Department of Health and Human Services

OFFICE OF

INSPECTOR GENERAL

Daniel R. Levinson 

Inspector General

October 2012

OEI-01-11-00211

DIETARY SUPPLEMENTS: 

COMPANIES MAY BE DIFFICULT 

TO LOCATE IN AN EMERGENCY
 

EXECUTIVE SUMMARY: DIETARY SUPPLEMENTS: COMPANIES MAY BE 

DIFFICULT TO LOCATE IN AN EMERGENCY

OEI-01-11-00211

WHY WE DID THIS STUDY 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 

requires certain dietary supplement companies to register with the Food and Drug 

Administration (FDA). Registration in the Food Facility Registry (the registry) is 

intended to provide FDA with sufficient information to contact companies in an 

emergency. Previous Office of Inspector General work identified problems with FDA’s 

registry. Recent recalls of dietary supplements tainted with prescription drugs, synthetic 

steroids, and other potentially dangerous ingredients highlight the importance of 

registration and adverse event contact information so that FDA can trace the source of the 

product. These problems raised questions about FDA’s ability to identify and contact 

manufacturers in a food emergency to protect public health. 

HOW WE DID THIS STUDY

We analyzed a purposive sample of 127 weight loss and immune support dietary 

supplements. For 123 of these supplements, we determined whether the companies that 

produced them were registered with FDA and compared the information in the registry 

with information obtained during structured interviews with company representatives. 

We also analyzed the labels of all 127 dietary supplements to determine whether they 

contained required adverse event contact information. 

WHAT WE FOUND

Twenty-eight percent of contacted companies had facilities that failed to register with 

FDA as required. Of the companies with facilities that did register, 72 percent failed to 

provide the complete and accurate information required in the registry. Finally, 

20 percent of dietary supplement labels in our sample did not provide the required 

telephone numbers or addresses. 

WHAT WE RECOMMEND

We recommend that FDA: (1) improve the accuracy of information in the registry, 

(2) seek authority to impose civil monetary penalties on companies that do not comply 

with registration requirements, and (3) educate the dietary supplement industry about 

registration and labeling requirements. FDA concurred with all of our recommendations. 
 

TABLE OF CONTENTS

Objectives ....................................................................................................1 

Background ..................................................................................................1 

Methodology ................................................................................................5 

Findings........................................................................................................7 

Twenty-eight percent of contacted companies failed to register 

with FDA as required .......................................................................7 

Among companies in our sample that registered with FDA, 

72 percent failed to provide complete and accurate information 

required in the registry .....................................................................8 

Twenty percent of dietary supplement labels in our sample did not 

provide the required telephone numbers or addresses .....................9 

Conclusion and Recommendations ............................................................ 11 

Agency Comments and Office of Inspector General Response .................13 

Appendix ....................................................................................................14 

A: Information on Sampled Dietary Supplements and 

Companies......................................................................................14 

B: Agency Comments ...................................................................15 

Acknowledgments......................................................................................18 
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 1

OBJECTIVES

1. To determine the extent to which selected weight loss and immune 

support dietary supplement companies are registered with the Food 

and Drug Administration (FDA) in compliance with the Public Health 

Security and Bioterrorism Preparedness and Response Act of 2002 (the 

Bioterrorism Act). 

2. To determine the extent to which information on selected weight loss 

and immune support dietary supplement companies in FDA’s registry 

is complete and accurate.

3. To determine the extent to which selected weight loss and immune 

support dietary supplement labels include required adverse event

contact information. 

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 

The Federal Food, Drug, and Cosmetic Act deems dietary supplements to 

be a category of food and defines them, in part, as products intended to 

supplement the diet. If a dietary supplement is contaminated or otherwise 

unsafe, FDA’s ability to quickly locate a company that is able to stop the 

distribution of the supplement is essential. Recent recalls of dietary 

supplements tainted with prescription drugs, synthetic steroids, and other 

potentially dangerous ingredients highlight the importance of registration 

and adverse event contact information so that FDA can trace the source of 

the product.4, 5, 6

1 Natural Products Foundation, What is the Current Economic Contribution of the Dietary 

Supplement Industry to the U.S. Economy? Accessed at www.naturalproducts foundation.org 

on May 31, 2010.

2 Government Accountability Office, 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

 FDA, Superior Metabolic Technologies Inc. Recalls Uprizing 2.0 Because the Product 

Contains Superdrol, Which is a Synthetic Steroid, Making it an Unapproved New Drug,

October 3, 2011. Accessed at www.fda.gov on February 17, 2012. 5

 FDA, Globe All Wellness, LLC, Issues a Voluntary Recall of Dietary Supplement Found to 

Contain an Undeclared Drug Ingredient, May 24, 2011. Accessed at www.fda.gov on 

February 17, 2012.

6

 FDA, Ethos Environmental, Inc., Issues a Voluntary Recall of Specific Lots of the Dietary 

Supplement Regenerect, April 28, 2011. Accessed at www.fda.gov on February 17, 2012.
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 2

The Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 (the Bioterrorism Act) requires that food facilities, including 

dietary supplement companies, register with FDA.7 Registration is 

intended to provide FDA with sufficient information to contact companies 

in an emergency.8 (The Bioterrorism Act requires facilities, rather than 

companies, to register, and a company may operate multiple facilities.) 

Previous Office of Inspector General (OIG) work identified problems with 

FDA’s Food Facility Registry (the registry). That work found that 

company contact information in the registry was frequently out of date or 

incorrect. These problems raised questions about FDA’s ability to identify 

and contact manufacturers in a food emergency to protect public health.9

Dietary Supplements

The Dietary Supplement Health and Education Act of 1994, an 

amendment to the Federal Food, Drug, and Cosmetic Act, defines a dietary 

supplement, in part, as 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.10

Consumers may purchase dietary supplements over the counter without a 

prescription. In the absence of a premarket approval requirement for 

dietary supplements, FDA gathers information about these products from a 

variety of sources and takes action against adulterated or misbranded 

supplements after they reach the market. FDA does this by monitoring 

adverse event reports and consumer complaints, searching the Internet for 

supplements that do not comply with regulations, conducting onsite 

7 Companies that manufacture, process, pack, or hold food, including dietary supplements, for 

consumption in the United States must register with FDA before producing or selling their 

products. P.L. 107-188 § 305(a) (codified at 21 U.S.C. § 350d).

8 68 Fed. Reg. 58893, 58895 (Oct. 10, 2003): Registration of Food Facilities Under the 

Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

9

 OIG, FDA’s Food Facility Registry, OEI-02-08-00060, December 2009.

10 P.L. 103-417 § 3 (codified at 21 U.S.C. § 321(ff)). Other statutory requirements for a 

dietary supplement include that it may not be represented for use as a conventional food or as 

a sole item of a meal and that it must be labeled as a dietary supplement.
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 3

inspections of manufacturers or imported shipments of supplements, and

reviewing new dietary ingredient notifications.11

Registration of Manufacturers and Distributors

Under the Bioterrorism Act, all companies that manufacture, process, 

pack, or hold food, including dietary supplements, for consumption in the 

United States must register with FDA before engaging in any of these 

activities.

12 (Companies that are solely retailers of dietary supplements 

and do not otherwise manufacture, process, hold, or pack the products are 

not required to register with FDA.13) Registration is intended to provide 

reliable information about these companies. The registry also enables

FDA to quickly locate companies during an outbreak of illness caused by 

contaminated food or supplements and to locate the facilities for 

inspection. Food and dietary supplement companies must register their 

contact information with FDA, including the company names, addresses, 

and emergency contact telephone numbers.14 Companies must update 

their registrations within 60 calendar days of any change in the 

information submitted previously.15 Currently, some categories of dietary 

supplements are not required to be identified in the registry; therefore, we 

could not determine the number of dietary supplement companies in the 

registry.

16 

The FDA Food Safety and Modernization Act, enacted in 2011 (FSMA) 

strengthened registration requirements.17 Beginning in 2012, companies 

must renew their registrations every 2 years.18 In addition, FSMA 

authorizes FDA to suspend registration of a company if it has reason to 

believe that a product poses a serious threat to public health.19 

FDA does not regularly review or test the data in the registry for accuracy, 

but has periodically reminded companies through postcards and telephone 

alerts to maintain accurate information in the registry. FDA uncovers 

registration violations primarily by inspecting a company’s manufacturing 

11 A new dietary ingredient is an ingredient that was first marketed in the United States after 

October 15, 1994. 21 U.S.C. § 350b.

12 21 U.S.C. § 350d(a); FDA’s implementing regulations on the registration of food facilities 

are located at 21 CFR §§ 1.225–1.243. 

13 21 U.S.C. § 350d(c)(1), 21 CFR §§ 1.226(c), 1.227(b)(11).

14 21 CFR § 1.232.

15 21 CFR § 1.234.

16 21 CFR § 170.3. 

17 P.L. 111-353, § 102, January 4, 2011. 18 21 U.S.C. § 350d(a)(3).

19 21 U.S.C. § 350d(b)
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 4

facilities.

20 FDA’s field offices also monitor their regions for unregistered 

facilities. FDA may notify unregistered facilities of registration 

requirements during a routine inspection or by letter. If a company 

continually fails to register as required, FDA may take regulatory action 

against it by issuing a warning letter, prohibiting the sale of the 

supplement through an injunction, or referring the matter for criminal 

prosecution.21 In the absence of complete information in the registry, FDA 

may use other sources of contact information to locate a company.22

Adverse Event Reporting and Required Contact Information on 

Dietary Supplement Labels

One way that FDA learns about unsafe dietary supplements is by 

monitoring adverse event reports. If consumers encounter a problem with 

a particular supplement, they must be able to quickly report adverse events 

to a responsible company so that FDA can respond if necessary.23 To 

facilitate consumer adverse event reporting, the Dietary Supplement and 

Nonprescription Drug Consumer Protection Act, enacted in 2006, 

amended the Federal Food, Drug, and Cosmetic Act to require that dietary 

supplement labels include the domestic telephone number or address of 

the dietary supplement firm responsible for receiving adverse event 

reports for the product and reporting them to FDA.24 FDA guidance 

specifies that a complete telephone number must include the area code and 

a complete address must include the full street address or post office box 

of the responsible party.25 The telephone number and address provided on 

the dietary supplement label are not intended to match those provided in 

FDA’s registry. Although contact information on the label is intended to 

provide consumers, health care providers, and others with the means to 

report an adverse event to a dietary supplement company, it may also be 

20 FDA, Registration of Food Facilities Under the Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002, Compliance Policy Guide § 110.300, 2003, revised 

2006.

21 21 U.S.C. § 331(dd); 21 U.S.C. § 332; 21 U.S.C. § 333; 21 CFR § 1.241. See also FDA 

Regulatory Procedures Manual. Accessed at www.fda.gov on May 17, 2012.

22 One such source is the Official Establishment Inventory, a database maintained by FDA to 

collect information on food, drug, and other types of FDA-regulated facilities for inspection 

purposes. FDA, Field Management Directives, Official Establishment Inventory Development 

and Maintenance Procedures, July 17, 2006. Accessed at www.fda.gov on June 21, 2012.

23 Federal regulations require dietary supplement companies to report serious adverse events 

to FDA, including death and life-threatening injury. Companies are not required to report 

minor adverse events. 21 U.S.C. § 379aa-1(b).

24 P.L. 109-462, § 3(c), codified at 21 U.S.C. § 343(y). 25 FDA, Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary 

Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer 

Protection Act, December 2007, revised September 2009.
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 5

helpful for FDA when tracing the source of a supplement or responding to 

adverse event reports. 

This report is being issued in conjunction with another OIG evaluation 

report, entitled Dietary Supplements: Structure/Function Claims Fail To 

Meet Federal Requirements (OEI-01-11-00210). Both reports are based 

on the same sample of dietary supplements. 

METHODOLOGY

Scope

This study assessed the extent to which selected dietary supplement 

companies registered with FDA and provided complete and accurate 

information. This study also assessed the extent to which a sample of 

dietary supplement labels provided required contact information for the 

purpose of reporting adverse events. This study did not assess FDA’s 

adverse event reporting system for dietary supplements. This study is 

limited to the sample of supplements that we purchased. 

We focused our review of the registry on key information that FDA would 

likely need to contact a dietary supplement company in an emergency. We 

included only domestic companies in our analysis and did not attempt to 

contact companies with foreign telephone numbers and addresses to 

confirm registration information. The findings are limited to selected 

companies and are not projectable to all dietary supplement companies 

subject to FDA’s registration requirements. 

Data Collection and Analysis

We analyzed a purposive sample of 127 dietary supplements that we 

purchased from retail stores in selected U.S. cities and from various 

Internet sites. We focused on two types of supplements—immune support 

supplements and weight loss supplements—after consulting with FDA. 

Our sample includes 67 immune support supplements and 60 weight loss 

supplements. We purchased 67 of the supplements from retail stores and 

60 from Internet sites. (For additional descriptive statistics, see Appendix 

A.)

Supplements Purchased From Retail Stores. We selected five major U.S. 

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.
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 6

Supplements Purchased From the Internet. 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.

Determining Registration Status of Sampled Dietary Supplement 

Companies. We used the company listed on the product’s label as the first 

point of contact. We first searched the registry to determine whether the 

company was registered with FDA. We considered a company to be 

required to register with FDA if its representative reported that it had at 

least one facility that manufactured, processed, packed, distributed, or 

stored dietary supplements. 

We dropped four dietary supplements from the analysis of FDA’s registry 

because the companies listed on the labels were located outside the United 

States. The 123 supplements included in the registry analysis were 

associated with 106 companies; 13 companies were associated with 

multiple supplements in the sample.

We then attempted to contact each of the 106 companies by telephone to 

confirm registry information and to administer a structured interview. We 

used either the telephone number listed on the supplement label or, if no 

telephone number was listed, the emergency contact number listed in the 

registry. To contact companies that did not have a telephone number listed 

on their products’ labels or in the registry, we searched the Internet for 

valid telephone numbers. 

Structured Interviews With Representatives of Dietary Supplement 

Companies. We conducted structured interviews with either the 

company’s emergency contact or the manager in charge of registration 

with FDA. We made three attempts to contact each company and reached 

91 company representatives. Five declined to complete the interview. In 

total, we interviewed representatives of 86 of the 106 companies, resulting 

in an 81-percent response rate. 

We asked each representative to verify the company’s registration 

information, including the company’s name, full address, emergency 

contact name, and emergency contact telephone number. We asked the 

representative to provide contact information for any facilities that 

manufactured the supplement in our sample. If the company or one of its 

manufacturing facilities was listed in the registry, we considered the 

company to be registered.

If the contact information provided by the company representative did not 

match the information in the registry, we questioned the representative 
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 7

about the discrepancy and asked when the information had changed. If we 

could not initially find a company in the registry, we asked the company 

representative about alternate company names and addresses. We then 

searched the registry again to determine whether the company was 

registered under an alternate name. We also asked company 

representatives about their familiarity with the registry.

Finally, we asked about the functions performed by the company with 

respect to the sampled dietary supplement (i.e., manufacturing, 

distributing, warehousing). We did not independently verify each 

company’s self-reported function. 

Analysis of Adverse Events Contact Information on Dietary Supplement 

Labels. We analyzed the labels of 127 dietary supplements to determine 

whether they were in compliance with Federal regulations regarding 

required adverse events contact information. We determined that a label 

provided complete contact information if it included either a complete 

telephone number or a complete address for a responsible party.

Limitations

Because no comprehensive list of dietary supplements or dietary 

supplement companies exists, the universe of supplements and companies 

is unknown. Therefore we were unable to draw a random sample of 

dietary supplements and companies and do not generalize our findings to 

all dietary supplement companies. Using self-reported information about 

the companies’ functions, we determined whether companies were 

required to be registered with FDA. Only FDA can make a final 

determination about whether each company was required to register. 

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.

FINDINGS

Twenty-eight percent of contacted companies failed to 

register with FDA as required

Dietary supplement companies must register with FDA if they 

manufacture, process, pack, or hold dietary supplements for consumption 

in the United States, pursuant to the Bioterrorism Act of 2002. Of the 

86 companies we interviewed, 79 had 1 or more facilities that were 
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 8

required to register with FDA.26 Of those 79 companies, 22 (28 percent) 

did not have any facilities registered with FDA. Thirteen of these 

companies were associated with products we purchased on the Internet 

and nine with products we purchased in retail stores (see Appendix A). 

FDA officials and other stakeholders told us that oversight of Internet 

companies is particularly challenging because of the vast number of Web 

sites and difficulty identifying those responsible for them. 

Of the 86 companies we contacted, company representatives of 32 were 

unaware of FDA’s registration requirements. Even among the 

57 companies that did have registered facilities, 13 company 

representatives we spoke with were unfamiliar with the registry. This 

raises questions about whether registered companies are keeping their 

contact information up to date. On the other hand, eight representatives of 

companies that failed to register with FDA reported that they were familiar 

with the registry. 

Among companies in our sample that registered with 

FDA, 72 percent failed to provide complete and 

accurate information required in the registry 

Of the 57 companies with registered facilities, 41 (72 percent) had 

incomplete or inaccurate required contact information in the registry.27 

FDA regulations require companies to maintain complete and accurate 

information in the registry so that it can locate them quickly in an 

emergency. If a company relocates to a new address or has other changes, 

it must update the registry with the accurate information within 60 days. 28 

Sixteen companies had inaccurate addresses in the registry, but none 

reported relocating within the 60-day window (see Chart 1). 

Additionally, 34 companies with registered facilities did not provide 

accurate emergency contact telephone numbers in the registry as required. 

The emergency contact name, which is not required, was often inaccurate 

as well. Thirty companies with registered facilities did not provide 

accurate emergency contact names. At a large company with multiple 

divisions, FDA may have trouble identifying and contacting a person who 

is able to respond to an emergency if no emergency contact name is 

26 These 79 companies were supplement manufacturers, distributors, warehousers, packagers, 

or some combination thereof. We determined that seven companies were not required to 

register because six were retailers and one was a wholesaler. 

27 As part of registration, a company is required to provide a complete and accurate name, 

address, and telephone number for the facility; the facility’s owner, operator, agent in charge, 

and U.S. agent (for a foreign facility); and, if the facility is a subsidiary, the facility’s parent 

company. In addition, an emergency telephone number must be provided for the facility or, in 

the case of a foreign facility, the facility’s U.S. agent. 21 CFR § 1.232.

28 21 CFR § 1.234.
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 9

provided. If a dietary supplement poses a public health threat, FDA 

should be able to rely on the registry for contact information. In an 

emergency involving a dietary supplement, it is critical that FDA be able 

to quickly trace the source of the product. Incomplete emergency contact 

information in the registry may cause a delay when FDA is tracing the 

source of an unsafe supplement. 

Chart 1: Dietary Supplement Companies With Inaccurate Required Contact 

Information in the Registry (n=58) 

Source: OIG analysis of data from FDA’s Food Facility Registry and interviews with dietary 

supplement companies, September 2011.

Note: Categories are not mutually exclusive. FDA requires that companies provide a company name, a 

physical address, and an emergency contact telephone number in the registry. 

Twenty percent of dietary supplement labels in our 

sample did not provide the required telephone 

numbers or addresses

Federal law requires that dietary supplement labels include the telephone 

numbers or complete addresses of the dietary supplement firms 

responsible for receiving adverse event reports.29 Consumers and medical 

providers use this information to report adverse events. Of the 127 dietary 

supplement labels in our sample, 26 did not include either the telephone 

numbers or complete addresses of responsible parties. Of these 

26 supplements, 17 also did not have responsible companies listed in 

FDA’s registry. This raises questions about the ease of obtaining contact 

information for these 17 companies. 

Complete contact information on dietary supplement labels is essential to 

enable consumers and their medical providers to report adverse events. If 

29 21 U.S.C. § 343(y).

41

4 

16

34

0

10

20

30

40

50

60

One or more

required pieces

of contact

information

inaccurate

Company name

inaccurate

Address

inaccurate

Emergency

contact

telephone

number

inaccurate

Number of Companies
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 10

a dietary supplement does not provide contact information on the label, 

FDA may not learn of unsafe supplements in a timely manner. 

Additionally, if information in FDA’s registry is inaccurate or incomplete, 

FDA must rely on other sources of information to contact a responsible 

company. Incomplete contact information on dietary supplement labels 

may put FDA at a disadvantage in learning about and tracing the source of 

unsafe supplements. 
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 11

CONCLUSION AND RECOMMENDATIONS

In a public health emergency involving a dietary supplement, FDA’s 

ability to quickly locate a company responsible for the supplement’s safety 

is essential. FDA’s Food Facility Registry is intended to provide sufficient 

contact information for dietary supplement companies in these 

circumstances. In addition, a dietary supplement label must include a 

telephone number or an address for a responsible company so that 

consumers and others can report adverse events.

This review raises questions about the accuracy and utility of the registry 

in emergencies and the availability of contact information on supplement 

labels that could be used to report adverse events to the responsible 

company. Twenty-eight percent of contacted companies failed to register 

as required. Of those that did register, 72 percent failed to provide 

complete and accurate information. Finally, 20 percent of dietary 

supplement labels in our sample did not provide required adverse event 

contact information. 

 To address the findings in this report, we recommend that FDA: 

Improve the Accuracy of the Information in the Registry

Beginning in 2012, all dietary supplement companies must renew their 

facilities’ registrations during defined periods every 2 years.30 To improve 

the accuracy of information in the registry, FDA could publicize this new 

requirement and remind registered companies of the requirement to update 

their information within 60 days of any change. FDA could accomplish 

this by: 

• emailing reminders to companies’ registered email addresses, 

• presenting information on registration requirements at industry 

meetings, 

• publishing reminders in trade and industry publications, and 

• posting reminders on the FDA Web site and listserv. 

FDA could also consider testing the accuracy of the information in the 

registry by regularly attempting to contact a sample of listed companies. 

This would provide FDA with information on the registry’s accuracy and 

help determine whether the registry can work as intended in an emergency. 

30 21 U.S.C. § 350d(a)(3).
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 12

Seek Statutory Authority To Impose Civil Monetary Penalties 

on Companies That Do Not Comply With Registration

Requirements

In 2009, OIG recommended that FDA consider seeking authority to 

impose civil monetary penalties on food facilities, including dietary 

supplement companies, that either fail to register or fail to provide 

accurate information.31 Civil monetary penalties may provide added 

incentive for companies to comply with registry requirements. FDA 

previously expressed support for this recommendation and indicated that it 

would be open to pursuing this authority in the future.32 

Educate the Dietary Supplement Industry About Registration

and Labeling Requirements

Such education could lead to an increase in the number of dietary 

supplement companies that register and comply with labeling 

requirements. FDA could focus on educating the dietary supplement 

industry about which types of companies are required to register. FDA 

could also educate companies about the requirement for labels to include a 

complete telephone number or address for reporting adverse events. FDA 

could consider providing education through industry and FDA Web sites, 

as well as trade association publications and meetings.

31 OIG, FDA’s Food Facility Registry, OEI-02-08-00060, December 2009.

32 Ibid.
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 13

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

In its comments on the draft report, FDA concurred with all of our 

recommendations. FDA acknowledged that its ability to ensure the safety 

of dietary supplements used by consumers should be improved and

described its plans to address our recommendations. 

FDA concurred that it should take steps to improve the accuracy of the 

Food Facility Registry. It noted that FSMA requires registrants to renew 

their registrations every 2 years, and the agency expects that this will 

improve the accuracy of the registry. FDA also said that it is preparing 

updated informational and guidance documents related to the biennial 

registration requirement and will make these available to facilities 

required to register. 

FDA also concurred with our recommendation to seek statutory authority 

to impose civil and monetary penalties on dietary supplement 

manufacturers or their facilities that fail to register. 

Finally, FDA concurred with our recommendation to educate the dietary 

supplement industry about registration and labeling requirements. In its 

comments, FDA focused on educating currently registered companies 

about the requirement to renew their registrations biennially but did not 

specify its plan for educating unregistered companies about the 

requirement to register their facilities. FDA plans to send letters to major 

trade associations and trade show providers regarding the new requirement 

to renew registrations biennially. In addition, FDA noted that in 2011, it 

produced a handout for industry regarding labeling requirements for 

adverse event reporting. 

We ask that in its final management decision, FDA clarify its plans for 

identifying and registering unregistered facilities and increasing 

compliance with registration requirements overall. For the full text of 

FDA’s comments, see Appendix B. 
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 14

APPENDIX A: 

Information on Sampled Dietary Supplements and Companies

Table A-1: Sampled Supplements by Source of Purchase and Supplement 

Type

Supplement Source Weight Loss 

Supplements

Immune Support 

Supplements Total

Retail 32 35 67

Internet 28 32 60

 Total 60 67 127

Source: Office of Inspector General (OIG) analysis of sampled dietary supplements, September 

2011.

Table A-2: Companies Contacted and Their Registration Status

Company Type Contacted Required To Register 

With FDA Registered With FDA

Retail 47 46 37

Internet 39 33 20

 Total 86 79 57

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

Agency Comments 

, .. -r;··--•.. 

Food and Ol\lg Admlnlstn!IJon 

Sliver Spring MD, 20993 

nate: August 3, 2012 

To: Inspector General 

From: Acting Associate Commissioner for Policy and Planning 

Subject: FDA's General Comment to 010 Draft Report on Dietary' Supplements: 

Companies May Be Difficult to Pind in an Emergency 

FDA is providing th:e attached general comments to the Office of Inspector General's draft report 

entitled, Dietary Supplements.: Companies May Be Di}ficult to Find In an Emergency 

(OB!-OI-11-00211), . 

FDA appreciates the opportunity to review and comment on this draft report before it is 

published. 

David H. Dorsey 

Attacluncnt 

i 

I. 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 15 
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 16

APPENDIX B (CONTINUED)
 

Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 17

APPENDIX B (CONTINUED)
Dietary Supplements: Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211) 18

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 Jessica Fargnoli, Danielle Fletcher, 

Maria Maddaloni, Jesse Valente, Alyson Cooper, and Tim Chettiath; 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.