Keto Super Fad: Fda-Approved Or Fiction?

The U.S. Food and Drug Administration (FDA) does not approve or disapprove of diets. However, it does regulate the marketing of products that claim to be in line with specific diets. For example, the FDA has issued warnings to companies that claim their products are keto-friendly, but contain ingredients that do not adhere to the keto diet. The FDA also regulates the language surrounding nutrition information on product labels. For instance, companies cannot make claims about the level of a nutrient unless the claim adheres to existing regulations, which the FDA does not have for characterizing low amounts of carbohydrates.

The FDA does not approve or regulate the term keto on food labels

One of the hallmarks of the keto diet is low carbohydrate consumption. The FDA does not have regulations that specify how a “net carb” or “low carb” claim could be made. Generally speaking, the FDA states that companies cannot make “a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling” unless the claim adheres to existing claim regulations, which the FDA does not have for characterizing a low amount of carbohydrates. The FDA will allow for quantitative amounts to be declared as long as the statement does not implicitly characterize the level of the nutrient, such as “2 grams of carbs per serving.” In the absence of specific regulations for “carb” claims, companies may find this to be the safest approach.

Consumers following the keto diet will also be looking for high fat and moderate to high protein levels on labels. “High can be listed on a food label, “provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.” Meal product labels may also be able to include a modified “high” claim if one of the foods within the meal qualifies. A “good source” claim in relation to a nutrient may also be possible if it is present at 10 to 19 percent of the RDI or DRV.

Many consumers on the keto diet will be calculating their nutrient intake. Placing the level of protein, fats, and carbs prominently on the front label is allowed, provided that the content is also listed in the manner and locations FDA requires on all other parts of the label.

Regardless of the presence of nutrition statements, all food labels must include a compliant “Nutrition Facts” panel that includes the levels of total carbohydrates, protein, total fat, and other required nutrients.

The FDA does not have regulations specifying how a net carb or low carb claim could be made

The U.S. Food and Drug Administration (FDA) does not have regulations specifying how a net carb or low carb claim could be made. The Ketogenic Diet, or keto, is a low-carb, moderate protein, and high-fat diet. FDA does not regulate the terms "keto" or "ketogenic" on food labels. However, companies marketing these products should be aware of the language surrounding nutrition information on their product's labels.

The keto diet is characterized by low carbohydrate consumption. FDA does not have regulations that specify how a "net carb" or "low carb" claim could be made. Generally speaking, FDA states that companies cannot make "a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling" unless the claim adheres to existing claim regulations, which FDA does not have for characterizing a low amount of carbohydrates.

To avoid making unsubstantiated claims, companies may want to declare quantitative amounts, such as "2 grams of carbs per serving," as long as the statement does not implicitly characterize the level of the nutrient. This approach can provide clarity to consumers while also ensuring compliance with FDA guidelines.

The FDA states that companies cannot make claims that characterise the level of a nutrient unless the claim adheres to existing regulations

The FDA does not regulate the terms "keto" or "ketogenic" on food labels. However, the FDA does regulate the language surrounding nutrition information on product labels.

The FDA does not have regulations that specify how a "net carb" or "low carb" claim could be made. The FDA states that companies cannot make a claim that expressly or implicitly characterises the level of a nutrient of the type required to be in nutrition labelling unless the claim adheres to existing claim regulations. In the absence of specific regulations for "carb" claims, companies may find it best to declare quantitative amounts, as long as the statement does not implicitly characterise the level of the nutrient, such as "2 grams of carbs per serving".

Consumers following the keto diet will also be looking for high fat and moderate to high protein levels on labels. "High" can be listed on a food label provided that the food contains 20% or more of the RDI or the DRV per reference amount customarily consumed. A "good source" claim in relation to a nutrient may also be possible if it is present at 10 to 19% of the RDI or DRV.

The FDA will allow for quantitative amounts to be declared as long as the statement does not implicitly characterise the level of the nutrient

The FDA has established a set of guidelines that govern the use of nutrient content claims. These claims describe the level of a nutrient in a food product using terms such as "free", "high", and "low" or by comparing the level of a nutrient to that of another food, e.g., "more", "reduced", and "lite". While an accurate quantitative statement (e.g., "200 mg of sodium") that does not characterise the nutrient level may be used, a statement such as "only 200 mg of sodium" implies that the level of sodium is low. Therefore, for the food to be labelled as having a "low sodium" content, it must meet the nutritional criteria for a low nutrient content claim.

The FDA allows for quantitative amounts to be declared as long as the statement does not implicitly characterise the level of the nutrient. For example, if a product has 200 mg of sodium per serving and the FDA's criteria for "low sodium" is 140 mg or less per serving, the label cannot state "only 200 mg of sodium" as this implicitly characterises the level of sodium as being low. Instead, the label should simply state "200 mg of sodium".

The FDA requires that all food labels include a compliant Nutrition Facts panel that includes the levels of total carbohydrates, protein, total fat, and other required nutrients

In 2016, the U.S. Food and Drug Administration (FDA) updated the requirements for the Nutrition Facts label on packaged foods and drinks. These changes were based on updated scientific information, new nutrition research, and input from the public. The refreshed design and updated information make it easier for consumers to make informed food choices that contribute to lifelong healthy eating habits.

The FDA now requires manufacturers to declare the actual amount, in addition to the percent Daily Value of vitamin D, calcium, iron, and potassium. They can voluntarily declare the gram amount for other vitamins and minerals. The footnote now better explains what percent Daily Value means: "*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice."

"Added sugars," in grams and as a percent Daily Value, must be included on the label. There are different labeling requirements for single-ingredient sugars. The list of nutrients that are required or permitted to be declared is being updated. Vitamin D and potassium are now required on the label. Calcium and iron will continue to be listed. Vitamins A and C are no longer required but can be included on a voluntary basis.

While continuing to require "Total Fat," "Saturated Fat," and "Trans Fat" on the label, "Calories from Fat" was removed because research shows the type of fat is more important than the amount. Daily values for nutrients like sodium, dietary fiber, and vitamin D have been updated based on newer scientific evidence.

By law, serving sizes must be based on amounts of foods and beverages that people are actually eating, not what they should be eating. For example, the reference amount used to set a serving of ice cream was previously 1/2 cup but is now 2/3 cup. Package size affects what people eat. So for packages that are between one and two servings, such as a 20-ounce soda, the calories and other nutrients are required to be labeled as one serving because people typically consume it in one sitting.

For certain products that are larger than a single serving but that could be consumed in one sitting or multiple sittings, manufacturers have to provide "dual column" labels to indicate the amount of calories and nutrients on both a "per serving" and "per package" basis. With dual-column labels available, people can more easily understand how many calories and nutrients they are getting if they eat or drink the entire package in one sitting.

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