MELAMINE IN FOOD
FDA ACTIONS/POSITION
Melamine has been added to various products in China in an effort to increase the apparent protein content found in various foods, both pet & human; and dairy products.
In 2007, numerous cat and dog illnesses and deaths were attributed to pet food and vegetable proteins that were contaminated with melamine and its related compounds. In September, 2008 FDA became aware of thousands of infant illnesses in China due to the consumption of infant formula reported to contain Melamine. Obviously, Melamine contamination is not limited to infant formula products, but can be contained in various milk compounds; especially dried milk powder, which is used in the manufacturing of a variety of finished foods.
To date FDA testing has found Melamine contamination in multiple products imported from China, and FDA continues its testing of a variety of products for Melamine and its analogs including Cyanuric Acid. Melamine is a compound used primarily in commercial and industrial applications and there is no approved Melamine use in direct addition to human or animal food.
FDA ACTION
In response to the wide-spread contamination of feeds and foods with Melamine the FDA (as of December 2008) has issued 4 separate and distinct import alerts.
- "Import Alert 72-05, issued 02/25/08 "Detention without Physical Examination of Pet and Laboratory Animal Food Due to the Presence of Melamine and/or Melamine Analogs Triazines."
- "Import Alert 99-29, dated 01/07/08 "Detention without Physical Examination of all Vegetable Protein Products from China for Animal of Human Food Use Due to the Presence of Melamine and/or Melamine Analogs."
- "Import Alert 99-30, issued 11/12/08 "Detention without Physical Examination of all Milk Products, Milk Derived Ingredients in Finished Food Products containing Milk from China to the Presence of Melamine and/or Melamine Analogs."
- "Import Alert 99-31, issued 10/10/08 "Detention without Physical Examin-ation of Food Products Due to the Presence of Melamine and/or Melamine Analogs."
METHODOLOGY
There are currently three methods
recognized by The US Food and Drug Administration for the determination of melamine and its analytes.
- "LIB4421, Volume 24, October, 2008 "Determination of Melamine and Cyanuric Acid Residues in Infant Formula using LC-MS/MS.
- "LIB4422, Issued October, 2008 "Interim Method for Determination of Melamine and Cyanuric Acid Residues in Food using LC-MS/MS; Version 1.0 and
- "LIB4423, Issued October, 2008 "GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide and Cyanuric Acid.
Certified Laboratories is equipped to handle all three.
SAMPLING PLAN
- Powdered Products - Open ten (10) units; remove 250g per unit, composite for 1 sample.
- Foods, Frozen and Semi-Frozen - Open ten (10) units; remove one (1) pint from each, composite for 1 sample.
- Liquids - open ten (10) units; remove eight (8) fluid ounces from each, composite for 1 sample.
LIMIT OF QUANTIFICATION (LOQ) AND ACTION LEVEL
- "Products held under Import Alert #99-30 will have a detection limit and an action level of 0.25ppm (250ppb).
- "Products held under Import Alerts #99-31, #99-29 and #72-05 will have a detection limit and an action level of 2.5ppm.
It is our understanding that regardless of the Import Alert the compounds of concern are Melamine and Cyanuric Acid with no need to analyze the other analogs.
LABORATORY ACCEPTANCE
Currently the FDA has no procedure to "certify or accredit" laboratories. Acceptance of laboratory submittals is done by each FDA District independently. Certified Laboratories is proud that its laboratory packages are routinely accepted by all FDA Districts.
IMPORTER REQUIREMENTS TO INITIATE ANALYSIS
In order for Certified Laboratories to appropriately sample, analyze and submit a report to the Food and Drug Administration we require the following items from you (the importer);
- "FDA Notice of Action
- "Packing List
- "Commercial Invoice
- "Warehouse Location, contact name and phone number
- "Full Contact Information of the Importer, including Company Name, Address, Phone Number and Fax (and e-mail address, if available)
Please be aware of the respond by dates in the Notice of Detention and if appropriate ask for an extension. We also strongly suggest that you do not move the goods without FDA approval and instruct the warehouse to allow us to sample the product.
For further information please contact:
Certified Laboratories Inc., Plainview, NY
Steven Mitchell-Vice President
516-576-1400
1-800-CERT-LAB
smitchell@800certlab.com
For additional information or a copy of the document, please contact Certified Laboratories at 1-800-CERT LAB.
