A Guide to FDA Regulation of Food Labeling Claims

In today's crowded marketplace, food companies find it essential to distinguish their products from the competition to increase their marketability. An effective way to make a product stand out is by making claims in reference to the nutritional value and unique characteristics of the food. Bold claims such as "reduced fat," "natural," "gluten free" and "high in fiber" can draw health-conscious consumers to a product and increase sales.

FDA regulates many of the claims that are made on food labeling. Among the FDA-regulated claims commonly declared on food labels are nutrient-content claims, health claims, qualified health claims and structure/function claims. Additionally, FDA has authority over claims related to gluten content, genetically modified organisms (GMOs) and "natural." It is critical that companies familiarize themselves with FDA regulations that pertain to claims made on their product labeling. FDA issues hundreds of warning letters every year, many of which are due to food labeling claims FDA considers inappropriate.

"Nutrient content claims" are explicit and implied claims that characterize the level of a nutrient in a food or dietary supplement, such as "high in protein" and "low fat."  Whether a product can be "high in" or "a good source of" a nutrient is based upon its percent of the daily recommended value (DRV) or recommended daily intake (RDI) of the nutrient as established by FDA. Nutrients that do not have a DRV or an RDI may not make nutrient-content claims. Instead, the quantitative amount may be declared (for example, 300 mg of L-tryptophan). FDA recently issued a final rule related to omega-3 claims, in which the agency is allowing "high," "good source" and "more" claims in reference to alpha-linolenic acid (ALA) based on specific nutrient levels. Nutrient-content claims in reference to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) remain prohibited.

FDA also permits "relative claims" such as "reduced fat sour cream" and "light potato chips." These claims must include the percentage or fraction by which the food has been modified, the reference food, and the amount of nutrient in the labeled food and in the reference food. Foods that have relatively high amounts of nutrients, such as calories and fat, may require additional disclosure statements adjacent to the claim.

"Health claims" are those that describe a relationship between a food, food component or dietary supplement ingredient, and reducing the risk of a disease or health-related condition. Health claims must be specifically authorized by FDA. Usually, FDA will authorize the exact claim and the nutrient requirements to make it, such as "diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease." Foods that make this claim must also qualify for "low saturated fat" and "low cholesterol" claims, bear quantitative trans fat labeling, contain less than 0.5 g of trans fat per reference amount customarily consumed (RACC), and contain less than 6.5 g of total fat. Health claims are approved based upon the standard of significant scientific agreement (SSA).

In response to court decisions, FDA also permits "qualified health claims" that are based on evidence that is not well enough established to meet the standard required for an FDA-approved "health claim." These claims must clarify the evidence supporting the claim is limited, such as "FDA has determined that, although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive."

“Structure/function claims" describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, describe general well-being from consumption of a nutrient or dietary ingredient, or describe a benefit related to a nutrient deficiency disease (such as vitamin C and scurvy). Generally, claims can "support" or "maintain" normal function, but not affect abnormal states. Structure/function claims are not pre-approved by FDA, but must be truthful and not misleading. In addition, the manufacturer must possess substantiation to support the claim. Products that make inappropriate claims may be deemed as unapproved new drugs or misbranded by FDA and may be refused entry into the United States.

FDA also exerts its authority over claims such as "natural" and "gluten free." Since 1993, companies have relied upon vague statements from FDA in the Federal Register regarding use of the term "natural" in reference to food products. FDA stated it would not object to use of the term on products that contained no artificial flavors, color additives or chemical preservatives. As use of the term has grown, FDA has come under fire to issue more substantive policies regarding its appropriateness. On Nov. 12, 2015, FDA issued a Federal Register notice in which FDA solicited comments regarding the use of the term "natural" in food labeling (80 FR 69905). The comment period was due to close on Feb. 10, 2016, but was extended until May 10, 2016. FDA may use the comments and information provided to develop a proposed rule in relation to this claim.

"Gluten free" claims were in a similar regulatory purgatory until the issuance of a final rule that went into effect in 2014. Foods may now claim to be gluten-free under specific conditions: when they are inherently free of gluten, do not contain an ingredient derived from wheat/barley/rye, contain less than 20 ppm of gluten, or have an ingredient derived from wheat/barley/rye that has been processed to remove gluten, resulting in a level of gluten below 20 ppm.

Imported products with inappropriate claims can be denied entry at port, resulting in financial loss and disruptions to the company supply chain. Domestic producers may receive warning letters that are published on FDA’s website, where they may be seen by buyers, suppliers and retail customers. As FDA has regulatory authority over many of the claims made on food labeling, it is critical that companies verify the claims made on their products are appropriate.

Anna Benevente ([email protected]) is a senior regulatory specialist at Registrar Corp. (registrarcorp.com), an FDA consulting firm that helps companies comply with FDA regulation. She has been assisting companies with FDA regulations since 2009 and has researched more than 370 products to determine whether they meet FDA requirements for compliance.