When you walk through a grocery store, you will likely see certain food labeling claims such as “healthy”, “low in sugar”, and “humanely sourced”. A “labeling claim” refers to a term on a label that is not required, but the manufacturer has chosen to include it usually for marketing purposes. Although not required to be on the label, if a manufacturer includes a labeling claim they usually must follow certain regulations. The type of food will determine which agency regulates the claims. The Food and Drug Administration (FDA) regulates the labeling of most food (around 80%). However, if the food is meat, poultry, catfish, or an unshelled-egg product, then it is regulated by the Food Safety and Inspection Service (FSIS), an agency within the United States Department of Agriculture.

Although food labeling claims can be helpful for consumers seeking certain qualities in the food they buy, sometimes labeling claims can mislead consumers. To prevent this deception, both the FDA and FSIS have promulgated regulations and guidance documents governing food labeling claims. However, under both agencies’ regulations and authorizing legislation, only the agency can bring legal action against a company violating the regulations or statutes. Therefore, other legal avenues have emerged for corporations seeking to prevent a competitor from using misleading labeling claims and for consumers seeking a remedy after they have been misled. This is the first post in a series that explains the regulations governing food labeling claims and the potential legal actions brought against companies who have allegedly violated the regulations and statutes.

This first post explains the different categories of claims under FDA’s regulations. As the FDA explains, for food under its jurisdiction, there are three general categories of food labeling claims. These three categories are (1) nutrient content claims, (2) health claims, and (3) structure and function claims.

Nutrient Content Claims

A nutrient content claim “expressly or implicitly characterizes the level of a nutrient” in a food product. 21 C.F.R. § 101.13(b); see also 21 U.S.C. § 343(r)(1)(A). A “nutrient” refers to the substances that food manufactures are required to include on the Nutrition Facts panel which is usually found on the back of food packages. These nutrients include fat, cholesterol, sodium, fiber, sugar, protein, vitamin D, calcium, iron, and potassium. See 21 C.F.R. § 101.9.

Nutrient content claims can be either expressed and implied. An expressed nutrient content claim states a specific level or range of a nutrient in the food. For example, “low in sodium” and “contains 3 grams of fat” are expressed nutrient content claims. 21 C.F.R. § 101.13(b)(1). Although “low in sodium” does not state an exact level of sodium, it is an expressed nutrient content claim because the regulations set thresholds for the use of terms such as “very low”, “low”, and “reduced” for each of the nutrients. See 21 C.F.R. § 101.54-101.62. To help illustrate what each of these terms mean, the FDA provides the following chart:

What the Label Says What it means
Salt/Sodium Free Less than 5 mg of sodium per serving
Very Low Sodium 35 mg of sodium or less per serving
Low Sodium 140 mg of sodium or less per serving
Reduced Sodium At least 25% less sodium than the regular product
Light in Sodium or Lightly Salted At least 50% less sodium than the regular product
No-Salt-Added or Unsalted No salt is added during processing – but these products may not be salt/sodium-free

 

If a food is naturally low in a nutrient, the label cannot express that it is low in that nutrient unless it also explains that all brands of that type of food are low in that particular nutrient. For example, a corn oil manufacturer may not label its product as “sodium free corn oil”, but may label it as “corn oil, a sodium-free food”. 21 C.F.R. § 101.13(e)(2).

On the other hand, implied nutrient content claims simply suggest that a nutrient is absent or present in a certain amount, such as “high in oat bran”. 21 C.F.R. § 101.13(b)(2)(i). “High in oat bran” implies that the food is a good source of dietary fiber. 21 C.F.R. § 101.65(c)(3). Implied nutrient content claims can also suggest that a food item is “useful in maintaining healthy dietary practices”. See 21 C.F.R. § 101.13(b)(2). “Healthy” is an example of such an implied nutrient content claim.

If a food manufacturer uses the implied nutrient content claim “healthy” (this also includes other variations of the term such as “health”, “healthful”, “healthier”, etc.), then the manufacturer must ensure the food meets certain conditions for fat, saturated fat, cholesterol, and vitamins as outlined in the regulations. 21 C.F.R. § 101.65(d)(2). However, the FDA is currently in the process of collecting information on how to update the “healthy” claim.

Additionally, the regulations allow food manufacturers to suggest that a food “may be useful in maintaining healthy dietary practices” by combining an implied nutrient content claim with an expressed claim, for example, “healthy, contains 3 grams of fat”. See 21 C.F.R. § 101.13(b)(2)(ii).

Health Claims

Health claims characterize the relationship between a nutrient and a reduced risk of disease or a health-related condition. 21 U.S.C. § 343(r)(1)(B); 21 C.F.R. § 101.14(a)(1).  Like nutrient content claims, health claims can be either expressed or implied. According to the regulations, “implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest … that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition.” 21 C.F.R. § 101.14(a)(1). However, the more important consideration is whether the health claim is authorized or qualified.

Authorized Health Claims

Only after the FDA promulgates regulations allowing the use of an authorized health claim can a food manufacturer include such a claim on its food product. There are two avenues through which health claims can become authorized. First, the FDA can authorize a health claim after it determines there is significant scientific agreement among health experts that the claimed relationship between the nutrient and reduced risk of disease exists. 21 U.S.C. § 343(r)(3)(B). Second, any interested person may petition the FDA to issue a regulation authorizing a health claim. 21 C.F.R. § 101.70(a). The FDA will accept the petition and start the regulatory process of creating a new authorized health claim only if the National Academy of Sciences or a scientific body of the U.S. government has published an authoritative statement on the petitioned relationship between a nutrient and a reduced risk of disease. 21 U.S.C. § 343(r)(3).

Currently, there are 12 authorized health claims found in Sections 101.72 through 101.83 of Title 21 of the Code of Federal Regulations. Each of these sections explains the relationship between a particular nutrient and a disease or health condition and offers model health claims. For example, section 101.72 first explains that an “inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis.” 21 C.F.R. § 101.72(a). The section then offers the following as an example for food manufacturers who wish to use this authorized health claim: “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis”. 21 C.F.R. § 101.72(e).

Qualified Health Claims

Unlike authorized health claims, qualified health claims are based on emerging evidence that does not meet the significant scientific agreement standard. Because there is not significant scientific agreement on the relationship between a nutrient and a reduced risk of disease, the FDA allows manufacturers to use the claim, but only if it is accompanied by qualifying language. The FDA does not have regulations outlining the process of obtaining a qualified health claim, instead the process is outlined in guidance documents. Through this process, anyone can file a petition with the FDA to use a particular qualified health claim. The FDA will review the scientific evidence presented in the petition and write a letter to the petitioner outlining the qualifying language which should accompany the proposed health claim. For example, if there is good evidence supporting a relationship, but the evidence does not reach the significant scientific agreement standard, then the qualifying language should be “although there is scientific evidence to support the claim, the evidence is not conclusive.”

Although the FDA only issues letters of enforcement discretion regarding qualified health claims to the petitioner, any food manufacturer can use a previously approved qualified health claim if they meet the conditions in the letter. The FDA archives the letters of enforcement discretion for qualified health claims here.

Structure & Function Claims

Structure and function claims are primarily seen on dietary supplements, but are sometimes seen on conventional food products. According to the FDA, these claims “describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, ‘calcium builds strong bones.’” The line between structure and function claims and health claims is not always clear. However, structure and function claims describe the effect that a nutrient has on the body and do not reference a disease. Although dietary supplement manufacturers are required to notify the FDA if they intend to use a structure and function claim on a product, food manufacturers are not required to do so.

How the FDA Enforces these Claims

The Federal Food, Drug, and Cosmetic Act (FFDCA) does not grant a private right of action. This means that only the FDA can enforce FFDCA violations and private citizens or corporations cannot sue other citizens or corporations to enforce the FFDCA. To enforce the FFDCA, the FDA can take a number of enforcement actions. According to the FDA, “the type of enforcement activity FDA uses will depend on the nature of the violation.” These actions include:

  • Warning letters—The FDA’s first enforcement action is usually issuing a warning letter in which the FDA requests the recipient to respond with steps it will take to correct the FFDCA violation.
  • Seizures—If the FDA deems it appropriate, it will remove all of the misbranded or adulterated production from commerce. The FDA does not usually seize food products for mislabeling issues.
  • Injunctions—The FDA can seek a court order requiring a company to stop producing a product that violates the FFDCA. Again, the FDA usually does not seek injunctions against mislabeled food.
  • Criminal prosecution—The FDA can bring criminal charges against a product manufacturer when an FFDCA violation is so egregious that the product causes harm. Historically, the FDA has brought criminal charges against companies whose products are connected to a foodborne illness outbreak, and not against companies whose products are mislabeled.

Notably, the FDA does not conduct pre-market label approval for food labels. Therefore, if the FDA takes any of these enforcement actions, it is taking the action after the mislabeled product is already in commerce.

Conclusion

To help market their products, food manufacturers often include labeling claims on their food packaging. However, a food manufacturer should be aware that certain claims must adhere to the FDA’s food labeling regulations. Depending on the claim, the food manufacturer should make sure the claim used follows the regulations or the appropriate guidance document. If food manufacturers fail to follow the regulations, then the FDA can bring enforcement actions.

 

To learn more about food labeling, read FDA’s Food Labeling Guide, click here.

To read more National Agricultural Law Center resources on food labeling, click here.

 

 

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