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.

More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best science, prevention, and public health risk; (3) increase compliance with newly created preventive control standards across the farm-to-table continuum; (4) improve public health indicators through better nutrition and dietary choices; (5) develop and swiftly deploy the fastest and most effective methods for identifying, containing, and eliminating food and cosmetic hazards.

Each of the six goals corresponds to specific objectives. For example, the Center intends to continue to implement the provisions of the Food Safety and Modernization Act (FSMA). Particularly, in 2014 and 2015, it plans to publish preventive controls—as required by FSMA—for produce, food processing facilities, and food transportation. CFSAN will also publish a final rule for intentional contamination, address an approach to determine high-risk foods and the most significant foodborne contaminants, and draft recordkeeping requirements for high-risk foods.

Additionally, the Center plans to improve the safety and labeling of dietary supplements. This includes developing regulations for “energy drinks” and publishing final guidance to help dietary supplement and beverage manufacturers determine whether a liquid food product, such as an energy drink, may be labeled and marketed as a dietary supplement. By the end of 2013, it will publish draft guidance for new dietary ingredients.

Next, CFSAN has been working to develop new food labeling regulations. Specifically, CFSAN will update the nutrition facts labeling and serving size information on food labels. The Center had also planned to publish a final rule defining gluten-free and on using the term on food labels in 2013, which the Center accomplished on August 5, 2013. In 2014, the Center plans to finalize rules required by the Affordable Care Act of 2010, specifically to require nutrition information on menus and vending machines.

Finally, CFSAN plans to reduce risks related to cosmetics. For example, it will publish guidance on current good manufacturing requirements for cosmetics and finalize guidance regarding the effects of manufacturing process changes, such as nanotechnology, on the safety of cosmetics. In 2014, it intends to develop draft guidance on the use of lead in lipstick.

If you have any questions about this new plan or compliance with FDA regulations, 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.