According to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.
On August 5, 2013 the FDA published a rule final rule that established a definition the term “gluten free” for voluntary use in the labeling of foods, see my previous blog post on this here. This will enable Celiacs to trust food products that are labeled “gluten free.” With the compliance date, August 5, 2014, fast approaching, the FDA has now provided a guide to help small businesses comply with the new federal requirements for “gluten free” labeling.
The guide sets forth (in plain language) the requirements set forth in the final rule and defines the following terms:
- Gluten – the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease.
- Gluten-containing grain – any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye):
- Wheat, including any species belonging to the genus Triticum;
- Rye, including any species belonging to the genus Secale; or
- Barley, including any species belonging to the genus Hordeum.
- Gluten-free – food that does not contain any of the following ingredients:
- An ingredient that is a gluten-containing grain; or
- An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten; or
- An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten.
- This means that foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten-containing grains or other gluten-containing ingredients. 20ppm is equivalent to 20 milligrams of gluten per 1 kilogram of food.
According to the guide, the “gluten-free” claim can appear anywhere on the product, in any size or color.
After August 5, you are responsible for ensuring that your foods bearing a gluten-free claim meet the FDA requirements, including that any unavoidable gluten present in a food labeled “gluten-free” is less than 20 ppm. Failure to ensure your “gluten-free” labeled products meet the FDA requirements is considered “misbranding” and can subject you to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Penalties for non-compliance with FDA labeling requirements (misbranding) range from $1,000 to $10,000 fines and up to 3 years in prison.
All products must be labeled in accordance with the regulations in the FD&C Act. If you are not sure if your product is in compliance, and you mention this blog post, contact me at 305-260-1053 or firstname.lastname@example.org, and receive a complimentary consultation to discuss your labeling! Hurry, August 5 is around the corner!
Co-Authored by Melissa Rodriguez, a law clerk at Becker & Poliakoff and a student at the University of Florida Levin College of Law.