[Federal Register Volume 74, Number 64 (Monday, April 6, 2009)]
[Notices]
[Pages 15497-15499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0166]


Economically Motivated Adulteration; Public Meeting; Request for 
Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting pertaining to economically motivated adulteration (EMA). The 
purpose of the meeting is to stimulate and focus a discussion about 
ways in which the food (including dietary supplements and animal food), 
drug, medical device, and cosmetic industries, regulatory agencies, and 
other parties can better predict and prevent economically motivated 
adulteration with a focus on situations that pose the greatest public 
health risk. FDA invites interested individuals, organizations, and 
other stakeholders, including industry representatives, to present 
information pertaining to predicting and preventing EMA of food 
(including dietary supplements and animal food), drugs, medical 
devices, and cosmetics. The agency also requests interested parties to 
submit comments on this issue to the public docket.

DATES: The public meeting will be held on May 1, 2009, from 9 a.m. to 5 
p.m. Submit written or electronic comments by August 1, 2009. See 
section I of the SUPPLEMENTARY INFORMATION section for deadlines 
regarding the meeting.

ADDRESSES: The public meeting will be held in the Wiley Auditorium, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., 
College Park, MD 20740-3835. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD, 20852. Submit electronic 
comments to the docket at http://www.regulations.gov. See section V of 
this document for additional information on submitting comments.

FOR FURTHER INFORMATION CONTACT:
    For registration, requests to make an oral presentation, and 
submission of written material for the presentation: Deborah Harris, 
EDJ Associates, Inc., 11300 Rockville Pike, suite 1001, Rockville, MD 
20852, 240-221-4326, FAX: 301-945-4295, e-mail: 
[email protected].
    For general questions about the meeting, to request onsite parking 
for the meeting, or for special accommodations due to a disability: 
Juanita Yates, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-009), 5100 Paint Branch Pkwy., College Park, 
MD 20740, 301-436-1731, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. How to Participate in the Meeting

    Due to limited space and time, we encourage all persons who wish to 
attend the meeting, including those requesting an opportunity to make 
an oral presentation at the meeting, to register in advance. Attendees 
may register in advance for the meeting by April 23, 2009. Requests for 
oral presentations should be made by April 16, 2009. Presenters should 
submit final presentations by April 23, 2009, in order for us to 
accommodate their request. Requests for special accommodations due to 
disability should be made by April 23, 2009. Requests for onsite 
parking may be made until April 27, 2009.
    We encourage attendees to register for this meeting electronically 
at http://www.fda.gov/oc/meetings/ema.html. You may also register by 
mail, fax, e-mail, or telephone by providing registration information 
(including name, title, firm name, address, telephone number, fax 
number, and e-mail address) to the contact person (see FOR FURTHER 
INFORMATION CONTACT). Attendees will have an opportunity to provide 
oral comments. Depending on the number of oral presentations, we

[[Page 15498]]

may need to limit the time of each oral presentation (e.g., 5 minutes 
each). Requests to make an oral presentation, submission of written 
material for the presentation, requests for special accommodations due 
to disability, and requests for onsite parking should be directed to 
the contact person (see FOR FURTHER INFORMATION CONTACT).

II. Background on the Meeting

A. Suspected Economically Motivated Adulteration of FDA-Regulated 
Products

    For purposes of this public meeting, FDA proposes a working 
definition of EMA 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. 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.
    Several recent incidents involving FDA-regulated products are 
suspected to be examples of EMA. These incidents illustrate the 
potential for serious public health harm from such adulterated 
products.
    In March 2007, FDA received reports of kidney failure among cats 
and dogs and a report that cats died during taste tests of certain 
brands of pet food. In the subsequent investigation, melamine and 
melamine-related compounds were found in products labeled as wheat 
gluten and rice protein concentrate that had been imported from China. 
Wheat gluten and rice protein concentrate are common ingredients in 
numerous pet food products sold in the United States. Melamine and its 
related compounds are not approved for use as an ingredient in animal 
or human food, and FDA believes it was these contaminants that made the 
cats and dogs sick. At certain exposure levels, the interaction of 
melamine and melamine-related compounds appears to cause the formation 
of crystals in the kidneys, resulting in kidney damage. Based on the 
information that FDA has, it appears that these contaminants were added 
to the products handled by Chinese suppliers to increase the apparent 
protein content in those products. Consumers and veterinarians have 
since reported many more animal illnesses and deaths potentially 
associated with pet foods made from these products. Over 150 brands of 
pet food and 1,000 products were voluntarily recalled by a number of 
companies.
    In January 2008, FDA received reports of adverse reactions in 
pediatric dialysis patients in the U.S. Initial investigations by the 
Centers for Disease Control and Prevention indicated that the adverse 
events appeared to be associated with heparin manufactured by Baxter 
Healthcare Corp. that was administered during the dialysis procedures. 
In January and February 2008, Baxter Healthcare Corp. voluntarily 
recalled all of its heparin products. FDA's investigation ultimately 
identified almost 150 U.S. deaths occurring between January 1, 2007, 
and May 31, 2008, that appeared to be associated with the use of these 
heparin products. During the investigation, FDA scientists collaborated 
with academia and industry and identified a contaminant in the heparin 
active pharmaceutical ingredient (API) obtained from suppliers in 
China. The contaminant was a heparin-like molecule whose presence in 
heparin API was not detected by the United States Pharmacopoeia (USP) 
release tests for heparin. The contaminant was identified as 
oversulfated chondroitin sulfate (OSCS). FDA posted two new analytical 
tests to detect the contaminant OSCS on its Web site in March 2008, and 
the agency collaborated with USP to revise the test methods and modify 
the monograph for heparin to test for OSCS. These new tests were used 
on heparin API imported into the United States and throughout the 
world. Contaminated heparin API has been found in 11 countries.
    In September 2008, FDA issued a Health Information Advisory in 
response to reports of melamine contaminated milk-based infant formula 
manufactured in China. Melamine was apparently added to diluted milk in 
order to increase measured nitrogen levels (indicators of protein 
content) and thereby inflate the apparent protein content found in the 
product. FDA issued further advisories to address additional milk-based 
products. To date, official reports from the Chinese Ministry of Health 
state that nearly 300,000 Chinese infants were sickened by the 
contaminated infant formula, and that six infant deaths were likely due 
to the contamination. There have been no confirmed illnesses or deaths 
in the United States attributed to melamine in products containing milk 
or milk-derived ingredients, although some contaminated products were 
found at ethnic markets selling imported products.
    Adulteration of glycerin, an ingredient in cough syrup and other 
drugs, with diethylene glycol (DEG) has resulted in several mass 
poisonings around the world in the past two decades. In 1996, 
contaminated acetaminophen syrup was responsible for the deaths of more 
than 70 children in Haiti. In 2006, tainted cough syrup resulted in 
dozens of deaths in Panama. In Nigeria, between 2008 and 2009, more 
than 50 children died after ingesting contaminated teething syrup. 
Incidents of DEG contamination in these two decades have not resulted 
in any reported U.S. deaths or illnesses, but in 2007, foreign-made 
toothpaste contaminated with DEG was reported in the United States 
resulting in recalls and restriction on imports of suspect toothpastes. 
FDA has collaborated with USP to revise the test methods for glycerin 
and other monographs to test for the presence of DEG.
    As the preceding examples illustrate, despite longstanding FDA 
requirements to assure the safety of regulated products, such as 
requirements for the use of ingredients of known identity and quality 
in drugs, economically motivated adulteration remains a public health 
threat.

B. FDA Science Board Meeting and EMA Workgroup

    At the October 31, 2008, meeting of the FDA Science Board, FDA 
presented a conceptual model of EMA. The model describes circumstances 
and factors that are likely to lead to EMA, and points to certain types 
of information that may be useful in trying to prevent EMA. In response 
to the feedback obtained during the Science Board Meeting, FDA formed 
an internal working group focused on predicting and addressing EMA 
(``EMA Workgroup''). At the February 25, 2009, meeting of the Science 
Board, FDA announced its intent to hold a public meeting on EMA.

III. Purpose of Meeting and Questions for Discussion

    The purpose of the public meeting is to raise awareness about the 
potential for EMA and solicit input and comments on how industry, 
regulators, and other parties can better predict, prevent, and address 
EMA. FDA's EMA Workgroup has developed a set of questions to focus 
discussion on the matter. These questions apply to food (including 
dietary supplements and animal food), drug, device and cosmetic 
products and their components/ingredients. The EMA Workgroup requests 
comment and input on these

[[Page 15499]]

questions, as well as any responses to the questions themselves based 
on information that may already be in the public domain. The EMA 
Workgroup further requests comment on the utility of the working 
definition of EMA used here. A transcript of the public meeting will be 
made available.
    Please note that FDA does not wish to publicize sensitive 
information that could potentially be used by those who wish to commit 
EMA or other adulteration or that identifies those who may be 
committing adulteration FDA would like to remind the public that if 
they have information about these or any other problems they have 
encountered with FDA products, they may report such information at 
http://www.fda.gov/opacom/backgrounders/problem.html. In addition, if 
the public has information pertaining to suspected criminal activity 
with regard to FDA-regulated products (e.g., information about 
individuals who may be committing EMA or other adulteration), they may 
contact FDA's Office of Criminal Investigations at http://www.fda.gov/oci/default.htm in lieu of responding publicly to this document.
(1) General Questions:
     a. What information should U.S. regulators seek and from what 
sources to help predict and prevent EMA? What further steps can U.S. 
regulators take to predict and prevent EMA?
     b. What are members of industry doing to prevent EMA? What further 
steps can industry take to prevent EMA?
     c. What recent examples of known or suspected EMA domestically and 
internationally should U.S. regulators study and learn from?
     d. What information do other organizations (including, but not 
limited to, trade organizations and security service providers) have 
that would be useful in predicting and preventing EMA? What are members 
of other organizations doing to prevent EMA?
     e. What are other government regulators within and outside of the 
United States doing to predict and address EMA?
     f. What indicators (economic-based, chemistry-based, etc.) might 
be used to detect potential EMA?
(2) Questions pertaining to attributes of products, components/
ingredients that may be at risk for EMA:
     a. What are attributes of products or components/ingredients of 
products that may cause them to be more vulnerable to EMA?
     b. What food products are marketed based on measured content of 
certain constituents, such as content of certain proteins, certain 
fats, or certain sugars?
(3) Questions pertaining to changes in the marketing environment: What 
changes relevant to the risk for EMA have occurred recently in:
     a. The marketing environment of products or components/
ingredients?
     b. The sourcing and/or distribution of products?
     c. The prices, output, imports or exports of products or 
components/ingredients?
     d. The supply of components/ingredients or source materials for 
products?
(4) Questions about detection methods:
     a. What analytical equipment or methods currently used by industry 
and regulators to establish the identity or quality of a product or its 
conformity to specifications may be inadequate to detect evidence of 
EMA or adulterated products or ingredients?
     b. Are there appropriate analytical methods/equipment that could 
be used instead of, or in addition to, existing methods or equipment in 
particular situations?
     c. What rapid methods can be used to detect adulteration of 
products or ingredients?
(5) What systems are currently being used to track and verify 
components/ingredients from their source?
(6) Are there particular types of industry structures or supply chains 
that are especially vulnerable to or secure from potential EMA?

IV. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: April 1, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-7843 Filed 4-2-09; 4:15 pm]
BILLING CODE 4160-01-S