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FSC 211 Food Allergen Regulatory Requirements – Q&A
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FSC 211 Food Allergen Regulatory Requirements – Q&A
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FSC 211 Food Allergen Regulatory Requirements – Q&AFood Allergen Labeling and Consumer Protection Act (FALCPA) Correct
Ans - An amendment of the Federal Food, Drug, and Cosmetic Act and
requires that the label of a food that contains an ingredient that is or
contains protein from a "major food allergen" declare the presence of the
allergen in the manner described by the law.
Why did Congress pass this act? Correct Ans - To make it easier for
food allergic consumers and their caregivers to identify and avoid foods
that contain major food allergens.
When does FALCPA become effective? Correct Ans - FALCPA applies
to food products that are labeled on or after January 1, 2006.
What is a major food allergen? Correct Ans - FALCPA identifies
eight foods or food groups as the major food allergens. They are milk, eggs,
fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster,
shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and
soybeans.
FALCPA identifies only 8 allergens. Aren't there more foods consumers are
allergic to? Correct Ans - Yes. More than 160 foods have been
identified to cause food allergies in sensitive individuals. However, the
eight major food allergens identified by FALCPA account for over 90
percent of all documented food allergies in the U.S. and represent the foods
most likely to result in severe or life-threatening reactions.
How serious are food allergies? Correct Ans - It is estimated that 2
percent of adults and about 5 percent of infants and young children in the
U.S. suffer from food allergies. Approximately 30,000 consumers require
emergency room treatment and 150 Americans die each year because of
allergic reactions to food.
Does FALCPA apply to imported foods as well? Correct Ans -
FALCPA applies to both domestically manufactured and imported packaged
foods that are subject to FDA regulation.
, FDA held public meeting on allergens and gluten; what were the outcomes
of those meetings? Correct Ans - The first meeting evaluated FDA's
draft report, "Approaches to Establish Thresholds for Major Food Allergens
and for Gluten in Food." This draft report was written to help develop FDA's
policy on food allergens and to implement FALCPA.
FDA held a second public meeting to obtain expert comment and
consultation from stakeholders to help FDA develop a regulation to define
and permit the voluntary use on food labeling of the term "gluten-free".
The meeting focused on food manufacturing, analytical methods, and
consumer issues related to reduced levels of gluten in food. Information
presented during and following the meeting provided FDA important and
relevant data regarding current industry practices in the production of
foods marketed as "gluten-free," challenges faced by manufacturers of
"gluten-free" foods, and consumer perceptions and expectations of what
"gluten-free" means to them. FDA is using this information to develop its
proposal on the use of the term "gluten-free."
Will FDA establish a threshold level for any allergen? Correct Ans -
FDA may consider a threshold level for one or more food allergens.
How will food labels change as a result of FALCPA? Correct Ans -
FALCPA requires food manufacturers to label food products that contain an
ingredient that is or contains protein from a major food allergen in one of
two ways.
The first option for food manufacturers is to include the name of the food
source in parenthesis following the common or usual name of the major
food allergen in the list of ingredients in instances when the name of the
food source of the major allergen does not appear elsewhere in the
ingredient statement.
The second option is to place the word "Contains" followed by the name of
the food source from which the major food allergen is derived, immediately
after or adjacent to the list of ingredients, in type size that is no smaller
than the type size used for the list of ingredients.
Will the ingredient list be specific about what type of tree nut, fish, or
shellfish is in the product? Correct Ans - FALCPA requires the type
of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass,
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