Food Allergen Labeling and Consumer Protection Act of 2004
The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 is an amendment to the Federal Food, Drug, and Cosmetic Act. It requires that manufacturers clearly identify on the labels of food if it contains an ingredient that is or contains protein derived from a "major food allergen" declare the presence of the allergen in the manner described by the law.
Major Food Allergens under FALCPA
An ingredient that is one of the following five foods or from one of the following three food groups or is an ingredient that contains protein derived from one of the following:
- Milk
- Egg
- Fish
- Crustacean shellfish
- Tree nuts
- Wheat
- Peanuts
- Soybeans
FALCPA scope
FALCPA applies to packaged food subject to FDA regulation for both imported and domestically manufactured food. The regulation includes foods that package, label, and offer products for human consumption in retail and food-service establishments.
Labeling Exemptions
- Raw agricultural commodities (including fresh fruits and vegetables)
- Products not requiring labels
- Restaurant food
- Carry-out boxes / containers
Highly refined oils (or ingredients derived from them)
- Meat, poultry, and eggs (regulated by FSIS)
- Foods containing no protein from a major food allergen
- Incidental additives
Overview
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SEC. 202. FINDINGS |
· Identifies percentage of food allergies · Identifies 8 food groups accounting for allergies · Reviews manufactured food · Identifies gaps where labeling was not clear |
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SEC. 203. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING ALLERGENIC SUBSTANCES |
· Food to have the word ‘contains’ followed by the food source from where the major food allergen is derived · Food to list the common name of the major food allergen |
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SEC. 204. REPORT ON FOOD ALLERGENS |
· Analysis of food manufacturing process where unintentional contamination occurs · Advice on good manufacturing practices / methods to reduce or eliminate cross-contact of foods with major food allergens |
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SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS |
· Secretary of Health and Human Services shall conduct inspections of facilities in which foods are manufactured, processed, packed, or held to ensure - Compliance with practices to eliminate / reduce cross-contact - Ensure proper labeling of major food allergens |
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SEC. 206. GLUTEN LABELING |
· Rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods |
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SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-RELATED ALLERGIC RESPONSES |
· Improve collection and publishing of data on - Prevalence of food allergies - Incidence of adverse events related to food allergies - Use of different modes of treatment for and prevention of allergic responses to foods · Authorization of Appropriations |
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SEC. 208. FOOD ALLERGIES RESEARCH |
· Ad hoc panel of nationally recognized experts in allergy and immunology to review current basic and clinical research efforts related to food allergies · Recommendations from the panel to enhance and coordinate research activities concerning food allergies |
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SEC. 209. FOOD ALLERGENS IN THE FOOD CODE |
· Pursue revision of the Food Code to provide guidelines for preparing allergen-free foods in food establishments, including in restaurants, grocery store delicatessens and bakeries, and elementary and secondary school cafeterias |
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SEC. 210. RECOMMENDATIONS REGARDING RESPONDING TO FOOD-RELATED ALLERGIC RESPONSES |
· Include technical assistance relating to the use of different modes of treatment for and prevention of allergic responses to foods |
Compliance
Products labeled before January 1, 2006 do not need to be relabeled or recalled. Non-compliance can prove costly.
- Civil sanctions, criminal penalties, or both
- Seizure of food products where the label of the product does not conform to FALCPA's requirements
- Penalties for non-compliance range from $1,000 to $10,000 fines and up to 3 years in prison for any person who knowingly violates any provisions of the Food, drug, and Cosmetic Act.
Source
http://www.fns.usda.gov/fdd/facts/nutrition/foodallergenfactsheet.pdf
http://www.authorstream.com/Presentation/fortinne-477635-allergen-law/
Compliance Trainings
By - Christopher W. Olmsted
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime
Compliance Standards
