Allergens, GMO, Gluten Free, Natural

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Food Claims and Labeling

Food labeling must be truthful and not misleading.  There are certain items that must be declared on a label and also specific requirements for labeling of flavors (that can include spices) that are included in products, specified statements of identity (such as vanilla extract), requirements for FDA regulated food labels including the principle display panel and the information panel on the back of a food product.  Spices can be included in flavorings and/or consumer product goods, so it is important to understand and be familiar with these regulations.

Also, certain items must be declared on food labels such as disclosure of the seven major food allergens. FDA has also published guidance on labeling of products as “gluten free” and use of the term “natural” is another area where guidance may be forthcoming in the next few years.  There are also efforts under way at the federal and state level to require additional labeling requirements such as for foods containing genetically modified organisms (GMOs).

Allergens 

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires specified allergens to be declared on foods and flavors.  These allergens include: milk, eggs, peanuts, tree nuts (specified); soybeans, wheat, fish (specified), shellfish (specified) and sulfites (greater than 10 ppm).

The Food Allergen Labeling and Consumer Protection Act of 2004 (The Act) was signed into law by President George W. Bush on August 2, 2004

Although the U.S. Food and Drug Administration (FDA) may issue guidance documents on some aspects of the bill, federal regulations are not required to implement this law. Therefore, the labeling provisions, which apply to all FDA-regulated foods & beverages, are required for products labeled on or after January 1, 2006. These provisions apply to labels on consumer products and bulk shipments. Flavors, colors, and incidental additives that may currently be declared generically or are exempt from labeling requirements, will be subject to the new labeling requirements when they contain a major food allergen. A food will be deemed to be misbranded if it does not comply with these labeling requirements.

Key Provisions
The Act amends the Federal Food, Drug & Cosmetic Act to define “major food allergen” as any of the following: (1) milk; (2) egg; (3) fish (e.g., bass, flounder, or cod); (4) crustacean shellfish (e.g., crab, lobster, or shrimp); (5) tree nuts (e.g., almonds, pecans or walnuts); (6) wheat; (7) peanuts; (8) soybeans; or a food ingredient that contains protein derived from one of the eight major food allergens.

Under the new law, when a food contains a major food allergen and the name of the allergen is not included on the ingredient list there are two ways to comply with the labeling requirements. First, the word “contains” followed by the food source from which the major food allergen is derived can be printed in the same size type either immediately after or adjacent to the list of ingredients. The other way to comply is by including the name of the food source from which the major food allergen is derived.

Exceptions
The Act contains exceptions to the labeling requirement. First, highly refined oils that are derived from major food allergens do not require labeling. Highly refined oils are refined, bleached, deodorized oils.

An additional way to avoid labeling involves petitioning the FDA. Petitions must include scientific evidence that that food ingredient does not cause an allergic response that poses a risk to human health. FDA has 180 days to approve or deny the petition. After 180 days, the petition is deemed denied unless FDA has acted to approve it or to provide an extension for considering the petition.

The Act also contains a notification procedure. This provision allows a person to file a notification with FDA containing scientific evidence that a food ingredient does not contain allergenic proteins. This provision was included so that current efforts to establish threshold levels could be acknowledged in the future by FDA.
Inspections & “May Contain” Statements

The Act requires FDA to inspect food manufacturing, processing, and packaging facilities and provide a report to Congress regarding efforts to reduce or eliminate cross-contact of foods not intended to contain major food allergens. “May contain” labeling is not prohibited in The Act, but FDA must address the effectiveness of these statements in the report.

Appendix A – Provisions of the Food Allergen Labeling and Consumer Protection Act of 2004

TITLE II–FOOD ALLERGEN LABELING AND CONSUMER PROTECTION

SEC. 201. SHORT TITLE.
This title may be cited as the `Food Allergen Labeling and Consumer Protection Act of 2004′.

SEC. 202. FINDINGS.
Congress finds that–
1.   it is estimated that–
(A) approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and
(B) each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food;

2 .
(A) eight major foods or food groups–milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans–account for 90 percent of food allergies;
(B) at present, there is no cure for food allergies; and
(C) a food allergic consumer must avoid the food to which the consumer is allergic;

3.
(A) in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in 1999, the Food and Drug Administration found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels; and
(B) nationally, the number of recalls because of unlabeled allergens rose to 121 in 2000 from about 35 a decade earlier;

4.  a recent study shows that many parents of children with a food allergy were unable to correctly identify in each of several food labels the ingredients derived from major food allergens;

5.
(A) ingredients in foods must be listed by their ‘common or usual name’;
(B) in some cases, the common or usual name of an ingredient may be unfamiliar to consumers, and many consumers may not realize the ingredient is derived from, or contains, a major food allergen; and
(C) in other cases, the ingredients may be declared as a class, including spices, flavorings, and certain colorings, or are exempt from the ingredient labeling requirements, such as incidental additives; and
6.
(A) celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs;
(B) the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease; and
(C) a multicenter, multiyear study estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population.

SEC. 203. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING ALLERGENIC SUBSTANCES.
(a) IN GENERAL – Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:
(w)(1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either–

(A) the word “Contains”, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or
(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when–

(i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or
(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 201(qq)(2)(A) or (B).

(2) As used in this subsection, the term `name of the food source from which the major food allergen is derived’ means the name described in section 201(qq)(1); provided that in the case of a tree nut, fish, or Crustacean shellfish, the term `name of the food source from which the major food allergen is derived’ means the name of the specific type of nut or species of fish or Crustacean shellfish.
(3) The information required under this subsection may appear in labeling in lieu of appearing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an earlier finding under this paragraph) is effective upon publication in the Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirements of subparagraph (B) of paragraph (1), if the Secretary determines that the modification or elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is necessary to protect the public health.
(6)(A) Any person may petition the Secretary to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition within 180 days of receipt of the petition or the petition shall be deemed denied, unless an extension of time is mutually agreed upon by the Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.
(D) A determination regarding a petition under this paragraph shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all petitions received under this paragraph within 14 days of receipt and the Secretary shall promptly post the Secretary’s response to each.
(7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing–

(i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or
(ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409.

(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health.
(C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary.
(x) Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.’.
(b) EFFECT ON OTHER AUTHORITY- The amendments made by this section that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens.
(c) CONFORMING AMENDMENTS-

(1) Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by section 102(b)) is amended by adding at the end the following:

(qq) The term `major food allergen’ means any of the following:

(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:

(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) of section 403(w).’.

(2) Section 403A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking `or 403(i)(2)’ and inserting `403(i)(2), 403(w), or 403(x)’.

(d) EFFECTIVE DATE- The amendments made by this section shall apply to any food that is labeled on or after January 1, 2006.

SEC. 204. REPORT ON FOOD ALLERGENS.
Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the `Secretary’) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that–

1.
(A) analyzes–

(i) the ways in which foods, during manufacturing and processing, are unintentionally contaminated with major food allergens, including contamination caused by the use by manufacturers of the same production line to produce both products for which major food allergens are intentional ingredients and products for which major food allergens are not intentional ingredients; and
(ii) the ways in which foods produced on dedicated production lines are unintentionally contaminated with major food allergens; and

(B) estimates how common the practices described in subparagraph (A) are in the food industry, with breakdowns by food type as appropriate;
2.  advises whether good manufacturing practices or other methods can be used to reduce or eliminate cross-contact of foods with the major food allergens;
3.  describes–

(A) the various types of advisory labeling (such as labeling that uses the words `may contain’) used by food producers;
(B) the conditions of manufacture of food that are associated with the various types of advisory labeling; and
(C) the extent to which advisory labels are being used on food products;

4.   describes how consumers with food allergies or the caretakers of consumers would prefer that information about the risk of cross-contact be communicated on food labels as determined by using appropriate survey mechanisms;
5.  states the number of inspections of food manufacturing and processing facilities conducted in the previous 2 years and describes–
(A) the number of facilities and food labels that were found to be in compliance or out of compliance with respect to cross-contact of foods with residues of major food allergens and the proper labeling of major food allergens;
(B) the nature of the violations found; and
(C) the number of voluntary recalls, and their classifications, of foods containing undeclared major food allergens; and

6.   assesses the extent to which the Secretary and the food industry have effectively addressed cross-contact issues.

SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS.
The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of facilities in which foods are manufactured, processed, packed, or held–

1.  to ensure that the entities operating the facilities 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
2.  to ensure that major food allergens are properly labeled on foods.

SEC. 206. GLUTEN LABELING.
Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term `gluten-free’ on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term `gluten-free’ on the labeling of foods.

SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-RELATED ALLERGIC RESPONSES.
(a) IN GENERAL- The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Commissioner of Food and Drugs, shall improve (including by educating physicians and other health care providers) the collection of, and publish as it becomes available, national data on–

1.  the prevalence of food allergies;
2.  the incidence of clinically significant or serious adverse events related to food allergies; and
3.  the use of different modes of treatment for and prevention of allergic responses to foods.

(b) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.

SEC. 208. FOOD ALLERGIES RESEARCH.
(a) IN GENERAL- The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene an ad hoc panel of nationally recognized experts in allergy and immunology to review current basic and clinical research efforts related to food allergies.
(b) RECOMMENDATIONS- Not later than 1 year after the date of enactment of this Act, the panel shall make recommendations to the Secretary for enhancing and coordinating research activities concerning food allergies, which the Secretary shall make public.

SEC. 209. FOOD ALLERGENS IN THE FOOD CODE.
The Secretary of Health and Human Services shall, in the Conference for Food Protection, as part of its efforts to encourage cooperative activities between the States under section 311 of the Public Health Service Act (42 U.S.C. 243), 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. The Secretary shall consider guidelines and recommendations developed by public and private entities for public and private food establishments for preparing allergen-free foods in pursuing this revision.

SEC. 210. RECOMMENDATIONS REGARDING RESPONDING TO FOOD-RELATED ALLERGIC RESPONSES.
The Secretary of Health and Human Services shall, in providing technical assistance relating to trauma care and emergency medical services to State and local agencies under section 1202(b)(3) of the Public Health Service Act (42 U.S.C. 300d-2(b)(3)), include technical assistance relating to the use of different modes of treatment for and prevention of allergic responses to foods.
108th CONGRESS
2d Session
S. 741

GMOs

The Coalition for Safe Affordable Foods includes information on the benefits of bioengineered foods.  The group is pursuing federal legislation to require labeling of GMOs and that would eliminate a myriad of state initiatives resulting in a patchwork of differing requirements that would be detrimental to food business operations.

Gluten Free

FDA published a final rule that defines “gluten-free” for food labeling, providing a standard definition for voluntary food labeling in an effort to assist those affected by celiac disease to effectively manage their condition by eating a gluten free diet.  The FDA was directed to set guidelines for the use of the term “gluten-free” by the Food Allergen Labeling and Consumer Protection Act (FALCPA), 

Under this new federal definition, in order to use the term “gluten-free” on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

Natural

Although “natural” products in the U.S. are extremely popular, there is no regulatory definition in the U.S. for “all natural” or “100% natural” for claims on consumer retail products.  In a 1993 FDA Guidance, FDA stated that it would “maintain its policy regarding the use of “natural” as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected in food.” The only area where the FDA has defined natural is for “natural flavors” or “natural flavorings” as noted in 21 CFR 101.22. USDA also has no regulatory definition of “all-natural”, However USDA does have guidance as to the definition of “natural” that states that the product does not contain artificial flavor, coloring ingredient, or chemical preservative, or any other artificial or synthetic ingredient, and the product and its ingredients are not more than minimally processed. USDA definition of natural flavor ingredients lists spices and spice and vegetable oils.