When you walk through a grocery store, you will likely see certain food labeling claims such as “healthy”, “low sodium”, 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. However, if a manufacturer includes a labeling claim, they usually must follow certain federal food labeling 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 egg product, then it is regulated by the Food Safety and Inspection Service (FSIS), an agency within the United States Department of Agriculture (USDA). Additionally, the Agricultural Marketing Service (AMS), another agency housed within USDA, administers certain voluntary programs that allow food manufacturers to include terms and phrases such as “organic” on food products.

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 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. This is the third 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.

FDA, FSIS, and AMS all have jurisdiction over labeling claims found on egg and dairy labels. This blog post explains what claims on which products are regulated by FDA, similarly which are regulated by FSIS, and the programs AMS administers for egg and dairy products.

Eggs

FSIS and the FDA share jurisdiction over the labeling of eggs and egg products. FSIS regulates “egg products” which includes “any dried, frozen, or liquid eggs”. 9 C.F.R. § 590.5. The FDA regulates the labeling found on the packages of eggs in the shell, or shell eggs. AMS administers a voluntary shell egg grading program.

FSIS: Egg Products

Since December 2020, FSIS regulates egg product labels the same way it regulates labels on meat and poultry products. See 85 Fed. Reg. 68640. This means that FSIS conducts generic approval of an egg product if any labeling claim on the label is defined in FSIS’s regulations or the Food Standards and Labeling Policy Book (Policy Book). As explained in the second post in this blog series, FSIS will conduct sketch approval if the label contains a term not defined in FSIS’s regulations, a term not defined in the Policy Book, a natural claim, or a negative claim. See 9 C.F.R. § 590.411(a). For example, if a carton of egg whites indicates that egg whites are “a cholesterol free and fat free food”, then it contains a nutrient content claim. FSIS generically approves nutrient content claims, which means that as long as the claim follows the regulations, FSIS does not need to pre-approve the label before the product enters commerce. See 9 C.F.R. § 590.412(a). If instead, the carton of egg whites includes the health claim that “diets low in saturated fat and cholesterol may reduce the risk of heart disease”, then FSIS must sketch approve the label before it is marketed. See 21 C.F.R. § 101.75(e)(1).

FDA: Shell Eggs

Generally, FDA has jurisdiction over the labels found on shell egg cartons. In regulating shell egg labels, FDA applies the same regulations it applies to other food labels. FDA does not require any food manufacturer to submit a label to FDA before the labeled product enters commerce. Therefore, FDA does not pre-approve shell egg carton labels.

However, if a shell egg processor wants to include a claim on its shell egg cartons, it must follow FDA’s labeling regulations. For example, if a shell egg carton states the eggs are an “excellent source of vitamins D, E, B2, B12, and B5”, then the carton contains expressed nutrient content claims. Under FDA’s regulations for nutrient content claims, the phrase “excellent source” has a particular meaning. 21 C.F.R. § 101.54(b). The shell egg processor must ensure that the level of each stated nutrient is high enough to meet the regulatory definition of “excellent source”. If FDA discovers there is a shell egg label on the market that does not comply with the regulations, then FDA can take the regulatory actions discussed in the first blog post in this series.

FDA does not have any finalized regulations on “natural” or animal raising claims. However, at the request of the shell egg processor, AMS will pre-approve shell egg carton labels that contain a “cage-free claim”.

AMS: Shell Eggs

AMS administers a voluntary shell egg grading program.  According to USDA, “packaging materials that bear a USDA Grade Shield must be pre-approved by USDA to ensure the labeling is truthful and not misleading. This includes claims regarding the method of production (cage-free, free range, etc.), making the USDA Grade Shield a symbol of quality and integrity.” USDA further explains that “eggs packed under a USDA Grade Shield and marketed as cage-free—or with any other production claim—must be source-verified by USDA through onsite farm visits, at least twice annually, to check that the laying hens are housed in the appropriate production system.”

USDA explains that “state agencies monitor compliance for egg packers who do not use the [AMS] grading service.” Therefore, as required by the Egg Products Inspection Act (EPIA), all shell eggs that enter commerce are graded, and are at least a Grade B (Grade B is the lowest of the three permitted grades, the other two are Grade A and Grade AA). However, only the eggs that are graded through AMS’s grading service state both the grade and depict the USDA Grade Shield. Eggs graded by a state agency will indicate a grade on the carton, but will not include the USDA Grade Shield.

One of the AMS Grade Shields is specifically for source verified “cage-free” eggs. The egg cartons that carry this shield were inspected and verified by AMS. However, as USDA explains, “not all USDA graded eggs are cage-free, and not all cage-free eggs are graded by USDA.”

Dairy

Like eggs, the oversight of dairy labeling claims is spilt between FDA and USDA. FDA has primary jurisdiction, but AMS conducts a voluntary grading program for dairy products.

FDA

Under the Federal Food, Drug, and Cosmetic Act, FDA has primary jurisdiction over the labeling and safety of dairy products. Therefore, most of the labeling claims found on dairy products are regulated and enforced as described in the first blog post in this series. This means that dairy food producers should be aware of and adhere to FDA’s food labeling regulations, or face potential enforcement actions taken by FDA.

On dairy products, fat nutrient content claims are very popular. The following list explains what different fat content claims mean when used on dairy products:

  • Reduced fat: contains at least 25% less fat than a reference food. A reference food is a similar product or brand which can be used in place of the product carrying the label. For example, a reduce fat claim may say “this product has reduced fat as compared to the leading competitor”.
  • Low fat: contains 3 grams of fat or less per serving.
  • Fat free or Skim: contains less than 0.5 grams of fat per serving.

See 21 C.F.R. § 101.62.

Because FDA has jurisdiction over dairy products, animal raising claims on dairy products are regulated differently than animal raising claims found on meat, poultry, and egg products. For FSIS regulated products, labels that contain animal raising claims must be pre-approved, or sketch approved, before they enter commerce. However, FDA does not pre-approve labels. Therefore, FDA does not verify that animal raising claims such as “grass-fed” or “pasture-raised” on dairy products are truthful before the product enters commerce. If FDA discovers that the use of a term is misleading, however, it can take enforcement actions against the dairy processor or producer responsible for the label.

A popular labeling claim on dairy products, particularly fluid milk, is the claim that the cows were not treated with rBST, or that the milk is rBST-Free. According to FDA, rBST stands for recombinant bovine somatotropin which is a manufactured version of a naturally occurring bovine growth hormone. FDA approved the use of rBST in dairy cows in 1993 after determining that there was no significant difference between the milk from treated and untreated cows. Because FDA made this determination, any products derived from an animal treated with rBST does not need to carry a label that indicates that the animal was treated with the hormone. However, some dairy producers and processors that do not use rBST have chosen to include an “rBST-free” claim on their labels, and they can do so as long as the claim is not misleading.

Like shell eggs and egg products, milk and dairy products are graded. FDA published, and regularly updates, the Model Grade “A” Pasteurized Milk Ordinance (PMO). As a model, this document is not legally enforceable at the federal level. However, 46 states have adopted the PMO while four states have enacted their own laws similar to the PMO. The PMO sets food safety standards for what production methods, processes, and packaging are required for grade A milk.

AMS

In addition to the PMO, AMS offers a voluntary milk and dairy product grading program. AMS has standards, which translate to different grades, for different dairy products. According to AMS “U.S. Grade Standards for Dairy are voluntary and aid in the marketing of milk and dairy products by providing a common language of trade through the development, improvement, and interpretation of standards, specifications and quality improvement programs.” Therefore, AMS’s diary grading program is very similar to its shell egg grading program.

Conclusion

To help market their products, food manufacturers often include labeling claims on their food packaging. However, egg and dairy processors and producers should be aware that, depending on the product, either the FDA or FSIS has jurisdiction over the labeling of their products. Producers and processors should be aware of the differences in how the two agencies regulate. Although not legally required, shell egg and dairy producers and processors can take advantage of AMS’s programs which may add value to their products. For consumers, it is beneficial to know what these claims mean when making purchasing decisions.

 

To explore more about food label claims on a variety of different food products, visit is the Center for Agriculture & Food Systems Labels Unwrapped interactive webpage, here.

To learn more about food labeling generally, visit the National Agricultural Law Center’s Food Labeling Reading Room, here.

To read the first two posts in this blog series, click here and here.

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