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United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

October 2011: 

Food and Drug Administration: 

Better Coordination Could Enhance Efforts to Address Economic 
Adulteration and Protect the Public Health: 

GAO-12-46: 

GAO Highlights: 

Highlights of GAO-12-46, a report to congressional requesters. 

Why GAO Did This Study: 

In recent years, the United States experienced public health crises 
suspected to have been caused by the deliberate substitution or 
addition of harmful ingredients in food and drugs—specifically 
melamine in pet food and oversulfated chondroitin sulfate in the blood 
thinner heparin. These ingredients were evidently added to increase 
the apparent value of these products or reduce their production costs, 
an activity GAO refers to as economic adulteration. The Food and Drug 
Administration (FDA), an agency within the Department of Health and 
Human Services (HHS), has responsibility for protecting public health 
by ensuring the safety of a wide range of products that are vulnerable 
to economic adulteration. This report examines (1) the approaches that 
FDA uses to detect and prevent economic adulteration of food and 
medical products and (2) the challenges FDA faces in detecting and 
preventing economic adulteration and views of stakeholders on options 
for FDA to enhance its efforts to address economic adulteration. GAO 
reviewed FDA documents and interviewed FDA officials and stakeholders 
from academia and industry, among others. 

What GAO Found: 

FDA primarily approaches economic adulteration as part of its broader 
efforts to combat adulteration in general, such as efforts to ensure 
the safety of imported products. Agency officials noted that the 
Federal Food, Drug, and Cosmetic Act does not distinguish among 
motives or require motive to be established to determine whether a 
product is adulterated. However, a senior FDA official told GAO that 
there is value in making a distinction between economic adulteration 
and other forms of adulteration to guide the agency’s thinking about 
how to be more proactive in addressing this issue. An FDA official 
told GAO when the agency detects any form of adulteration that poses 
an adverse public health effect, it can conduct an investigation, 
request a recall to get the product off the market, and take 
enforcement action. In addition to these broader efforts, some FDA 
entities also have undertaken efforts that specifically focus on 
economic adulteration. For example, FDA’s Office of Regulatory Affairs 
has contracted with a research center to model risk factors for 
improved detection of economic adulteration of food. However, FDA 
entities have not always communicated or coordinated their economic 
adulteration efforts. For example, FDA’s Center for Veterinary 
Medicine was unaware of and did not participate in two other entities’ 
economic adulteration efforts involving products the veterinary center 
regulates. In another instance, two FDA entities engaged in similar 
efforts but did not communicate or coordinate them, even though 
officials said such communication might be beneficial. Furthermore, 
FDA has not issued specific written guidance on how its centers and 
offices should approach or address their economic adulteration 
efforts. This is not consistent with federal standards for internal 
control, which require agencies to have documented policies and 
procedures. 

FDA officials and stakeholders GAO interviewed cited several key 
challenges to detecting and preventing economic adulteration, 
including increased globalization and lack of information from 
industry. Globalization has led to an increase in the variety, 
complexity, and volume of imported food and drugs, which complicates FDA
’s task of ensuring their safety. In addition to globalization, an 
increase in supply chain complexity—the growth in the networks of 
handlers, suppliers, and middlemen—also complicates FDA’s task, making 
it difficult to trace an ingredient back to its source. FDA officials 
and stakeholders also said that gathering information from industry, 
such as information on potentially adulterated ingredients, presents 
challenges for FDA in detecting and preventing economic adulteration 
due to industry’s reluctance to share such information because it is 
proprietary. Stakeholders cited greater oversight and information 
sharing as options to improve FDA’s ability to combat economic 
adulteration. Specifically, some stakeholders supported increased 
oversight, such as the use of technology to trace adulterated 
ingredients back to the point of contamination, as an option to obtain 
more information on supply chains. Many stakeholders also suggested 
that FDA increase its regulatory and enforcement actions to address 
economic adulteration, including in instances that may not have a 
large negative public health impact. Stakeholders also suggested that 
greater communication with industry, through such means as an 
information clearinghouse or more informal interactions, could enhance 
FDA efforts to gather information on economic adulteration. 

What GAO Recommends: 

GAO recommends that FDA adopt a working definition of economic 
adulteration, enhance communication and coordination of agency 
efforts, and provide guidance to agency centers and offices on the 
means of addressing economic adulteration. HHS neither agreed nor 
disagreed with GAO’s recommendations, but cited planned actions 
related to adopting a definition and enhancing communication and 
coordination. 

View [hyperlink, http://www.gao.gov/products/GAO-12-46] or key 
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov, or Marcia Crosse at (202) 512-7114 or 
crossem@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

FDA Has Many Efforts to Address Economic Adulteration but Has Missed 
Opportunities to Communicate and Coordinate: 

FDA Faces Challenges in Addressing Economic Adulteration, and 
Stakeholders Identified Options That May Help Agency Efforts: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Comments from the Department of Health and Human Services: 

Appendix III: GAO Contacts and Staff Acknowledgments: 

Related GAO Products: 

Figure: 

Figure 1: Illustrative Supply Chain for Canned Tuna: 

Abbreviations: 

API: active pharmaceutical ingredient: 

CBER: Center for Biologics Evaluation and Research: 

CDER: Center for Drug Evaluation and Research: 

CDRH: Center for Devices and Radiological Health: 

CFSAN: Center for Food Safety and Applied Nutrition: 

CVM: Center for Veterinary Medicine: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

ORA: Office of Regulatory Affairs: 

PREDICT: Predictive Risk-based Evaluation for Dynamic Import 
Compliance Targeting: 

USP: United States Pharmacopeia: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

October 24, 2011: 

The Honorable Henry A. Waxman: 
Ranking Member: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Frank Pallone, Jr. 
Ranking Member: 
Subcommittee on Health: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable John D. Dingell: 
House of Representatives: 

In recent years, the United States experienced two crises suspected to 
have been caused by the deliberate substitution or addition of harmful 
ingredients in food and drugs. These ingredients were evidently added 
to increase the apparent value of these products or reduce their 
production costs, an activity we refer to as "economic adulteration." 
Specifically, in 2007, vegetable protein products imported to the 
United States from China were found to contain melamine, an industrial 
chemical, which later investigation suggested had been added to give 
the appearance of higher protein content. The products were used as 
ingredients in pet food, sickening and killing an unknown number of 
dogs and cats.[Footnote 1] In 2008, heparin--a commonly used blood 
thinner--was imported from China and found to contain oversulfated 
chondroitin sulfate, a toxic contaminant that mimics heparin. The 
contaminated heparin was linked to a number of serious allergic 
reactions and deaths in the United States. In addition to harming 
public health, such incidents can undermine confidence in the safety 
of the nation's food and medical products and have significant 
economic consequences for industry. For example, the melamine incident 
prompted pet food manufacturers to recall over 150 brands of dog and 
cat food across the United States, and the heparin crisis prompted 16 
drug and device firms to recall at least 11 drug products and 72 
heparin-containing medical devices. 

The Food and Drug Administration (FDA), an agency within the 
Department of Health and Human Services (HHS), has responsibility for 
protecting public health by ensuring the safety of a wide range of 
food and medical products (drugs, medical devices, and 
biologics[Footnote 2]) that are vulnerable to, among other things, 
economic adulteration. With increasing globalization of food 
production and medical product manufacturing, the volume of imported 
goods regulated by FDA has more than doubled in the last decade. As a 
result, according to FDA documents, from 10 to 15 percent of all food 
consumed in the United States is now imported, as are about 80 percent 
of the active pharmaceutical ingredients in drugs, nearly 40 percent 
of finished drugs, and half of all medical devices. FDA expects the 
growth in imports to continue. The FDA Commissioner has said that 
globalization presents huge and growing challenges and that economic 
adulteration remains a public health threat. She indicated that 
another public health crisis like heparin or melamine seems inevitable 
unless FDA is able to forge changes in how it ensures the safety and 
quality of food and medical products. In part due to regulatory 
challenges posed by increased globalization, we included federal 
oversight of both food and medical products in our 2011 list of 
federal programs at high risk for waste, fraud, abuse, or 
mismanagement that warrant attention by Congress and the executive 
branch.[Footnote 3] We first added federal oversight of food safety to 
our High-Risk list in January 2007 and federal oversight of medical 
products in January 2009.[Footnote 4] 

This report responds to your request that we review how FDA oversees 
the safety of food and drugs in order to prevent and respond to 
economic adulteration. This report examines (1) the approaches that 
FDA uses to detect and prevent economic adulteration of food and 
medical products and (2) the challenges, if any, FDA faces in 
detecting and preventing economic adulteration and stakeholder views 
on options for FDA to enhance its efforts to address economic 
adulteration. 

For purposes of this report, we define economic adulteration as "the 
fraudulent, intentional substitution or addition of a substance in a 
product for the purpose of increasing the apparent value of the 
product or reducing the cost of its production, i.e., for economic 
gain. [It] includes dilution of products with increased quantities of 
an already-present substance (e.g., increasing inactive ingredients of 
a drug with a resulting reduction in strength of the finished product, 
or watering down of juice) to the extent that such dilution poses a 
known or possible health risk to consumers, as well as the addition or 
substitution of substances in order to mask dilution." This definition 
is the same as the working definition of "economically motivated 
adulteration" that FDA developed for a May 2009 public meeting 
[Footnote 5] to raise awareness and solicit input on the topic. 
[Footnote 6] 

To determine the approaches FDA uses to detect and prevent economic 
adulteration, we interviewed FDA officials about the agency's efforts 
to address economic adulteration and reviewed relevant FDA documents. 
We also reviewed our previous reports on FDA's oversight of food and 
medical products, as well as the agency's strategic planning efforts. 
We compared FDA's efforts to address economic adulteration with 
federal standards for internal control. To determine the challenges 
FDA faces in detecting and preventing economic adulteration, we 
interviewed FDA officials and stakeholders, including former FDA 
officials and some representatives from academia, industry, and 
consumer groups who made presentations at FDA's May 2009 meeting on 
economically motivated adulteration. We also interviewed the 
stakeholders to obtain their views on options for FDA to enhance its 
efforts to address economic adulteration. The views of these 
stakeholders are not representative of and cannot be generalized to 
all stakeholders. Appendix I contains a detailed discussion of the 
scope and methodology of our review. 

We conducted this performance audit from September 2010 to October 
2011 in accordance with generally accepted government auditing 
standards. Those standards require that we plan and perform the audit 
to obtain sufficient, appropriate evidence to provide a reasonable 
basis for our findings and conclusions based on our audit objectives. 
We believe that the evidence obtained provides a reasonable basis for 
our findings and conclusions based on our audit objectives. 

Background: 

FDA is responsible for protecting public health by ensuring the safety 
and efficacy of medical products marketed in the United States-- 
including drugs, medical devices, and biologics--and the safety of 
nearly all food products other than meat and poultry,[Footnote 7] 
regardless of whether they were manufactured domestically or overseas. 
The agency's responsibilities for overseeing food and medical products 
are divided among the following five FDA product centers, each 
responsible for specific types of products: 

* The Center for Biologics Evaluation and Research (CBER) is 
responsible for regulating biologics for human use, such as blood, 
blood products, vaccines, and allergenic products, and ensuring that 
biologics are safe and effective. 

* The Center for Devices and Radiological Health (CDRH) is responsible 
for regulating firms that manufacture and import medical devices and 
for ensuring that radiation-emitting products, such as lasers and x-
ray systems, meet radiation safety standards. 

* The Center for Drug Evaluation and Research (CDER) is responsible 
for regulating over-the-counter and prescription drugs for human use, 
including generic drugs. 

* The Center for Food Safety and Applied Nutrition (CFSAN) is 
responsible for ensuring the safety of most foods for humans (except 
meat and poultry and processed egg products, which are regulated by 
the U.S. Department of Agriculture), including dietary supplements. 

* The Center for Veterinary Medicine (CVM) is responsible for 
regulating the manufacture and distribution of drugs, devices, and 
food given to, or used by animals. 

Among other things, the centers monitor the safety and effectiveness 
of marketed medical products and the safety of food, formulate 
regulations and guidance, conduct research, communicate information to 
industry and the public, and set their respective program priorities. 

In addition to the work of the five centers, FDA's Office of 
Regulatory Affairs (ORA) conducts field work for the product centers 
to promote compliance with agency requirements and applicable laws. 
ORA field activities include inspecting domestic and foreign 
manufacturing facilities, examining products offered for import, 
collecting and analyzing samples, and taking enforcement action. 
[Footnote 8] ORA's Office of Criminal Investigations is responsible 
for investigating potential criminal violations involving FDA-
regulated products and may refer cases to the Department of Justice 
for prosecution. 

FDA's Office of the Commissioner is responsible for providing 
leadership and direction to the product centers and ORA. FDA's Office 
of International Programs is responsible for leading, managing, and 
coordinating all of FDA's international activities and its recently 
established overseas offices. 

In July 2011, FDA created "directorates" that align similar functions 
under common leadership within the Office of the Commissioner--the 
Office of Medical Products and Tobacco, which oversees CBER, CDER, and 
CDRH, as well as the Center for Tobacco Products; the previously 
established Office of Foods, which oversees CFSAN and CVM; and the 
Office of Global Regulatory Operations and Policy, which oversees ORA 
and the Office of International Programs. 

In recent years, we have reported on a variety of concerns related to 
FDA's resource management, strategic planning, and internal 
communications and coordination. Specifically, in June 2009, we found 
that FDA was unable to provide complete and reliable estimates of its 
resource needs for its medical products.[Footnote 9] In February 2010, 
we reported on management challenges the agency faces and FDA's 
difficulties in using practices for effective strategic and workforce 
planning.[Footnote 10] Coordinating internally among its centers and 
offices and externally with outside experts were among the agency's 
major management challenges. Also, in September 2010, we reported on 
FDA's overseas offices and the need for better coordination among the 
centers.[Footnote 11] For a list of these and other related reports, 
see Related GAO Products at the end of this report. 

Federal Law on the Adulteration of FDA-Regulated Food and Medical 
Products: 

The Federal Food, Drug, and Cosmetic Act prohibits the introduction of 
adulterated food, drugs, and medical devices into interstate commerce. 
However, the act does not define or use the term "economic 
adulteration" or "economically motivated adulteration." The act 
includes, but is not limited to, the following: 

* A food is deemed to be adulterated if, among other circumstances, it 
bears or contains any added poisonous or deleterious substance that 
may render it injurious to health. A food is also deemed to be 
adulterated (1) if any valuable constituent has been omitted in whole 
or in part, or (2) if any substance has been substituted wholly or in 
part, or (3) if damage or inferiority has been concealed in any 
manner, or (4) if any substance has been added so as to increase its 
bulk or weight, or reduce its quality or strength, or make it appear 
better or of greater value than it is. 

* A drug is deemed to be adulterated if it purports to be a drug whose 
name is recognized in an official compendium[Footnote 12] and its 
strength differs from, or its quality or purity falls below, the 
standards set forth in such compendium. If a drug does not purport to 
be a drug listed in an official compendium, it is deemed to be 
adulterated if its strength differs from, or its purity or quality 
falls below, that which it purports to possess. A drug is also deemed 
to be adulterated if, among other circumstances, any substance has 
been (1) mixed or packed with it so as to reduce its quality or 
strength or (2) substituted wholly or in part. 

* A device is deemed to be adulterated if it is, or purports to be or 
is represented as, a device which is subject to a performance standard 
established or recognized under the act unless such device is in all 
respects in conformity with such standard. It is also deemed 
adulterated if, among other circumstances, the device was not 
manufactured, packed, stored, or installed in conformity with good 
manufacturing practices. 

Economic Adulteration: 

Economic adulteration is not a new problem and ranges from simple 
actions, such as adding material to increase a product's weight, to 
more sophisticated substitutions or additions that are designed to 
avoid detection by tests known to be used to authenticate ingredients 
or products. Economic adulteration differs from other forms of 
intentional adulteration, such as bioterrorism or sabotage, whose 
primary purpose is to cause harm. Because economic adulteration is 
intentional, it also differs from unintentional adulteration, such as 
adulteration through failure to follow good manufacturing practices. 

Although the primary driver of economic adulteration is financial gain 
rather than causing harm, it can pose a variety of public health 
risks. The actual risks will vary depending on the adulterant used, 
the person who consumes the product, and the length of use or 
exposure. There is a direct and immediate threat to public health when 
the adulterant is a toxic or lethal substance, as was the case in the 
melamine and heparin incidents. There are also risks that arise as a 
result of long-term, low-dosage exposure to a contaminant or as a 
result of using a product whose nutritional value or efficacy has been 
compromised by an adulterant. Certain populations, such as infants, 
the elderly, and persons with compromised immune systems are 
particularly vulnerable to these risks. In some cases, an adulterant 
may only pose a public health risk for those who are allergic to it, 
such as fish substituted with a less expensive fish to which a person 
is allergic. Furthermore, economic adulteration that poses no known 
health risk may expose a vulnerability in the supply chain--the 
network of handlers, suppliers, and middlemen involved in the 
production of food and drugs--that could be further exploited in the 
future, with serious consequences. 

Following the melamine and heparin incidents, FDA formed an internal 
work group focused on predicting and addressing what the agency 
referred to as "economically motivated adulteration." The work group, 
comprising representatives from FDA's food and medical product centers 
and ORA, held a May 2009 public meeting on the topic. For purposes of 
the meeting, FDA developed a working definition of economically 
motivated adulteration. The meeting, attended by representatives of 
academia, industry, and consumer groups, was designed to raise 
awareness about the potential for this problem and gather information 
on how to better predict, prevent, and address it. According to FDA 
officials, the work group stopped meeting shortly after the public 
meeting was held. FDA made a transcript of the meeting publicly 
available, but issued no report. 

FDA Has Many Efforts to Address Economic Adulteration but Has Missed 
Opportunities to Communicate and Coordinate: 

FDA primarily approaches economic adulteration as part of its broader 
efforts to detect and prevent adulteration of food and medical 
products in general. In addition, CDER, ORA, CFSAN, and CBER have 
undertaken efforts specific to economic adulteration, while CVM and 
CDRH have not. However, agency entities have missed opportunities to 
communicate and coordinate efforts specifically directed at economic 
adulteration and identify potential public health risks. 

FDA Primarily Approaches Adulteration Broadly, but Some Centers and 
ORA Have Undertaken Efforts Specific to Economic Adulteration: 

According to FDA officials, the agency primarily approaches economic 
adulteration as part of its broader efforts to combat adulteration in 
general. Such efforts include, for example, the agency's actions to 
ensure the safety of imported products. According to FDA officials, 
these broad efforts to combat adulteration could also combat economic 
adulteration. Agency officials noted that the Federal Food, Drug, and 
Cosmetic Act does not distinguish among motives or require motive to 
be established to determine whether a product is adulterated. FDA 
adopted a working definition of economically motivated adulteration 
for the purposes of discussing the topic at its May 2009 public 
meeting. In its written comments on our draft report, HHS told us that 
the recently formed FDA Working Group on Economically Motivated 
Adulteration will use the working definition proposed at the public 
meeting, enabling FDA centers to focus their discussions and 
encouraging communication and collaboration. According to an FDA 
official, the agency generally does not expend resources to 
distinguish between economic and other motives for adulteration. 
Rather, when the agency detects any form of adulteration that poses an 
adverse public health effect, it can conduct an investigation, request 
a recall to get the product off the market, and take enforcement 
action. A senior FDA official told us there is value in making a 
distinction between economic adulteration and other forms of 
adulteration to guide the agency's thinking about how to be more 
proactive in addressing this issue. 

Examples of broader FDA efforts to address adulteration include: 

* ORA's Predictive Risk-Based Evaluation for Dynamic Import Compliance 
Targeting (PREDICT). This tool generates a numerical risk score for 
all FDA-regulated products by analyzing importers' shipment 
information using sets of FDA-developed risk criteria based in part on 
publicly available information,[Footnote 13] which may indicate 
opportunities for economic adulteration. PREDICT then targets for 
examination products that have a high risk score. As of September 
2011, PREDICT was operating in ports of entry in 13 of 16 FDA 
districts, and FDA officials said the agency expects PREDICT to be 
operational in all ports of entry by the end of 2011. 

* CVM's Pet Event Tracking Network (PETNet). In August 2011, CVM 
launched PETNet, a secure, Internet-based network comprised of FDA and 
other federal and state agencies with authority over pet food that 
would allow them to exchange real-time information about outbreaks of 
illness in animals associated with pet food and other pet food-related 
incidents. PETNet members can elect to receive alerts about pet food 
incidents and create alerts when they are aware of a pet food incident 
within their jurisdiction. According to FDA, the information would be 
used to help federal and state regulators determine how best to use 
inspectional and other resources to either prevent or quickly limit 
the adverse events caused by adulterated pet food. Use of the system 
is voluntary. 

* CDER's Secure Supply Chain Pilot Program. This program, which is in 
the process of being implemented, is intended to help the agency 
ensure the safety of imported drugs by enabling it to focus its 
resources on preventing the importation of drugs that do not comply 
with applicable FDA requirements. The program is intended to allow a 
limited number of drug companies to import their products on an 
expedited basis if, among other things, they can meet FDA criteria 
showing that they maintain control over their products from 
manufacture through entry into the United States. FDA expects to 
announce the date on which it will begin accepting applications for 
the pilot by the end of 2011. 

In addition to these broader efforts, some FDA entities have 
undertaken efforts specific to economic adulteration. For example, in 
the aftermath of the melamine and heparin incidents, CDER, ORA, CFSAN, 
and CBER have taken the following steps to specifically address 
economic adulteration: 

* CDER has developed a model to rank the 1,387 active pharmaceutical 
ingredients (API) known to be in current use according to their 
susceptibility to economic adulteration.[Footnote 14] According to 
CDER officials, the ranking model incorporates various risk factors, 
such as estimates for volume of use, cost per unit of the API, and 
reliance on testing methods to check quality that are known to be less 
accurate than more modern methods developed for other APIs. CDER 
officials told us the center sampled and tested 20 of the 77 higher-
ranked APIs in 2010 and found no evidence of any significant 
contamination suggesting intentional adulteration. According to agency 
officials, after this pilot program is completed, FDA will determine 
if the program was valuable and, if so, whether the model's risk 
factors may need to be adjusted. 

* CDER is leading efforts to work with United States Pharmacopeia 
(USP) to focus on the vulnerability of drugs to economic adulteration. 
USP is a nonprofit organization that sets standards for medicines, 
food ingredients, and dietary supplements. USP's drug standards are 
enforceable under the Federal Food, Drug, and Cosmetic Act. Actions 
CDER officials say they have taken include selecting 20 USP 
standards[Footnote 15] for updating that include certain over-the- 
counter drugs, inactive ingredients used in high volume, and APIs that 
use outdated technology or for which there are no procedures to 
identify impurities. The goal of this modernization effort is to 
replace outdated USP standards with more modern, accurate, and 
specific ones. CDER has also worked closely with USP in revising the 
heparin testing standard and the standards for glycerin and five other 
similar drug product ingredients to prevent economic adulteration with 
diethylene glycol, a cheaper, but deadly ingredient often substituted 
for glycerin. 

* ORA, along with the Department of Homeland Security and the 
Department of Agriculture's Food Safety and Inspection Service, 
contracted in 2010 with the University of Minnesota's National Center 
for Food Protection and Defense to model risk factors for improved 
detection of economic adulteration.[Footnote 16] The contract consists 
of three phases: (1) a survey of U.S. companies to collect information 
on prior or potential economic adulteration experiences and identify 
characteristics of potential targets of economic adulteration; (2) the 
development of strategies to group test methods to identify those 
methods that pose the greatest potential risk for economic 
adulteration, including the level of technical sophistication required 
to exploit the test method; and (3) the development of supply chain 
models in order to identify shifts in these supply chains that may 
indicate the potential for economic adulteration. 

* CFSAN formed a work group on the economic adulteration of food, 
which started meeting in February 2008. CFSAN officials said the 
group, which includes representatives from CVM and ORA, generally 
meets monthly and is looking at the impact of economic adulteration on 
food safety and whether there is other work that FDA could undertake 
to mitigate that impact. Among other things, the group has proposed 
creating a page on FDA's website on economic adulteration, and it has 
developed a methodology for the testing of pomegranate juice, which 
officials said they chose to focus on because it is expensive and 
because its health benefits have been widely touted. CFSAN officials 
said the group is also looking at ways to make industry more 
comfortable with providing information to FDA on possible economic 
adulteration. 

* CFSAN has a number of efforts under way to develop analytical tests 
and tools for detecting economic adulteration. For example, the center 
has developed a method for analyzing nitrogen-containing compounds 
similar to melamine that might be used to boost apparent nitrogen 
content in milk and other protein products. CFSAN's research office 
has a project to develop methods to detect the adulteration of 
powdered milk products and fruit juices. One element of this project 
involves the creation of a library of powdered milk signatures, 
against which new samples can be compared (and adulterants identified) 
using modern statistical methods. This project is slated for 
completion over the next 2 years. 

* CBER established a process in late 2008 to extract relevant product 
component information from regulatory applications and input this data 
into a database. The center has since expanded its process of 
extracting product component information from applications to include, 
for example, ingredients that may be subject to contamination. The 
database includes nonproprietary, unique ingredient identifiers and 
other information designed to facilitate faster identification of 
products made from components suspected of being economically 
adulterated. 

In contrast to the other entities, senior CVM officials we spoke with 
said that although the center has broad initiatives designed to 
prevent and detect adulteration in general (i.e., PETNet), CVM has 
undertaken no efforts targeted to economic adulteration and has no 
plans to do so.[Footnote 17] Officials said that the melamine incident 
gave them greater awareness that products with high-value ingredients 
could be susceptible to economic adulteration and that this was the 
only lesson they learned from the melamine incident. Officials said 
they recognize that CVM-regulated products may be vulnerable to 
economic adulteration because they are composed of numerous 
byproducts, any one of which could be adulterated. Nevertheless, they 
said that they do not believe economic adulteration is a growing 
problem because of industry's overall awareness of its supply chain 
through efforts such as verifying certificates of analysis of 
ingredients from suppliers. 

Officials from CDRH told us that, other than its broader efforts to 
combat adulteration in general, the center had no initiatives 
specifically directed at addressing economic adulteration, but 
indicated they are responsible for products that are vulnerable to 
economic adulteration. For example, CDRH officials said that they have 
found that a manufacturer of imported sunglass lenses may have been 
substituting inferior material. However, center officials were unaware 
of any actual cases of economic adulteration involving products for 
which they are responsible. 

Agency Entities Have Not Communicated or Coordinated on Economic 
Adulteration Efforts: 

We found two instances in which CVM did not know about or participate 
in efforts on economic adulteration that involved CVM-regulated 
products. First, the director of the University of Minnesota's 
National Center for Food Protection and Defense told us that, as part 
of the center's contract with ORA, it will be drafting a list of foods 
at high risk of economic adulteration and that the list will likely 
include foods that are also used as animal feed ingredients. The 
director noted that, with the exception of certain kinds of fats, the 
global supply chain for animal food and feed is the same as that for 
human foods. The director said that, for this reason, his center had 
considered finding ways to make its work for FDA even more applicable 
to animal feed. Although CVM provided developmental input, direction, 
and technical support with regard to the contract, CVM officials said 
they were not aware of the center's work under the contract to develop 
this list of high-risk foods. Second, CFSAN has a research project 
that focuses primarily on developing methods for authenticating 
protein-based foods and ingredients, detecting the presence of 
adulterants, and identifying chemical hazards in protein-based 
products. Among other things, this project is to develop methods for 
screening skim milk powder, which can be found in both food and animal 
feed, for the presence of soy or other vegetable protein. Senior CVM 
officials said they were unaware of this research project, but they 
stated that CVM has been involved in developing methods to identify 
contaminants of protein-based ingredients. 

We also found an instance where FDA entities engaged in similar 
efforts on economic adulteration but did not communicate or coordinate 
about those efforts. Specifically, as we mentioned earlier, ORA and 
CDER are engaged in similar efforts to determine which human foods and 
drugs, respectively, are at greatest risk for economic adulteration. 
However, according to ORA and CDER officials, they have not 
coordinated those efforts or communicated about them, even though they 
are using some of the same risk factors in their efforts--including 
price fluctuations and reliance on less specific test methods. 
Officials from both entities said that such communication and 
coordination could be beneficial to both efforts. 

In addition, we have previously identified internal coordination--
among FDA's centers and offices--as one of the agency's major 
management challenges based on a review of evaluations of FDA by HHS 
and the FDA Science Board, among others.[Footnote 18] Also, in our 
2009 survey of FDA managers, 70 percent reported that better internal 
coordination and communication would greatly improve their ability to 
contribute to FDA's goals and responsibilities, though 28 percent 
reported that FDA was making great progress in this area. Furthermore, 
we asked FDA managers in our survey to identify the top priorities 
that FDA leadership should address to achieve agency goals and 
responsibilities, and the second most commonly identified issue was 
improving coordination within FDA. In detailed written responses in 
our survey, some managers noted that better coordination among FDA's 
centers could increase effectiveness and decrease redundancy. 

Furthermore, a recommendation made by FDA's work group on economic 
adulteration in August 2009 related to communication--that FDA 
designate a lead office and develop standard operating procedures for 
information sharing--was not implemented. A senior FDA official told 
us that there has been some work across FDA centers on economic 
adulteration but that the centers did not see a lot of value in 
additional coordination because of the differences between the 
products each center oversees. However, the issue of economic 
adulteration cuts across the agency, and without communicating about 
and coordinating on economic adulteration efforts, FDA may not be 
making the best use of scarce resources. 

In August 2011, FDA officials told us that the agency's Compliance 
Policy Council, which consists of senior representatives of ORA and 
the FDA centers, met in July 2011 and discussed whether and how the 
agency should coordinate work on economic adulteration. The council 
directed risk management staff from ORA and the centers to form a 
group to discuss opportunities to share intelligence and approaches to 
economic adulteration and then report back to the council. According 
to FDA officials, the proposed agenda included discussion about the 
development of standard operating procedures. In its written comments 
on our draft report, HHS told us that the work group held its first 
meeting on September 23, 2011, while our report was at the agency for 
comment. 

The Commissioner and other senior FDA officials have often spoken 
publicly about the threat posed by economic adulteration. In its July 
2011 report entitled Pathway to Global Product Safety and Quality, 
[Footnote 19] FDA stated that globalization has fundamentally altered 
the economic and security landscape, requiring FDA to transform itself 
into a global agency prepared to regulate in an environment in which 
product safety and quality know no borders. The report also called 
economically motivated harms perhaps the most serious challenge on the 
horizon for the agency and noted that the heparin and melamine 
incidents underscore how serious the potential danger can be. The 
report also noted that FDA needs to move beyond its current efforts 
and think strategically across the agency. However, FDA officials told 
us that the Office of the Commissioner has not issued specific written 
guidance on how FDA centers and offices should approach or address 
their economic adulteration efforts. The Office of the Commissioner's 
role is to provide policy making, program direction, coordination, 
liaison, and expert advice for agency programs. According to federal 
standards for internal control, agencies should have documented 
policies and procedures in place to carry out management's directives. 
[Footnote 20] This documentation should be readily available for 
examination in management directives, administrative policies, or 
operating manuals in paper or electronic form. In addition, the 
federal standards call for effective communication, with information 
flowing down, across, and up the organization. 

FDA Faces Challenges in Addressing Economic Adulteration, and 
Stakeholders Identified Options That May Help Agency Efforts: 

FDA officials and stakeholders we interviewed cited several key 
challenges the agency faces in detecting and preventing economic 
adulteration, and stakeholders identified options for enhancing the 
agency's efforts to address economic adulteration. 

Key Challenges Include Increased Globalization and Lack of Information 
from Industry: 

FDA officials and stakeholders told us that responding to increased 
globalization and the expanding complexity of the supply chains for 
both food and medical products is a key challenge in addressing 
economic adulteration. Globalization has led to an increase in the 
variety, complexity, and volume of imported food and drugs, which 
complicates FDA's task of ensuring their safety. In addition to 
globalization, an increase in supply chain complexity--the growth in 
the networks of handlers, suppliers, and middlemen--also complicates 
FDA's task. According to FDA, the market for outsourcing portions of 
pharmaceutical production has more than doubled in the past 9 years. 
FDA noted in its July 2011 Pathway report that more products are 
following increasingly complex paths through multi-step supply chains 
before reaching the United States. Figure 1 illustrates the complex 
supply chain of a single commodity, canned tuna. As the figure shows, 
after the tuna is caught in East Asia, it can travel through many 
countries for processing and canning before the finished product 
finally reaches store shelves in the United States. 

Figure 1: Illustrative Supply Chain for Canned Tuna: 

[Refer to PDF for image: illustrated world map] 

The map depicts example paths for the following: 

Processed into frozen pieces; 
Pre-canning processing; 
Canning; 
Distribution; 
US consumption. 

Source: FDA. 

[End of figure] 

FDA officials gave several reasons that this increasing complexity 
poses a challenge. For example, CFSAN officials told us that food 
companies can change ingredients and suppliers at will without having 
to notify FDA of those changes, making it difficult to track or trace 
an ingredient back to its source or supplier. However, many food 
manufacturers are required to keep records of the immediate previous 
sources of all foods received. Similarly, CDER officials said that it 
is increasingly difficult to trace ingredients through drug supply 
chains due to the increasing number of parties involved and the 
increase in transfers between parties in other countries. Stakeholders 
from associations representing the food and medical product industries 
agreed that the large number of imported ingredients and foreign 
establishments, as well as the difficulties related to tracking an 
ingredient back to the original source, are of particular concern. 

FDA officials and stakeholders said that obtaining information on 
potential instances of economic adulteration is critical to addressing 
the problem, but they also agreed that the agency faces challenges in 
gathering such information from industry. Industry may be a source of 
information on potential incidents of adulteration because companies 
regularly test ingredients from suppliers. The responsible party for a 
firm that introduces into commerce an article of food containing an 
adulterated ingredient that could cause serious adverse health 
consequences or death must report this information to FDA through the 
Reportable Food Registry. However, agency officials and industry 
representatives said industry is often reluctant to share such 
information when an adulterated ingredient has not entered into 
commerce. For example, a company may be concerned that it could 
provoke a lawsuit if it reported a supplier for intentionally 
adulterating products and the accusation was subsequently determined 
to be unfounded. They said that a wrongful accusation can have serious 
consequences, such as compromising the integrity of the company's 
brands and products if certain information became public. 

In addition to a need for more information about industry suppliers, 
FDA officials told us that they need more information about substances 
that could be used to adulterate products. These officials said that 
new, more precise testing methods need to be developed to detect these 
adulterants because some current tests are outdated or insufficiently 
specific. Recent cases of melamine contamination in pet food 
illustrate the need for such tests. The presence of melamine in pet 
food was not initially discovered by the standard test for protein 
because that test was designed to detect nitrogen and could not 
distinguish between protein and melamine. The contamination was 
ultimately discovered when FDA scientists developed a specific test to 
identify melamine. FDA and others determined that melamine was 
apparently selected as an adulterant to evade the original testing and 
increase the apparent protein content. 

CDER officials also told us that it is difficult to detect instances 
of economic adulteration because the potential adulterant is often 
unknown or has not yet been identified. For example, during the 
heparin incident, the available test methods for heparin were not able 
to detect the contaminant oversulfated chondroitin sulfate. FDA 
collaborated with scientists outside the agency to identify the 
contaminant and develop new tests to detect it. Industry may be the 
best source of tests to detect adulteration because companies develop 
such tests to monitor the products they receive from their suppliers; 
however, industry officials indicated that they are often reluctant to 
share such information because it is proprietary. 

Stakeholders cited additional challenges that FDA faces in addressing 
economic adulteration, including its legal authorities. For example, 
one stakeholder said that FDA does not have the authority to accredit, 
or approve third parties to inspect establishments that make drugs; 
the stakeholder said that if FDA did have that authority, such 
inspections may help decrease FDA's inspection workload and could 
increase the total number of facilities inspected. FDA recently 
received authority to recognize, in certain situations, accreditation 
bodies that may then accredit qualified third parties to inspect food 
establishments. The FDA Food Safety Modernization Act provides that, 
no later than January 2013, FDA is to establish a program to recognize 
these accreditation bodies. It is worth noting, though, that FDA has 
had the authority to accredit third parties to conduct inspections of 
certain domestic and foreign medical device manufacturing 
establishments since 2002. FDA implemented its accreditation programs, 
permitting eligible establishments to voluntarily request inspections 
from third-party organizations, but relatively few establishments have 
chosen to take advantage of this program.[Footnote 21] 

Some stakeholders also told us that FDA's limited resources, including 
staffing, present a challenge. Specifically, they said FDA has limited 
ability to investigate potentially economically adulterated products 
because such investigations are resource-intensive. They also told us 
that FDA does not have the range of expertise among staff that is 
needed to address economic adulteration, in particular staff with a 
background in intelligence gathering or law enforcement. We have 
previously reported on FDA's own concerns about its staffing levels 
and oversight responsibilities for certain activities, such as its 
oversight of medical devices and inspections of establishments that 
manufacture approved drugs.[Footnote 22] 

Some Stakeholders Cited Greater Oversight and Information Sharing as 
Options to Address Economic Adulteration: 

Some stakeholders supported increased oversight by FDA, in particular, 
as an option to obtain more information on supply chains--information 
that is useful in tracing the source of economic adulteration. For 
example, one stakeholder suggested that the use of track-and-trace 
technology--such as using standard numerical identifiers on 
prescription drug packages--could facilitate FDA's oversight of the 
supply chain by making it easier for FDA and industry to trace 
adulterated ingredients back to the point of contamination. Under the 
new FDA Food Safety Modernization Act, the Secretary of HHS, acting 
through FDA, is directed to establish a system that will improve its 
ability to rapidly track and trace both domestic and imported foods. 
Similarly, the Food and Drug Administration Amendments Act of 2007 
required FDA to develop a unique device identifier system to 
adequately identify a medical device through distribution and use. 
According to FDA officials, the agency expects to publish a proposed 
rule on the establishment of this system by the end of 2011.[Footnote 
23] 

Many stakeholders also suggested that FDA increase its regulatory and 
enforcement actions to address economic adulteration. These 
stakeholders said that public health risk should be FDA's priority in 
taking such actions, but many also told us that FDA should pursue 
those who adulterate for economic gain, including in instances that 
may not have a large negative public health impact. For example, some 
stakeholders suggested building criminal cases against those who 
adulterate for economic gain and prosecuting them swiftly and visibly 
to help ensure that companies are complying with laws and regulations. 
In addition, these stakeholders said that, even when the adulteration 
has little health impact, such actions could help protect public 
health by deterring future instances, some of which may pose a 
significant health threat. Depending on the circumstances, such as the 
type of violation and product involved, a range of enforcement actions 
or penalties could be pursued. However, in February 2009, we reported 
that FDA has taken few actions in pursuing instances of economic fraud 
in seafood.[Footnote 24] In that report, we found that FDA did not 
issue any regulatory letters to companies regarding seafood fraud from 
2005 through 2008, and according to a senior FDA official, the agency 
had not taken any enforcement actions for seafood fraud since 2000. 

Even with the challenges related to the disclosure of proprietary 
information, stakeholders also suggested that greater communication 
with industry could enhance FDA efforts to gather information on 
economic adulteration. One option for greater communication that 
several stakeholders identified was the creation of an information 
clearinghouse, through which companies could anonymously share 
information on adulterated ingredients with FDA and other companies. 
Stakeholders noted that the clearinghouse could enhance FDA's ability 
to disseminate information on adulterated products quickly, facilitate 
secure information sharing across industries, and enable FDA and 
industry to respond more rapidly to potential instances of 
adulteration. For example, they said that a clearinghouse could allow 
the sharing of information, such as information on market price 
fluctuations, environmental disasters, or other macroeconomic factors. 
In the view of these stakeholders, this type of information may help 
both industry and FDA better target their efforts to detect and 
prevent economic adulteration. One stakeholder said that such a 
clearinghouse was an opportunity for industry and FDA to share 
information from various sources in a central location, which would 
help them draw conclusions about the authenticity of ingredients or 
raw materials. This stakeholder suggested that if an information 
clearinghouse had existed prior to the heparin incident, it could have 
contained critical information--such as the sudden increase or 
decrease in the price of ingredients for food or drugs --to alert FDA 
and industry to the potential for adulteration. 

One stakeholder noted that because some of the industries affected by 
economic adulteration are small, some companies might easily be 
identified by the information reported, even if they reported it 
anonymously. Consequently, some stakeholders suggested engaging a 
neutral third party to operate the information clearinghouse, thus 
helping to ensure that the information shared was free of specific 
company identifiers. FDA officials said that they are examining 
various ways to facilitate information sharing with industry and have 
discussed the idea of a clearinghouse, but they have no plans to 
develop one. 

In addition to formal information sharing, some stakeholders suggested 
more informal interaction between industry and FDA. Stakeholders noted 
that increased dialogue could provide opportunities for FDA to 
communicate to industry its overall strategy on economic adulteration. 
Some stakeholders told us that FDA's communication during adverse 
public health events was clear and timely but that at other times they 
were unsure what FDA was doing to address potential economic 
adulteration. Some stakeholders expressed a willingness to work with 
FDA on the issue but said that they need to better understand FDA's 
expectations of industry. For example, one stakeholder suggested a 
forum where FDA officials can talk to industry directly and engage in 
dialogue to clarify the agency's strategy. 

Some stakeholders from food industry groups also said that they 
believe the recent passage of the FDA Food Safety Modernization Act 
provides new opportunities for both FDA and industry to address 
economic adulteration. One stakeholder noted that the new law may give 
FDA more opportunities to include economic adulteration in its 
inspection program. In addition, stakeholders told us that they 
believe the law provides a science-and risk-based approach for 
companies to verify their ingredient suppliers, including multiple 
ways of assuring the public and FDA that industry has processes in 
place to detect economic adulteration. Specifically, under the act, 
certain facilities are required to identify reasonably foreseeable 
hazards and to prepare written control plans that illustrate 
reasonable approaches to looking for intentional adulteration. 

Lastly, one stakeholder said that FDA may need additional authority to 
require the drug industry to provide the agency with information 
critical to securing the medical product supply chain. Additional 
authority may include, for example, allowing FDA to require enhanced 
documentation from industry on its supply chains to increase 
transparency. In its comments on one of our recent reports, HHS also 
mentioned legislation previously under consideration by Congress that 
it believed would, if enacted, provide FDA with helpful tools to 
further secure the nation's drug supply chain.[Footnote 25] For 
example, according to the agency, the proposed legislation would have 
provided FDA authority to require foreign and domestic drug 
manufacturers to implement quality systems and adopt plans to identify 
and mitigate hazards. In its comment letter, FDA said that such 
legislation could ensure that the agency can hold industry accountable 
for the security and integrity of its supply chains and quality 
control systems. 

Conclusions: 

Economic adulteration is not a new problem. It can undermine 
confidence in the safety of the nation's food and medical products and 
have significant economic consequences for industry. The recent crises 
involving the contamination of pet food with melamine and the 
adulteration of heparin with oversulfated chondroitin sulfate showed 
that economic adulteration continues to be a problem and can have 
serious public health consequences. Senior FDA officials, including 
the Commissioner, have often spoken publicly about the threat posed by 
economic adulteration. However, FDA does not have a definition of 
economic adulteration. Without such a definition, when FDA detects 
adulteration, it is more difficult for the agency to make a 
distinction between economic adulteration and other forms of 
adulteration to guide the agency's thinking about how to be more 
proactive about this issue. In addition, FDA has not provided guidance 
to its centers and offices on how they should approach or address 
their economic adulteration efforts. This is not consistent with 
federal standards of internal control, which state that agencies 
should have documented policies and procedures in place to carry out 
management's directives. Some entities have undertaken efforts that 
specifically focus on economic adulteration, but they have not always 
communicated or coordinated their efforts with other FDA entities. 
Without such communication and coordination, in these times of 
economic uncertainty, FDA may not be making the best use of its scarce 
resources. As food and medical product supply chains become increasing 
global and complex, economic adulteration will continue to remain a 
threat. 

Recommendations for Executive Action: 

To enhance FDA's efforts to combat the economic adulteration of food 
and medical products, we recommend that the Commissioner of FDA take 
the following three actions: 

* adopt a working definition of economic adulteration, 

* provide written guidance to agency centers and offices on the means 
of addressing economic adulteration, and: 

* enhance communication and coordination of agency efforts on economic 
adulteration. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to HHS for review and comment. We 
received written comments from HHS, which are reproduced in appendix 
II. HHS neither agreed nor disagreed with our recommendations. In its 
comments, HHS stated that FDA views the term "economically motivated 
adulteration" as describing a subset of cases within the broader 
concept of adulteration, and believes that a holistic approach toward 
understanding and addressing adulteration generally is the best course 
forward. HHS also said that this approach will best serve the agency 
as it strives to protect the health and well-being of the American 
people by preventing, detecting, and taking appropriate responses to 
all adulterations of food and medical products. As we note in our 
report, however, agency entities have missed opportunities to 
communicate and coordinate efforts specifically directed at economic 
adulteration and identify potential public health risks. At the same 
time, FDA said that it recognizes the importance of sharing and 
leveraging information relevant to economically motivated adulteration 
and the utility of a mechanism for facilitating such sharing and 
collaboration at FDA. The department provided additional information 
in its written comments on planned actions of FDA's Working Group on 
Economically Motivated Adulteration that are consistent with two of 
the three recommendations we made in our draft report. The additional 
comments related to our recommendations that FDA adopt a working 
definition of economic adulteration and enhance communication and 
coordination of agency efforts on economic adulteration are as follows: 

* Adopt a working definition of economic adulteration. HHS stated that 
the Working Group on Economically Motivated Adulteration will use the 
working definition of economically motivated adulteration that FDA 
proposed at its May 2009 public meeting on the topic. 

* Enhance communication and coordination of agency efforts on economic 
adulteration. HHS stated that FDA expects the efforts of the working 
group will result in enhanced collaboration and communication at FDA 
on ways to approach and address situations of economically motivated 
adulteration. 

We have included this additional information in our report. 

HHS also provided technical comments, which we incorporated as 
appropriate. 

As agreed with your offices, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies of this report 
to the appropriate congressional committees, the Secretary of Health 
and Human Services, the Commissioner of the Food and Drug 
Administration, and other interested parties. In addition, the report 
will be available at no charge on the GAO website at [hyperlink, 
http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov or Marcia 
Crosse at (202) 512-7114 or crossem@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. GAO staff who made key contributions to 
this report are listed in appendix III. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

Signed by: 

Marcia Crosse: 
Director, Health Care: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

This report examines (1) the approaches the Food and Drug 
Administration (FDA) uses to detect and prevent economic adulteration 
of food and medical products, and (2) the challenges, if any, FDA 
faces in detecting and preventing economic adulteration and 
stakeholder views on options for FDA to enhance its efforts to address 
economic adulteration. For this report, we define economic 
adulteration as "the fraudulent, intentional substitution or addition 
of a substance in a product for the purpose of increasing the apparent 
value of the product or reducing the cost of its production, i.e., for 
economic gain. [It] includes dilution of products with increased 
quantities of an already-present substance (e.g., increasing inactive 
ingredients of a drug with a resulting reduction in strength of the 
finished product, or watering down of juice) to the extent that such 
dilution poses a known or possible health risk to consumers, as well 
as the addition or substitution of substances in order to mask 
dilution." Our definition of economic adulteration is the same as the 
working definition of "economically motivated adulteration" that FDA 
developed for a May 2009 public meeting to raise awareness and solicit 
input on the topic. We did not include counterfeiting of a finished 
product because counterfeiting concerns the unauthorized use of 
intellectual property rights. 

To determine the approaches FDA uses to detect and prevent economic 
adulteration of food and medical products, we interviewed officials 
from the five FDA centers responsible for food and medical products, 
including the Center for Food Safety and Applied Nutrition, the Center 
for Veterinary Medicine, the Center for Drug Evaluation and Research, 
the Center for Devices and Radiological Health, and the Center for 
Biologics Evaluation and Research, as well as FDA's Office of 
Regulatory Affairs, Office of International Programs, and Office of 
the Commissioner. We also interviewed former FDA officials and 
representatives of organizations that have been assisting FDA in its 
efforts to detect and prevent economic adulteration, including the 
United States Pharmacopeia, the University of Minnesota's National 
Center for Food Protection and Defense, and New Mexico State 
University's Center for Animal Health, Food Safety and Bio-Security. 
We reviewed relevant FDA documents, including regulations, compliance 
manuals and inspection guides, sampling surveillance results, 
statements and presentations by agency officials, a contract to fund a 
research project at the National Center for Food Protection and 
Defense, and communications with industry and the public. We also 
reviewed published information from FDA, including its Strategic 
Priorities 2011-2015 report, its Pathway to Global Product Safety and 
Quality report, and Federal Register notices. We also reviewed 
previous GAO reports and recommendations on FDA's oversight of food 
and medical products, as well as the agency's strategic planning 
efforts. We compared FDA's efforts to address economic adulteration 
with federal standards for internal control.[Footnote 26] 

To determine the challenges FDA faces in detecting and preventing 
economic adulteration, we interviewed and obtained the views of FDA 
officials and stakeholders about the challenges the agency faces in 
addressing economic adulteration. Stakeholders included members of 
academia and representatives of industry and consumer groups who made 
presentations at FDA's May 2009 meeting on economically motivated 
adulteration, as well as former FDA officials who were involved in 
agency efforts that led to that meeting. We also interviewed and 
obtained the views of the stakeholders on options for FDA to enhance 
its efforts to address economic adulteration. The views of these 
stakeholders are not representative of and cannot be generalized to 
all stakeholders. In addition, we reviewed FDA and stakeholder 
documents related to challenges and options, as well as portions of 
the FDA Food Safety Modernization Act. 

We conducted this performance audit from September 2010 to October 
2011 in accordance with generally accepted government auditing 
standards. Those standards require that we plan and perform the audit 
to obtain sufficient, appropriate evidence to provide a reasonable 
basis for our findings and conclusions based on our audit objectives. 
We believe that the evidence obtained provides a reasonable basis for 
our findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Comments from the Department of Health and Human Services: 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

October 7, 2011: 

Lisa Shames, Director: 
Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Shames: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) draft report entitled, "Food And Drug Administration: Better 
Coordination Could Enhance Efforts to Address Economic Adulteration 
and Protect the Public Health" (GAO-12-46). 

The Department appreciates the opportunity to review this report 
before its publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

cc: Marcia Crosse, Director, Health Care: 

[End of letter] 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled, 
"Food And Drug Administration: Better Coordination Could Enhance 
Efforts To Address Economic Adulteration And Protect The Public 
Health" (GAO-12-46): 

The Department appreciates the opportunity to comment on this draft 
report. 

More and more of the foods and medical products that the Food and Drug 
Administration (FDA) regulates are produced overseas, by hundreds of 
thousands of firms, and the paths by which these products reach our 
borders and travel on to our grocery stores, hospitals, pharmacies and 
doctors' offices are increasingly long and complex. The global nature 
of the U.S. marketplace presents formidable challenges to the FDA as 
it works to ensure the safety of these foods and medical products. The 
sheer number of firms and complexity of these supply chains provide 
myriad opportunities for many forms of adulteration, any of which 
poses risk to the health and well-being of the American people. For 
example, FDA has grappled with adulteration of food and medical 
products arising from deficient manufacturing practices, including 
insufficient attention to the sources and supply chains for 
ingredients; cargo theft; counterfeiting; and apparent economic 
motivation. It is also conceivable that FDA-regulated products could 
be used as a vehicle for terrorists. 

FDA's first priority is to protect the American public by enhancing 
its capacity to prevent, detect, and respond to all adulterations that 
may harm American consumers and patients. The adulteration of pet food 
with melamine, and heparin with oversulfated chondroitin sulfate, 
serve as compelling illustrations of the challenges that FDA faces in 
securing our food and pharmaceutical supply chains. These incidents 
demonstrate the increasing opportunities that extended and fractured 
supply chains present to those who, for economic gain or to 
intentionally harm people, are willing to adulterate foods and drugs. 
The melamine and heparin contamination incidents are not the first 
such examples, and they may not be the last. They are clarion calls to 
the agency, and anyone with an interest in promoting the public 
health, to improve controls on quality in, and collect better 
information about, the supply chains of products, and to develop tools 
for anticipating, preventing, and taking actions to address the 
adulteration. These iconic incidents have served to heighten the 
efforts across the FDA to address these challenges. 

FDA views the term "economically motivated adulteration," as 
describing a subset of cases within the broader concept of 
adulteration, and believes that a holistic approach toward 
understanding and addressing adulteration generally is the best course 
forward. Securing the supply chains of FDA-regulated goods will help 
the agency to minimize opportunities for contamination and 
adulteration--whether intentional or otherwise. In terms of motivation 
or intention, often it is the ignorance, indifference or recklessness 
of someone downstream in the supply chain that provides opportunities 
for intentional adulteration by someone up-stream. Only a holistic, 
quality systems approach toward securing these supply chains will 
effectively constrain opportunities for adulteration, regardless of 
motivation. In addition, the agency believes that in responding to 
instances of adulteration, its first focus must be to identify the 
adulterated product and remove it from the supply chain so that it is 
not circulating in the market place where it can harm consumers or 
patients, regardless of the reason or motivation for the adulteration. 

Prompted by the ever-changing and unpredictable global environment 
that threatens the safety of pharmaceutical and food supply chains, 
FDA has developed a strategy, articulated in FDA's Pathway to Global 
Product Safety and Quality, that fundamentally changes its posture 
from intercepting adulterated product to anticipating and preventing 
conditions and actions that could threaten the health and safety of 
the American people. Although this particular GAO study focuses 
specifically on what it calls "economic adulteration," and GAO would 
have the agency focus on discerning whether adulteration is economic 
or not, FDA emphasizes its strategy to address the increasingly 
complex and unpredictable global environment through a holistic 
approach that recognizes and adapts to the broad challenges of 
globalization and the numerous opportunities it provides for all forms 
of adulteration. As explained in the Pathway to Global Product Safety 
and Quality, FDA's approach is to transform itself fully into a global 
regulatory agency with an "international operating model that relies 
on enhanced intelligence, information sharing, data-driven risk 
analytics, and the smart allocation of resources through leveraged 
partnerships." This approach will best serve the agency as it strives 
to protect the health and well-being of the American people by 
preventing, detecting, and taking appropriate responses to all 
adulterations of food and medical products.[Footnote 1] 

The Food Safety Modernization Act of 2011 (FSMA) charged FDA with 
building a modern, prevention-oriented food safety system suited for 
today's globalized food supply. Specifically, FSMA provided FDA with 
new authority to promulgate a wide range of regulations, with an 
enhanced focus on risk-based resource allocation, and partnership 
across the public and private sectors to minimize hazards from farm-to-
table. Many of FDA's new authorities under FSMA enhance FDA's ability 
to prevent adulteration, including economically motivated 
adulteration. These authorities include requirements for a system of 
hazard analysis and risk-based preventive controls in most food 
facilities, new standards for produce safety, mandatory recall 
authority, administrative detention, requirements to specifically 
protect against the intentional adulteration of high-risk foods, 
enhanced tracking and tracing of food and new recordkeeping 
requirements, enhanced authority to inspect foreign food facilities, 
and the development of a foreign supplier verification program. 

Similarly, obtaining new drug safety regulatory authorities directed 
toward an increasingly complex and globalized world may help ensure 
the security and integrity of drug supply chains and the systems used 
to produce pharmaceutical products for the American people. Such new 
authorities, if enacted, could help to level the playing field between 
domestic and foreign drug manufacturers, ensure drug product safety, 
and provide FDA with the information it needs to protect consumers. 
Those authorities may include: 

* Refusal of drug product admission to the United States if inspection 
of the manufacturing facility is delayed, limited, or denied; 

* Requirement of information or other assurance of compliance with 
applicable standards or requirements as a condition of importation; 

* Quality management systems to place greater responsibility on 
manufacturers to account for the quality and provenance of the 
materials that go into their products; 

* Mandatory recall authority; 

* Administrative destruction at the border; 

* Administrative detention; 

* Enhanced criminal and civil penalties for foreign and domestic 
suppliers; 

* Modernization of drug registration and listing; 

* Notification to FDA from foreign and domestic companies of complete 
information on threats such as counterfeiting, theft, non-compliance 
with regulatory standards, mislabeling or misbranding, or other 
threats to the security of the drug supply chain; 

* Unique facility identifiers as a condition of registration and 
importation to help FDA to follow threats up the supply chain and to 
properly cross-reference; 

* Authority to share certain non-public information with other 
regulatory agencies and foreign governments in order to allow FDA to 
share certain information that could lead to timely identification, 
prevention, and resolution of emerging threats; and; 

* The requirement of a cost-effective track-and-trace system for all 
drug products throughout the supply chain to improve the security and 
integrity of the drug supply and ensure transparency and 
accountability of product manufacturing and distribution, whether the 
product is manufactured domestically or internationally. 

Within this broad strategic framework to address the challenges of 
globalization, FDA recognizes the importance of sharing and leveraging 
information relevant to economically motivated adulteration and the 
utility of a mechanism for facilitating such sharing and collaboration 
at FDA. To that end, FDA recently established the Working Group on 
Economically Motivated Adulteration (WEMA). Comprised of staff from 
all of the Centers, ORA, and Office of the Commissioner, including 
risk managers, economists, regulatory counsel, and policy analysts, 
WEMA seeks to encourage information sharing across FDA on issues 
relevant to economically motivated adulteration. Because such threats 
have common risk factors, FDA can benefit from sharing intelligence, 
experiences, data, models, and strategies. This collaboration may 
include the development of approaches to prevent economically 
motivated adulteration and processes for information sharing. 

To identify topics of broad FDA interest, the WEMA will use the 
working definition proposed at the May 1, 2009 Public Meeting on 
economically motivated adulteration: 

The fraudulent, intentional substitution or addition of a substance in 
a product for the purpose of increasing the apparent value of the 
product or reducing the cost of its production, i.e., for economic 
gain. EMA includes dilution of products with increased quantities of 
an already-present substance (e.g., increasing inactive ingredients of 
a drug with a resulting reduction in strength of the finished product, 
or watering down of juice) to the extent that such dilution poses a 
known or possible health risk to consumers, as well as the addition or 
substitution of substances in order to mask dilution. 

This working definition has been used to generate dialogue between the 
FDA, the regulated community, and advocacy groups. It has gained 
traction as a practical working definition, and although it does not 
serve as a legal definition or require conformance or uniform 
acceptance, it is a functional and adaptable means of identifying 
situations of economically motivated adulteration that may concern 
multiple Centers, enabling them to focus their discussions and 
encouraging communication and collaboration. 

Organized by the Office of Regulatory Affairs' Risk Management Staff, 
the WEMA held its first meeting on September 23, 2011, with plans to 
meet regularly to accomplish its goals. The WEMA will facilitate 
discussion and recommendations on the exchange of information and 
intelligence related to economically motivated adulteration. FDA 
expects that the work group's efforts will result in enhanced 
collaboration and communication at FDA on ways to approach and address 
these important public health issues. 

Appendix II Footnote: 

[1] In addition, in September 2011 FDA issued for comment a draft FDA 
Foods and Veterinary Medicine Program Strategic Plan for 2012-2016. 
The draft Strategic Plan identifies "intentional contamination" as a 
growing concern in the food and veterinary medicine program areas and 
indicates that key initiatives in coming years include setting 
preventive control standards for intentional contamination. 

[End of section] 

Appendix III: GAO Contacts and Staff Acknowledgments: 

GAO Contacts: 

Lisa Shames at (202) 512-3841 or shamesl@gao.gov: 

Marcia Crosse at (202) 512-7114 or crossem@gao.gov: 

Staff Acknowledgments: 

In addition to the contacts named above, Jose Alfredo Gomez (Assistant 
Director), Geraldine Redican-Bigott (Assistant Director), Cheryl 
Williams (Assistant Director), Kevin Bray, Mollie Hertel, Sherrice 
Kerns, Susan Malone, Michael Rose, Cynthia Saunders, Ben Shouse, and 
Kiki Theodoropoulos made key contributions to this report. 

[End of section] 

Related GAO Products: 

High-Risk Series: 

High-Risk Series: An Update. [hyperlink, 
http://www.gao.gov/products/GAO-11-278]. Washington, D.C.: February 
2011. 

Reports and Testimonies: 

Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug 
Manufacturing Supply Chain. [hyperlink, 
http://www.gao.gov/products/GAO-11-936T]. Washington, D.C.: Sept. 14, 
2011. 

Medical Devices: FDA Should Enhance Its Oversight of Recalls. 
[hyperlink, http://www.gao.gov/products/GAO-11-468]. Washington, D.C.: 
June 14, 2011. 

Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and 
Better Leverage Limited Resources. [hyperlink, 
http://www.gao.gov/products/GAO-11-286]. Washington, D.C.: April 14, 
2011. 

Federal Food Safety Oversight: Food Safety Working Group Is a Positive 
First Step but Governmentwide Planning Is Needed to Address 
Fragmentation. [hyperlink, http://www.gao.gov/products/GAO-11-289]. 
Washington, D.C.: March 18, 2011. 

Food Labeling: FDA Needs to Reassess Its Approach to Protecting 
Consumers from False or Misleading Claims. [hyperlink, 
http://www.gao.gov/products/GAO-11-102]. Washington, D.C.: January 14, 
2011. 

Food and Drug Administration: Response to Heparin Contamination Helped 
Protect Public Health; Controls That Were Needed for Working With 
External Entities Were Recently Added. [hyperlink, 
http://www.gao.gov/products/GAO-11-95]. Washington, D.C.: October 29, 
2010. 

Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to 
Improve Its Information on Foreign Establishments, but More Progress 
Is Needed. [hyperlink, http://www.gao.gov/products/GAO-10-961]. 
Washington, D.C.: September 30, 2010. 

Food and Drug Administration: Overseas Offices Have Taken Steps to 
Help Ensure Import Safety, but More Long-Term Planning Is Needed. 
[hyperlink, http://www.gao.gov/products/GAO-10-960]. Washington, D.C.: 
September 30, 2010. 

Food Safety: FDA Could Strengthen Oversight of Imported Food by 
Improving Enforcement and Seeking Additional Authorities. [hyperlink, 
http://www.gao.gov/products/GAO-10-699T]. Washington, D.C.: May 6, 
2010. 

Food and Drug Administration: Opportunities Exist to Better Address 
Management Challenges. [hyperlink, 
http://www.gao.gov/products/GAO-10-279]. Washington, D.C.: February 
19, 2010. 

Food Safety: Agencies Need to Address Gaps in Enforcement and 
Collaboration to Enhance Safety of Imported Food. [hyperlink, 
http://www.gao.gov/products/GAO-09-873]. Washington, D.C.: September 
15, 2009. 

Food and Drug Administration: FDA Faces Challenges Meeting Its Growing 
Medical Products Responsibilities and Should Develop Complete 
Estimates of Its Resource Needs. [hyperlink, 
http://www.gao.gov/products/GAO-09-581]. Washington, D.C.: June 19, 
2009. 

Seafood Fraud: FDA Program Changes and Better Collaboration among Key 
Federal Agencies Could Improve Detection and Prevention. [hyperlink, 
http://www.gao.gov/products/GAO-09-258]. Washington, D.C.: February 
19, 2009. 

Dietary Supplements: FDA Should Take Further Actions to Improve 
Oversight and Consumer Understanding. [hyperlink, 
http://www.gao.gov/products/GAO-09-250]. Washington, D.C.: January 29, 
2009. 

[End of section] 

Footnotes: 

[1] According to FDA officials, the imported vegetable protein 
products also contained cyanuric acid, a melamine-related compound. 
Melamine and cyanuric acid individually are relatively nontoxic. 
However, when combined, they produce crystals, which can lead to 
kidney failure. For purposes of this report, we use the term melamine 
to mean melamine and its related analogs (e.g., melamine and cyanuric 
acid). 

[2] Biologics are generally materials--such as vaccines--derived from 
living sources, such as humans, animals, and microorganisms, as well 
as materials produced by biotechnology methods. See 42 U.S.C. § 
262(i); 21 C.F.R. § 600.3(h). 

[3] GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February 
2011). 

[4] GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January 
2007); and High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January 
2009). 

[5] See 74 Fed. Reg. 15498 (Apr. 6, 2009). 

[6] For the purposes of this report, we are using the term "economic 
adulteration" to mean "economically motivated adulteration." 

[7] The United States Department of Agriculture is responsible for 
ensuring the safety of meat and poultry products. 

[8] According to FDA's Office of Chief Counsel, formal enforcement 
actions available to FDA include initiating a seizure of an 
adulterated product, seeking an injunction to stop a company from 
engaging in certain behavior, or referring a firm for criminal 
prosecution. FDA can also issue warning letters, which are intended to 
prompt companies to voluntarily correct violations of regulatory 
significance. 

[9] GAO, Food and Drug Administration: FDA Faces Challenges Meeting 
Its Growing Medical Product Responsibilities and Should Develop 
Complete Estimates of Its Resource Needs, [hyperlink, 
http://www.gao.gov/products/GAO-09-581] (Washington, D.C.: June 19, 
2009). 

[10] GAO, Food and Drug Administration: Opportunities Exist to Better 
Address Management Challenges, [hyperlink, 
http://www.gao.gov/products/GAO-10-279] (Washington, D.C.: Feb. 19, 
2010). 

[11] GAO, Food and Drug Administration: Overseas Offices Have Taken 
Steps to Help Ensure Import Safety, but More Long-Term Planning Is 
Needed, [hyperlink, http://www.gao.gov/products/GAO-10-960] 
(Washington, D.C.: Sept. 30, 2010). 

[12] The official drug compendium of the United States is the United 
States Pharmacopeia/National Formulary, published by the United States 
Pharmacopeial Convention, a non-governmental, standard-setting 
authority. 

[13] For more information on PREDICT, see Food Safety: FDA Has Begun 
to Take Action to Address Weaknesses in Food Safety Research, but Gaps 
Remain, [hyperlink, http://www.gao.gov/products/GAO-10-182R] 
(Washington, D.C.: Apr. 23, 2010). 

[14] API refers to any component that is intended to provide 
pharmacological activity or other direct effect in the diagnosis, 
cure, mitigation, treatment, or prevention of disease. 

[15] These standards are in the form of monographs--written standards 
that describe a substance or product, including information on tests 
needed to ensure that the substance is of the appropriate strength, 
quality, and purity. 

[16] The National Center for Food Protection and Defense is a research 
consortium that addresses the vulnerability of the nation's food 
system to attack through intentional contamination with biological or 
chemical agents. 

[17] While CVM has not undertaken any efforts exclusively targeting 
economic adulteration, in its written comments on our draft report, 
HHS noted that CVM is participating in an FDA Monograph Modernization 
Task Group to help USP prioritize monographs in need of modernization, 
which includes reduction of economic adulteration. 

[18] [hyperlink, http://www.gao.gov/products/GAO-10-279]. 

[19] Department of Health and Human Services, U.S. Food and Drug 
Administration, Pathway to Global Product Safety and Quality 
(Washington, D.C.: July 2011). 

[20] GAO, Standards for Internal Control in the Federal Government, 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). 

[21] GAO, Medical Devices: Shortcomings in FDA's Premarket Review, 
Postmarket Surveillance, and Inspections of Device Manufacturing 
Establishments, [hyperlink, http://www.gao.gov/products/GAO-09-370T] 
(Washington, D.C.: June 18, 2009). 

[22] [hyperlink, http://www.gao.gov/products/GAO-09-581], and GAO, 
Food and Drug Administration: Effect of User Fees on Drug Approval 
Times, Withdrawals, and Other Agency Activities, [hyperlink, 
http://www.gao.gov/products/GAO-02-958] (Washington, D.C.: Sept. 17, 
2002). 

[23] GAO, Medical Devices: FDA Should Enhance Its Oversight of 
Recalls, [hyperlink, http://www.gao.gov/products/GAO-11-468] 
(Washington, D.C.: June 14, 2011). 

[24] GAO, Seafood Fraud: FDA Program Changes and Better Collaboration 
among Key Federal Agencies Could Improve Prevention and Detection, 
[hyperlink, http://www.gao.gov/products/GAO-09-258] (Washington, D.C.: 
Feb. 19, 2009). 

[25] [hyperlink, http://www.gao.gov/products/GAO-11-95]. 

[26] GAO, Standards for Internal Control in the Federal Government, 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). 

[End of section] 

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