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USP Global Public Policy Position
Ensuring the Quality of Dietary Supplements
osition: he United States harmacopeial
onvention US4 supports a comprehensive
public policy framewor to ensure the quality of
dietary supplements. he framewor should focus
on education, investment in the public agencies
responsible for consumer protection, public quality
ISSUE: While dietary supplement use is increasing standards, and surveillance.
around the world, there have been quality and safety ey elements of a holistic public policy framework to ensure
issues with some products. ew approaches are needed dietary supplement safety and uality 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.
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reach almost $180 billion by 2020. n the nited States .S. • ublic health agencies enforcement officials associations
dietary supplements are used by 80 of adults.2 Dri ers include
an aging population more emphasis on wellness and a desire industry and other organiations should in est in education
by some consumers to economie and eercise control in campaigns that pro ide guidance on selecting uality dietary
healthcare choices. supplements and outline potential risks from products whose
identity and uality has not been independently assured.
recently renewed focus on dietary supplement uality • onsumers should be made aware that independent third
and safety has generated discussion around public health party erification 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. oncerns ha e
included too little of an acti e ingredient in a supplement • wareness campaigns should focus on segments of the
etraneous material substitution of a synthetic substance for consumer population that are most ulnerable or likely to
a claimed naturally deri ed material and products adulterated eperience the most potentially serious physiological
with drugs or drug analogs. There ha e been reported cases of effects from poor uality products e.g. seniors pregnant
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supplements causing ad erse e ents including injury to young women children and militaryarmed forces.
adults taking products for weight loss or energy.3
bjections
ha e been epressed that dietary supplements can be unsafe or Advance consumer protection.
of unknown origin and that the industry needs more o ersight. 2. a e adequate public investment in the agencies
n the midst of this epanding con ersation there is a growing responsible for ensuring the quality of dietary
consensus that new approaches are needed to ensure uality supplements.
and public trust in dietary supplements and ingredients. • rotecting consumers by ensuring uality in dietary
supplements is a shared responsibility across different
agencies at the federal and statepro incial le els.
• gencies such as D and state health departments
in the .S. should be pro ided with the resources they
need to carry out these responsibilities.
OTH430F _ 2016-02 www.usp.org
www.usp.org
Safeguard the consistency and uality of dietary supplements. Why Should We e oncerned bout
Supplement uality
3. Ensure that all dietary supplement products adhere s the globaliation of manufacturing and distribution
to sciencebased public standards for identity, continues the need for stronger systems to assess and ensure
strength, quality, and purity. uality in dietary supplements becomes more pressing. any
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sing public standards to ensure uality creates certainty dietary supplements and ingredients are made in countries
for consumers and regulators ad ances transparency and around the world and may be of unknown pro enance or may
fairness within the industry and also helps keep dietary e en be mislabeled problems that can ha e serious health
supplements that are tainted with drugs and drug analogs conseuences. or eample hinese star anise either as a food
off the market. ingredient supplement or medicinal product is pried for its
reputed health benefits while apanese star anise is toic and
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Promote greater transparency for consumers and regulators. can kill a consumer if passed off as the former.
”7 n the .S. clinical and other research studies are not reuired
4. Establish “public registries that lin supplements
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 shel es. d erse reactions
although rare can be life threatening or e en lethal. lack of
• egistries should utilie a uniform nonproprietary name understanding of the interactions of dietary supplements with
linked to a sciencebased public standard to pro ide prescription and o erthecounter 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 nonefficacious or e en toic to patients.
ealthcare practitioners can be eually disad antaged in
eport uality and safety issues. the absence of clinical data and instruction surrounding
these products.
5. Enhance surveillance programs, giving
policyma ers and regulators more information ccording to Dthe federal agency that o ersees the uality
and ensuring more complete trac ing of reported of dietary supplements in the .S. “the choice to use a dietary
adverse events from dietary supplements. supplement can be a wise decision that pro ides health benefits.
owe er under certain circumstances these products may be
• Enhanced tracking programs can protect consumer unnecessary for good health or they may e en create unepected
safety and help regulators and policymakers determine 11
risks.” D notes that people choosing to supplement their diet
whether oluntary standards are effecti e and point with herbals itamins 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 uality. informed decisions. The agency pro ides helpful tips for dietary
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supplement users including for seniors.
n the .S. in early 2015 concerns about the uality and safety
of dietary supplements resulted in an in estigation by the ew
Background ork State ttorney eneral’s
ffice into herbal supplement
What re ietary Supplements manufacturers and sellers. The in estigation spread to se eral
other states and generated calls by industry and some lawmakers
dietary supplement is a product taken by mouth and intended for greater application of eisting federal law—and ultimately
to supplement the diet—for eample itamins minerals herbs or saw a multiagency federal enforcement action. The enhanced
other botanicals.8 hile not always called as such supplements regulatory attention also prompted efforts by industry to show
and other botanical or herbal preparations in arious forms ha e greater responsi eness and accountability including ad ancing
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been around for a long time. or eample the Egyptians and proposals for heightened public information “registries”
hinese used botanicals o er 3,000 years ago for their reputed about dietary supplements and ingredients. ncidents also
9 generated retailer interest in learning how to ensure the uality
benefits. hile in some countries dietary supplements are
regulated as drugs or as some intermediate category in other of supplement products on their shel es.
countries like the .S. they are regulated as foods.
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utside the .S. a number of countries including ndia and botanical amino acid or a concentrate metabolite constituent
hina ha e been separately seeking to update and epand etract or combination of any of these ingredients.
regulation of dietary supplements. nder DSE dietary supplement manufacturers are responsible
to establish the safety and uality of a product but are not
ow re ietary Supplements egulated reuired to share that information with D before the product
for uality enters the market unless it contains a new dietary ingredient
defined as a dietary ingredient that was not marketed in the
Global Situation 16
.S. in a dietary supplement before
ctober 15, 1994. To date
round the world dietary supplements may be regulated as D has not issued final guidance on what constitutes new
foods or drugs or sometimes a hybrid. or eample oQ10 dietary ingredients although it has issued final guidance on
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considered a dietary supplement in the .S. is included in distinguishing liuid dietary supplements from be erages.
the apanese harmacopoeia and regulated as a drug similarly
the European harmacopoeia has monographs for Echinacea Special hallenges for
as a drug while it is treated as a supplement in the .S.
t the same time many countries ha e an intermediate hile D has the authority under DSE to remo e a
category of “traditional medicines” with different reuirements product from the marketplace if it presents “significant or
for registration than those reuired for drugs. unreasonable risk of illness or injury” D is first charged with
Some countries ha e recently determined that there is a need to the responsibility to pro e that the product presents such a
create a new regulatory framework for dietary supplements and risk to public health. ecause D has limited resources in
such similar products. n some cases international agencies ascertaining harm and many of these products also ha e an
are creating regulations similar to those found in the .S. but inherently high threshold for safety products of unknown uality
generally they are more stringent. and unestablished safety can de facto be marketed in the .S.
without any o ersight.
Eamples of international regulatory reuirements for dietary 18
supplements that are not mandatory in the .S. include The .S. o ernment ccountability
ffice
has called on
D to do a better job in tracking serious ad erse e ents related
§ egistration to dietary supplements including utiliing data from poison
§ remarketing appro al of chemical and manufacturing centers in addition to its present sources industry reports. t
controls and least one ongressional committee has called for clarification of
§ remarketing re iew of safety and benefit claims. whether retailers feel they are obligated under DSE to report
ad erse incidents noting this as a possible weak link in the
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ad erse reporting chain.
Eamples of recent international proposals include ndia’s draft D is able to catch noncompliant facilities on inspection—in
regulation on “ood or ealth Supplements utraceuticals fact more than 50 of inspections lead to agency obser ations
oods for Special Dietary ses oods for Special edical warning letters. ut finding offending products can be a
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urpose unctional oods and o el oods” which seeks to resourceintensi e acti ity. The agency needs more resources to
impro e labeling reuirements for food and supplements and ascertain compliance and undertake enforcement.
references arious nations’ compendia and other sources and
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hina’s final re ision of its 2009 ood Safety aw specifying lthough identity testing is reuired by D regulations
registration and notification reuirements go erning special manufacturers can de elop andor choose the standards to which
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foods such as health foods i.e. dietary supplements. they test. ecause there are few uniform reuirements and no
D premarketing o ersight many of these testing standards
he United States remain pri ate and unknown to the public. This makes it difficult
n the .S. the Dietary Supplement ealth and Education ct for a consumer or other concerned party to compare the “same”
DSE ublic aw 103-417
ctober 25, 1994 pro ides a product e.g. Echinacea made by two different manufacturers.
regulatory framework for manufacturing and marketing dietary n fact the uality of dietary supplements may ary significantly
supplements that are intended to supplement the diet and from one manufacturer to another or e en within a single
contain dietary ingredients itamin mineral herb or other brand—without uniform standards it is hard to know for sure.
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pportunities for anufacturers and hina uses the category “health food” classified as food
egulators dietary supplement or Traditional hinese edicine T
on a casebycase basis. ll health food products sold within
§ S’s compendial uality standards are published in the hina must be appro ed and registered with the hina ood
United States Pharmacopeia–ational ormulary USP– and Drug dministration D which will assess and eamine
an official compendium of the .S. the security effecti eness and uality control and labeling of
• USP–’s drug uality standards are legally enforceable products. health food can promote only its appro ed health
by D for o erthecounter and prescription drugs under functions on its label and ad ertisement e.g. enhancing
the adulteration and misbranding pro isions of the ederal immune functions assisting blood lipids reduction assisting
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ood Drug and osmetic ct. blood sugar reduction assisting memory impro ement.
• USP–’s dietary supplement and dietary ingredient he European Union uses the category “food supplements”
standards are legally enforceable by D for products classified as foods. ood supplements are concentrated
that are oluntarily labeled as meeting “S.” n that sources of nutrients or other substances with a nutritional or
respect USP– is also an official compendium for dietary physiological effect whose purpose is to supplement the normal
supplements in the .S. although it is not recognied for diet. They are marketed “in dose” form i.e. as pills capsules
dietary supplements in the same way as for drugs. liuids in measured doses per ES definition. egistration is
§ ollowing S compendial uality standards for dietary not reuired but for harmoniation purposes there is a list of
supplements can help manufacturers establish adherence permitted itamin or mineral preparations that may be added for
to ood anufacturing ractices s and pro ide specific nutritional purposes in food supplements the marketing
assurance that ingredients they use are of good uality. of products containing itamins and minerals not listed is
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prohibited. unctional claims are allowed.
§ Testing to sciencebased public uality 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 uality. “health supplement.” The product cannot claim to mitigate
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§ ¡oluntary erification programs 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 30
are permitted.
right purity and strength. apan uses the categories “foods for specific health use”
S or “food and nutrient functional claims” based
on their product claims. o go ernment appro al is reuired for
EI I: egulation of ietary claims because they are standardied and preappro ed.
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S claims must pro ide e idence to the go ernment of the
Supplements utside the U.S.
rgentina reuires registration of dietary supplements prior to product’s physiological effect uality control processes and
marketing therapeutic claims not scientifically supported are not safety prior to marketing. Standardied and appro ed claims are
24 permitted for products.
S claims are permitted after
allowed.
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go ernment appro al.
ustralia uses the category of “complementary medicines” ordan uses the categories “herbal medicines” “herbal food
essentially classified as drugs with categories based on health products” “ itamin and mineral products” “food supplement”
risk. anufacturers are reuired to hold a manufacturing or “herbal medicine product” and the product is considered a
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license. drug or food depending on how it is classified. erbal medicines
rail uses the category of “ itamin or mineral supplement.” herbal products and itamins and minerals products reuire
egistration is reuired subject to the same registration registration. edical health nutrient content and structure
reuirements as food. laims to pre ent alle iate or treat a 32
function claims are allowed.
disease are prohibited.26
eico uses the category “nutritional supplements” and they
anada uses the category “natural health products” classified are classified as foods. egistration is not reuired. laims are
like drugs as Therapeutic roducts. egistration is reuired not permitted to be used on food supplement products. ts only
but premarketing is allowed prior to appro al. ealth claims are intended use is to increase total dietary intake complement
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acceptable pro ided the product is registered. it or replace any component or treat a disease symptom or
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condition.
age 4
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