Dietary Supplements

FDA regulates both finished dietary supplement products and dietary ingredients. FDA
regulates dietary supplements under a different set of regulations than those covering
"conventional" foods and drug products. Under the Dietary Supplement Health and
Education Act of 1! "DSHEA#$
%anufacturers and distributors of dietary supplements and dietary ingredients are
prohibited from mar&eting products that are adulterated or misbranded. 'hat means that
these firms are responsible for evaluating the safety and labeling of their products before
mar&eting to ensure that they meet all the re(uirements of DSHEA and FDA regulations.
FDA is responsible for ta&ing action against any adulterated or misbranded dietary
supplement product after it reaches the mar&et.
'his section provides detailed information about$
)*A on Dietary Supplements
Fre(uently as&ed (uestions about dietary supplements+ including definitions+ labeling
re(uirements+ and regulatory roles and responsibilities.
Using Dietary Supplements
'ips for dietary supplement users+ including older supplement users.
,eport an Adverse Event
-earn ho. consumers+ health care providers+ and others can report a complaint+ concern+
or problem related to dietary supplements. /ncludes lin&s to guidance for dietary
supplement manufacturers+ pac&ers+ and distributors.
0e. Dietary /ngredients 0otification 1rocess2ac&ground information for industry+
instructions for submitting premar&et notifications+ and lin&s to relevant guidance and
Federal ,egister documents.
Ensuring the Safety and Accurate -abeling of Dietary Supplements
Although dietary supplement manufacturers must register their facilities .ith FDA+3 they
are not re(uired to get FDA approval before producing or selling dietary supplements.
%anufacturers and distributors must ma&e sure that all claims and information on the
product label and in other labeling are truthful and not misleading.
Under FDA regulations at 41 5F, part 111+ all domestic and foreign companies that
manufacture+ pac&age+ label or hold dietary supplement+ including those involved .ith
testing+ (uality control+ and dietary supplement distribution in the U.S.+ must comply .ith
the Dietary Supplement 5urrent 6ood %anufacturing 1ractices "56%1s# for (uality
control.
/n addition+ the manufacturer+ pac&er+ or distributor .hose name appears on the label of a
dietary supplement mar&eted in the United States is re(uired to submit to FDA all serious
adverse event reports associated .ith use of the dietary supplement in the United States.
FDA regulates dietary supplement labels and other labeling+ such as pac&age inserts and
accompanying literature. 'he Federal 'rade 5ommission "F'5# regulates dietary
supplement advertising.
3Domestic and foreign facilities that manufacture+ process+ pac&+ or hold food for human
or animal consumption in the United States are re(uired to register .ith FDA. For more
information+ see ,egistration of Food Facilities.
)*A on Dietary Supplements
7hat is a dietary supplement8
5ongress defined the term "dietary supplement" in the Dietary Supplement Health and
Education Act "DSHEA# of 1!. A dietary supplement is a product ta&en by mouth that
contains a "dietary ingredient" intended to supplement the diet. 'he "dietary ingredients"
in these products may include$ vitamins+ minerals+ herbs or other botanicals+ amino acids+
and substances such as en9ymes+ organ tissues+ glandulars+ and metabolites. Dietary
supplements can also be e:tracts or concentrates+ and may be found in many forms such
as tablets+ capsules+ softgels+ gelcaps+ li(uids+ or po.ders. 'hey can also be in other
forms+ such as a bar+ but if they are+ information on their label must not represent the
product as a conventional food or a sole item of a meal or diet. 7hatever their form may
be+ DSHEA places dietary supplements in a special category under the general umbrella
of "foods+" not drugs+ and re(uires that every supplement be labeled a dietary
supplement.
7hat is a "ne. dietary ingredient" in a dietary supplement8
'he Dietary Supplement Health and Education Act "DSHEA# of 1! defined both of the
terms "dietary ingredient" and "ne. dietary ingredient" as components of dietary
supplements. /n order for an ingredient of a dietary supplement to be a "dietary
ingredient+" it must be one or any combination of the follo.ing substances$
; a vitamin+
; a mineral+
; an herb or other botanical+
; an amino acid+
; a dietary substance for use by man to supplement the diet by increasing the total
dietary inta&e "e.g.+ en9ymes or tissues from organs or glands#+ or
; a concentrate+ metabolite+ constituent or e:tract.
A "ne. dietary ingredient" is one that meets the above definition for a "dietary
ingredient" and .as not sold in the U.S. in a dietary supplement before <ctober 1=+ 1!.
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Should / chec& .ith my doctor or healthcare provider before using a supplement8
See 'ips For 'he Savvy Supplement User$ %a&ing /nformed Decisions And Evaluating
/nformation.
7hat is FDA>s role in regulating dietary supplements versus the manufacturer>s
responsibility for mar&eting them8
/n <ctober 1!+ the Dietary Supplement Health and Education Act "DSHEA# .as signed
into la. by 1resident 5linton. 2efore this time+ dietary supplements .ere sub?ect to the
same regulatory re(uirements as .ere other foods. 'his ne. la.+ .hich amended the
Federal Food+ Drug+ and 5osmetic Act+ created a ne. regulatory frame.or& for the safety
and labeling of dietary supplements.Under DSHEA+ a firm is responsible for determining
that the dietary supplements it manufactures or distributes are safe and that any
representations or claims made about them are substantiated by ade(uate evidence to
sho. that they are not false or misleading. 'his means that dietary supplements do not
need approval from FDA before they are mar&eted. E:cept in the case of a ne. dietary
ingredient+ .here pre@mar&et revie. for safety data and other information is re(uired by
la.+ a firm does not have to provide FDA .ith the evidence it relies on to substantiate
safety or effectiveness before or after it mar&ets its products.Also+ manufacturers need to
register themselves pursuant to the 2ioterrorism Act .ith FDA before producing or
selling supplements. /n Aune+ 4BBC+ FDA published comprehensive regulations for
5urrent 6ood %anufacturing 1ractices for those .ho manufacture+ pac&age or hold
dietary supplement products. 'hese regulations focus on practices that ensure the identity+
purity+ (uality+ strength and composition of dietary supplements.
7hen must a manufacturer or distributor notify FDA about a dietary supplement it
intends to mar&et in the U.S.8
'he Dietary Supplement Health and Education Act "DSHEA# re(uires that a
manufacturer or distributor notify FDA if it intends to mar&et a dietary supplement in the
U.S. that contains a "ne. dietary ingredient." 'he manufacturer "and distributor# must
demonstrate to FDA .hy the ingredient is reasonably e:pected to be safe for use in a
dietary supplement+ unless it has been recogni9ed as a food substance and is present in
the food supply.'here is no authoritative list of dietary ingredients that .ere mar&eted
before <ctober 1=+ 1!. 'herefore+ manufacturers and distributors are responsible for
determining if a dietary ingredient is "ne."+ and if it is not+ for documenting that the
dietary supplements its sells+ containing the dietary ingredient+ .ere mar&eted before
<ctober 1=+ 1!. For more detailed information+ see ne. dietary ingredients.
7hat information must the manufacturer disclose on the label of a dietary supplement8
FDA regulations re(uire that certain information appear on dietary supplement labels.
/nformation that must be on a dietary supplement label includes$ a descriptive name of
the product stating that it is a "supplementD" the name and place of business of the
manufacturer+ pac&er+ or distributorD a complete list of ingredientsD and the net contents of
the product./n addition+ each dietary supplement "e:cept for some small volume products
or those produced by eligible small businesses# must have nutrition labeling in the form
of a"Supplement Facts" panel. 'his label must identify each dietary ingredient contained
in the product.
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%ust all ingredients be declared on the label of a dietary supplement8
Ees+ ingredients not listed on the "Supplement Facts" panel must be listed in the "other
ingredient" statement beneath the panel. 'he types of ingredients listed there could
include the source of dietary ingredients+ if not identified in the "Supplement Facts" panel
"e.g.+ rose hips as the source of vitamin 5#+ other food ingredients "e.g.+ .ater and sugar#+
and technical additives or processing aids "e.g.+ gelatin+ starch+ colors+ stabili9ers+
preservatives+ and flavors#. For more details+ see$ Federal ,egister Final ,ule @ F4 F,
!G4F September 4H+ 1C.
Are dietary supplement serving si9es standardi9ed or are there restrictions on the amount
of a nutrient that can be in one serving8
<ther than the manufacturer>s responsibility to ensure safety+ there are no rules that limit a
serving si9e or the amount of a nutrient in any form of dietary supplements. 'his decision
is made by the manufacturer and does not re(uire FDA revie. or approval.
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7here can / get information about a specific dietary supplement8
%anufacturers and distributors do not need FDA approval to sell their dietary
supplements. 'his means that FDA does not &eep a list of manufacturers+ distributors or
the dietary supplement products they sell. /f you .ant more detailed information than the
label tells you about a specific product+ you may contact the manufacturer of that brand
directly. 'he name and address of the manufacturer or distributor can be found on the
label of the dietary supplement.
7hat are some tips on searching the .eb for information on dietary supplements8
See 'ips For 'he Savvy Supplement User$ %a&ing /nformed Decisions And Evaluating
/nformation.
7ho has the responsibility for ensuring that a dietary supplement is safe8
2y la. "DSHEA#+ the manufacturer is responsible for ensuring that its dietary
supplement products are safe before they are mar&eted. Unli&e drug products that must be
proven safe and effective for their intended use before mar&eting+ there are no provisions
in the la. for FDA to "approve" dietary supplements for safety or effectiveness before
they reach the consumer. Under DSHEA+ once the product is mar&eted+ FDA has the
responsibility for sho.ing that a dietary supplement is "unsafe+" before it can ta&e action
to restrict the product>s use or removal from the mar&etplace. Ho.ever+ manufacturers
and distributors of dietary supplements must record+ investigate and for.ard to FDA any
reports they receive of serious adverse events associated .ith the use of their products
that are reported to them directly. FDA is able to evaluate these reports and any other
adverse event information reported directly to us by healthcare providers or consumers to
identify early signals that a product may present safety ris&s to consumers. Eou can find
more information on reporting adverse events associated .ith the use of dietary
supplements at Dietary Supplements @ Adverse Event ,eporting.
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Do manufacturers or distributors of dietary supplements have to tell FDA or consumers
.hat evidence they have about their product>s safety or .hat evidence they have to bac&
up the claims they are ma&ing for them8
0o+ e:cept for rules described above that govern "ne. dietary ingredients+" there is no
provision under any la. or regulation that FDA enforces that re(uires a firm to disclose
to FDA or consumers the information they have about the safety or purported benefits of
their dietary supplement products. -i&e.ise+ there is no prohibition against them ma&ing
this information available either to FDA or to their customers. /t is up to each firm to set
its o.n policy on disclosure of such information. For more information+ see claims that
can be made for dietary supplements
Label Claims for Conventional Foods and Dietary Supplements
December 4B1H
Among the claims that can be used on food and dietary supplement labels are three
categories of claims that are defined by statute andIor FDA regulations$ health claims+
nutrient content claims+ and structureIfunction claims.
I. Health Claims
Health claims describe a relationship bet.een a food substance "a food+ food component+
or dietary supplement ingredient#+ and reduced ris& of a disease or health@related
condition. 'here are three .ays in .hich FDA e:ercises its oversight in determining
.hich health claims may be used on a label or in labeling for a conventional food or
dietary supplement$ 1# the 1B 0utrition -abeling and Education Act "0-EA# provides
for FDA to issue regulations authori9ing health claims for foods and dietary supplements
after revie.ing and evaluating the scientific evidence+ either in response to a health claim
petition or on its o.n initiativeD 4# the 1C Food and Drug Administration
%oderni9ation Act "FDA%A# provides for health claims based on an authoritative
statement of the 0ational Academy of Sciences or a scientific body of the U.S.
government .ith responsibility for public health protection or nutrition researchD such
claims may be used 14B days after a health claim notification has been submitted to FDA+
unless the agency has informed the notifier that the notification does not include all the
re(uired informationD and H# as described in FDAJs guidance entitled/nterim 1rocedures
for )ualified Health 5laims in the -abeling of 5onventional Human Food and Human
Dietary Supplements+ the agency revie.s petitions for (ualified health claims .here the
(uality and strength of the scientific evidence falls belo. that re(uired for FDA to issue
an authori9ing regulation. /f FDA finds that the evidence supporting the proposed claim is
credible and the claim can be (ualified to prevent it from misleading consumers+ the
agency issues a letter of enforcement discretion specifying the (ualifying language that
should accompany the claim and describing the circumstances under .hich it intends to
e:ercise enforcement discretion for use of the claim in food labeling. 'he differences
bet.een these three methods of oversight for health claims are summari9ed belo..
Appendi: 5 of The Food Labeling Guidecontains a summary of those health claims that
have been approved for use on food and dietary supplement labels. A Food -abeling
6uide @ Appendi: 5$ Health 5laims.
A "health claim" by definition has t.o essential components$ "1# a substance ".hether a
food+ food component+ or dietary ingredient# and "4# a disease or health@related condition.
A statement lac&ing either one of these components does not meet the regulatory
definition of a health claim. For e:ample+ statements that address a role of dietary
patterns or of general categories of foods "e.g.+ fruits and vegetables# in maintaining good
health are considered to be dietary guidance rather than health claims. Dietary guidance
statements used on food labels must be truthful and non@misleading. Statements that
address a role of a specific substance in maintaining normal healthy structures or
functions of the body are considered to be structureIfunction claimsD see
StructureIFunction 5laims. Unli&e health claims+ dietary guidance statements and
structureIfunction claims are not sub?ect to premar&et revie. and authori9ation by FDA.
NLEA Authorized Health Claims. 'he 0utrition -abeling and Education Act of 1B
"0-EA# provides for the use in food labeling of health claims that characteri9e a
relationship bet.een a food+ a food component+ or dietary ingredient and ris& of a disease
"for e:ample+ "ade(uate calcium throughout life may reduce the ris& of osteoporosis"#+
provided the claims meet certain criteria and are authori9ed by an FDA regulation. FDA
authori9es these types of health claims based on an e:tensive revie. of the scientific
literature+ generally as a result of the submission of a health claim petition+ using the
significant scientific agreement standard to determine .hether the substanceIdisease
relationship is .ell established.
Health Claims ased on Authoritative Statements. 'he Food and Drug Administration
%oderni9ation Act of 1C "FDA%A# provides a second .ay for the use of a health
claim in food labeling to be authori9ed. Under FDA%A+ a ne. health claim can be
authori9ed by submitting a notification to FDA of a claim based on an "authoritative
statement" from certain scientific bodies of the U.S. 6overnment or the 0ational
Academy of Sciences. FDA has issued guidance on ho. a firm can submit such a
notification and ma&e use of authoritative statement@based health claims. 'his guidance
can be found at$ 0otification of a Health 5laim or 0utrient 5ontent 5laim 2ased on an
Authoritative Statement of a Scientific 2ody. FDA%A does not include dietary
supplements in the provisions for health claims based on authoritative statements.
5onse(uently+ this method of oversight for health claims cannot be used for dietary
supplements at this time. E:amples of health claims based on authoritative statements
may also be found at$ A Food -abeling 6uide @ Appendi: 5$ Health 5laims.
!ualified Health Claims. FDA>s /nterim 1rocedures for )ualified Health 5laims in the
-abeling of 5onventional Human Food and Human Dietary Supplements describes the
agencyJs process for considering petitions for the use of a (ualified health claim in food
labeling. 7hen there is emerging evidence for a relationship bet.een a food substance "a
food+ food component+ or dietary ingredient# and reduced ris& of a disease or health@
related condition+ but the evidence is not .ell enough established to meet the significant
scientific agreement standard re(uired for FDA to issue an authori9ing regulation+ the
(ualified health claim petition process provides a mechanism to re(uest that FDA revie.
the scientific evidence and e:ercise enforcement discretion to permit the use of the
(ualified claim in food labeling. /f+ after evaluating the (uality and strength of the totality
of the scientific evidence+ FDA finds that credible evidence supports the claim+ the
agency issues a letter outlining the circumstances under .hich it intends to consider the
e:ercise of enforcement discretion for use of the claim in food labeling. )ualifying
language is included as part of the claim to indicate that the evidence supporting the
claim is limited. Although FDA>s letters of enforcement discretion are issued to the
petitioner re(uesting the (ualified health claim+ the (ualified claims are available for use
on any food or dietary supplement product meeting the enforcement discretion conditions
specified in the letter. FDA has issued guidance on interim procedures for (ualified health
claims "see /nterim 1rocedures for )ualified Health 5laims in the -abeling of
5onventional Human Food and Human Dietary Supplements# and on the scientific
criteria the agency uses in conducting health claim evaluations "see Evidence@2ased
,evie. System for the Scientific Evaluation of Health 5laims#. )ualified health claim
petitions that are submitted to FDA .ill be available for public revie. and comment. A
listing of petitions open for public comment is at the FDA Doc&ets %anagement .ebsite.
A summary of the (ualified health claims authori9ed by FDA may be found at$ )ualified
Health 5laims Sub?ect to Enforcement Discretion. For more information see )ualified
Health 5laims.
II. Nutrient Content Claims
'he 0utrition -abeling and Education Act of 1B "0-EA# permits the use of label
claims that characteri9e the level of a nutrient in a food "i.e.+ nutrient content claims# if
they have been authori9ed by FDA and are made in accordance .ith FDA>s authori9ing
regulations. 0utrient content claims describe the level of a nutrient in the product+ using
terms such as free, high, and low+ or they compare the level of a nutrient in a food to that
of another food+ using terms such as more, reduced+ and lite. An accurate (uantitative
statement "e.g.+ 4BB mg of sodium# that does not other.ise "characteri9e" the nutrient
level may be used to describe the amount of a nutrient present. Ho.ever+ a statement
such as "only 4BB mg of sodium" characteri9es the level of sodium by implying that it is
lo.. 'herefore+ the food .ould have to meet the nutritional criteria for a Klo.L nutrient
content claim or carry a disclosure statement that it does not (ualify for the claim "e.g.+
Knot a lo. sodium foodL#. %ost nutrient content claim regulations apply only to those
nutrients that have an established Daily Malue$ A Food -abeling 6uide @ M//. 0utrition
-abeling. 'he re(uirements that govern the use of nutrient content claims help ensure that
descriptive terms+ such as high or low+ are used consistently for all types of food products
and are thus meaningful to consumers. Healthy is an implied nutrient content claim that
characteri9es a food as having "healthy" levels of total fat+ saturated fat+ cholesterol and
sodium+ as defined in the regulation authori9ing use of the claim. 1ercentage claims for
dietary supplements are another category of nutrient content claims. 'hese claims are
used to describe the percentage level of a dietary ingredient in a dietary supplement and
may refer to dietary ingredients for .hich there is no established Daily Malue+ provided
that the claim is accompanied by a statement of the amount of the dietary ingredient per
serving. E:amples include simple percentage statements such as "!BN omega@H fatty
acids+ 1B mg per capsule+" and comparative percentage claims+ e.g.+ "t.ice the omega@H
fatty acids per capsule "GB mg# as in 1BB mg of menhaden oil "!B mg#." "See 41 5F,
1B1.1H"(#"H#"ii##. A summary of the rules for use of nutrient content claims can be found
in 5hapter M/ of 'he Food -abeling 6uide. E:amples of nutrient content claims can be
found in Appendices A and 2 of 'he Food -abeling 6uide$ Appendi: A$ Definitions of
0utrient 5ontent 5laims and Appendi: 2$ Additional ,e(uirements for 0utrient 5ontent
5laims.
III. Stru"ture#Fun"tion Claims and $elated Dietary Supplement Claims
StructureIfunction claims have historically appeared on the labels of conventional foods
and dietary supplements as .ell as drugs. 'he Dietary Supplement Health and Education
Act of 1! "DSHEA# established some special regulatory re(uirements and procedures
for using structureIfunction claims and t.o related types of dietary supplement labeling
claims+ claims of general .ell@being and claims related to a nutrient deficiency disease.
StructureIfunction claims may describe the role of a nutrient or dietary ingredient
intended to affect the normal structure or function of the human body+ for e:ample+
"calcium builds strong bones." /n addition+ they may characteri9e the means by .hich a
nutrient or dietary ingredient acts to maintain such structure or function+ for e:ample+
"fiber maintains bo.el regularity+" or "antio:idants maintain cell integrity." 6eneral .ell@
being claims describe general .ell@being from consumption of a nutrient or dietary
ingredient. 0utrient deficiency disease claims describe a benefit related to a nutrient
deficiency disease "li&e vitamin 5 and scurvy#+ but such claims are allo.ed only if they
also say ho. .idespread the disease is in the United States. 'hese three types of claims
are not pre@approved by FDA+ but the manufacturer must have substantiation that the
claim is truthful and not misleading and must submit a notification .ith the te:t of the
claim to FDA no later than HB days after mar&eting the dietary supplement .ith the claim.
/f a dietary supplement label includes such a claim+ it must state in a "disclaimer" that
FDA has not evaluated the claim. 'he disclaimer must also state that the dietary
supplement product is not intended to "diagnose+ treat+ cure or prevent any disease+"
because only a drug can legally ma&e such a claim. StructureIfunction claims may not
e:plicitly or implicitly lin& the claimed effect of the nutrient or dietary ingredient to a
disease or state of health leading to a disease. Further information regarding
structureIfunction claims can be found in FDA>s Aanuary + 4BB4 StructureIFunction
5laims Small Entity 5ompliance 6uide.
StructureIfunction claims for conventional foods focus on effects derived from nutritive
value+ .hile structureIfunction claims for dietary supplements may focus on non@nutritive
as .ell as nutritive effects. FDA does not re(uire conventional food manufacturers to
notify FDA about their structureIfunction claims+ and disclaimers are not re(uired for
claims on conventional foods.
O
'his document .as issued on %arch 4B+ 4BB1 and revised <ctober 4BB1+ September
4BBH+ and December 4B1H.
Ho. can consumers inform themselves about safety and other issues related to dietary
supplements8
/t is important to be .ell informed about products before purchasing them. 2ecause it is
often difficult to &no. .hat information is reliable and .hat is (uestionable+ consumers
may first .ant to contact the manufacturer about the product they intend to purchase "see
previous (uestion "7here can / get information about a specific dietary supplement8"#. /n
addition+ to help consumers in their search to be better informed+ FDA is providing the
follo.ing sites$ 'ips For 'he Savvy Supplement User$ %a&ing /nformed Decisions And
Evaluating /nformation "includes information on ho. to evaluate research findings and
health information on@line# and 5laims 'hat 5an 2e %ade for 5onventional Foods and
Dietary Supplements+ "provides information on .hat types of claims can be made for
dietary supplements#.
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7hat is FDA>s oversight responsibility for dietary supplements8
2ecause dietary supplements are under the "umbrella" of foods+ FDA>s 5enter for Food
Safety and Applied 0utrition "5FSA0# is responsible for the agency>s oversight of these
products. FDA>s efforts to monitor the mar&etplace for potential illegal products "that is+
products that may be unsafe or ma&e false or misleading claims# include obtaining
information from inspections of dietary supplement manufacturers and distributors+ the
/nternet+ consumer and trade complaints+ occasional laboratory analyses of selected
products+ and adverse events associated .ith the use of supplements that are reported to
the agency.
Does FDA routinely analy9e the content of dietary supplements8
/n that FDA has limited resources to analy9e the composition of food products+ including
dietary supplements+ it focuses these resources first on public health emergencies and
products that may have caused in?ury or illness. Enforcement priorities then go to
products thought to be unsafe or fraudulent or in violation of the la.. 'he remaining
funds are used for routine monitoring of products pulled from store shelves or collected
during inspections of manufacturing firms. 'he agency does not analy9e dietary
supplements before they are sold to consumers. 'he manufacturer is responsible for
ensuring that the "Supplement Facts" label and ingredient list are accurate+ that the
dietary ingredients are safe+ and that the content matches the amount declared on the
label. FDA does not have resources to analy9e dietary supplements sent to the agency by
consumers .ho .ant to &no. their content. /nstead+ consumers may contact the
manufacturer or a commercial laboratory for an analysis of the content.
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/s it legal to mar&et a dietary supplement product as a treatment or cure for a specific
disease or condition8
0o+ a product sold as a dietary supplement and promoted on its label or in labeling3 as a
treatment+ prevention or cure for a specific disease or condition .ould be considered an
unapproved@@and thus illegal@@drug. 'o maintain the product>s status as a dietary
supplement+ the label and labeling must be consistent .ith the provisions in the Dietary
Supplement Health and Education Act "DSHEA# of 1!.3-abeling refers to the label as
.ell as accompanying material that is used by a manufacturer to promote and mar&et a
specific product.
7ho validates claims and .hat &inds of claims can be made on dietary supplement
labels8
FDA receives many consumer in(uiries about the validity of claims for dietary
supplements+ including product labels+ advertisements+ media+ and printed materials. 'he
responsibility for ensuring the validity of these claims rests .ith the manufacturer+ FDA+
and+ in the case of advertising+ .ith the Federal 'rade 5ommission.2y la.+
manufacturers may ma&e three types of claims for their dietary supplement products$
health claims+ structureIfunction claims+ and nutrient content claims. Some of these
claims describe$ the lin& bet.een a food substance and disease or a health@related
conditionD the intended benefits of using the productD or the amount of a nutrient or
dietary substance in a product. Different re(uirements generally apply to each type of
claim+ and aredescribed in more detail.
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7hy do some supplements have .ording "a disclaimer# that says$ "'his statement has not
been evaluated by the FDA. 'his product is not intended to diagnose+ treat+ cure+ or
prevent any disease"8
'his statement or "disclaimer" is re(uired by la. "DSHEA# .hen a manufacturer ma&es
a structureIfunction claim on a dietary supplement label. /n general+ these claims describe
the role of a nutrient or dietary ingredient intended to affect the structure or function of
the body. 'he manufacturer is responsible for ensuring the accuracy and truthfulness of
these claimsD they are not approved by FDA. For this reason+ the la. says that if a dietary
supplement label includes such a claim+ it must state in a "disclaimer" that FDA has not
evaluated this claim. 'he disclaimer must also state that this product is not intended to
"diagnose+ treat+ cure or prevent any disease+" because only a drug can legally ma&e such
a claim.
Ho. are advertisements for dietary supplements regulated8
'he Federal 'rade 5ommission "F'5# regulates advertising+ including
infomercials+ for dietary supplements and most other products sold to consumers. FDA
.or&s closely .ith F'5 in this area+ but F'5>s .or& is directed by different la.s. For
more information on F'5+ go to the F'5 .eb site . Advertising and promotional material
received in the mail are also regulated under different la.s and are sub?ect to regulation
by the U.S. 1ostal /nspection Service.
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Ho. do /+ my health care provider+ or any informed individual report a problem or illness
caused by a dietary supplement to FDA8
/f you thin& you have suffered a serious harmful effect or illness from a dietary
supplement+ the first thing you should do is contact or see your healthcare provider
immediately. 'hen+ you or your health care provider can report this by submitting a report
through the Safety ,eporting 1ortal. /f you do not have access to the internet+ you may
submit a report by calling FDA>s %ed7atch hotline at 1@GBB@FDA@1BGG.
FDA .ould li&e to &no. .hen a dietary supplement causes a problem even if you are
unsure the product caused the problem or even if you do not visit a doctor or clinic.
Anyone may report a serious adverse event or illness thought to be related to a dietary
supplement directly to FDA by accessing the S,1 mentioned above.
5onsumers are also encouraged to report instances of product problems using the Safety
,eporting 1ortal . E:amples of product problems are foreign ob?ects in the pac&aging or
other apparent (uality defects.
/n addition to communicating .ith FDA on@line or by phone+ you may use the postage@
paid %ed7atch form available from the FDA 7eb site.
0<'E$ 'he identity of the reporter andIor patient is &ept confidential. For a general
complaint or concern about food products+ including dietary supplements+ you may
contact the consumer complaint coordinator at the local FDA District <ffice nearest you.
See the follo.ing 7eb address for the telephone number$ 5onsumer 5omplaint
5oordinators1=.