mx/Paginas/Idiomas/Ingles.aspx; http://www.cofepris.gob.mx/
maintaining the quality of dietary supplements or ingredients. Paginas/Suplementos%20Alimenticios/%C2%BFQue-son-los-suplementos-alimenticios.aspx
(Spanish)
34
ANZTPA
35
NAFDAC
1
http://globenewswire.com/news-release/2015/04/23/727513/10130416/en/Dietary-
36
Roszdravnadzor, Rospotrebnazador
Supplements-Market-is-Expected-to-Reach-US-179-8-Billion-Globally-in-2020-Persistence- 37
MCCZA
Market-Research.html 38
IEGM
2
http://oig.hhs.gov/oei/reports/oei-01-11-00211.pdf 39
http://www.usp.org/dietary-supplements/reference-standards
3
A study in the New England Journal of Medicine reported more than 20,000 emergency 40
http://www.usp.org/usp-verification-services
room visits a year from injuries caused by dietary supplements, http://www.nejm.org/doi/
full/10.1056/NEJMsa1504267
41
http://www.usp.org/news/dietary-ingredient-and-supplement-manufacturers-can-
demonstrate-superior-quality-systems-using-newly-launched-united-states;
4
USP is a nongovernment, nonprofit organization that was founded in 1820 with a mission to http://www.usp.org/dietary-supplements/verification-services/gmp-facility-audit-program
improve global health through public standards and related programs. USP standards are
set through leading scientific expert volunteers, with participation of government liaisons
42
http://www.usp.org/meetings-courses
from the U.S. Food and Drug Administration (FDA). 43
http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/
5
Rand Center for Military Health Policy Research, Regulation of Dietary Supplements in the healthcare-professionals (see section titled “Dietary Supplement Quality Education
Military, Report of an Expert Panel, http://www.rand.org/content/dam/rand/pubs/conf_ Programs”)
proceedings/2011/RAND_CF288.pdf 44
http://www.usp.org/sites/default/files/usp_pdf/EN/meetings/usp-education-course-
6
U.S. FDA regulations permit supplement manufacturers to choose the standards to which to catalog.pdf (see page 12 of the catalog)
test. These standards can remain private and unknown (see footnote 21). USP recommends 45
http://www.usp.org/meetings-courses/workshops/adulteration-and-fraud-food-
that dietary supplement manufacturers and regulators adhere to science-based public ingredients-and-dietary-supplements-attend-two-key-learning-events; see also https://
standards. uspharmacopeia.csod.com/LMS/catalog/Welcome.aspx?tab_page_id=-67&tab_
7
The concept of “registries” has been advanced by industry, http://www.naturalproducts id=20000339
insider.com/blogs/supplement-perspectives/ 2015/11/voluntary-registry-for-dietary- 46
See e.g., http://www.usp.org/meetings-courses/expert-committee-meetings/adulteration-
supplements-next-s.aspx. While such concepts are still being fleshed out, as described, expert-panel-roundtable-meeting
they would involve a publicly available catalogue of information (database) about dietary 47
http://www.usp.org/meetings-courses/stakeholder-forums/dietary-supplements-ds/
supplements and ingredients, with such information likely being offered voluntarily by
meeting-2-2014
industry and maintained by a yet-to-be-determined party or parties. To be useful and
effective, registries must have the characteristics described in recommendation 4, and 48
http://www.usp.org/meetings-courses/user-forums
be comprehensive and publicly accessible, whether operated by the private sector, 49
http://www.usp.org/store/free-resources/newsletter-and-information
government, or some other entity. 50
http://www.foodfraud.org/
8
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm195635.htm
9
http://umm.edu/health/medical/altmed/treatment/herbal-medicine
10
http://www.ahpa.org/Default.aspx?tabid=326

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Addis Ababa
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Jakarta
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