The FDA issued the final rule about labeling food products “gluten-free” on August 1, 2013. The gluten-free food market is growing rapidly with the growing awareness of celiac disease, gluten sensitivity and intolerance, and wheat allergies. Here’s what food companies need to know about the new gluten-free food labeling rule.
Why the Special Rule?
For persons with celiac disease, gluten destroys the lining of the small intestine so that the body cannot absorb nutrients. This can result in nutritional deficiencies, osteoporosis, delayed growth, infertility, miscarriages, short stature and intestinal cancers. Celiac disease is an inherited, chronic auto-immune disorder and may affect as many as 3 million Americans.
The treatment for celiac disease is dietary: Avoid ingesting gluten. Before regulations took effect, the FDA estimated that 5 percent of food products with gluten-free labels contained more than 20 parts per million of gluten.
Gluten sensitivity and wheat allergies also are an issue for which the treatment is to avoid eating gluten. Thirty percent of American adults claim to cut down on or avoid gluten, according to research by the NPD Group.
Here’s what food companies need to know about the new gluten-free food labeling rule.
1. One Year to Comply. The rule takes effect at the end of August, but food companies have one year from August 1, 2013 to comply with the rule.
2. Voluntary (Sort of). Labeling food products gluten-free is not mandatory, but if you do so you must comply with the rule.
3. Applies to Most Food. The rule applies to labels of food products regulated by the FDA, including dietary supplements. It does not apply to meat poultry, and certain egg products (foods regulated by the USDA) or most alcoholic beverages (which are regulated by the Alcohol and Tobacco Tax and Trade Bureau). The rule does not apply to products that are not food.
4. The Limit. To be labeled gluten-free, food products must have less than 20 ppm (parts per million) gluten. 20 ppm is the lowest level of gluten that can be detected on a consistent basis using valid scientific analytical tools. The level also conforms to the food safety standards set by other countries and international bodies.
5. The Gluten Grains. The gluten grains are wheat, rye, barley, or their crossbred hybrids like triticale. To be labeled gluten-free, the food product must not contain:
- Any wheat, rye, barley or their crossbred hybrids like triticale
- Any ingredients derived from these grains if the gluten has not been removed
- Any ingredients derived from these grains if the gluten has been removed if the gluten content remains above 20 parts per million
6. Oats and other Grains. Food products containing oats or any other grains can be labeled gluten-free as long as they contain less than 20 ppm gluten. (These foods may contain some gluten because of cross-contact with gluten grains that may occur in crop rotation or because of shared use of harvesting equipment, transport machinery and storage silos.)
7. Okay to Use Label on Inherently Gluten-Free Food. It is usually considered deceptive to make a claim about a food that is an inherent quality of the food; for example, to claim your apple is “fat-free.” That is not the case with gluten-free labeling.
8. Certification by Third-Parties. Third-party certifications that products are gluten-free are allowed if they are truthful, not misleading and meet the requirements of the rule. See also the Green Guides, published by the Federal Trade Commission (FTC), for more information about third-party certifications.
9. Labels with the Same Meaning. Labels such as “no gluten,” “free of gluten” or “without gluten” can be used only if a food product contains less than 20 parts per million of gluten.
10. Imports Too. The rule applies equally to imported foods regulated by the FDA.
11. Testing Not Required. The rule does not require manufacturers to test for the presence of gluten in their foods labeled gluten-free, but manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule.
12. The Risk. Failure to comply exposes companies to risk of regulatory enforcement action. The FDA may use any of its routine monitoring activities to enforce the final rule on gluten-free food labeling, including periodic inspections of food manufacturing facilities, food label reviews, investigating consumer and industry complaints reported to the agency, and gluten analyses of food samples. The FDA does not currently plan to authorize third-parties to inspect food manufacturing facilities.
There are, of course, numerous issues with food labeling, and we can’t cover them all in this article. These examples are intended as general information and not specific legal advice. Products and situations can be unique and we encourage food producers to speak with an attorney to discuss their individual situations.
Brian Dunkiel and Rebecca Boucher are attorneys from the Burlington, Vt. based law firm Dunkiel, Saunders, Elliott, Raubvogel & Hand.