The warning statement required by paragraph (g)(2) of this section, when on a label, shall be set off in a box by use of hairlines.
(7) (i) The requirements in this paragraph (g) shall not apply to a juice that has been processed in a manner that will produce, at a minimum, a reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, of the following magnitude:A 5‐log (i.e., 100,000‐fold) reduction; orA reduction that is equal to, or greater than, the criterion established for process controls by any final regulation requiring the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of juice.
(ii) For the purposes of this paragraph (g), the “pertinent microorganism” is the most resistant microorganism of public health significance that is likely to occur in the juice.
* * * * *
NOTES
1 3.28 Saccharin. In 1977, FDA proposed banning saccharin in food because animal studies indicated it might be a carcinogen and thus prohibited under the Delaney Clause. 42 Fed. Reg. 19996 (Apr. 15, 1977). Congress stopped the ban with enactment of the Saccharin Study and Labeling Act, 91 Stat. 1451 (1977), but which also required any food product that contained saccharin to be labeled, “USE OF THIS PRODUCT MAY BE HAZARDOUS TO YOUR HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN DETERMINED TO CAUSE CANCER IN LABORATORY ANIMALS.” FD&C Act section 403(o). There was also a requirement that the same warning statement be posted in every retail establishment selling food containing saccharin. In 1996, Congress repealed the retail notice requirement. 110 Stat. 882 (1996). In 2000, Congress repealed the labeling requirement. 114 Stat. 2763, 2763A‐73 (Dec. 21, 2000), the “SWEETEST ACT,” the Saccharin Warning Elimination via Environmental Testing Employing Science and Technology Act. This decision was supported by the recommendations of the 9th Report on Carcinogens prepared by the National Toxicology Program and the position of the World Health Organization.
2 3.29 Culture can play an important role in how warnings are applied and how effective they are. For example, the warnings on cigarette packs in Japan illustrate how Japan takes a gentle tone when it warns against smoking: “There is a fear it can damage your health, so let’s be careful not to smoke too much. Let’s obey smoking manners.” Other countries have taken a different tack. In Malaysia, for example, the government found that smokers shrugged off government warnings, so now packages warn that “women smokers have more facial wrinkling than non‐smokers” and warn male smokers that the habit may make them impotent. Lawrence Bartlett, Tobacco: One Million Chinese Deaths Make It Wrong, THE AUSTRALIAN (Aug. 23, 2004).
3.8 ALLERGENS
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
The FALCPA of 200472 amended the Federal FD&C Act to create a category of “major food allergens.” FALCPA require special identification of major allergens in food that contains a major food allergen or contains a derivative of a major allergen.
The act defines “major food allergen” as any of the following:
milk,
eggs,
fish,
crustacea,
tree nuts,
wheat,
peanuts, and
soybeans.
sesame (effiective jan. l, 2023)
The declaration that a food contains a major food allergen must be met by one of the following:
1 Stating the common or usual name of the food allergen in the list of ingredients followed in parentheses by the name of the food source from which the major food allergen is derived (unless the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list); or
2 Stating immediately after or is adjacent to the list of ingredients, “Contains,” followed by the name of food source from which the major food allergen is derived.73
If the labeling includes an allergen “Contains” statement, then all major allergens must be included in the statement even if the common name of the allergen is already listed in the ingredient statement. This is designed to protect against consumer misunderstanding and confusion from the omission.
Note that the list of “major food allergens” consists of five individual food sources, such as milk and peanuts, and three categories of foods, fish, crustacea, and tree nuts. These categories include many individual foods, so the list of major food allergens contains more than eight allergens. In addition, FDA interprets the categories broadly. Thus, by FDA’s count there are twenty‐nine major allergens under FALCPA.
The act requires allergens in flavoring, coloring, or incidental additives to also be labeled in accordance with these requirements. Thus, although flavorings or colorings may be listed generically, a major allergen source must be specifically declared. Similarly, the incidental additive exception from ingredient labeling does not apply to major allergens.
To gain an exemption from the FALCPA labeling requirements, the law provides for a petition for exemption and for a notification of exemption.
3.8.1 Petitions for Exemption
FALCPA establishes a process by which a person may petition FDA with scientific evidence that demonstrates that an ingredient as derived by the method specified in the petition does not cause an allergenic response that poses a risk to human health. FDA has 180 days to approve or deny the petition.74
3.8.2 Notifications for Exemption
FALCPA establishes a process by which a person may file a notification containing scientific evidence demonstrating that an ingredient “does not contain allergenic protein.”75 The scientific evidence must include the analytical method used and the ingredient must be derived by the specified method. FDA has ninety days to object to a notification. Absent an objection, the food ingredient is exempt from FALCPA’s labeling requirements for major food allergens.
NOTES
3.30 Tree Nuts. Section 201(qq) of the FD&C Act defines “major food allergen” to include “tree nuts.” Three examples are provided in section 201(qq): almonds, pecans, and walnuts. A nut is a fruit composed of a hard shell and a seed, but a number of hard kernels from plants are also called “nuts.” FDA has taken a broad approach to the category of “tree nuts,” which includes some, but not all, plant seeds that are commonly called “nuts.” Therefore, coconuts (a one‐seeded fruit or drupe), pine nuts or pinyons (seeds), ginkos (seeds), and dried lychees (fruit) are deemed to be “tree nuts” by FDA. However, surprisingly FDA does not consider annatto to be a tree nut even though the seeds are sometimes called annatto nuts and comes from trees, and they are a known allergen.
3.31 “The Common Name Identification of Major Allergens Law.” The food allergen labeling law is not the sole law on allergen labeling, and this imprecision in naming the law sometimes creates confusion. This law would more precisely be called something like, “The Common Name Identification of Major Allergens Law.” For example, peas are not a major allergen under the FALCPA. Nonetheless, peas are still required to be listed in the ingredient statement.