• Milk;
• eggs;
• fish;
• crustacean shellfish;
• tree nuts;
• peanuts;
• wheat, and
• soy.

Food Allergen Labeling

Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the major allergens are not appropriately declared, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is important for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes.

Interestingly, although the major food allergen list in the United States has some overlap with those food ingredients considered major allergens abroad, there are some distinctions. For example, in the European Union, sesame seeds are already deemed a common allergen, as are celery, mustard and other items not named on the major allergen list in the United States. Thus, as with other labeling components, it is important that importers and marketers of FDA-regulated food products are knowledgeable of FDA food labeling requirements since there are key differences for products sold in the U.S. market.

For more information about food regulations or our services, please visit us at Giannamore-law.com.

Although the Food Safety Modernization Act (FSMA provides the U.S. Food & Drug Administration (FDA) with the authority to issue mandatory recalls for unsafe food products, most companies issue voluntarily recalls when a mislabeling or adulteration issue arises. One reason that we continue to see voluntary recalls is that the FDA must undertake certain procedures before ordering a mandatory recall.

In order to issue a mandatory recall, the FDA must first determine that the criteria for mandatory recall has been met. Criteria for a mandatory recall may be that the food is adulterated under Section 402 of the Federal Food Drug & Cosmetic Act (FDCA). Adulteration occurs when the food (including dietary supplements) contains poisonous or deleterious substances or a substance that is otherwise unfit for food.  A food may be misbranded under the FDCA when the product labeling does not meet federally mandated requirements. For mandatory recall authority, misbranding under Section 403(w) of the FDCA would be where required major allergens are not displayed in product labeling, thus creating risk to consumers who rely on allergen warnings when making food choices.

Once mandatory recall authority has been established, the FDA must then give the company an opportunity to issue a voluntary recall. If the company still does not undertake a voluntary recall, despite FDA correspondence indicating that the criteria for recall has been met, then FDA can issue a mandatory recall. Because FDA must follow this protocol, it is unlikely that FDA’s exercise of mandatory recall authority will ever become the rule rather than the exception.

If you have any questions about FDA regulation or how you can establish and maintain compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

Every year, countless food product recalls are caused by “undeclared allergens”, which are major allergens not listed on product labels. A list of all current recalls, including those that were recalled due to food allergen labeling issues, can be found here. For example, The U.S. Food and Drug Administration (FDA) published notification of a recent recall of vegan gingersnap cookies, which were removed them from shelves when it was found that they contained tree nuts, milk, soy, and egg, none of which were listed on the product labels and therefore the products were not compliant with food allergen labeling regulations.

Federal law requires that food producers and distributors include allergy information on their labels. The Food Allergen Labeling And Consumer Protection Act of 2004 (FALCPA) governs the disclosure of certain allergens on food labels. The FALCPA only requires disclosure of 8 major food groups on labels, although there are over 160 foods that produce allergies in humans. However, the FDA has found that over 90% of food allergies are caused by the following 8 major food groups: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In addition, on August 5, 2013, the FDA issued a final rule regarding the labeling of “gluten free” foods, which as also authorized by FALCPA as part of the laws on food allergen labeling. As of August 2014, the FDA has started to enforce this rule, just as they do with the other 8 major food allergens.

The Food Allergen Labeling and Consumer Protection Act requires that food products be labeled in very specific ways. There are two ways to label foods containing allergens. First, the common name of the allergen can be placed in the ingredient statement. Second, the food producer can include a “contains” statement, which includes the food source from which the major food allergen is derived. For example, the food label should look like this.

The FALCPA does not apply to “cross-contact” situations that may arise during manufacturing, such as shared equipment or processing lines. Food producers are encouraged to use food allergen advisory statements, such as “may contain [allergen]” or “produced in a facility that also produces [allergen].”

When a company violates the food allergen labeling requirements of the FALCPA, they may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act. FDA may also request seizure of food products where the label of the product does not conform to FALCPA’s requirements. To avoid these heightened enforcement measures, many companies will opt to recall their products, as shown above.

Labeling your product requires intricate knowledge of many different statutes and regulations, such as FALCPA, the Federal Food, Drug, and Cosmetic Act, and the Food Safety Modernization Act (FSMA). We have previously blogged about the FSMA, food labeling, and the penalties for not complying with FDA regulations. For questions regarding food labeling and for inquiries about label reviews of your  product labels, please contact us at contact@sglawfl.com.

Major food allergens are defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as “[m]ilk, 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” and also as any food ingredients that contain protein derived from these foods. This definition currently excludes highly refined oil that has been derived from a major food allergen and any ingredient derived from such highly refined oil. The term “major food allergen” was first defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Public Law 108-282), which was incorporated into and amended the FFDCA.

Exemptions from the food allergen labeling requirements as found in section 403(w)(1) of the FFDCA, as amended by FALCPA, must be done through a petition and notification process. Such process includes a declaration by the petitioner that the ingredient for which exempted relief is being sought does not cause an allergic reaction, pose a significant risk to human health, or contain an allergenic protein. However, as explained in the guidance document, manufacturers of such products that wish to claim the exemptions must submit detailed petitions to the FDA before omitting major allergen labeling.

Understanding how to properly label foods with the necessary food allergen labeling information is important. Products that are improperly labeled (i.e. contains an undeclared allergen) often result in recalls and enforcement actions by the FDA. More information the consequences of failure to declare allergens in labeling may be accessed here.

If you have any questions about food labeling, including compliance with FDA requirements pertaining to major food allergen labeling, please contact us at: contact@sglawfl.com.

More specifically, under the final rule, only foods that comply with the FDA’s definition of “gluten-free” are allowed to include the term on the label. “Gluten-free” is defined under Section 101. 91 as any food that unavoidably contains less than 20 parts per million (ppm) gluten and is either inherently free of gluten or does not include an ingredient that is a gluten-containing grain; an ingredient derived from a gluten-containing grain that has not been processed to remove the gluten; or an ingredient derived from a gluten-containing grain that has been processed to remove gluten if it results in the food containing 20 or more ppm gluten.

A food that is labeled as “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” and does not meet this definition will be considered misbranded pursuant to the Food, Drug, and Cosmetic Act (FDCA). Additionally, a food whose labeling includes the term “wheat” in the ingredient list or in a separate “Contains wheat” statement– as required by Section 403(w)(4) of the FDCA–and is also labeled “gluten-free” will be considered to be misbranded unless its labeling also contains additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim.

The regulation applies to all foods regulated by the FDA, including dietary supplements. The actual use of the label “gluten-free” is voluntary, however, which means that manufacturers are not required to disclose if their food products are gluten-free. The regulation also does not replace other labeling requirements under the FDCA and FDA regulations, including those regarding allergens.

It is interesting to note that the final rule differs somewhat from the proposed rule on gluten-free labeling. In particular, the proposed rule would have required labelers of inherently gluten-free foods that voluntarily label their products as “gluten-free” to declare in labeling that all foods of that type are gluten-free. The final rule does not require this added distinction be made in product labeling.

In all, the final rule becomes effective on September 4, 2013. Food manufacturers will have one year after the date of publication—until August 5, 2014–to bring their labels into compliance with the rule’s requirements. More information about gluten-free labeling of foods is provided on the FDA’s website. If you have any questions about the final rule or compliance with any of these regulations, please contact us at: contact@sglawfl.com.

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) to help Americans avoid health risks posed by allergens. This law applies to all foods whose labeling is FDA-regulated, and it includes all domestically-produced and imported foods, including dietary supplements. Under FALCPA, any food product that contains a major food allergen or a protein derived from a major food allergen must declare the presence of such ingredient on the product’s label. Further, the eight major food allergens are defined under FALCPA as: (1) milk; (2) egg; (3) fish; (4) crustacean shellfish; (5) tree nuts; (6) wheat; (7) peanuts, and (8) soybeans. More information about FALCPA and FDA’s regulation of major food allergens in labeling may be accessed here.

If you have additional questions about food allergen labeling requirements or how you can maintain compliance with FDA labeling regulations, please contact us at contact@sglawfl.com.

Under the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), all food labels must declare the presence of major food allergens. Pursuant to FALCPA, “major allergens” consist of eight foods and food groups, including the following: milk, eggs, soy, peanuts, tree nuts, fish, crustacean shellfish and wheat. Despite FALCPA’s effective date of January 1, 2006, there remain to be countless recalls as a result of the failure to properly declare the presence of these major food allergens. While it is unclear why there have been so many deficiencies with respect to compliance with FALCPA, it appears that these types of firm-initiated recalls will continue until manufacturers and labelers can get a handle on FALCPA’s labeling requirements.

For more information about FALCPA or how you can comply with these labeling requirements, please feel free to contact us at contact@sglawfl.com.

]]> https://giannamore-law.com/fda-and-faan-aim-to-educate-public-during-food-allergy-awareness-week/?utm_source=rss&utm_medium=rss&utm_campaign=fda-and-faan-aim-to-educate-public-during-food-allergy-awareness-week Mon, 14 May 2012 19:25:19 +0000 http://giannamore-law.com/?p=159 This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer from them. An annual event since 1998, FAAW began at a time when companies were not required to declare major food allergens in labeling.

In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), thereby giving the U.S. Food and Drug Administration (“FDA”) the authority to regulate in this area. Since the passage of FALCPA, the FDA has developed regulations requiring labelers to identify the “major food allergens” in product labeling. The eight major food allergens, as defined by FALCPA are: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.

Under FDA regulations, any of these foods, including ingredients derived from them, must be listed in accordance with food labeling rules. If manufacturers and/or packagers of foods do not comply with these labeling regulations and such non-compliance is discovered, the FDA may take action against a firm. Additionally, non-compliant firms may voluntarily issue recalls of affected goods to dissuade the FDA from taking further enforcement action. For more information about recalls of this type and food allergen information, please see our previous reports here and here. In conjunction with FAAW, the FDA has provided consumers with an overview of food allergen issues, which may be accessed here.

Under the Food Allergen Labeling and Consumer Protection Act and its corresponding FDA regulations, manufacturers and/or labelers of finished food products are required to declare the presence of major food allergens in labeling. “Major food allergens” include the following ingredients and the derivatives thereof: milk, egg, fish, shellfish, tree nuts, wheat, peanuts and soybeans. In the present case, the presence of an undeclared milk derivative caused Jonlly to run afoul of FDA regulations, necessitating this recall by the company.

Recalls of this type are not infrequent. In April 2012, we reported on a similar recall that was initiated as a result of undeclared milk and/or nuts. Despite being common, these recalls are preventable. Compliance with the laws and regulations pertaining to labeling is critical to ensure the seamless distribution of all FDA-regulated products. For more information about labeling requirements, please contact us at Contact@Giannamore-Law.com.

Under the Food Allergen Labeling and Consumer Protection Act of 2004 and FDA regulations, manufacturers and/or distributers of finished food products are required to declare the presence of major food allergens in labeling. “Major food allergens” include the following: milk, egg, fish, shellfish, tree nuts, wheat, peanuts and soybeans. According to the FDA, TWI Foods did not properly label the affected products in that they contain milk and/or almonds but the presence of these ingredients are not clearly stated on the labels. More information about food allergen labeling may be found here.

Compliance with the laws and regulations pertaining to labeling is critical to ensure the seamless distribution of all FDA-regulated products. For more information about labeling requirements, please contact us at Contact@Giannamore-Law.com.