[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