Why “Keto” Claims Cannot Appear On USDA-Inspected Packaging
When walking through the aisles of your local grocery store, chances are that you will come across dozens of food brands that label their food products as “low calorie,” “low fat,” “low sugar,” and even “low sodium.” You won’t find, however, any food products that are listed as “low carb.” Despite the fact that millions of people across the world are discovering the health benefits that come with reducing their total carbohydrate intake on a Keto Diet, the United States Department of Agriculture (USDA) and the Food Safety and Inspection Service (FSIS) continue to forbid food brands from making low-carb, or “keto” claims on their products.
A recent research paper titled Health Effects of Low-Carbohydrate Diets: Where Should New Research Go? notes that “the American Diabetes Association has noted that weight and metabolic improvements can be achieved with low carbohydrate, low fat (implicitly higher carbohydrate), or a Mediterranean style diet (usually an intermediate level of carbohydrate).” If leading nutritional research backed by renowned institutions such as the American Diabetes Association recognizes the potential health benefits of low carb diets, why are “Keto-Certified” or “Low Carb” labels, or simply “keto” claims still prohibited by USDA inspected packaging?
We recently sat down to talk with an FSIS spokesperson to learn why “low carb,” as a nutritional content claim continues to be not allowed by the USDA, and why “Keto” claims cannot appear on USDA-Inspected packaging.
Types of Products inspected by the USDA FSIS
The Food Safety and Inspection Service (FSIS) is an agency of the United States Department of Agriculture (USDA). Its main function is as a public health regulatory agency that is responsible for ensuring that the United States’ commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.
Essentially, all meat, poultry, and eggs that destined for public consumption in the United States must be inspected by the USDA. If a meat, poultry, or egg product does not have the USDA inspection stamp, then it is not considered to fit for human consumption and could be pulled from the shelves. In some states, animal farmers can opt for state inspection agencies to inspect their meat, poultry, or eggs, but those products cannot be sold across state lines.
During the inspection process, USDA inspectors first check the conditions of the live animal to make sure they were raised in healthy environments. They also inspect the slaughtering process, the temperature of the meat, and the process of turning the carcass into packaged and ready-to-market products. This meticulous inspection process has helped to ensure that meat and poultry products in the United States are virtually free of any potential pathogens or disease agents.
While the USDA is in charge of the actual inspection process, the FSIS is the agency that oversees the labeling process for meat, poultry, and egg products. According to the FSIS website, “FSIS develops and provides labeling guidance, policies, and inspection methods and administers programs to protect consumers from misbranded and economically adulterated meat, poultry, and egg products which ensure that all labels are truthful and not misleading.”
What Is a “Health Claim” and a “Nutrient Content Claim” According to the USDA FSIS
For people on any type of diet or nutritional program, understanding what you are eating is certainly important. Checking the nutritional labels of the foods we eat is especially important for people on low carb diets who want to meticulously limit their overall carbohydrate consumption. Without any type of regulation, food brands could knowingly mislead consumers into believing that a box of Oreos was actually healthy for you.
For this reason, the USDA FSIS has strict policies regarding “health claims” and “nutrient content claims (NCC)” on the food labeling process that they oversee. Currently, food labeling claims that mention the carbohydrate content of food come under scrutiny of the USDA FSIS. Low carb claims, for example, are considered to be a nutrient content claim (NCC) and is not permissible. While the USDA does allow for other nutrient content claims such as “low fat” and “low sodium”, low carb claims are still rejected for most food products.
Why “Keto” Is a Health Claim According To the Rules and Regulations
Furthermore, the USDA FSIS does not have regulations for health claims. Rather, this agency works in accordance with FDA oversight. In regards to meat and poultry products, an FSIS final rule announced that any individual meat and poultry products that bear the claim “healthy” (or any other derivative of the term “health”) are only judged on the amount of sodium they contain. To be labeled as healthy, these products must have less than 480 milligrams of sodium. The low carbohydrate content of meat products is not considered by the FSIS to constitute an element of healthy meat products.
Lastly, the FSIS maintains that the Ketogenic diet is a strictly medical diet. While the Keto diet was originally devised by medical professionals to help people suffering from epilepsy, the agency has been slow to recognize that millions of people who are not epileptics that rely on low carb diets such as the Keto diet for improved health. As it stands, the FSIS does not allow medical claims for meat, poultry, and egg products, and thus prohibits any mention of the word “Keto”, “Keto Diet”, or the Keto Certified label.
Why the Word “Keto” Cannot Be On the Packages
For the above-mentioned reasons, the word “Keto” simply cannot be added to any packaging of meat or poultry food products. Additionally, “low carb” or “zero-carb” claims are also strictly regulated by the FSIS. To give meat and poultry food brands a better idea of how the FSIS regulates carbohydrate claims, we include here a lengthy quote from an official FSIS document published in 2003 that is still valid today:
There are an increasing number of carbohydrate-restricted dietary and lifestyle plans available to consumers today. Most of the plans focus on limiting total carbohydrates and certain types of carbohydrates, e.g., simple sugars. Manufacturers of meat and poultry products have expressed growing interest in making carbohydrate-related claims and statements on the labeling of meat and poultry products to meet consumers’ needs in making food choices that are consistent with these dietary approaches. To date, the Food Safety and Inspection Service (FSIS) has permitted factual statements of the number of grams of total carbohydrates per serving to be included (outside of the Nutrition Facts panel) on the labeling of meat and poultry products.
However, the nutrition labeling regulations in Title 9, Code of Federal Regulations (9 CFR), Subpart B, Section 317.300, 317.400, for meat products, and Subpart Y, Sections 381.400, 381.500, for poultry products, clearly state that claims that, expressly or by implication, characterize the level of a nutrient, may not be made on the labeling of a meat or poultry product unless the claim is made in accordance with the nutrition labeling regulations. Because there are no existing regulations permitting the use of carbohydrate claims on foods governed by the FSIS, labeling of meat and poultry products bearing expressed carbohydrate claims, including, but not limited to, Low Carbohydrate, Lower Carbohydrate, and Carb Free, cannot be approved.
Despite this strict policy, the FSIS does allow for statements that do not expressly state or imply a specific level of carbohydrates. Terms such as “Carb Conscious” or “Carb Wise”, are permissible by current USDA FSIS policies. The fact that these guidelines have not been updated since at least 2003 shows that there could be an opportunity for change in the coming years.
According to one analysis, “petitions have been filed by several companies in the industry asking the FDA to define the terms that can characterize the level of carbohydrates in food. FDA has indicated that it intends to initiate the rulemaking proceedings for carbohydrate nutrient content claims soon, but the timeframe is uncertain.” More recently, the FDA Nutrition Innovation Strategy, which is committed to finding new ways to reduce the burden of chronic disease through improved nutrition, could be an opportunity for Keto and low carb food brands to petition for nutrient content claims (NCCs) that are specifically related to the carbohydrate content of specific foods.
The Potentially Costly Mistake of Adding the word “Keto” to USDA-Inspected Products
As it currently stands today, adding the word “Keto” or “low carb” to meat and poultry products that are inspected by the USDA could be a potentially costly mistake. Despite the current regulation, it is possible to find food products that use the “low carb” label. Keto snacks and other such products often challenge the strict regulation that low carb diets face.
However, meat and poultry products that are inspected by the USDA will obviously face much more scrutiny in the labeling process. A food brand that decided to disregard current FSIS policy regarding “low carb” or “keto” claims on their labeling, might be forced to recall an enormous amount of products that had already been distributed across the country. Not only would this amount to lost product, but it could also hurt your relationships with retail and wholesale clients.
For example, the Kentucky-based meat brand “Blue Grass Quality Meats” was forced by the FSIS to recall over 120,000 pounds of pork bacon and ready-to-eat turkey products. The reason for this was because the company did not announce that the products contained soy, which is a known allergen. Recalling 120,000 pounds of products obviously comes with a major economic cost, and smaller businesses and food brands would most likely be forced to close operations after such an event.
A Short Interview with a USDA Food Safety and Inspection Service (FSIS) Spokesperson about Keto Certified labels and “Keto” claims on packaging
To give Keto food brands a better idea of the USDA FSIS regulations on approved labeling practices, we include here the full interview with an FSIS Spokesperson:
Q: What are some of the types of products inspected by the USDA?
The Food Safety and Inspection Service (FSIS) regulates meat, poultry, and egg products.
Q:What constitutes a health claim by the USDA FSIS?
FSIS does not have regulations for health claims. The FSIS allows health claims in compliance with the Food and Drug Administration’s (FDA) regulations in Title 21 of the Code of Federal Regulations (CFR), Part 101, Subpart E, to be applied to meat and poultry products.
Q: In a nutshell, why is the word “Keto” or “Keto-certified” not allowed to be printed on food packages according to USDA FSIS regulation?
Keto can refer to the Ketogenic diet; a medical diet. There is no regulatory allowance to make references or claims about medical foods for meat and poultry products under FSIS jurisdiction. In addition, it is considered an implied low carbohydrate claim on food labeling. Nutrient content claims may only be made on foods, in this case, meat, and poultry, in accordance with 9 CFR 317.300-317.400 and 381.400-381.500. There is no regulatory allowance to make references or claims about carbohydrates, for example, there is no regulatory definition in 9 CFR for “low carbohydrate.”
Q: Would the USDA require food packaging with the word “Keto” to be recalled?
If a label is not in compliance with FSIS regulations, the Agency has the authority to rescind or refuse approval of the label in accordance with 9 CFR 500.8.
Q: Does the USDA accept a nutrient content claim (NCC) for “low-carb?” Why or why not?
No, nutrient content claims may only be made on foods, in this case, meat, and poultry, in accordance with 9 CFR 317.300-317.400 and 381.400-381.500. There is no regulatory allowance to make references or claims about carbohydrates, for example, there is no regulatory definition in 9 CFR for “low carbohydrate.”
Q: Does the USDA or FDA have future plans to include NCC regarding carbohydrate levels in food products?
No, FSIS is not considering amending its nutrient content claim regulations to define “low carbohydrate.”
Q: What should a brand do if they see a USDA-Inspected brand with a “Keto” Claim?
FSIS has not approved labeling for meat and poultry products that references “Keto” in any way, including but not limited to, “Keto,” “Keto Friendly,” “Ketogenic”, “Keto Diet,” etc. Similarly, such terms including “Keto” may not be added to labeling through generic approval. Labeling as “Ketogenic Registered Dietitian Approved” would also be an issue with it being considered a medical food reference.
If there are companies with references to “Keto” on their meat or poultry product labeling, the company should send us copies of the competitor labels. If we have the label and establishment number we can follow up with the establishment as we have the authority to rescind the use of a label or reduce to temporary approval when labels are deficient in some particular.