Randall Lutter, Ph.D. Deputy Commissioner for Policy U.S. Food and Drug Administration May 2009 Addressing Challenges of Economically-Motivated Adulteration

2 Recent Cases Melamine In Food –Added to infant formula & dairy apparently to enhance perceived quality –Added to flour intended for pet food apparently to enhance protein content Contaminated Heparin –Contaminated with oversulfated chondroitin sulphate apparently to evade an analytical test Diethylene Glycol –Drugs and foods contaminated from substitution with toxic syrup. At least eight mass poisonings around the world in the past two decades. Common theme: contaminant thought to have been intentionally introduced for economic gain.

3 Working Definition 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.

4 Common Theme Suggests a New Approach New Strategy –Identify new efficient ways of predicting risk, based on new risk factors such as assays, ingredients, product characteristics, early signals, etc, associated with economically motivated adulteration. New Process –Formed internal work group –Sought advice from Science Board –Sought advice from other agencies –Public meeting (and other information)

5 Contact Us FDA does not wish to publicize sensitive information that could potentially be used by those who wish to profit from adulterating food or medical products or that identifies those that may be committing adulteration People with information about these or other problems they have encountered with FDA products may report such information at People with information pertaining to suspected criminal activity with regard to FDA-regulated products may contact FDA’s Office of Criminal Investigations at

6 Deliberate contamination for economic purposes is not new 1858: Sale of “swill milk” in NYC—milk derived from cows fed alcoholic mash that killed up to 8000 children in a year. New York Times, August 13, 1890:

7 Congressional Actions to Address Intentional Adulteration Federal Food and Drugs Act of finding food adulterated –If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength. –If any substance has been substituted wholly or in part for the article. –If any valuable constituent of the article has been wholly or in part abstracted. –If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed. Filled Milk Act of deeming “filled milk” adulterated –Filled milk means “any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated, to which has been added, or which has been blended or compounded with, any fat or oil other than milk fat, so that the resulting product is in imitation or semblance of milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated.” Indeed, the effort of FDA to reduce risks associated with inadvertent contamination and poor quality control is relatively recent.

8 New Challenges: Globalization Globalization has raised economically motivated adulteration as a key concern. Volume of imported “lines” of FDA-regulated products has grown 14% annually since Imports of FDA-regulated products as a percent of US consumption: –Food: 15% * –Drugs: 27% ** –Devices: 22%** –Cosmetics: 9% ** –* USDA, Economic Research Service, September 2008 ** based on: US custom value and US value of shipments

9 New Challenges: Globalization Protection at the border is intrinsically more challenging –Inspections more costly overseas and equivalent state regulatory agencies do not exist. –Other information more scarce. Despite ongoing efforts at strengthening –We have opened new offices in China, India, Latin America and Europe to better ensure quality and safety of imported products.

10 Strategy for Identifying the “Next Melamine” Large-scale economically motivated contamination is likely where: Expected reward from adulteration > Expected cost of being discovered and penalized

11 General Questions 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? What are members of industry doing to prevent EMA? What further steps can industry take to prevent EMA? What recent examples of known or suspected EMA domestically and internationally should U.S. regulators study and learn from? 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? What are other government regulators within and outside of the U.S. doing to predict and address EMA? What indicators (economic-based, chemistry-based, etc.) might be used to detect potential EMA?

12 Questions About Attributes Of Products, Components / Ingredients That May Be At Risk For EMA: –What are attributes of products or components / ingredients of products that may cause them to be more vulnerable to EMA? –What food products are marketed based on measured content of certain constituents, such as content of certain proteins, certain fats, or certain sugars?

13 Questions About The Marketing Environment What changes relevant to the risk for EMA have occurred recently in: –The marketing environment of products or components/ingredients? –The sourcing and/or distribution of products? –The prices, output, imports or exports of products or components / ingredients? –The supply of components/ingredients or source materials for products?

14 Questions About Detection Methods: 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? Are there appropriate analytical methods/equipment that could be used instead of, or in addition to, existing methods or equipment in particular situations? What rapid methods can be used to detect adulteration of products or ingredients?

15 Additional Questions What systems are currently being used to track and verify components / ingredients from their source? Are there particular types of industry structures or supply chains that are especially vulnerable to or secure from potential EMA?

16 Today’s Agenda 5 panels –Academic –Pharmaceuticals –Foods –Dietary Supplements and Cosmetics –Public Interest Groups Questions from our panel Open public hearing at 3:45 Any comments may be submitted to the docket.

17 Thanks To Steven Solomon, Irene Chan, Kevin Whittlesley, and other FDA staff. For your participation and your help!