FDA Food Allergen Inspections
An A. & L. Shatto Advisory
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As many as 6,000 food manufacturers can expect inspectors from the Food and Drug Administration (FDA) during the next two years, as the agency gears up to ensure ingredients that cause common allergic reactions aren't getting into food accidentally.  The FDA decided on the inspections, which would focus on candy makers, bakeries, ice cream producers and other processors, after working with state inspectors to test several plants in Minnesota and Wisconsin.  One-fourth of the cookie, ice cream and candy makers tested had ingredients such as peanuts that weren't disclosed on product labels.

Some seven million Americans who suffer from food allergies rely on ingredient labels to tell which processed foods are safe for them to consume.  Some food allergies, particularly peanut allergies, can be fatal. In rare cases, life-threatening anaphylactic shock occurs, claiming an estimated 150 lives a year.  According to the FDA, allergy-related food recalls jumped 20 percent last year to more than 120.  Most of these costly recalls could have been avoided if food labeling had been in accordance with the actual food ingredients.

The FDA believes there is a scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies:

• Peanuts
• Soybeans
• Cow's Milk
• Hen's Eggs
• Fish
• Crustacea
• Tree nuts
• Wheat

Currently, 2,500 inspectors are being trained by the FDA to determine how food manufacturers deal with these risks based on the new Office of Regulatory Affairs' (ORA) Guide to Inspections of Firms Producing Food Products Susceptible to Contamination With Allergenic Ingredients - April 2001.  The inspection process includes all phases of production and includes:

• Product Development
• Incoming Inspection Procedures
• Production Equipment and Cleaning
• Processing Control Measures
• Final Product Testing
• Product Labeling

Become Proactive
Costly recalls need not be a part of your corporate future. Work with an experienced Process Engineering Firm to review your current production procedures and labeling practices.  Recognize the need for an independent review of your Hazard Analysis and Critical Control Point Plans (HACCP).  Subject your Product Development Plans to a careful review and audit for possible points of allergen susceptibility before production begins.

State-of-the-art techniques for the detection of allergen residues are currently available commercially.  Enzyme-linked immunosorbent assay (ELISA) test kits for the detection of food allergens for raw materials, processing equipment, and finished products can be used in conjunction with extensive validation procedures using a wide variety of food matrices.  Currently, the FDA has no definitive method of allergen testing for regulatory purposes; however, ELISA testing for allergens has a definite place in company HACCP and allergen control plans.