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 
 

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Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11-00210) 

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.
 

2 

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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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. 
 

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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).
 

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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, metaanalyses, 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, metaanalyses, review articles, comments and letters to the editor, and product monographs. 
 

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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).
 

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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. 
 

8 

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.
 

9 

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. 
 

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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.
 

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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.

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 

Table 1: Examples of Structure/Function Claims From Sampled Dietary 

Supplements, by Type

Weight Loss Supplement Immune Support Supplement

“Helps burn fat faster with exercise ... helps 

stimulate metabolism ... helps support healthy 

weight maintenance”

“Maintains peak natural killer cell function, 

supports enhanced cytokine production, 

promotes optimal T-cell and macrophage 

activity”

“Controls your appetite and sugar cravings ... 

burns excess calories for energy ... antioxidants 

to enhance health and radiance”

“Traps the toxins, free radicals, and metals 

from your body ... a one-two punch in 

detoxifying the body, balancing the body's 

pH, and boosting the immune system”

“Delays the digestion and absorption of 

carbohydrates ... enjoy many of the foods you 

love without worrying about the carbohydrates”

“Possesses 3 times more IgG and total 

immunoglobulins than colostrum and has 

twice as much cysteine, an important amino 

acid for maintaining glutathione levels”

“Suppress appetite, reduce weight, increase 

energy, stimulate metabolic processes”

“Boosts the immune system ... supports 

breast, prostate, cardiovascular, vision, skin 

and colon health”

Source: OIG analysis of structure/function claims from sampled dietary supplements, 2011. 
 

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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

Background Document Type Weight Loss Supplement 

(n=280) 

Immune Support Supplement 

(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. 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. 
 

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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 

nutritional support include cancer, HIV/AIDS, 

MRSA, Chronic Fatigue Syndrome” 

Treatment of human immunodeficiency virus, 

methicillin-resistant Staphylococcus aureus, 

chronic fatigue syndrome

“To cure cough and chest problems; a cure for 

every ailment” Cure of the common cold or other illnesses 

“Provides defense against heart diseases, blood 

pressure, diabetes and other terrible conditions”

Prevention of heart disease, high blood 

pressure, or diabetes

“Contains natural cancer fighters, boosts 

immune system, helps prevent colds, flu”

Treatment or prevention of cancer, the 

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 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 
 

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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. 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. 
 

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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 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. 
 

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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

Supplement Type Manufacturer Submitted 

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

Weight Loss Immune 

Support

Total number of substantiation documents received 667 957

Median (range) number of 

documents per supplement

substantiation 21 (1–54) 21 (1–137)

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

Weight Loss Immune 

Support

Median (range) number of structure/function claims 

per supplement 3 (1–7) 2 (1–12)

Median (range) number of substantiation 

documents per structure/function claim 8 (1–137) 6 (1–54)

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

Weight Loss Immune 

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 

intestinal microflora and stimulates 

specific immune activity” 

non- “Contains natural cancer fighters, boosts 

immune system, helps prevent colds, flu” 

Source: OIG analysis of sampled dietary supplement labels, September 2011.
 

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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. 
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 

Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (OEI-01-11 -00210) 

24 
 

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) 

APPENDIX B (CONTINUED)
 

27

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. 
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.