Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
D S :  
IETARY  UPPLEMENTS  
 
 
S /F C
TRUCTURE UNCTION  LAIMS 
 
F  T M F
AIL  O  EET  EDERAL 
 
R  
EQUIREMENTS 
 
Daniel R. Levinson  
Inspector General 
 
October 2012 
OEI-01-11-00210   
   
DIETARY SUPPLEMENTS:  STRUCTURE/FUNCTION CLAIMS FAIL TO MEET 
FEDERAL REQUIREMENTS, OEI-01-11-00210 
 
WHY WE DID THIS STUDY  
The Government Accountability Office and public interest groups have raised concerns 
about a specific type of claimcalled a structure/function claimthat manufacturers 
may use on dietary supplement labels.  Manufacturers have used these claims to promote 
health benefits of their products.  Stakeholders have urged the Food and Drug 
Administration (FDA) to strengthen oversight of these claims because they are 
potentially misleading and may lack scientific support.  FDA lacks authority to review or 
approve these claims before products enter the market.  Manufacturers must have 
competent and reliable scientific evidence to show that claims are truthful and not 
misleading, but they do not have to submit the substantiation to FDA, and FDA has only 
voluntary standards for it.  A manufacturer must notify FDA when it uses 
structure/function claims, and a product label must include a disclaimer stating that FDA 
has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or 
prevent any disease. 
 
HOW WE DID THIS STUDY 
We analyzed structure/function claims for a purposive sample of 127 dietary supplements 
marketed for weight loss or immune system support.  We reviewed the claims to 
determine the extent to which they complied with FDA regulations.  We reviewed 
substantiation provided by manufacturers to describe the quantity and nature of the 
evidence.  We also assessed the accuracy and completeness of notification letters that 
manufacturers must submit to FDA for their structure/function claims.   
 
WHAT WE FOUND 
Overall, substantiation documents for the sampled supplements were inconsistent with 
FDA guidance on competent and reliable scientific evidence.  FDA could not readily 
determine whether manufacturers had submitted the required notification for their claims.  
Seven percent of the supplements lacked the required disclaimer, and 20 percent included 
prohibited disease claims on their labels.  These results raise questions about the extent to 
which structure/function claims are truthful and not misleading. 
 
WHAT WE RECOMMEND 
We recommend that FDA seek explicit statutory authority to review substantiation for 
structure/function claims to determine whether they are truthful and not misleading.  We 
recommend that FDA improve the notification system for these claims to make it more 
organized, complete, and accurate.  We also recommend that FDA expand market 
surveillance to enforce the use of disclaimers for structure/function claims and to detect 
disease claims.  In its comments on the draft report, FDA did not explicitly concur with 
our first recommendation, but said it would consider it.  FDA concurred with our second 
and third recommendations. 
   
   
   
TABLE OF CONTENTS 
 
Objectives ....................................................................................................1 
Background ..................................................................................................1 
Methodology ................................................................................................7 
Findings...................................................................................................... 11 
Supplements had multiple structure/function claims that stated 
various health benefits ................................................................... 11 
Substantiation documents for structure/function claims were not 
consistent with FDA guidance ....................................................... 11 
FDA could not readily determine the extent to which 
manufacturers of sampled supplements had submitted the    
required notification for their structure/function claims ................15 
Seven percent of supplements in our sample were missing the 
required disclaimer for structure/function claims ..........................16 
Twenty percent of the supplements in our sample had prohibited 
disease claims on the labels ...........................................................16 
Conclusion and Recommendations ............................................................18 
Agency Comments and Office of Inspector General Response .....20 
Appendix ....................................................................................................21 
A:  Additional Descriptive Statistics ..............................................21 
B:  Agency Comments ...................................................................24 
Acknowledgments......................................................................................27 
 
   
   
OBJECTIVES 
1.  To determine the extent and nature of structure/function claims on 
selected weight loss and immune support dietary supplement labels. 
2.  To assess the extent to which documentation used to substantiate 
structure/function claims on selected weight loss and immune support 
supplement labels was consistent with Food and Drug Administration 
(FDA) guidance. 
3.  To determine the extent to which structure/function claims on selected 
weight loss and immune support dietary supplements complied with 
FDA regulations related to notification and disclaimers. 
4.  To determine the extent to which selected weight loss and immune 
support dietary supplement labels included prohibited disease claims. 
BACKGROUND  
In the United States, dietary supplements are a $20 billion-per-year 
industry and are used by 80 percent of adults for a wide range of 
purposes.1  Products for weight loss or immune system support represent 
some of the fastest growing segments of the dietary supplement market.2, 3  
Previous Office of Inspector General (OIG) and Government 
Accountability Office (GAO) reports highlighted problems with dietary 
supplement labels and the claims used to market supplements.4, 5  GAO 
and public interest groups have raised concerns about a specific type of 
claimcalled a structure/function claimthat manufacturers may use on 
dietary supplement labels.6, 7, 8  In recent years, manufacturers have 
 
1
 Natural Products Foundation, What is the Current Economic Contribution of the Dietary 
Supplement Industry to the U.S. Economy?  Accessed at www.naturalproductsfoundation.org 
on May 31, 2010. 
2 GAO, Dietary Supplements for Weight Loss:  Limited Federal Oversight Has Focused More 
on Marketing than on Safety, GAO-02-985T, July 2002. 
3
 Nutraceuticals World, Getting Ahead of the Curve:  Immunity, October 1, 2010.  Accessed at 
www.nutraceuticalsworld.com on March 16, 2012. 
4 OIG, Dietary Supplement Labels:  Key Elements, OEI-01-01-00120, March 2003;  and 
Dietary Supplement Labels:  An Assessment, OEI-01-01-00121, March 2003. 
5 GAO, Dietary Supplements:  Examples of Deceptive or Questionable Marketing Practices 
and Potentially Dangerous Advice, GAO-10-662T, May 25, 2010; and Dietary Supplements:  
FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, 
GAO-09-250, January 2009. 
6 GAO, Food Labeling:  FDA Needs to Reassess Its Approach to Protecting Consumers from 
False or Misleading Claims, GAO-11-102, January 2011. 
7 Center for Science in the Public Interest, Food Label Trickery:  New Claims On Foods Can 
Mislead & Confuse, May 30, 2003.  Accessed at www.cspinet.org on March 19, 2012.  
8 Public Citizen, Reduction In Cancer Risk Claim for Antioxidant Vitamins Rejected by the 
Food and Drug Administration, July 2001.  Accessed at www.citizen.org on March 19, 2012. 
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
increasingly used structure/function claims, which do not require 
preapproval by FDA, to promote the health benefits of their products.9  
Stakeholders have urged FDA to strengthen its oversight of 
structure/function claims because such claims are potentially misleading to 
consumers and may lack scientific support.10  Critics of structure/function 
claims have asserted that the claims imply that the supplement will 
prevent or treat disease or dysfunction, which is prohibited for dietary 
supplements.11, 12, 13, 14 
Dietary Supplements 
The Dietary Supplement Health and Education Act (DSHEA) of 1994, an 
amendment to the Federal Food, Drug, and Cosmetic Act, defines a dietary 
supplement as, in part, a product that is ingested by mouth to supplement 
the diet and contains one or more of the following ingredients: 
  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 intake; or 
  a concentrate, a metabolite, a constituent, or an extract.15 
DSHEA does not require manufacturers to submit dietary supplements to 
FDA for safety testing or approval prior to sale.16  As a result, FDA has no 
comprehensive list of dietary supplements on the market.  Dietary 
supplement manufacturers must ensure that their products are safe, that 
 
9
 GAO, Food Labeling:  FDA Needs to Reassess Its Approach to Protecting Consumers from 
False or Misleading Claims, GAO-11-102, January 2011. 
10
 Ibid. 
11
 Center for Science in the Public Interest, FDA Needs Authority To See Evidence on 
Structure/Function Claims, Says GAO, January 14, 2011.  Accessed at www.cspinet.org on 
March 23, 2012. 
12
 USA Today, Many Food Label Claims May Mislead Rather Than Inform, January 31, 
2011.  Accessed at www.usatoday.com on March 23, 2012. 
13
 P. Wilde, GAO:  FDA Lacks the Power It Needs to Address Structure /Function Claims, 
January 15, 2011.  Accessed at www.usfoodpolicy.blogspot.com on March 23, 2012. 
14
 21 U.S.C.  343(r)(6). 
15
 P.L. 103-417  3 (codified at 21 U.S.C.  321(ff)(1)). 
16
 The law does consider a dietary supplement product containing a new dietary ingredient, 
which is any dietary ingredient not marketed in the United States prior to 1994, as adulterated 
unless it meets one of two statutory requirements:  the supplement must contain only dietary 
ingredients that have been present in the food supply, or there must be a history of use or other 
evidence of safety establishing that the dietary ingredient will reasonably be expected to be 
safe.  21 U.S.C.  350b. 
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they have evidence to substantiate structure/function claims, and that 
product labels are truthful and not misleading.17   
FDA is responsible for ensuring that dietary supplements marketed to U.S. 
consumers are safe.  FDA does this by monitoring adverse event reports 
and consumer complaints, searching the Internet for supplements that do 
not comply with regulations, conducting onsite inspections of 
manufacturers facilities or imported shipments of supplements, and 
reviewing new dietary ingredient notifications.18  FDA does not conduct 
surveillance of dietary supplements sold in retail establishments; however, 
it does conduct limited surveillance of supplements sold on the Internet.  
Claims on Dietary Supplement Labeling 
FDAs Center for Food Safety and Applied Nutrition has primary 
responsibility for overseeing claims made on dietary supplement 
labeling.19   Among the most commonly used claims on dietary 
supplement labels are nutrient content claims, health claims, and 
structure/function claims.  FDA regulates each of these types of claims 
differently.20   
Nutrient content claims describe the level of a nutrient in a dietary 
supplement or other food (e.g., 200 mg of folic acid, low fat, or high 
fiber).21  Health claims describe a relationship between a food or food 
component (including a dietary supplement ingredient) and reduced risk of 
a disease or health-related condition.  Adequate calcium throughout life, 
as part of a well-balanced diet, may reduce the risk of osteoporosis is an 
example of a health claim.22  FDA reviews petitions for nutrient content 
claims and health claims and either authorizes or denies them depending 
on the amount of supporting scientific evidence.23, 24  Generally, nutrient 
 
17
 21 U.S.C.  343(a)(1); 21 U.S.C.  343(r)(6)(B); 21 U.S.C.   342(f). 
18
 21 U.S.C.  350b. 
19
 Label  means a display of written, printed, or graphic matter upon the container,            
21 U.S.C.  321(k); labeling means all labels and other written, printed, or graphic matter 
upon the product or any of its containers, wrappers, or accompanying promotional material,          
21 U.S.C.  321(l).  See also 21 CFR  1.3.  FDA may take enforcement action against claims 
made on Web sites as well as claims printed on the supplement package.   
20
 In addition, dietary supplements may bear claims that do not fall into a defined category as 
long as the claim is truthful and not misleading. 
21
 21 CFR  101.13(b);  mg=milligrams. 
22
 21 CFR  101.14(a)(1). 
23
 FDA has authorized 12 health claims by regulation, none of which relates to weight loss or 
immune support.  
24
 Qualified health claims, which are also permitted by FDA, are health claims that do not 
meet the evidentiary standard for an FDA-authorized health claim (see 21 U.S.C.  
343(r)(3)(B)(i)), but are supported by credible evidence and include a disclaimer or other 
qualifying language to prevent the claims from being misleading. 
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content claims or health claims not explicitly authorized by FDA are 
prohibited. 
Structure/Function Claims 
In general, structure/function claims describe the role of a dietary 
supplement in the structure and function of human bodies, but the claims 
may not explicitly or implicitly claim to prevent, treat, mitigate, cure, or 
diagnose a disease.25  A structure/function claim may also: 
  claim a benefit related to a classical nutrient deficiency disease 
(e.g., scurvy) and disclose the prevalence of such disease in the 
United States, 
  characterize the documented mechanism by which a nutrient or 
dietary ingredient acts to maintain such structure or function, or  
  describe general well-being from consumption of a nutrient or 
dietary ingredient.26 
For example, a supplement may claim that it curbs appetite to help with 
weight loss, but it may not claim to aid weight loss to treat obesity 
because obesity is a disease.  Similarly, a supplement may claim to 
support immunity, but may not claim to boost the immune system 
against colds and flu because the latter references specific diseases.  
Although FDA has issued regulations and published guidance describing 
the difference between structure/function claims and disease claims, it 
acknowledges the challenge of distinguishing between the two.27   
DSHEA requires manufacturers to meet three requirements for placing a 
structure/function claim on a supplement label:  (1) substantiation that the 
claim is truthful and not misleading, (2) notification to FDA within         
30 days of marketing the supplement with the claim, and (3) a disclaimer 
on the supplement label.28   
Substantiation of Structure/Function Claims.  Manufacturers must have 
substantiation for the structure/function claims on their products labels to 
ensure that they are truthful and not misleading.  In any legal proceeding 
concerning structure/function claims, FDA must prove that the claim is 
 
25
 21 U.S.C.  343(r)(6); 21 CFR  101.93(f)-(g); FDA, Structure/Function Claims, Small 
Entity Compliance Guide, January 9, 2002.  Accessed at www.fda.gov on February 13, 2012. 
26
 21 U.S.C.  343(r)(6)(A); see also 21 CFR  101.93. 
27
 21 CFR  101.93(f)-(g); FDA, Structure/Function Claims, Small Entity Compliance Guide, 
January 9, 2002.  Accessed at www.fda.gov on February 13, 2012. 
28
 21 U.S.C.  343(r)(6). 
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false or misleading.29  However, DSHEA does not require manufacturers 
to submit the substantiation to FDA to determine its adequacy, and FDA 
may not compel manufacturers to produce substantiation upon request.  
Therefore, FDA has limited authority to enforce the substantiation 
requirement. 
FDA has published guidance on the extent and nature of substantiation 
that manufacturers should have to comply with the law.30  In general, FDA 
recommends that evidence be derived primarily from human studies that 
use widely accepted scientific methods.  The guidance also lists types of 
background informationsuch as in vitro or animal studies, meta-
analyses, and review articlesthat manufacturers may use to substantiate 
claims.  However, the guidance notes that background information, when 
used alone, may not be adequate to substantiate claims.31   
FDA uses a standard of competent and reliable scientific evidence for 
substantiation.  To meet this standard, FDA recommends that 
manufacturers consider the following when substantiating 
structure/function claims: 
  The relationship of the evidence to the claim.  The evidence should 
demonstrate a direct effect of the supplement on a structure or 
function of the body in a population similar to that which will be 
consuming the product.  The evidence should test either the 
product itself or an amount and potency of the active ingredients 
that are similar to the product. 
  The totality of the evidence.  Manufacturers should consider the 
total body of evidenceboth favorable and unfavorablein 
determining whether it is adequate to substantiate a claim.  If 
evidence conflicts or shows inconsistent results, it will raise 
questions about whether a structure/function claim is substantiated. 
  The quality of the evidence.  Manufacturers must consider the 
scientific quality of studies used to substantiate claims.  FDA 
considers human studies that are randomized, double-blind, 
 
29
 An enforcement action against a dietary supplement based on an unsubstantiated 
structure/function claim could be brought under certain provisions of the Federal Food, Drug 
and Cosmetic Act, such as 21 U.S.C. 343(a)(1) and 343(r)(6) and 21 U.S.C.   331, 332, 
and/or 334. 
30
 FDA, Guidance for Industry:  Substantiation for Dietary Supplement Claims Made Under 
Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act, December 2008.  Accessed 
at www.fda.gov on February 17, 2012.  Following FDAs guidance on substantiation is 
recommended, but not required. 
31
 FDA guidance lists seven types of documentation that would be considered background 
information:  animal studies, in vitro studies, testimonials or anecdotal evidence, meta-
analyses, review articles, comments and letters to the editor, and product monographs.   
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parallel group, placebo-controlled trials that focus on a 
representative population to be the gold standard for 
substantiation.  Manufacturers may use other human or nonhuman 
studies to substantiate claims, but should consider factors in the 
studies methods that may affect the results. 
  The meaning of the claim(s) being made.  Manufacturers should 
have substantiation for each possible interpretation of a 
structure/function claim.  For example, a supplement may claim to 
promote weight loss.  If the manufacturers evidence is a study 
showing that the supplements main ingredient temporarily 
increases metabolism, but not showing actual weight loss, then the 
manufacturer has not accounted for the meaning of the claim in its 
substantiation.32 
Notification to FDA.  Dietary supplement manufacturers must notify FDA 
of any structure/function claims no later than 30 days after first 
introducing a product into the market.  The notification must include the 
name and address of the manufacturer, the text of the claim, the name of 
the ingredient for which the claim is being made, and the name of the 
dietary supplement.  In the notification, the manufacturer must attest that it 
has substantiation that the claim is truthful and not misleading.  The 
notification must be signed by a person who can certify the accuracy and 
completeness of the information.33    
FDA reviews each notification to ensure it meets the definition of a 
structure/function claim.  If it does not, FDA sends a letter to the 
manufacturer notifying it that the claim is not in compliance and follows 
up as needed.  FDA keeps copies of all notifications on file.34 
Disclaimer.  All structure/function claims must be accompanied by the 
following mandatory disclaimer:  This statement has not been evaluated 
by the Food and Drug Administration.  This product is not intended to 
diagnose, treat, cure, or prevent any disease.35 
Prohibition on disease claims 
Dietary supplements may not include disease claims on their labels or in 
other labeling.  A disease claim is defined as a claim that mentions or 
implies the mitigation, treatment, diagnosis, prevention, or cure of a 
 
32
 FDA, Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the 
Federal Food, Drug, and Cosmetic Act, December 2008.  Accessed at www.fda.gov on 
February 17, 2012.  
33
 21 CFR  101.93(a)(2). 
34
 The number of manufacturers that do not submit structure/function claims to FDA is 
unknown. 
35
 21 CFR  101.93(c)(1). 
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disease or its symptoms.36  For example, a dietary supplement may not 
claim that it prevents or treats cancer, reduces pain associated with 
arthritis, or relieves bronchospasms (which would imply treatment of a 
disease because bronchospasms are a symptom of asthma).  A product that 
assists in the diagnosis, mitigation, treatment, cure, or prevention of a 
disease is considered a drug under the Federal Food, Drug, and Cosmetic 
Act.37 
If FDA learns that the label of a product marketed as a dietary supplement 
contains a disease claim, it treats the product as an unapproved drug and 
may take enforcement action against the manufacturer or distributor.  
Actions include issuing a warning letter, seizing the product, seeking 
criminal prosecution, or prohibiting the sale of the product through an 
injunction.38   
Companion Report on Dietary Supplements 
This report is being issued in conjunction with another OIG evaluation 
report entitled Dietary Supplements:  Companies May Be Difficult To 
Locate in an Emergency (OEI-01-11-00211).  Both reports are based on 
the same sample of dietary supplements.
 
METHODOLOGY 
Scope 
This study analyzed the structure/function claims on a purposive sample of 
127 dietary supplements marketed for weight loss or immune system 
support in retail stores and on the Internet.  All of the supplements in our 
sample had one or more structure/function claims on their labels.  We 
reviewed the structure/function claims to determine the extent to which 
they complied with FDA regulations.  We also reviewed substantiation 
documents submitted by dietary supplement manufacturers to describe the 
quantity and nature of the evidence.  We did not test the scientific validity 
of the substantiation, nor did we determine whether the documents were 
adequate to substantiate the claims.  For the supplements in our sample, 
we also assessed the accuracy and completeness of notification letters that 
manufacturers must submit to FDA for their structure/function claims.  
Our findings from this evaluation are limited to the weight loss and 
immune support supplements in our sample. 
 
36
 21 U.S.C.  343(r)(6); 21 CFR  101.93(g).  
37
 21 U.S.C.  321(g)(1)(B).   
38
 21 U.S.C.  332; 21 U.S.C.  333; 21 U.S.C.  334.   
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Data Collection and Analysis 
We focused on two types of supplementsimmune support supplements 
and weight loss supplementsafter consulting with FDA.  Our sample 
included 67 immune support supplements and 60 weight loss supplements.  
We purchased 67 of the supplements from retail stores and 60 from 
Internet sites. 
Supplements Purchased From Retail Stores.  To purchase supplements 
from retail stores, we selected five major cities to achieve a wide regional 
distribution:  New York, Chicago, Dallas, Los Angeles, and Seattle.  
Within each city, we purchased a minimum of 12 unique supplements 
from a mix of small and large pharmacies, supermarkets, and supplement 
retailers.  We did not seek supplements that appeared to violate FDA 
regulations, but rather we sought to purchase a variety of weight loss and 
immune support supplements with a variety of structure/function claims 
on their labels. 
Supplements Purchased From the Internet.  To select supplements from 
Internet sources, we created a set of search terms related to weight loss or 
immune support.  Using three major search engines, we searched the 
Internet with these terms.  We selected sites and products with the goal of 
purchasing as many different brands of supplements as possible.  
Review of Structure/Function Claims and Disease Claims on Supplement 
Labels.  We reviewed the structure/function claims on the labels and 
labeling of sampled supplements to determine the extent to which they 
included disease claims.39  We also reviewed labels and labeling for the 
required disclaimer.  
Review of Notification Letters for Structure/Function Claims.  To 
determine the extent to which structure/function claims are on file at FDA, 
we asked FDA to retrieve notification letters using a list of the                
127 sampled supplements and the companies that make them.  We 
analyzed the letters to determine the extent to which they included 
required information (e.g., manufacturer contact information, notice that 
the manufacturer has substantiation for the claim).  We also compared the 
claims on the product with those in the letters to determine whether they 
matched.   
Manufacturers Substantiation of Structure/Function Claims.  We 
requested substantiation from manufacturers for 119 of the supplements in 
 
39
 21 CFR  1.3.  Labeling includes any text or graphics on Web sites where the 
supplements are sold.  FDA may take enforcement action against claims made on Web sites as 
well as claims printed on the actual product package.  We reviewed structure/function claims 
on Web sites for supplements purchased from the Internet. 
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our sample.  We dropped 8 supplements from our original sample of      
127 either because the manufacturers were outside the United States or 
because we could not reach them by telephone or mail.  We asked 
manufacturers to submit documentation that substantiated the 
structure/function claims on their products.   
We requested the substantiation by mail and followed up by telephone or 
email when necessary.  We made three attempts to contact each 
manufacturer.  
We received 1,624 substantiation documents from 66 manufacturers, 
representing 72 (61 percent) of the 119 supplements for which we 
requested substantiation.    
From each substantiation document, we abstracted key pieces of 
information, such as what type of document it was (e.g., human study, 
review article, product monograph), whether it included the name of the 
supplement, and which structure/function claim it was intended to support.  
For human studies, we also noted the methods and population studied and 
the results of the studies and noted whether they clearly stated support for 
the structure/function claims.  We did not assess factors such as statistical 
power, selection biases, or limitations.  (For additional descriptive 
statistics, see Appendix A.) 
Limitations 
Because no comprehensive list of dietary supplements or manufacturers 
exists, the universe of supplements and manufacturers is unknown. 
Therefore, we were unable to select a random sample of supplements and 
we do not generalize our findings beyond the products in our review.   
We did not determine whether manufacturers submitted notifications for 
structure/function claims to FDA within 30 days of marketing their 
supplements because FDA lacks information on when supplements enter 
the retail market.   
Manufacturers were not required to respond to our requests for 
substantiation of their structure/function claims.  Therefore, any 
substantiation we received may not be representative of substantiation in 
general. 
Through guidance documents, FDA outlines the amount, type, and quality 
of evidence it believes is necessary to substantiate a claim.  When 
reviewing substantiation documents, we focused on human studies 
because FDA recommends them as the primary basis for structure/function 
claims.  We did not assess background documents (e.g., in vitro studies, 
animal studies) against FDA guidance on competent and reliable scientific 
evidence because the nature and methods of the studies varied widely.   
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We also did not determine whether manufacturers adequately substantiated 
their structure/function claims because this would require a full scientific 
review, which was beyond the scope of this evaluation.  Instead, we 
described the substantiation documents and compared them with FDA 
guidance.  
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency. 
   
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FINDINGS 
Supplements had multiple structure/function claims 
that stated various health benefits 
The 127 supplements in our sample had a total of 378 structure/function 
claims, ranging from 1 to 12 per supplement.  The median number of 
structure/function claims per supplement was three.  Structure/function 
claims related to weight loss generally focused on reducing or burning 
body fat, increasing metabolism, suppressing appetite, or overall weight 
reduction.  Claims related to immune support varied, focusing on free 
radicals or antioxidant properties, increasing antibody production, or 
supporting general immune function.  See Table 1 for examples. 
  Table 1:  Examples of Structure/Function Claims From Sampled Dietary 
Supplements, by Type 
 
 
 
 
Weight Loss Supplement  Immune Support Supplement 
 
 
  Maintains peak natural killer cell function, 
Helps burn fat faster with exercise ... helps 
supports enhanced cytokine production, 
  stimulate metabolism ... helps support healthy 
promotes optimal T-cell and macrophage 
  weight maintenance 
activity 
 
Traps the toxins, free radicals, and metals 
  Controls your appetite and sugar cravings ... 
from your body ... a one-two punch in 
burns excess calories for energy ... antioxidants 
  detoxifying the body, balancing the body's 
to enhance health and radiance 
  pH, and boosting the immune system 
  Possesses 3 times more IgG and total 
Delays the digestion and absorption of 
  immunoglobulins than colostrum and has 
carbohydrates ... enjoy many of the foods you 
twice as much cysteine, an important amino 
  love without worrying about the carbohydrates 
acid for maintaining glutathione levels 
 
Boosts the immune system ... supports 
  Suppress appetite, reduce weight, increase 
breast, prostate, cardiovascular, vision, skin 
  energy, stimulate metabolic processes 
and colon health 
 
Source:  OIG analysis of structure/function claims from sampled dietary supplements, 2011.   
 
Substantiation documents for structure/function 
claims were not consistent with FDA guidance  
Manufacturers are not required to submit substantiation to FDA or OIG for 
structure/function claims.  However, 66 of 104 manufacturers voluntarily 
submitted substantiation documents in response to our request.  We 
reviewed 1,624 substantiation documents for 72 of the supplements in our 
sample.  The number of substantiation documents per supplement ranged 
from 1 to 137, with a median of 7. 
In contrast to FDA guidance, most substantiation was not derived from 
human studies.  Just over half of the substantiation documents would be 
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considered background information according to FDA guidance, and       
10 percent of the documents appeared to have no significance in 
supporting structure/function claims. 
Of the 34 percent of substantiation documents that were human 
studies, none met all of FDAs recommendations for competent 
and reliable evidence 
Among the 1,624 substantiation documents that manufacturers submitted,      
557 were human studies.  Manufacturers of 55 supplements provided at 
least 1 human study as substantiation for their claims.  Although FDA does 
not specify a minimum number of human studies needed to substantiate a 
claim, it does recommend that such studies use widely accepted scientific 
methods. 
However, none of the human studies we reviewed met all four of the 
elements that FDA recommends for competent and reliable scientific 
evidence:  (1) the relationship of the evidence to the claim; (2) the totality 
of evidence; (3) the quality of the evidence, specifically high-quality 
human studies; and (4) the meaning of the claim.40     
Human Studies Rarely Showed a Direct Relationship to the Claims.  Only        
2 percent of the 557 human studies that we reviewed studied the actual 
products in our sample, in contrast to FDA guidance.  FDA recommends 
that studies used to substantiate claims identify a specific dietary 
supplement or ingredient and serving size and that the conditions of use in 
the studies are similar to the labeling conditions of the dietary supplement 
product.  FDA guidance also states that the results of studies that focus on 
an ingredient in a product (but not the product itself or a similar 
formulation) are not applicable to the specific dietary supplement product.   
The remaining 98 percent of human studies focused on an active 
ingredient that may have been in a different form, dose, or potency.41  For 
example, a weight loss supplement in our sample claimed that the 
supplement burns fat because it contains green tea extract.  A human study 
supporting this claim involved subjects ingesting brewed green tea rather 
than the green tea extract formulation used in the supplement.  A study of 
this type does not have a direct relationship to the claim because it 
 
40
 FDA, Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the 
Federal Food, Drug, and Cosmetic Act, December 2008.  Accessed at www.fda.gov on 
February 17, 2012. 
41
 Because many supplement formulations are proprietary, their labels did not always list the 
form, dose, or potency of the active ingredients.  We could be certain of the form, dose, and 
potency only in the 2 percent of studies that focused on the actual products.  These were 
generally proprietary studies commissioned by the manufacturers.  The remaining 98 percent 
of studies were published in trade or scientific journals. 
12 
Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
demonstrates the effect of a green tea in a formulation that is different 
from that contained in the supplement. 
Most Human Studies Did Not Appear To Represent the Totality of 
Evidence.  Among the 557 human studies that manufacturers submitted,    
4 percent (20 studies) had results that contradicted the claims of sampled 
supplements.42  FDA guidance recommends that when determining 
whether a claim is substantiated, manufacturers should consider all 
available scientific evidenceboth favorable and unfavorableand 
present the evidence in context.   
Interviews with staff at the National Center for Complementary and 
Alternative Medicine at the National Institutes of Health indicated that a 
large body of science exists that contradicts existing structure/function 
claims.  Yet, 96 percent of the human studies we received were favorable 
to the supplements claims, suggesting that manufacturers either have not 
considered the body of available scientific evidence, that there is a positive 
bias in the documents selected to substantiate their claims, or that no such 
contradictory evidence exists. 
Most Human Studies Were Not Consistent With FDA Guidance on Quality. 
Overall, 85 percent of the 557 human studies we reviewed were not 
randomized, double-blind, parallel group, placebo-controlled trials.  FDA 
guidance recommends that human intervention studies use these methods 
because they offer the greatest assessment of a relationship between a 
dietary supplement and an outcome.   
In addition, 49 percent of the human studies were not based on 
populations similar to those that will be consuming the supplements.  FDA 
guidance recommends that high-quality human studies use representative 
populations with respect to factors such as age, geographic location, and 
health status.  For example, studies tested a supplement or its active 
ingredient in elderly women with diabetes.  But the effect of a product in 
an older population with a disease (as opposed to a representative sample 
of healthy individuals) could not be expected to translate to the general 
population. 
About a Third of Human Studies Were Not Consistent With FDA Guidance 
on the Meaning of the Claim.  One hundred eighty-nine (34 percent) of the 
557 human studies we reviewed focused on disease research rather than 
 
42
 To assess the totality of evidence, we focused on human studies because their 
methodologies are intended to show a direct effect on humans from a supplement or an 
ingredient.  The other types of substantiation documents varied widely and could not be 
aggregated. 
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
the meaning of the structure/function claim.43  FDA guidance recommends 
that when assembling substantiation for claims, manufacturers consider 
the meaning of the claims they are substantiating, including any implied 
claims, and tailor the substantiation accordingly.  For example, because 
supplements may not make claims that directly state or imply the 
treatment of a disease, studies that focus on diseases are inconsistent with 
FDA guidance.  If substantiation documents demonstrate a supplements 
effect on a disease, they raise questions about the implied meaning of the 
structure/function claims.   
Among the substantiation documents, 56 percent would be 
considered background information according to FDA 
guidance   
According to FDA guidance, information in background documents may 
provide indirect support or context for structure/function claims, but this 
information alone may not be sufficient to support the claims.  
Manufacturers of eight supplements submitted only background 
information as substantiation.  In our review, background documents 
submitted by manufacturers included in vitro or animal studies, review 
articles, and other types shown in Table 2.  Although manufacturers are 
free to submit such documentation as part of their substantiation, FDA 
does not consider these to be primary sources of evidence. 
 
Table 2:  Percentages of Substantiation Documents That Are Background 
Information for Selected Supplements, by Type 
 
Weight Loss Supplement  Immune Support Supplement 
Background Document Type 
(n=280)  (n=621) 
In vitro study  13%  32% 
Animal study  40%  35% 
Reference book  14%                      9% 
Review article  28%  20% 
Product monograph  4%  5% 
Meta-analysis  2%  2% 
Testimonial/anecdotal  0  0 
Source:  OIG analysis of dietary supplement manufacturers substantiation documents, 2011.   
Columns do not sum to 100 percent because some studies used more than one methodology. 
 
43
 We counted a study as focusing on a disease when the disease or its major symptoms (e.g., 
insulin resistance in diabetics) was plainly stated.  Other studies may have involved biological 
processes associated with diseases, but we did not count these in our analysis. 
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
The remaining 10 percent of documents did not qualify as 
substantiation 
Among the substantiation documents we reviewed, 166 did not fall into 
any of the categories defined in FDA guidance.  Manufacturers of nine 
supplements submitted only this type of documentation as substantiation.  
For example, one company submitted a 30-year-old handwritten college 
term paper to substantiate its structure/function claim, while others 
included articles from trade newsletters; press releases; advertisements; 
and links to Web pages, such as Wikipedia or an online dictionary.  Such 
extraneous information suggests that some manufacturers may be 
unfamiliar with FDA guidance on substantiation or that they performed 
only cursory research to substantiate their claims. 
FDA could not readily determine the extent to which 
manufacturers of sampled supplements had submitted 
the required notification for their structure/function 
claims 
FDA could retrieve notification letters for only 21 of 127 supplements in 
our sample.  FDAs failure to locate notification letters raises questions 
about its ability to adequately monitor and enforce manufacturers 
compliance with structure/function claim requirements.   
FDA lacks a reliable tracking system for notification letters 
FDA keeps two versions of notification letters:  scanned letters, which are 
filed in a centralized document management system; and paper copies, 
which are stored in multiple locations.  FDA saves letters in a PDF format 
that cannot be searched by keyword.  As a result, FDA could not locate 
letters for our sampled supplements using the product name or the 
manufacturers name.  
As of December 2011, FDA staff told us the agency had letters waiting to 
be scanned that dated back almost a year.  FDA files the paper copies of 
notification letters chronologically.  Therefore, FDA would have had to 
search thousands of files by hand to locate letters for our sample of 
supplements. 
   
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
The majority of notification letters we reviewed were missing 
required information 
Among the 21 letters FDA was able to retrieve, 17 did not contain all the 
required information.  Eleven notification letters contained 
structure/function claims that did not match those listed on the products 
labels.  Manufacturers may have submitted other letters to FDA with the 
correct claims, but FDA could not retrieve them.  Only 12 of the              
21 letters attested that the companies had substantiation that the claims 
were truthful and not misleading.  Finally, because FDA regulations do not 
require manufacturers to include in their notifications the date that they 
first marketed a supplement, FDA cannot verify whether the notification 
was submitted within 30 days as required.  Of the 21 letters we reviewed, 
only 4 made any reference to the 30-day timeframe and none listed the 
date that the supplement was first marketed. 
Seven percent of supplements in our sample were 
missing the required disclaimer for structure/function 
claims 
Nine supplements in our sample were missing the required disclaimer on 
the label (see Table 3).  By law, all structure/function claims must be 
accompanied by the following disclaimer:  This statement has not been 
evaluated by the Food and Drug Administration.  This product is not 
intended to diagnose, treat, cure, or prevent any disease.44  Academic 
researchers have found that the lack of disclaimers can lead consumers to 
assume that FDA has reviewed or approved a product.45  
 
  Table 3:  Supplement Labels That Were Missing the Required Disclaimer 
  Supplement Type (n=127)  Label Missing Required  Disclaimer 
Immune Support     5 
 
Weight Loss     4 
  Source:  OIG analysis of dietary supplement labels, 2011.   
 
Twenty percent of the supplements in our sample had 
prohibited disease claims on the labels 
The 26 supplements in our sample that had prohibited claims purported to 
treat diseases, such as influenza, the common cold, herpes, and HIV, while 
 
44
 21 U.S.C.  343(r)(6); 21 CFR  101.93(c)(1). 
45
 Neal Hooker and Ratapol Teratanavat, Dissecting Qualified Health Claims:  Evidence From 
Experimental Studies, Critical Reviews in Food Science and Nutrition, vol. 48, issue 2, February 2008. 
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
others claimed to reduce cholesterol or prevent diabetes (see Table 4).  
Pursuant to FDA regulations, dietary supplements may not make explicit 
or implicit disease claims.  If a product marketed as a dietary supplement 
bears a disease claim, it must be regulated as a drug.46  Supplements that 
make disease claims could mislead consumers into using them as  
replacements for prescription drugs or other treatments for medical 
conditions, with potentially dangerous results. 
 
Table 4:  Examples of Disease Claims From Labels of Sampled Dietary 
  Supplements 
  Disease Claim  Implied or Stated Benefit 
  Conditions which may benefit from aggressive  Treatment of human immunodeficiency virus, 
nutritional support include cancer, HIV/AIDS,  methicillin-resistant Staphylococcus aureus, 
  MRSA, Chronic F atigue Syndrome   chronic fatigue syndrome 
To cure cough and chest problems; a cure for 
Cure of the common cold or other illnesses  
every ailment 
Provides defense against heart diseases, blood  Prevention of heart disease, high blood 
pressure, diabetes and other terrible conditions  pressure, or diabetes 
Contains natural cancer fighters, boosts  Treatment or prevention of cancer, the 
immune system, helps prevent colds, flu  common cold, influenza virus 
Source:  OIG analysis of sampled dietary supplement labels, September 2011. 
 
46
 21 CFR  101.93(f). 
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
CONCLUSION AND RECOMMENDATIONS 
Under Federal law, FDA does not test or approve dietary supplements 
prior to sale.  Therefore, consumers rely on a supplements claims to 
determine whether the product will provide a desired effect, such as 
weight loss or immune support.  Although supplement manufacturers use 
of structure/function claims has grown, FDAs authority to monitor such 
claims remains limited by law.   FDA currently has three main 
requirements to help ensure that structure/function claims on dietary 
supplement labels are truthful and not misleading:  substantiation to 
support the claims, which manufacturers must possess but need not submit 
to FDA; notification to FDA of claims within 30 days of first marketing 
the supplement with the claim; and a required disclaimer on supplement 
labels.   
The results of our analysis, which is based on 127 dietary supplements, 
demonstrate the extent to which submitted substantiation of 
structure/function claims fell short of meeting FDAs recommendations for 
competent and reliable evidence.  In addition, our analysis revealed 
noncompliance with requirements regarding disclaimers and problems 
with FDAs notification process.  These results raise questions about the 
extent to which structure/function claims are truthful and not misleading.  
Finally, our analysis also found that more than one in five supplements in 
our sample had disease claims, which are prohibited, in addition to 
structure/function claims.   
To improve oversight of structure/function claims, we recommend that 
FDA take the following steps: 
Seek Explicit Statutory Authority To Review Substantiation for 
Structure/Function Claims To Determine Whether Claims Are 
Truthful and Not Misleading 
To better ensure that structure/function claims are truthful and not 
misleading as required by DSHEA, FDA requires explicit statutory 
authority to compel manufacturers to submit substantiation that supports 
their claims.   We defer to FDA concerning the breadth of that authority.  
FDA could seek legislation requiring approval for all structure/function 
claims in the labeling of dietary supplements.  However, absent dedicated 
funding to support such an activity, FDAs resource constraints could be 
prohibitive.   
The legislation could require manufacturers to submit for review their 
substantiation for all structure/function claims upon request by FDA or in 
circumstances identified by FDA in regulation or guidance.  For example, 
by focusing on supplements that appear to make false or misleading 
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
structure/function claims, FDA could target its resources where major 
vulnerabilities exist.  If FDA obtains explicit statutory authority to review 
substantiation, its current guidance could form the basis of new regulation.  
Furthermore, FDA could also develop a protocol by which to assess 
substantiation.    
Improve the Notification System To Make It More Organized, 
Complete, and Accurate 
The current filing system for notification letters does not enable FDA to 
readily locate information on existing structure/function claims or the 
manufacturers that submit them.  An effective notification system would 
include:  
  An organized and indexed filing system that permits FDA to search 
for and retrieve notification letters using the name of the 
supplement and manufacturer. 
  Updated guidance that informs manufacturers of the information 
required in notification letters.  FDAs Web site and ongoing 
communication with the supplement industry could create 
additional opportunities to provide this information. 
  Useful information to be provided, such as the date that 
manufacturers first marketed the supplement with the claim.  
Having this date would enable FDA to determine whether 
manufacturers are complying with the 30-day timeframe for 
notification and would provide FDA with a more complete view of 
structure/function claims as they enter the market.  This may 
require FDA to amend its current regulations. 
Expand Market Surveillance of Dietary Supplements To 
Enforce the Use of Disclaimers for Structure/Function Claims 
and Detect Disease Claims  
FDA currently conducts Internet surveillance to detect supplements that 
are sold online with disease claims or false and misleading claims.  FDA 
could also consider expanding its surveillance to retail establishments to 
detect disease claims and ensure that manufacturers that make 
structure/function claims are placing the required disclaimer on their 
products.  FDA may also find additional opportunities to review 
supplements at industry gatherings, such as trade shows or promotional 
events.     
 
 
   
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
In its comments on the draft report, FDA did not explicitly concur with our 
first recommendation, but said it would consider it.  FDA concurred with 
our second and third recommendations. 
In addressing our first recommendation to seek explicit statutory authority 
to review substantiation for structure/function claims, FDA stated that it 
will consider seeking expanded authority.  FDA commented that a 
manufacturer must have substantiation that a structure/function claim used 
in the labeling of a supplement is truthful and not misleading.  Further, the 
agency stated that it may ask manufacturers for such substantiation, but 
these requests are not always granted.  We ask that FDAs final 
management decision clarify the agencys plans for seeking explicit 
statutory authority to review substantiation. 
FDA concurred with our recommendation to improve its notification 
system for structure/function claims to make it more organized, complete, 
and accurate.  FDA stated that it has initiated a feasibility study to 
determine whether adapting its existing system would enable it to access 
all structure/function claim notifications. The agency said it would also 
assess regulatory changes that would be required to ensure that 
supplement manufacturers comply with the 30-day notification 
requirement.  
Finally, FDA concurred with our recommendation to expand market 
surveillance to enforce the use of disclaimers for structure/function claims 
and to detect disease claims.  FDA commented that it will continue to 
focus primarily on disease claims because they pose the greatest threat to 
public health, but that it will continue to address situations in which 
products fail to meet dietary supplement labeling requirements, including 
the use of structure/function claims without a disclaimer.   
For the full text of FDAs comments, see Appendix B. 
 
   
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
APPENDIX A     ADDITIONAL DESCRIPTIVE STATISTICS 
Table A-1:  Sampled Supplements, by Supplement Type and Source 
 
Supplement Type  Number in Sample 
 
Immune Support  67 
 Weight Loss  60 
   
 
Retail  67 
 Internet  60 
     Total   127 
Source:  Office of Inspector General (OIG) analysis of sampled dietary supplements, 
September 2011. 
Table A-2:  Number of Supplements for Which Manufacturers Submitted 
Substantiation, by Supplement Type and Source 
 
Manufacturer Submitted 
Supplement Type 
Substantiation 
 
Immune Support  39 
 Weight Loss  33 
   
 
Retail  42 
 Internet  30 
     Total  72 
 
Source:  OIG analysis of sampled dietary supplements, September 2011. 
 
Table A-3:  Number of Substantiation Documents Received, by Supplement 
Type 
  Immune 
  Weight Loss 
Support 
 
 Total number of substantiation documents received    667  957 
 
Median (range) number of  substantiation 
21 (154)  21 (1137) 
documents per supplement 
 
Source:  OIG analysis of sampled dietary supplements, September 2011. 
 
 
   
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Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
Table A-4:  Number of Structure/Function Claims and Substantiation 
Documents, by Supplement Type 
 
Immune 
  Weight Loss 
  Support 
  Median (range) number of structure/function claims 
 3 (17)  2 (112) 
per supplement 
 
 
Median (range) number of  substantiation 
8 (1137)  6 (154) 
  documents per structure/function claim 
  Source:  OIG analysis of substantiation documents submitted by manufacturers of 
sampled dietary supplements, September 2011. 
 
Table A-5:  Median Population of Human Studies Submitted by 
Manufacturers as Substantiation, by Supplement Type 
 
Immune 
  Weight Loss 
  Support 
 
Median population of human studies overall   27  40 
 
 
Median population of human intervention studies  27  34 
 
 
Median population of human observational studies  83  267 
 
Source:  OIG analysis of substantiation documents submitted by manufacturers of 
  sampled dietary supplements, September 2011. 
 
Table A-6:  Examples of Structure/Function Claims and Disease Claims 
From Labels of Sampled Supplements 
 
  Structure/Function Claim  Disease Claim 
 
Conditions which may benefit from 
  Supports healthy immune function  aggressive nutritional support include 
cancer, HIV/AIDS, MRSA, Chronic 
  Fatigue Syndrome  
   
Increases your body's metabolic rate and   To cure cough and chest problems; a 
decreases your appetite  cure for every ailment 
Provides defense against heart diseases, 
Promotes fat-burning and weight loss  blood pressure, diabetes and other terrible 
conditions 
Enhances the growth of beneficial 
Contains natural cancer fighters, boosts 
intestinal microflora and stimulates non-
immune system, helps prevent colds, flu 
specific immune activity 
Source:  OIG analysis of sampled dietary supplement labels, September 2011. 
22 
Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
Table A-7:  Supplement Labels That Had Disease Claims  
Supplement Type (n=127)  Label Included Disease Claim 
 
Immune Support     17  
 
Weight Loss     11 
 
Source:  OIG analysis of dietary supplement labels, 2011.   
 
 
   
23 
Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
  APPENDIXB 
Agency Comments 
... 
/"'""" 
~DEPARTMENT
(  OF HEALTH AND HUMAN SERVICES 
....:::::~}\.- -------------
. 
Food and Drug Administration 
Silver Spring MD 20993 
Date:  August 21, 2012 
To:  Inspector General 
From:  Acting Associate Commissioner for Policy and Planning 
Subject:  FDA's General Comment to OlG Draft Report on Dietary Supplements: 
Stmcturc!Function Claims Fail to Meet Federal Requirements 
FDA is providing the attached general comments to the Ofticc of Inspector General's draft report 
entitled, Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements 
(OE!-01-11-00210). 
FDA appreciates the opportunity to review and comment on this draft repmi before it is 
published. 
David H. Dorsey 
Attachment 
24 
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11 -00210)   
   
APPENDIX B (CONTINUED) 
 
 
 
   
25 
Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
APPENDIX B (CONTINUED) 
 
 
   
26 
Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
   
ACKNOWLEDGMENTS 
This report was prepared under the direction of Joyce Greenleaf, Regional 
Inspector General for Evaluation and Inspections in the Boston regional 
office, and Russell Hereford, Deputy Regional Inspector General.   
Melissa Hafner served as the team leader for this study.  Other principal 
Office of Evaluation and Inspections staff from the Boston regional office 
who contributed to the report include Tim Chettiath, Alyson Cooper, 
Jessica Fargnoli, Danielle Fletcher, Maria Maddaloni, and Jesse Valente; 
other regional office staff who contributed include Maria Balderas and 
Margarita Rodriguez; central office staff who contributed include Heather 
Barton, Kevin Farber, and Debra Roush.  
 
 
 
27 
Dietary Supplements:  Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 
   
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.