Services - Food Label Review
FDA and USDA Labeling format requirements are specific and complicated, if you
do not work with them regularly. We will assist you and your label design team
to achieve a regulation compliant, accurate label for your product. We can also provide assistance in labeling your products according to the new Allergen Labeling requirements. President Bush signed the Food Allergen and Consumer Protection Act of 2004, into law on August 2, 2004. This regulation goes into effect January 1, 2006. The act amends the Federal Food Drug and Cosmetic Act and requires food manufacturers to identify, in plain, common language, the presence of any of the eight major food allergens (milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) that are or might be present in any ingredient contained in a food product. For example, sodium caseinate will have to be declared in the ingredient list as being derived from milk.
The law also requires that labels must declare if flavorings, colorings, and other additives are derived from or have been in contact with a major allergen at any time during the manufacturing process.
The bill has other requirements including facility inspections and the publication of a final rule to define and permit use of the term gluten-free on food labels. Manufacturers can read the bill by searching Bill Number "S.741.ENR" at http://thomas.loc.gov.
According to FDA, Only about 1.5 percent of adults and up to 6 percent of children younger than 3 years in the United States--about 4 million people--have a true food allergy, according to researchers who have examined the prevalence of food allergies.
It's critical for people who have food allergies to identify them and to avoid foods that cause allergic reactions. Some foods can cause severe illness and, in some cases, a life-threatening allergic reaction (anaphylaxis) that can constrict airways in the lungs, severely lower blood pressure, and cause suffocation by the swelling of the tongue or throat.
An estimated 150 Americans die each year from severe allergic reactions to food, says Hugh A. Sampson, M.D., director of the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai School of Medicine in New York City and a food allergy expert.
The Food and Drug Administration's Center for Food Safety and Applied Nutrition has made it a high priority to boost consumer and food industry awareness of food allergens. As part of these efforts, the FDA is conducting food allergen education programs for consumers and industry. The agency has also developed a strategy for clear, easy-to-understand labeling of food allergens.
On April 6th, FDA published a new final version of “Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 3)”. For those who still have questions about how and what to label, this may be of some assistance. See www.cfsan.fda.gov/~dms/alrguid3.html.
Strasburger & Siegel assists food companies in meeting FDA label requirements. We offer a full range of food labeling services including product analysis (both database and laboratory), nutrition facts panels, ingredient statements, allergen information, full label compliance packages, shelf life evaluations, and final label reviews. Contact us for more information.
