In May 2024, Nestle announced its development of a new food brand created for customers who are users of GLP-1 weight-loss drugs. GLP-1, which stands for glucagon-like peptide 1, is a hormone that naturally occurs in the small intestine and plays a role in the pathways that signal fullness to the brain. A GLP-1 weight-loss drug is a medication that mimics the hormone by stimulating the feeling of fullness and reducing the appetite of drug users. As the use of these types of medications for weight loss becomes more popular, food companies are searching to find ways to combat the resulting decrease in snack food sales. Nestle, for example, is creating Vital Pursuit, a brand to “support GLP-1 users” which advertises food high in protein, fiber, and essential nutrients. This article is part one in a two-part series exploring the regulatory framework involved in the process of labeling and advertising foods specifically for GLP-1 users. This article will look at labeling claims.
Background on GLP-1 Drugs
According to a survey conducted by KFF, one in eight adults have taken a GLP-1 agonist and of those who have taken it, four in ten report taking the medication primarily for weight loss. GLP-1 agonists are a class of medications that mostly help patients with Type 2 diabetes manage their blood sugar levels. However, some GLP-1 agonists are also used for weight-loss management. GLP-1 is a naturally occurring hormone found in the small intestine that, among other things, signals to your body that you have eaten. GLP-1 agonist medications mimic the hormone by stimulating satiety and reducing food intake, appetite, and hunger. There are several GLP-1 drugs, approved for Type 2 diabetes treatment, currently being used for weight loss effects; however, only three are currently approved for weight management by the Food and Drug Administration (FDA). For example, Wegovy (semaglutide) is approved for chronic weight management in adults with obesity or who are overweight with at least one weight-related condition. However, one of the more popular GLP-1 drugs used for weight management, Ozempic, which is also made with semaglutide, is only FDA-approved for Type 2 diabetes treatment.
Food companies’ response
As more people are incorporating GLP-1 drugs into their weight loss treatment or management plans, food companies are preparing to address a hole that could open in their markets. For example, as the appetite of GLP-1 drug users continues to decrease, the likelihood of their purchasing snack foods also decreases. To address this, companies, like Nestle, are creating food brands that will be specifically marketed towards customers using GLP-1 drugs. There are two ways these brands will be marketing toward GLP-1 drug users – labeling and advertising. Labeling refers to the claims made on the food products packaging, while advertising refers to other off-label claims.
For example, Nestle expressed that the packing of Vital Pursuit’s foods will not mention GLP-1 medications, but will focus on the food’s inclusion of specific nutrients that GLP-1 drug users need to stay healthy. This means that Vital Pursuit packaging will not mention specific medications, like Wegovy, but may claim the food product is “high in protein.” A claim, like “high in protein,” stated on the packaging of the food product would qualify as labeling. Additionally, Nestle indicated that while it will not mention medications on the food labels, it will use social media to “more directly connect the brands to the drugs.” Nestle’s website also directly links the new brand to GLP-1 drugs, introducing Vital Pursuit as a “brand to support GLP-1 users.” Social media posts and messaging on its website are two examples of off-label advertising.
Regulation of Food Label Claims
On-label claims, or labeling claims, are regulated on the federal level by two agencies – the U.S. Department of Agriculture (USDA) and the FDA. Specifically, the USDA regulates meat, poultry, catfish, or unshelled-egg products, while the FDA regulates the remaining 80% of food products. Food companies introducing these brands are indicating the food products will be premade, frozen meals which could either fall under FDA regulation or USDA regulation depending on the amount of meat, poultry, catfish, or unshelled-egg product present in the food product. Both the Federal Meat Inspection Act (FMIA) and the Poultry Product Inspection Act (PPIA), which govern the USDA’s regulation of meat and poultry products respectively, create an exception for food products with “relatively small proportion[s]” of meat or which have not been historically considered meat products by consumers. The USDA determines a “relatively small proportion” of meat to mean 3 percent or less of raw meat, less than 2 percent cooked meat, 30 percent or less fat, tallow, or meat extract, and determines a “relatively small proportion” of poultry meat as less than 2 percent cooked poultry meat, less than 10 percent cooked poultry skins, giblets or fat, separately, or less than 10 percent cooked poultry skins, giblets, fat and poultry meat in any combination. For example, a premade, frozen meal like “Grilled Chicken Marinara” which contains over 2 percent of cooked poultry meat would be regulated by the USDA. However, a premade frozen meal like “Lasagna with Meat Sauce” that contains less than 2 percent of meat would fall in the FMIA exception and could be regulated by the FDA.
FDA Regulation of Labeling Claims
Under the FDA, labeling claims are considered terms which the manufacturer is not required to include but chooses to. In general, there are three types of labeling claims recognized by FDA: health claims, nutrient content claims, and structure/function claims.
Health Claims
The FDA defines health claims as “any claim made on the label or in labeling of a food . . . that expressly or by implication . . . characterizes the relationship of any substance to a disease or health-related condition.” 21 CFR § 101.14. Substance refers to a food, component of food, or a dietary supplement. Health claims must show the relationship between the substance and disease or health-related condition and can either be expressly stated or implied through the context in which they are presented. Additionally, a health claim will be authorized or qualified. An authorized health claim must show a “significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence.” This means that an authorized health claim must show the relationship between the substance and disease/health-related condition is supported by scientific evidence that meets the “significant scientific agreement” standard. Authorized health claims are promulgated through FDA regulations, and there are currently 12 found in 21 CFR § 101.72 through 101.83. For example, 21 CFR § 101.74 authorizes a health claim addressing the relationship between sodium and hypertension. It includes the following as a model health claim, “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”
A qualified health claim is supported by scientific evidence but, unlike an authorized health claim, is not required to meet the “significant scientific agreement” standard. Qualified health claims must be accompanied by a disclaimer or other language that accurately communicates the level of scientific evidence supporting the claim to consumers. For example, a qualified health claim linking the relationship between magnesium and reduced risk of high blood pressure allows the following labeling claim, “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, FDA has concluded that the evidence is inconsistent and inconclusive.”
Nutrient Content Claims
A nutrient content claim will characterize the level of a nutrient in a food. A “nutrient” is defined as any substance that is required to be included in the nutrient facts panel. 21 CFR § 106.3. A nutrient content claim can be expressed or implied and must be made in accordance with FDA regulations. An expressed nutrient content claim is a direct statement about the level of a nutrient in the food. 21 CFR § 101.13(b)(1). For example, “low in sodium” or “contains 100 calories” are both expressed nutrient content claims. Though “low in sodium” does not directly state an exact level of sodium, the FDA still considers this an expressed nutrient content claim because FDA regulations include thresholds for terms like “low” for each of the nutrients. 21 CFR § 101.54 – 69. An implied nutrient content claim can suggest a nutrient is absent or present in a certain amount or can suggest a food item is “useful in maintaining healthy dietary practices” when made in “association with an explicit claim or statement about a nutrient.” 21 CFR § 101.13(b)(2). For example, “high in oat bran,” which implies the food product is a good source of fiber is considered an implied nutrient content claim. Additionally, using “healthy, contains 3 grams of fat” would count since it suggests consuming a food with only 3 grams of fat is useful in maintaining healthy dietary practices.
Structure/Function Claims
Structure/Function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” 21 CFR § 101.93. For example, “calcium builds strong bones” or “antioxidants maintain cell integrity” would both qualify. Structure/Function claims appear on both conventional foods and dietary supplements but are limited to statements about “nutritive value” for conventional foods. Both conventional foods and dietary supplements must be careful to avoid claims that make their product into a drug. For example, neither should make claims about a specific disease, unless the claim is an authorized health claim, or it will be subject to drug regulation. Under 21 CFR § 101.93(g), a disease includes conditions like cardiovascular disease and hypertension, and excludes diseases resulting from essential nutrient deficiencies, like scurvy. Additionally, to avoid regulation as a drug, these claims must include a disclaimer that the dietary supplement product is not intended to “diagnose, treat, cure, or prevent any disease;” however, conventional foods are not required to include a disclaimer. While the scope of this article is food products created for GLP-1 drug users, there are a number of dietary supplements, such as biocare dietary beverages, which are advertising to “reduce side effects” and “preserve muscle mass” for GLP-1 users. To learn more about structure/function claims for dietary supplements, click here to view FDA guidelines “Small Entity Compliance Guide on Structure/Function Claims.”
USDA Regulation of Label Claims
Though both government agencies have their own process for regulating food products, the USDA and FDA have worked to create a food label that presents consistency to consumers across the board. The USDA regulates the labels on meat, poultry, catfish, and unshelled egg products through its agency the Food Safety and Inspection Service (FSIS). Under FSIS regulations, labels must be “submitted for approval to the FSIS Labeling and Program Delivery Staff . . . except for generically approved labels.” 9 CFR § 412.2. A label is considered a generically approved label if it includes the following mandatory components – product name, handling statement, ingredients statement, the name and place of the business of the manufacturer, packer or distributor, net weight, legend, safe handling instructions, and nutrition labeling. If the label includes the listed components, then its manufacturer is not required to submit the label to FSIS for pre-market approval. Furthermore, FSIS has a process for manufacturers who wish to utilize generic label approval but want to include an additional labeling claim. The manufacturer is able to do so if the labeling claim is defined in either FSIS regulations or in the Food Standards and Labeling Policy Book. Included in the FSIS regulations for labeling claims are “nutrient content claims.” FSIS regulations define nutrient content claims the same as FDA – “expressly or by implication characterizes the level of a nutrient of the type required in nutrition labeling.” 9 CFR § 317.313. Outside of the generic approval process, FSIS requires other labels to go through a more demanding “pre-market sketch approval” process. One of the categories subject to sketch approval is “labels with special statements and claims.” 9 CFR § 412.1. FSIS regulations include both health claims and structure/function claims under its definition for special statements and claims, and like nutrient content claims, health claims and structure/function claims carry the same definition here as under the FDA regulations.
Use of nutrient content claims
Through Nestle and other food companies are avoiding specific mentions of GLP-1 drugs on food products, there are multiple regulatory avenues for its inclusion of the nutrient benefits of these products. Nestle has not announced specifics on what the packaging will look like, but it has indicated it will make labeling claims highlighting the essential nutrients present in its food products. Claims that address essential nutrients will be categorized as nutrient-content claims. This means that these claims will expressly or impliedly state a level of nutrient present in food products. Both the FDA and FSIS regulations detail the use of terms like “good source,” “high,” and “more” as nutrient content claims. 21 CFR § 101.54; 9 CFR § 317.354. These claims will compare the level of a nutrient in foods in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV) established for that nutrient. For example, under these regulations, the Vital Pursuit food product could include the claim “good source of protein” if its food product contains 10 to 19 percent of the RDI or DRV. Additionally, these food products could include implied nutrient content claims. 21 CFR § 101.65. For example, “as much potassium as a banana” would imply the amount of potassium in the food product is equivalent to the amount in a banana – a reference food that is generally known to be a good source of potassium.
Conclusion
As an increasing number of people incorporate GLP-1 drugs into their weight loss management plans, food companies are seeking to compensate for the resulting negative market effects for snack food products. Nestle announced its creation of a food brand specifically marketed for GLP-1 drug users. These products, while created for GLP-1 drug users, will not include direct mentions of the drugs on its packaging, but will focus on claims about the food’s essential nutrients. The claims, called nutrient-content claims, are regulated by the FDA and USDA and notify consumers of the level of nutrients present in a particular food. This is part 1 in a series focusing on the regulatory framework surrounding the labeling and advertising of these food products. The next article will focus on off-label advertising.
For more information on FDA’s Food Labeling Regulations, click here for NALC article “The Legality of Food Labeling Claims: FDA’s Regulations”
For more information on USDA’s Food Labeling Regulations, click here for NALC article “The Legality of Food Labeling Claims: FSIS’s Regulations for Meat and Poultry Labeling”
For more information on food labeling, click here for NALC Food Labeling Reading Room