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. If the labeling claim is on the label of a meat or poultry product, then the government must approve the label before the food manufacturer can market the product. The labels on meat and poultry, along with catfish, and “egg products,” (eggs that have been removed from the shell), are regulated by the Food Safety and Inspection Service (FSIS), an agency within the United States Department of Agriculture (USDA). The Food and Drug Administration (FDA) regulates the labeling of the rest of the American food supply (around 80%).
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 second 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 second post explains the different categories of claims under FSIS’s regulations as they apply to meat and poultry. Under FSIS’s regulations, if a meat or poultry manufacturer chooses to include certain claims on a product label, then FSIS must pre-approve the label before it enters commerce. This blog post explains which labels FSIS will “generically approve” and which labels FSIS must “sketch approve”.
Generic Approval v. Sketch Approval
According to FSIS’s regulations “no final label may be used on any product unless the label has been submitted for approval to the FSIS Labeling and Program Delivery Staff, …, except for generically approved labels”. 9 C.F.R. § 412.2(a)(1). The regulations and guidance documents explain which labels are subject to generic approval and which must go through the more rigorous sketch approval process.
An establishment “is authorized to use generically approved labels” and does not have to submit a product label to FSIS for pre-market approval if the label “displays all mandatory features in a prominent manner …, and is not otherwise false or misleading in any particular [way].” 9 C.F.R. § 412.2(a)(1). Mandatory labeling features include the product name; a safe handling statement; an ingredients statement; the name and place of business of the manufacturer, packer, or distributor; the net weight; a legend; safe handling instructions; and nutrition labeling. 9 C.F.R. § 412.2(b).
If a food manufacturer wants to include an additional labeling claim beyond the mandatory labeling features and still wants to utilize generic label approval, it can do so if the additional labeling claim is defined in FSIS’s regulations or the Food Standards and Labeling Policy Book. 9 C.F.R. § 412.2(b). FSIS has deemed the claims defined in the regulations and the Food Standards and Labeling Policy Book as not false or misleading. However, there are two exceptions: the Food Standards and Labeling Policy book defines both “natural” claims and negative claims, but both require sketch approval.
Most of the claims defined by the regulations fall under the category of nutrient content claims. The term “nutrient content claim” is defined the same way under FSIS’s regulations as it is under the FDA’s regulations. As explained in the first blog post in this series, a nutrient content claim “expressly or by implication, characterizes the level of a nutrient of the type required in nutrition labeling”. 9 C.F.R. § 317.313(b); 9 C.F.R. § 381.413(b). Much like the FDA, FSIS has regulations defining the nutrient content claims for terms such as “good source”, “high”, and “more”; as well as for “light” or “lite”. See 9 C.F.R. §§ 317.354, 317.356. FSIS also regulates the use of nutrient content claims regarding calorie, sodium, and fat content. See 9 C.F.R. §§ 317.360-62. Finally, FSIS regulates the nutrient content claim for “healthy”. See 9 C.F.R. § 317.363.
In addition to nutrient content claims, there are a few other labeling claims which FSIS will generically approve. If the claim is a factual statement such as “extra cheese”, a defined geographic style, or an allergen statement, then FSIS will generically approve the label.
If a label is subject to pre-market sketch approval, the food manufacturer must submit the label to FSIS before the labeled product may enter the stream of commerce. One of the four categories subject to sketch approval is “labels with special statements and claims.” See 9 C.F.R. § 412.1(c)(3). According to FSIS, “special statements and claims including logos, trademarks, and other symbols on labels that are generally not defined in FSIS regulations or the Food Standards and Labeling Policy Book must be submitted to FSIS for approval”.
Although FSIS has interpreted the regulations to include a list of examples of special statements and claims, the regulations specifically list the following special statements and claims that require sketch approval:
- Natural claims
- Negative claims
- Health claims
- Structure and function claims
- Animal raising claims
- Organic claims
9 C.F.R. § 412.1(e).
Although the Food Standards and Labeling Policy Book defines both “natural” and negative claims, these types of claims require sketch approval. According to the Food Standards and Labeling Policy Book, meat and poultry manufacturers seeking approval of a “natural” label should submit to FSIS documentation that indicates “(1) the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (…), or any other artificial or synthetic ingredient; and (2) the product and its ingredients are not more than minimally processed.” Additionally, the Food Standards and Labeling Policy Book offers a list of examples of allowed negative claims. One of these examples states that “negative labeling is allowed if the statement is beneficial for health, religious preferences, or other similar reasons. For example, highlighting the absence of salt in a product would be helpful to those persons on sodium-restricted diets.”
Health claims and structure and function claims on FSIS regulated food products are the same as those claims on FDA regulated products. Health claims characterize a relationship between a nutrient and a reduced risk of disease or a health-related condition. 21 C.F.R. § 101.14(a)(1). Structure and function claims are similar to health claims, but instead of identifying a disease or specific health related claim, they describe the intended affect a nutrient will have on the structure and function of the human body. If a food company includes either type of claim on a label, they must submit the label to FSIS along with documentation that substantiates the claim.
Animal raising claims include statements about animal welfare and environmental stewardship; the breed of an animal; the diet the animal consumed; the living and raising conditions of the animal; the lack of antibiotics used; the lack of hormones used; the source and traceability of the food product; and third-party certifications. According to FSIS, it approves “such claims if the animal raising information submitted with the label application support[s] the claim being made and the claim is truthful and not misleading.”
FSIS must sketch approve all product labels that include an “organic” claim, or another certified claim regardless of who the certifying entity is. The Agricultural Marketing Service (AMS), an agency housed within the USDA, certifies food products (including FDA regulated food products) for a number of different claims. For example, AMS is in charge of classifying and grading meat, poultry, and eggs. AMS also oversees organic certification. Separate from AMS, private sector groups also conduct certifications. For example, Low Carbon Beef, LLC, certifies beef products that claim to emit low levels of carbon into the environment. Regardless of whether the certifying entity is the government or a private entity, FSIS must sketch approve labels bearing a “certified” statement. In addition to submitting the label to FSIS, the food manufacturer must also submit documentation that explains the certification criteria and illustrates how the product meets that criteria.
Some special statements and claims fall into multiple categories. For example, a “no antibiotics” claim is both a negative claim and an animal raising claim, and a claim such as “gluten free” might be both a negative claim and a third-party certification. For both of these claims, the food manufacturer must submit documentation that substantiates the claim whether that be veterinary records or a certification from the Gluten Intolerance Group.
How FSIS Enforces these Claims
Despite these regulations, FSIS regulated food may still enter commerce in a way that violates FSIS’s regulations. Generally, regulatory violations occur when manufacturers fail to seek sketch approval when they were required to or fail to follow the regulations for generically approved labels. The Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) do not grant a private right of action. This means that only FSIS can enforce these statutes and their implementing regulations. To enforce these statutes, FSIS can take a number of enforcement actions. These actions include:
- Seizures—with the help of the USDA Office of General Counsel (OGC) and the U.S. Attorney, FSIS can seize and hold a product while the case is being adjudicated.
- Injunctions—similar to seizures, FSIS, with the help of OGC, can seek an injunction from a U.S. District Court which would prohibit the violating food manufacturer or retailer from distributing the misbranded product.
- Notices of Warning—FSIS will issue a notice of warning (NOW) to notify the violating party that they are violating an FSIS statute or regulation. FSIS issues NOWs for minor violations. NOWs identify what statutes and regulations were violated and what actions FSIS may take if the violating party does not correct the violations.
- Trial Diversion Agreements—to avoid trial, FSIS with the help of OGC and the U.S. Attorney, may enter into an agreement with an alleged violator. These agreements usually state that the government will not seek prosecution if the alleged violating party takes certain actions.
- Criminal Prosecution—if FSIS, OGC, and the U.S. Attorney find it appropriate, the government can criminally prosecute someone who sells misbranded meat or poultry.
To help market their products, food manufacturers often include labeling claims on their food packaging. However, meat and poultry manufacturers should be aware of FSIS’s food labeling regulations, and which claims require pre-market approval. Similarly, producers and consumers should be aware of how FSIS regulates these terms. Producers should be aware of which documents they need to create and keep track if they wish to market their products with a particular term. For consumers, knowing how FSIS defines certain labeling claims may influence 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 read the first post in this blog series, click here.
For a list of FSIS’s claims guidance documents, click here.
To read more National Agricultural Law Center resources on food labeling, click here.
**This article was written by former NALC Staff Attorney Jana Caracciolo.