Allergen Law

ALLERGEN LABELING : 

ALLERGEN LABELING Neal D. Fortin Director and Professor Institute for Food Laws & Regulations Michigan State University fortinne@msu.edu www.IFLR.msu.edu © 2006 Neal Fortin

Outline : 

Sept. 13, 2006 Food Regulation & Litigation Outline Background FALCPA overview Exemptions Petitions & notifications Challenges presented FSIS

Why a New Law Now? : 

Sept. 13, 2006 Food Regulation & Litigation Why a New Law Now? Increased government attention Rise in number of product recalls 35 in 1990 121 in 2000 Rising consumer interest E.g., Kellogg’s: 6,000 inquiries in 2001 13,000 in 2004

Food Allergy on the Rise : 

Sept. 13, 2006 Food Regulation & Litigation Food Allergy on the Rise and here’s a list of my known food allergies.

The Burden of Food Allergy : 

Sept. 13, 2006 Food Regulation & Litigation The Burden of Food Allergy “What is food to one man may be fierce poison to others.” Lucretius De Rerum Natura - On the Nature of Things, 50 B.C. Estimated 4 million sufferers 2% of adult; 5% of children 150-200 food allergy deaths/year Roughly 30,000 hospitalizations/year

FALCPA : 

FALCPA The Food Allergen Labeling and Consumer Education Act

FALCPA : 

Sept. 13, 2006 Food Regulation & Litigation FALCPA Signed into law in August 2004 Became effective January 1, 2006 FDA did not issue regulations and provided limited substantive guidance prior to 1/1/06

FALCPA Requirements : 

Sept. 13, 2006 Food Regulation & Litigation FALCPA Requirements Amends the Food, Drug, and Cosmetic Act Does not amend Federal Meat Inspection Act Poultry Products Inspection Act Egg Products Inspection Act Must declare the common name for major allergenic substances

Major Allergen Defined : 

Sept. 13, 2006 Food Regulation & Litigation Major Allergen Defined 2) A food ingredient that contains protein derived from a food specified in paragraph (1), except: (A) Any highly refined oil . . . Major food allergens are: milk, eggs, fish, Crustacea (shellfish), tree nuts, wheat, peanuts, and soybeans The “Big 8” allergens

FALCPA : 

Food Allergen Labeling and Consumer Protection Act (FALCPA) Effective date: food labeled on or after January 1, 2006 FALCPA July 2007 10 Food Labeling Workshop

Slide 11: 

Food Labeling Workshop 11 July 2007

Labeling Options : 

Sept. 13, 2006 Food Regulation & Litigation Labeling Options Declare the common name for major food allergens on the labels Two labeling options: Ingredient statement (as part of ingredient name or in a parenthetical) “Casein (Milk) “Contains _______” statement immediately after or adjacent to the list of ingredients “Contains peanuts”

Labeling Options cont. : 

Sept. 13, 2006 Food Regulation & Litigation Labeling Options cont. If an allergen source name appears elsewhere in the ingredient list: Not necessary to repeat the allergen parenthetical If using the “Contains: _______” option All major food allergens must be listed

Exemptions : 

Exemptions Direct and Indirect

Exemptions Directly : 

Sept. 13, 2006 Food Regulation & Litigation Exemptions Directly Raw agricultural commodities Products that do not require labels E.g., Restaurant food Single ingredient exemption in statute “Highly refined oils” Contain no protein Undefined Senate Report & industry use: Refined, bleached, and deodorized

Other Exemptions : 

Sept. 13, 2006 Food Regulation & Litigation Other Exemptions Foods with no protein from a major food allergen Note overlap with notification procedure “Enforcement Discretion” Major food allergens unintentionally added to a food as the result of cross-contact A “residue or other trace amount”

Petitions & Notifications : 

Petitions & Notifications

Petition : 

Sept. 13, 2006 Food Regulation & Litigation Petition May petition to exempt a food from the allergen labeling requirements Burden on the petitioner to provide scientific evidence the food ingredient does not cause an allergic response that poses a risk to human health One petition received for a soy protein used in culture media, which is still pending

Notification : 

Sept. 13, 2006 Food Regulation & Litigation Notification Either for food containing no allergic protein or Presents no risk to human health Protein below allergenic threshold Protein present is not the allergic protein 90 days to deny or ingredient may enter commerce FDA has rejected all notifications received—two are “pending”

Issues Presented : 

Issues Presented Incidental additives Thresholds: How much is too much? The little boy who cried wolf FSIS Issues

Incidental Additives : 

Sept. 13, 2006 Food Regulation & Litigation Incidental Additives Exempt from ingredient labeling because at in insignificant levels in the finished food E.g., soy lecithin as a baking pan release agent FALCPA applies to incidental additives Application to incidental additives is creating most of the issues

Soy Lecithin : 

Sept. 13, 2006 Food Regulation & Litigation Soy Lecithin Soy Lecithin Guidance (May 2, 2006) FDA will exercise enforcement discretion and will not subject soy lecithin to allergen labeling requirements when: The food was labeled after 1/1/06 The soy lecithin meets requirements of FCC 5th Edition Soy lecithin is used exclusively as a release agent Soy lecithin is used at minimum level per GMPs

Soy Lecithin Guidance : 

Sept. 13, 2006 Food Regulation & Litigation FDA intends to exercise enforcement discretion for approximately 18 months Manufacturers using soy lecithin should “revise as necessary the labels of their relevant food products to comply with FALCPA and begin to label their products using the FALCPA-compliant labels by the end of the enforcement discretion period.” Enforcement discretion will remain in effect until FDA amends or revokes the guidance Soy Lecithin Guidance

Soy Lecithin : 

Sept. 13, 2006 Food Regulation & Litigation NB: limited to release agent uses Other uses, even at very low levels (e.g. an emulsifier in flavors) not covered Such uses required to be labeled Even if soy protein in finished food is in ppb Soy Lecithin

How Much is Too Much? : 

Sept. 13, 2006 Food Regulation & Litigation How Much is Too Much? Soy Oil Derivatives Tocopherols Stanols/Sterols Does the ingredient contain protein? No protein in the ingredient—outside the definition of “major allergen” How do you define “No protein?”

FDA Threshold Guidance : 

Sept. 13, 2006 Food Regulation & Litigation FDA Threshold Guidance Guidance does not establish thresholds— identifies processes that could be used Guidance recognizes four approaches Analytical Methods-Based Safety Assessment-Based Risk Assessment-Based Statutorily Derived

Thresholds : 

Sept. 13, 2006 Food Regulation & Litigation Safety and risk assessment approaches are the “best” approaches for setting thresholds But—the scientific evidence likely is not yet available Thresholds

Thresholds : 

Sept. 13, 2006 Food Regulation & Litigation FDA recognizes thresholds could be established using the analytical method Limit of detection Threshold would be 0.1 to 1 ppm Method must exist and be validated If used, the threshold should be replaced using a different method “as soon as possible” Thresholds

Thresholds : 

Sept. 13, 2006 Food Regulation & Litigation Statutory Approach Highly refined oils contain protein FDA: the mean level of protein plus 1, 2 and 3 standard deviations found in soy and peanut oils are, 0.74, 2.05, 3.36 and 4.67 ppm Likely thresholds would be between 1-5 ppm Thresholds

Thresholds : 

Sept. 13, 2006 Food Regulation & Litigation FDA observations on the statutory approach Approach could be used to set a single threshold for any major allergen If used, it should be used on an “interim basis” and should be reevaluated as new knowledge, data, and risk assessment tools become available” Thresholds

Thresholds : 

Sept. 13, 2006 Food Regulation & Litigation FDA observations on the statutory approach “might yield thresholds that are unnecessarily protective of public health compared to thresholds established using the safety assessment based and risk assessment-based approach.” “However, confirming this would require additional data.” Thresholds

Threshold Guidance : 

Sept. 13, 2006 Food Regulation & Litigation FDA Guidance document “signals” willingness to establish thresholds If FDA establishes thresholds, the agency will resolve the major issues presented by allergen labeling The big issue is “if” and “when” Threshold Guidance

Commingling : 

Sept. 13, 2006 Food Regulation & Litigation Co-mingled Grains and Soy Soy, corn and wheat often share farm equipment, transport, and storage USDA grading standards allow foreign grains FDA considered treating the co-mingled grain as part of the “major allergen” definition FDA will treat as a “may contain” issue But only “trace amount” Commingling

Fermentation Products : 

Sept. 13, 2006 Food Regulation & Litigation Fermentation Products Fermentation products, e.g.: Cultures Amino Acids Enzymes FALCPA applies to “food ingredients” Fermentation media are used as a nutrient source and arguably are not “ingredients” that are subject to FALCPA

The little boy who cried wolf : 

Sept. 13, 2006 Food Regulation & Litigation The little boy who cried wolf Precautionary labeling (e.g., may contain) Not required nor regulated by FALCPA Excessive use of warnings can foster: Confusion Counterproductive behavior

What is a major allergen? : 

Sept. 13, 2006 Food Regulation & Litigation What is a major allergen? Spelt – is it wheat? USDA says no Codex Alimentarius says no EU says no FDA says yes Kola nut and annatto are tree nuts

“30,000 loaves of . . . bread were temporarily declared ‘toast’” : 

Sept. 13, 2006 Food Regulation & Litigation “30,000 loaves of . . . bread were temporarily declared ‘toast’” “More than 30,000 loaves of . . . bread were temporarily declared ‘toast’ Tuesday when federal officials seized them, claiming that the popular organic bakery in south Minneapolis has been [mislabeling the loaves of] bread as wheat-free, when they aren't.” Minneapolis Star Tribune (Jan. 11, 2006)

FSIS Issues : 

Sept. 13, 2006 Food Regulation & Litigation FSIS Issues FSIS historically has required labeling of all proteinaceous ingredients in meat and poultry products FSIS has label pre-approval FSIS has said it will initiate rulemaking and harmonize its regulations with FALCPA

Ingredients of Public Health Concern : 

Sept. 13, 2006 Food Regulation & Litigation Ingredients of Public Health Concern FSIS Issued Notice 45-05 in July ‘05 and a Q&A in November ’05 Ingredients of public health concern must be addressed as part of HACCP plans Non-compliance reports (NRs) should be issued when establishments do not address ingredients of public health concern

Notice 45-05 : 

Sept. 13, 2006 Food Regulation & Litigation Notice 45-05 Notice 45-05 and the Q&A identify the following as ingredients of public health concern: Big 8 allergens Sulfites MSG Lactose Yellow 5

Concerns with 45-05 : 

Sept. 13, 2006 Food Regulation & Litigation Concerns with 45-05 FSIS stated in Q&A that soy lecithin must be labeled as an ingredient when used as a release agent Industry historically has not labeled these uses of soy lecithin

Concerns with 45-05 : 

Sept. 13, 2006 Food Regulation & Litigation Concerns with 45-05 Includes ingredients other than Big 8 allergens While FSIS recognizes in the Q&A the data do not demonstrate MSG causes adverse reactions, FSIS did not remove MSG from Notice 45-05 Many establishments have addressed Big 8 in HACCP plans, but many did not address MSG, lactose, Yellow 5, or sulfites

FSIS Response to 45-05 Concerns : 

Sept. 13, 2006 Food Regulation & Litigation FSIS Response to 45-05 Concerns GMA raised concerns Soy Lecithin “FSIS will not verify that labels declared soy lecithin when it is used as a release agent until FDA starts to enforce compliance.” MSG “MSG is an ingredient of consumer concern but not of public health concern.”

FSIS Response to 45-05 : 

Sept. 13, 2006 Food Regulation & Litigation FSIS Response to 45-05 “May Contain” Statements “‘May contain’ statements are important health-related information that needs to be transferred to the meat or poultry product label when the FDA food or ingredient bearing such statement is used in formulating a meat or poultry product.”

FSIS Response to 45-05 : 

Sept. 13, 2006 Food Regulation & Litigation FSIS Response to 45-05 “May Contain” Statements When “may contain” statements appear on a product specification sheet, establishment be able to have documents explaining why the statement has not been carried forward

Pending FSIS Initiatives : 

Sept. 13, 2006 Food Regulation & Litigation Pending FSIS Initiatives May 5, 2006 FSIS issued a notice that it expects establishments to include ingredients of public health concern in HACCP programs Unlike 45-05, focuses primarily on Big 8 Allergens Comments were due July 7, 2006

Conclusion : 

Sept. 13, 2006 Food Regulation & Litigation Conclusion FDA and FSIS policies on allergens evolving Soy lecithin — a limited reprieve Thresholds would provide relief to consumers by preventing the over-labeling If and when FSIS likely would follow FDA if thresholds set

Long-Standing Requirements : 

July 2007 Long-Standing Requirements Food manufacturers must give consumers adequate warnings of the potential allergic characteristics of the food 1938 Federal Food, Drug, and Cosmetic Act mandated ingredient labeling Congress recognized that allergic consumers need to know which foods were safe for them to eat Exemption for standardized foods NLEA 1991 closed some exemptions 48 Food Labeling Workshop

Previous Requirements - Limitations : 

Even the most diligent label readers could inadvertently be exposed to allergens Generic listing of colors, flavors, and spices Flavors and colors may contain hidden allergens because they were derived from a major food allergen Previous Requirements - Limitations July 2007 49 Food Labeling Workshop

Previous Requirements – Limitations cont. : 

Consumers may become confused by the names of ingredients E.g.: Potassium caseinate derived from milk “Non-dairy” labels a particular concern Previous Requirements – Limitations cont. July 2007 50 Food Labeling Workshop

FALCPA Requirements : 

Labeling must identify the major allergens by their common name (column two above). Two labeling options are available: Label with the statement, “Contains [allergen food source]” immediately after or adjacent to the list of ingredients in a type size no smaller than the type size used in the list of ingredients (e.g., “Contains peanuts”); or Include the allergen source name in parentheses in the list of ingredients immediately after the ingredient; e.g., “Casein (Milk).” Exemption from the above if the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list FALCPA Requirements July 2007 51 Food Labeling Workshop

FALCPA Requirements : 

Note: flavorings, colorings, and incidental additives are subject to the new allergen labeling requirements Firms should check for the eight major allergens FALCPA applies notwithstanding exemptions listed for flavorings, colorings, and incidental additives in other laws FALCPA Requirements July 2007 52 Food Labeling Workshop

Exemptions, Petition, and Notification : 

Highly refined oils, and ingredients derived from those oils, are specifically exempt May petition FDA for exemption for other foods Notification may be filed instead of a petition Exemptions, Petition, and Notification July 2007 53 Food Labeling Workshop

FALCPA More to Come : 

Congress directed FDA to define “gluten free” in order to help consumers with celiac disease FDA is also directed to report to Congress on: Contamination of food with food allergens Use of “may contain” advisories on labels FDA given the authority to require by regulation further labeling of food allergens Congress directed the Centers for Disease Control (CDC) to improve the collection of data on the prevalence, incidence, and treatment of food allergies FALCPA More to Come July 2007 54 Food Labeling Workshop

Courses : 

Sept. 13, 2006 Food Regulation & Litigation Courses International Food Laws & Regulations (Overview Course) Codex Alimentarius United States European Union Canada Latin America Winner 2003 ADEC National Excellence in Distance Education Award http://www.vu.msu.edu/preview/anr-ifl/