Food Allergy Labeling and Consumer Protection Act

1

• Food Allergy Labeling and Consumer Protection Act
  
  
• Joseph A. Levitt
• Hogan Hartson L.L.P.
• Washington, D.C.
• March 2005

2
Topics to Cover

• Background
• New Labeling Requirements
• Other Provisions

3
FALCPA

• Review of Legislative History
• President signed into law the Food Allergy
  Labeling and Consumer Protection Act in August
  2004
  
• Amended the FFDCA and establishes specific
  labeling requirements for the Big 8 Major
  Allergens

4
FALCPA

• Prior to FALCPA
• Complete list of ingredients
• Exception for incidental additives
• Generic labeling of spices, flavors, colors
• Allergenic foods had to be identified by common
  or usual name (e.g., casein, whey)

5
Major Allergen

• The term major food allergen means any of the
  following
  
• 1) milk, egg, fish (e.g., bass, flounder),
  Crustacean shellfish (e.g., crab, lobster, or
  shrimp), tree nuts (e.g., almonds, pecans, or
  walnuts), wheat, peanuts and soybeans

6
Major Allergen (contd)

• 2) A food ingredient that contains protein
  derived from a food specified in paragraph (1),
  except
  
• (A) Any highly refined oil derived from a food
  specified in paragraph (1) and any ingredient
  derived from such highly refined oil.
  
• (B) A food ingredient that is exempt under
  paragraph (6) or (7).

7
FALCPA Labeling

• The Big 8 allergens must be labeled by common
  English names specific to the allergen source
  
• FDA can modify the list by regulation
• Labeling applies to ingredients derived from the
  Big 8 allergens that contain protein

8
FALCPA Labeling

• Requires labeling for flavors, colors, and
  incidental additives
  
• Contains exceptions
• Highly refined oils
• Refined, bleached, deodorized oils
• C/U name of such oils has always required
  identification of source oil (e.g., peanut oil,
  soy oil)

9
FALCPA Labeling

• FDA can exempt ingredients via
• Premarket Notification
• Available when scientific evidence shows that the
  ingredient does not contain an allergenic
  protein
  
• Available when, as part of a food additive
  review, FDA concludes that the ingredient does
  not cause allergic response posing a risk to
  health
• Unavailable as part of GRAS notification review

10
FALCPA Labeling

• FDA can exempt ingredients via
• Petition
• Available for those ingredients that are
  ineligible for the notification
  
• Requires data showing that the ingredient does
  not cause allergic response posing risk to human
  health
  
• Petitioner has burden of proof

11
FALCPA LABELING FORMAT

• Contains ____
• Must list all major food allergens in the
  product
  
• Must be immediately adjacent to the ingredient
  statement

12
FALCPA LABELING FORMAT

• Parenthetical in Ingredient Statement (casein
  (milk))
  
• Not required if ingredient name already
  identifies the major allergen
  
• Not required if the name of the major food
  allergen appears elsewhere unless the other
  listing is for an ingredient that is exempt from
  the major food allergen definition

13
FALCPA LABELING FORMAT

• Requires use of common English names for the
  major food allergens
  
• Tree nuts must identify specific nut such as
  almond, pecan, walnut
  
• Fish/Shellfish must identify species, such as
  tuna, bass, flounder, shrimp, lobster

14
FALCPA LABELING FORMAT

• Ingredient Statement Examples
• Ingredients Semolina, rice flour, rolled oats,
  pine nuts, tomato juice, whey, sodium caseinate,
  tuna gelatin, natural flavoring
  
• Contains wheat, milk, pine nuts and peanuts

15
FALCPA LABELING FORMAT

• Ingredient Statement Examples (contd)
• Ingredients Semolina (wheat), rice flour,
  rolled oats, pine nuts, tomato juice, whey
  (milk), sodium caseinate, tuna gelatin, natural
  flavoring (peanuts)

16
FALCPA

• A food that does not comply with the labeling
  requirements is deemed misbranded
  
• FALCPA is self-executing and becomes effective
  for any food labeled after January 1, 2006
  
• FDA does NOT have to implement regulations

17
FALCPA Studies/Reports

• Analysis of cross-contact issues
• Review of GMPs
• Review use of advisory (may contain) labeling
• Survey of consumer labeling preferences
• Review of allergen inspections conducted by FDA
• Assessment of food industry and government
  response to cross-contact issues

18
FALCPA/Inspections

• Directs FDA to conduct inspections of facilities
  to ensure they comply with practices to reduce or
  eliminate cross-contact of a food with residues
  of major food allergens that are not intentional
  ingredients of the food, and to ensure major food
  allergens are properly labeled

19
FALCPA (cont.)

• Requires FDA to issue a proposed rule within two
  years, and a final rule within four years, to
  define, and permit use of, the term gluten-free
  on food labels
• Requires FDA to collect and publish national
  data on the prevalence of food allergies, the
  incidence of clinically significant or serious
  adverse events, and the use of different modes of
  treatment for and prevention of allergic
  responses to foods

20
FALCPA Issues

• Places the burden of proof on petitioner to
  demonstrate that an ingredient does not present a
  concern to food allergic consumer
  
• Soy lecithin
• Fish gelatin (ID SOURCE!)
• Lactose
• Wheat Starch
• Lysozyme
• Lactoferrin
• Soy sauce

21
Conclusion

• FALCPA imposes labeling requirements for
  allergens as of January 2006.
  
• The time is now to begin FALCPA compliance

22
Contact Information

• Joseph A. Levitt
• Hogan Hartson L.L.P.
• 555 13th Street NW
• Washington, DC 20004
• [phone] (direct)
• [phone] (fax)
• JALevitt_at_HHLaw.com