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FDA Claims

This document summarizes a study conducted by the Office of Inspector General on structure/function claims made on dietary supplement labels. The study found that: 1) Substantiation documents for structure/function claims made on 127 weight loss and immune support supplements did not consistently provide reliable scientific evidence to support the claims, as required. 2) The FDA could not determine if manufacturers had submitted required notifications for structure/function claims for many of the supplements sampled. 3) Some supplements lacked the required disclaimer stating that FDA had not reviewed structure/function claims or approved the product to treat or prevent disease. 4) Some supplements contained prohibited disease treatment or prevention claims. The report recommends that FDA strengthen its oversight of structure

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0% found this document useful (0 votes)
33 views31 pages

FDA Claims

This document summarizes a study conducted by the Office of Inspector General on structure/function claims made on dietary supplement labels. The study found that: 1) Substantiation documents for structure/function claims made on 127 weight loss and immune support supplements did not consistently provide reliable scientific evidence to support the claims, as required. 2) The FDA could not determine if manufacturers had submitted required notifications for structure/function claims for many of the supplements sampled. 3) Some supplements lacked the required disclaimer stating that FDA had not reviewed structure/function claims or approved the product to treat or prevent disease. 4) Some supplements contained prohibited disease treatment or prevention claims. The report recommends that FDA strengthen its oversight of structure

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Department of Health and Human Services

OFFICE OF
INSPECTOR GENERAL

DIETARY SUPPLEMENTS:
STRUCTURE/FUNCTION CLAIMS
FAIL TO MEET FEDERAL
REQUIREMENTS

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 claim—called a structure/function claim—that 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
claim—called a structure/function claim—that 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.
1
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.
2
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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
FDA’s 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.
3
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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).
4
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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 information—such as in vitro or animal studies, meta-
analyses, and review articles—that 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 evidence—both favorable and unfavorable—in
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 FDA’s 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.
5
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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 manufacturer’s evidence is a study
showing that the supplement’s 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).
6
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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.
7
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
Data Collection and Analysis
We focused on two types of supplements—immune support supplements
and weight loss supplements—after 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.
8
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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.
9
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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.

10
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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
11
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210)
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 FDA’s 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.
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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 evidence—both favorable and unfavorable—and
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 supplement’s
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.
14
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. FDA’s 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
manufacturer’s 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.

15
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.

16
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 Fatigue 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).

17
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 supplement’s 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, FDA’s 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 FDA’s recommendations for
competent and reliable evidence. In addition, our analysis revealed
noncompliance with requirements regarding disclaimers and problems
with FDA’s 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, FDA’s 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

18
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. FDA’s 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.

19
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 FDA’s final
management decision clarify the agency’s 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 FDA’s comments, see Appendix B.

20
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 (1–54) 21 (1–137)
documents per supplement

Source: OIG analysis of sampled dietary supplements, September 2011.

21
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 (1–7) 2 (1–12)
per supplement

Median (range) number of substantiation


8 (1–137) 6 (1–54)
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


aggressive nutritional support include
“Supports healthy immune function”
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.

/S/
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 OIG’s 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.

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