Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
D S : 
  IETARY  UPPLEMENTS
 
C M B D
OMPANIES  AY  E  IFFICULT 
 
T L  E  
O  OCATE IN AN  MERGENCY
 
 
 
Daniel R. Levinson  
Inspector General 
 
October 2012 
OEI-01-11-00211   
   
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 FDAs 
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 FDAs 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 
 
   
   
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 FDAs 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, FDAs 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)  1 
   
   
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 
FDAs 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 FDAs 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, FDAs 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)  2 
   
   
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 companys 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); FDAs implementing regulations on the registration of food facilities 
are located at 21 CFR  1.2251.243.   
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)  3 
   
   
facilities.20  FDAs 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 
FDAs 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)  4 
   
   
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 FDAs 
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 FDAs 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 supplementsimmune support 
supplements and weight loss supplementsafter 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)  5 
   
   
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 products 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 FDAs 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 
companys 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 companys registration 
information, including the companys 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)  6 
   
   
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 
companys 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)  7 
   
   
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 FDAs 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 facilitys owner, operator, agent in charge, 
and U.S. agent (for a foreign facility); and, if the facility is a subsidiary, the facilitys parent 
company.  In addition, an emergency telephone number must be provided for the facility or, in 
the case of a foreign facility, the facilitys 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)  8 
   
   
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)  
60
s 
e50
ni
a 41 
p40
m 34 
o
C30
f 
o
er 20 16 
b
m
Nu10 4 
0
One or more Company name Address Emergency
required pieces inaccurate inaccurate contact
of contact telephone
information number
inaccurate inaccurate
 
Source:  OIG analysis of data from FDAs 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 
FDAs 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). 
Dietary Supplements:  Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211)  9 
   
   
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 FDAs 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.   
 
   
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CONCLUSION AND RECOMMENDATIONS 
In a public health emergency involving a dietary supplement, FDAs 
ability to quickly locate a company responsible for the supplements safety 
is essential.  FDAs 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 registrys accuracy and 
help determine whether the registry can work as intended in an emergency. 
 
 
 
30
 21 U.S.C.  350d(a)(3). 
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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, FDAs Food Facility Registry, OEI-02-08-00060, December 2009. 
32
 Ibid. 
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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 
FDAs comments, see Appendix B. 
 
   
Dietary Supplements:  Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211)  13 
   
   
APPENDIX A:   
Information on Sampled Dietary Supplements and Companies 
 
Table A-1:  Sampled Supplements by Source of Purchase and Supplement 
Type 
Weight Loss  Immune Support 
Supplement Source   Total 
Supplements  Supplements 
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 
Required To Register 
Company Type  Contacted  Registered With FDA 
With FDA 
Retail  47  46  37 
Internet  39  33  20 
     Total  86  79  57 
Source:  OIG analysis of sampled dietary supplements, September 2011. 
Dietary Supplements:  Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211)  14 
  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   
   
APPENDIX B (CONTINUED) 
 
 
 
 
 
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 
   
   
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.  
 
 
 
Dietary Supplements:  Companies May Be Difficult To Locate in an Emergency (OEI-01-11-00211)  18 
   
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.