By: Vanessa K. Fulton and Cynthia L. Meyer
Updated November 28, 2022, to reflect that FDA has extended the comment period for the proposed rule by 50 days in response to requests from stakeholders. The new deadline for comments is February 16, 2023.
On September 29, 2022, the U.S. Food and Drug Administration (“FDA”) published its long-awaited proposed rule regarding the use of “healthy” as a label claim for foods (“Proposed Rule”).[1]
This summary provides background on the Proposed Rule, an overview of the requirements of the Proposed Rule, application of the Proposed Rule, and FDA’s specific requests for comment.
Comments on the Proposed Rule were originally due by December 28, 2022. However, on November 28, 2022, FDA extended the comment period for the proposed rule by 50 days to February 16, 2023. ]
A. Background
FDA’s current regulation regarding the use of the implied nutrient content claim “healthy” was issued in 1994. It focused on individual nutrients in food, as recommended by nutrition science and dietary recommendations at the time. Specifically, the current regulation requires that most products meet the following conditions to bear a “healthy” claim: (1) comply with certain limits on total fat, saturated fat, cholesterol, and sodium; and (2) contain at least 10% of the daily value (“DV”)) of Vitamin A, Vitamin C, calcium, iron, protein, or dietary fiber).[2] The required nutrient criteria vary for certain food groups (e.g., there are different criteria for seafood, game meat, and raw fruits and vegetables) (§ 101.65(d)(2)).
In 2015, FDA send a warning letter to Kind, LLC, complaining about “healthy” claims for various snack bars that did not meet the conditions of the “healthy” regulation. Kind pushed back, alleging that the “healthy” regulation was outdated and inconsistent with more recent federal nutritional guidance. As Kind pointed out, the “healthy” regulation prevented many obviously healthy foods from being labeled with the claim, such as nuts, avocados, olives, and salmon. Kind submitted a citizen petition in December of 2015 asking that the claim be revised.
In September of 2016 FDA released a guidance document indicating it was in the process of re-evaluating the regulatory criteria for use of the claim “healthy” and intended to exercise enforcement discretion with respect to some of the existing criteria for a “healthy” claim in the interim.[3] Specifically, FDA indicated that it intended to exercise enforcement discretion for foods that use the implied nutrient content claim “healthy” on their labels which: (1) do not meet the regulatory definition of “low fat,” but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) do not contain at least 10% DV per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, provided the food contains at least 10% DV per RACC of potassium or vitamin D.
Along with releasing the guidance document in September 2016, FDA also established a docket to receive comments on the use of the term “healthy” on food products.[4] FDA received almost 1,200 comments to the docket. Additionally, FDA held a public meeting on March 9, 2017, giving interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food.
B. Overview of Proposed Rule
The Proposed Rule relies heavily on the Dietary Guidelines for Americans, 2020-2025 (Dietary Guidelines, 2020-2025) and reflects FDA’s recognition that dietary guidelines have shifted away from a focus on minimums or maximums of certain nutrients and towards an emphasis on “nutrient dense” foods that provide vitamins, minerals, and other health-promoting components and have little added sugars, saturated fat, and sodium.[5]
First, the Proposed Rule clarifies that a “healthy” claim is considered an implied nutrient content claim when “healthy” is used to characterize the food itself and there is also implied or explicit information about the nutrition content of the food. The implied or explicit information about the nutrition content of the food does not need to appear directly adjacent to the “healthy” claim or involve a specific nutrient. In contrast, a “healthy” claim not used in a nutritional context (e.g., “our manufacturing processes support a healthy planet”) would not be considered an implied nutrient content claim and thus would not be subject to the Proposed Rule.[6]
Second, the Proposed Rule establishes new criteria for making a “healthy” claim, generally requiring that a food product bearing a “healthy” claim: (1) contain a certain amount of food from at least one of the recommended food groups or subgroups (vegetables, fruits, grains, dairy, protein foods, and, in certain circumstances, oils) and (2) meet specified limits for saturated fat, sodium, and added sugars.[7] The minimum amount of a food group required (referred to as a “food group equivalent”) and nutrient limits that apply depend on the type of food. The concept of “food group equivalents” is discussed in more detail below. Note, however, that these requirements do not apply to raw, whole fruits and vegetables or plain water (including carbonated water), which are permitted to bear a “healthy” claim without meeting any additional requirements.
These are notable changes from the existing “healthy” regulation. FDA explains that the reason for the requirement to include certain “food group equivalents” is that current nutrition science and dietary guidelines recommend consuming certain quantities from specified food groups (vegetables, fruits, grains, dairy, protein foods, and oils) to achieve adequate nutrient intake, based on the understanding that each food group contributes an array of important nutrients to the diet.
Third, the Proposed Rule adds recordkeeping requirements for foods bearing the claim where compliance cannot be verified through information on the product label. The records must be kept for a period of at least two years after introduction or delivery for introduction of the food into interstate commerce.
C. Food Group Equivalents
As noted above, the Proposed Rule introduces the concept of “food group equivalent,” and requires that to bear a “healthy” claim a food product must meet certain “food group equivalent” requirements per RACC (in addition to meeting certain nutrient limits per RACC).
The chart below defines the “food group equivalent” for each product category needed to meet the first requirement for a “healthy” claim, as well as examples of how much of certain types of foods would be considered “equivalent.” For most food groups and subgroups, FDA determined the “food group equivalent” by dividing the daily recommended amount based on a 2,000-calorie level by four, for four eating occasions per day.[8] Note that not all foods are considered equal. For example, the Proposed Rule considers ½ cup cooked green beans to be “equivalent” to 1 cup raw spinach. Companies should use the reference amount customarily consumed (RACC) to determine whether the product meets the minimum food group equivalent requirement. For example, to be considered an individual vegetable product (i.e., predominant ingredient is a vegetable), one RACC of the product must contain at least ½ cup equivalent vegetables.
Note that foods fit into the food groups based on how they are consumed and their nutrient content, even if this is different from their botanical classification.[9] For example, a bell pepper is considered a vegetable even though it is botanically a fruit because of its nutrient content. Similarly, although soybean oil and tofu made from soybeans are both made from soybeans, soybean oil is classified as an oil and tofu from soybeans is classified as a protein food due to the nutrient content and how the products are consumed.
Table 1: Food Group Equivalents[10]
| Food Group and/or subgroup[11] | Food Group Equivalent | Examples of Quantities Equal to a Food Group Equivalent | |
| Vegetable[12] | ½ cup equivalent | ½ cup cooked green beans; ½ cup fresh or frozen green beans; ½ cup 100% vegetable juice; 1 cup raw spinach | |
| Fruit[13] | ½ cup equivalent | ½ cup strawberries; ½ cup 100% orange juice; ¼ cup raisins | |
| Grains | ¾ oz equivalent whole grain[14] | 1 slice of [whole wheat] bread; ½ cup cooked brown rice, ¾ oz dry whole grain pasta, ¾ oz ready to eat whole grain cereal | |
| Dairy[15] | ¾ cup equivalent | 6 oz fat free yogurt; 1 1/8 oz nonfat cheese; ¾ cup fat-free or low-fat milk; ¾ cup fortified soy beverage; ¾ cup lactose-free milk | |
| Protein Foods | Game meat | 1 ½ oz equivalent | 1 ½ oz venison |
| Seafood | 1 oz equivalent | 1 oz tuna | |
| Egg | 1 oz equivalent | 1 large egg | |
| Beans, peas, and soy | 1 oz equivalent | ¼ cup black beans; ¼ cup tofu | |
| Nuts and seeds | 1 oz equivalent | ½ oz walnuts; 1 tbsp nut or seed butter |
The proposed rule does not establish a food group equivalent for oils because the Proposed Rule only allows certain oil-based foods to meet the criteria for healthy and does not allow oil used in other foods to contribute to eligibility for bearing the “healthy” claim.[16]
D. The Proposed Rule’s Criteria for a “Healthy” Claim
As noted above, to bear a “healthy” claim a food product must meet: (1) certain “food group equivalent” requirements per RACC and (2) meet certain nutrient limits per RACC. Foods are evaluated differently depending on whether they are “raw, whole fruits and vegetables,” individual foods, mixed products, main dish products, or meal products.
1. Raw, Whole Fruits and Vegetables and Water
As stated above, the Proposed Rule permits “raw, whole fruits and vegetables” to bear a “healthy” claim without meeting any additional criteria. The preamble to the Proposed Rule defines “raw, whole” as “whole fruits and vegetables that have not been processed, such as whole apples, bananas, or carrots.”[17] The preamble notes that processed fruits and vegetables, such as canned, frozen, dried, or pureed fruits and vegetables do not fall under this category, but that such foods may still meet the criteria to bear a “healthy” claim under the individual foods category.[18] The preamble also excludes “fruits and vegetables that have been solely cut and packaged for sale” from this category. In other words, while a whole watermelon would fall under this category and be permitted to bear a “healthy” claim without meeting any additional criteria, cut and packaged watermelon would not fall under this category and would need to meet the requirements for individual foods to bear a “healthy” claim.
Additionally, the Proposed Rule permits plain water and plain, carbonated water to bear a “healthy” claim without meeting any additional criteria.[19]
2. Individual Foods
To bear a “healthy” claim, individual foods must contain at least one food group equivalent per RACC from one food group and meet the specified nutrient limits below.
The preamble to the Proposed Rule defines “Individual Foods” as “foods that are comprised entirely or almost entirely of one food group (excluding raw, whole fruits and vegetables).”[20] The Proposed Rule separates individual foods into six food groups: vegetables, fruits, grains, dairy, proteins (including all subgroups), and oils[21].
The preamble explains that if a food contains a meaningful amount of more than one food group, then the food would be considered a combination food (i.e., a mixed product, main dish, or meal). However, foods with ingredients from more than one food group are still considered “Individual Foods” as long as one food group predominates. For example, cinnamon raisin oatmeal has ingredients from both the grain and fruit food groups but is predominantly whole grain, so it would be considered a grain product. Similarly, yogurt with granola topping has ingredients from both the dairy and grain food groups but is predominantly dairy, so it would be considered a dairy product.
Table 2: Criteria for “Healthy” Claims for Individual Foods[22]
| If the individual food is… | And contains at least… | Added Sugars No Greater Than… | Sodium No Greater Than… | Saturated Fat No Greater Than… | |
| Vegetable | ½ cup food group equivalent vegetable | 0% DV | 10% DV | 5% DV | |
| Fruit | ½ cup food group equivalent fruit | 0% DV | 10% DV | 5% DV | |
| Grains | ¾ oz food group equivalent whole grain | 5% DV | 10% DV | 5% DV | |
| Dairy | ¾ cup food group equivalent dairy | 5% DV | 10% DV | 10% DV | |
| Protein Foods | Game meat | 1 ½ oz food group equivalent game meat | 0% DV | 10% DV | 10% DV |
| Seafood | 1 oz food group equivalent seafood | 0% DV | 10% DV | 10% DV | |
| Egg | 1 oz food group equivalent egg | 0% DV | 10% DV | 10% DV | |
| Beans, peas, and soy | 1 oz food group equivalent beans, peas, and soy | 0% DV | 10% DV | 5% DV | |
| Nuts and seeds | 1 oz food group equivalent nuts and seeds | 0% DV | 10% DV | 5% DV, excluding sat. fat derived from nuts & seeds | |
| Oils | 100% Oil | N/A | 0% DV | 0% DV | 20% of total fat |
| Oil-based spreads whose fats come solely from oil | N/A | 0% DV | 5% DV | 20% of total fat | |
| Oil-based dressings containing at least 30% oil and oils meet the requirements for 100% Oil above | N/A | 2% DV | 5% DV | 20% of total fat |
3. Mixed Products
The preamble to the Proposed Rule defines “mixed products” as foods that “are similar in size to an individual food but contain more than one food group” and do not contain a full food group equivalent per RACC of any single food group.[23] For example, a granola product that has both whole grains and nuts, where neither the whole grains or nuts are in sufficient quantities to equal a full good group equivalent, would be considered a mixed product.
The Proposed Rule requires that a mixed product: (1) contain at least half a food group equivalent of each of two different food groups per RACC, and (2) meet certain nutrient limits.
The nutrient limits for mixed products vary depending on the food group composition:
Table 3: Criteria for “Healthy” Claim for Mixed Products[24]
| If the mixed product contains at least . . . | Added Sugars No Greater Than… | Sodium No Greater Than… | Saturated Fat No Greater Than… (excluding sat. fat from nuts & seeds) |
| ½ food group equivalent each of two of the following: fruit, vegetable, and/or protein | 0% DV | 10% DV | 5% DV; or 7 ½% DV if the protein is a game meat, seafood, or egg |
| ½ food group equivalent of whole grain and ½ food group equivalent of fruit, vegetable, or protein | 2 ½% DV | 10% DV | 5% DV; or 7 ½% DV if the protein is a game meat, seafood, or egg |
| ½ food group equivalent of dairy and ½ food group equivalent of fruit, vegetable, or protein | 2 ½% DV | 10% DV | 7 ½% DV; or 10% DV if the protein is a game meat, seafood, or egg |
| ½ food group equivalent of dairy and ½ food group equivalent of whole grain | 5% DV | 10% DV | 7 ½% DV |
Note that oil is not considered a food group for purposes of food group equivalence requirements.
4. Main Dish Products
The Proposed Rule uses the definition of “main dish products” in 21 CFR § 101.13(m).[25]
The Proposed Rule requires that a main dish product: (1) contain at least one food group equivalent of each of two different food groups per labeled serving,[26] and (2) meet certain nutrient limits.
The nutrient limits for main dish products vary depending on the food group composition:
Table 4: Criteria for “Healthy” Claim for Main Dish Products[27]
| If the main dish product contains at least . . . | Added Sugars No Greater Than… | Sodium No Greater Than… | Saturated Fat No Greater Than… (excluding sat. fat from nuts & seeds) |
| A food group equivalent of each of two of the following: fruit, vegetable, and/or protein | 0% DV | 20% DV | 10% DV; or 15% DV if the protein is a game meat, seafood, or egg |
| A food group equivalent of whole grain and a food group equivalent of fruit, vegetable, or protein | 5% DV | 20% DV | 10% DV; or 15% DV if the protein is a game meat, seafood, or egg |
| A food group equivalent of dairy and a food group equivalent of fruit, vegetable, or protein | 5% DV | 20% DV | 15% DV; or 20% DV if the protein is a game meat, seafood, or egg |
| A food group equivalent of dairy and a food group equivalent of whole grain | 10% DV | 20% DV | 15% DV |
5. Meal Products
The Proposed Rule uses the definition of “meal products” in 21 CFR § 101.13(l).[28]
The Proposed Rule requires that a meal product: (1) contain at least one food group equivalent of each of three different food groups per labeled serving, and (2) meet certain nutrient limits.
The nutrient limits for meal products vary depending on the food group composition:
Table 5: Criteria for “Healthy” Claim for Meal Products[29]
| If the meal product contains at least . . . | Added Sugars No Greater Than… | Sodium No Greater Than… | Saturated Fat No Greater Than… (excluding sat. fat from nuts & seeds) |
| A food group equivalent each of fruits, vegetables, and protein foods | 0% DV | 30% DV | 15% DV; or 20% DV if the protein is a game meat, seafood, or egg |
| A food group equivalent of whole grain, and a food group equivalent each of fruit, vegetable, and/or protein | 5% DV | 30% DV | 15% DV; or 20% DV if the protein is a game meat, seafood, or egg |
| A food group equivalent of dairy and a food group equivalent each of fruit, vegetable, and/or protein | 5% DV | 30% DV | 20% DV; or 25% DV if the protein is a game meat, seafood, or egg |
| A food group equivalent of dairy, a food group equivalent of whole grain, and a food group equivalent of fruit, vegetable, and/or protein | 10% DV | 30% DV | 20% DV; or 25% DV if the protein is a game meat, seafood, or egg |
E. Proposed Effective Date and Compliance Dates
The preamble to the Proposed Rule indicates that the final rule would take effect 60 days after the date of the final rule’s publication in the Federal Register. Recognizing that it will take time for industry to comply with the Proposed Rule, the preamble proposes a compliance date three years after the effective date of the final rule.
F. Requests for Comment
The preamble to the Proposed Rule includes requests for comment on several issues, including:
- Whether nutrients to encourage should be included in addition to the food group equivalent and nutrients to limit criteria[30]
- Whether using food groups as criteria for a “healthy” claim, rather than a limited set of nutrients, better identifies foods with the nutrient content that may help consumers maintain healthy dietary practices[31]
- Whether the food group equivalent requirements should be calculated by dividing the daily recommended amount of each food group by four eating occasions per day[32]
- Whether the Proposed Rule should use a limit for saturated fat based on the ratio of saturated fat to total fat, including any data supporting this approach[33]
- Whether the Proposed Rule should adjust the limits for sodium and added sugars based on specific considerations of the different food groups[34]
- Whether the Proposed Rule should include limits on trans fat and cholesterol[35]
- Whether raw fruits and vegetables should be permitted to bear a “healthy” claim without meeting food group equivalent or nutrient limit requirements[36]
- Whether any fruits and vegetables for which the RACC size may impact the fruit or vegetable’s ability to qualify for a “healthy” claim because the RACC is smaller than the size of the required food group equivalent, and how to address these products[37] (For example, frozen avocado pieces may have a RACC that does not meet the food group equivalent criteria of ½ cup fruit and as a result would not meet the food group equivalent requirement to bear a “healthy” claim.)
- Whether FDA should consider certain fruit and vegetable powders to be fruits or vegetables for purposes of calculating food group equivalents[38]
- The proposed nutrient limits for all food types and categories
- The proposed food group equivalent requirements for all food types and categories
- For mixed products, whether lower amounts of food group equivalents (e.g., ¼ food group equivalent) would be as effective as the proposed ½ food group equivalent in helping consumers meet their total dietary amounts of recommended food groups for multicomponent foods[39]
- Whether nuts with relatively higher amounts of saturated fat should be eligible for the “healthy” claim[40]
- The proposed criteria for healthy claims for oil-based spreads and dressings, particularly whether the proposed saturated fat criteria would adequately ensure that spreads and dressings that are part of a healthy dietary pattern are eligible to bear the “healthy” claim[41]
- Whether “water” should be expanded to include waters containing non-caloric flavors or other non-caloric ingredients[42]
- Whether allowing bottled water to be labeled as “healthy” could potentially lead consumers to believe bottled water is healthier than tap water[43]
- Whether calorie-free beverages, coffee, and tea, should be permitted to bear a “healthy” claim without meeting any additional criteria
- The changes to when a “healthy” claim is considered an implied nutrient content claim and what qualifies as a “nutritional context”[44]
- Whether there are any other terms synonymous with “healthy” that FDA should consider[45]
- The proposed compliance date of three years after the effective date of the final rule[46]
- Estimates of costs and benefits of the proposed rule[47]
Comments on the Proposed Rule are due by February 16, 2023. Comments can be submitted electronically via the Federal eRulemaking Portal (https://www.regulations.gov) or via paper submission to Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions must include the Docket No. FDA–2016–D–2335 for ‘‘Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’”
[1] 87 Fed. Reg. 59,168 (Sept. 29, 2022).
[2] 21 C.F.R. § 101.65(d).
[3] FDA, Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry (Sept. 2016), https://www.fda.gov/media/100520/download.
[4] 81 Fed. Reg. 66,562 (Sept. 28, 2016).
[5] 87 Fed. Reg. at 59,170.
[6] 87 Fed. Reg. at 59,181-82. The preamble provides the following examples where “healthy” would constitute a nutrient content claim:
- A cereal product that includes the claim “healthy” on the front of the package and is described elsewhere on the label or labeling as high in dietary fiber (e.g., on the back of the package, or on a website)
- A cereal product that includes the claim “healthy” and the statement “provides all of your child’s essential vitamins and minerals.” These claims may or may not appear adjacent to one another
- A can of beans that includes the claim “healthy” and uses a “MyPlate” symbol or other front of pack labeling (such as the “Facts Up Front” labeling) to imply that the product meets nutritional needs
- A food product that includes “healthy” within the brand name and uses the “low sodium” nutrient content claim. These claims may or may not appear adjacent to one another
- A food product that includes the claim “healthy” and the statement “made with whole grain ingredients” or “made with real fruits and vegetables.” These claims may or may not appear adjacent to one another
- A food product includes the word “healthy” above a picture of vegetables
- A food product includes the word “healthy” next to another nutrient content claim such as “0g of fat”
[7] Note that the Proposed Rule specifically requires that the food group equivalent requirement and the nutrient limits be calculated based on RACC, not based on serving size
[8] Id. at 59,185.
[9] Id. at 59,177. The preamble indicates that FDA adopts the categorization used in the Dietary Guidelines, 2020-2025, to determine the appropriate food group for a food.
[10] This table contains the same information as the table in proposed rule at 21 C.F.R. § 101.65(d)(2), but also includes examples of food group equivalent quantities identified in the preamble.
[11] The preamble to the Proposed Rule notes that certain ingredients and/or foods can fit into more than one category. For example, the nutrient content of beans, peas, and lentils is similar to foods in both the vegetable group and the protein group, and as a result may be counted under either category. 87 Fed. Reg. at 59,188. Note, however, that an ingredient and/or food can only be counted under one category (i.e., beans could not be counted towards the food group equivalent for vegetables and the food group equivalent for protein).
[12] The preamble to the Proposed Rule indicates that FDA considers the following to be vegetables for purposes of calculating food group equivalents: fresh vegetables, frozen vegetables, canned vegetables, diced vegetables, 100% vegetable juice, concentrated vegetable purees, and vegetable pastes. 87 Fed. Reg. at 59,185. FDA would not consider vegetable powders to be vegetables for purposes of calculating food group equivalents. Id.
[13] As with vegetables, the preamble to the Proposed Rule indicates that FDA considers the following to be fruits for purposes of calculating food group equivalents: fresh fruits, frozen fruits, canned fruits, diced fruits, 100% fruit juice, concentrated fruit purees, and fruit pastes. 87 Fed. Reg. at 59,186. FDA would not consider fruit powders to be fruits for purposes of calculating food group equivalents. Id.
[14] The preamble to the Proposed Rule indicates that FDA considers “whole grains” to be grains that contain the entire kernel, including the endosperm, bran, and germ. 87 Fed. Reg. at 59,186.
[15] The preamble to the Proposed Rule indicates that FDA intends to evaluate “plant-based milk alternatives and plant-based yogurt alternatives whose overall nutritional content is similar to dairy (e.g., provide similar amounts of protein, calcium, potassium, magnesium, vitamin D, and vitamin A), and are used as alternatives to milk and yogurt . . . against the dairy criteria for the purposes of the ‘healthy’ nutrient content claim.” 87 Fed. Reg. at 59,187. However, FDA provides no additional information for what qualifies as “similar amounts” of the identified nutrients and does not expressly state that plant-based dairy alternatives would qualify as “dairy” for purposes of calculating food group equivalents.
[16] 87 Fed. Reg. at 59,183.
[17] 87 Fed. Reg. at 59,184.
[18] Id.
[19] Id. at 59,193.
[20] Id. at 59,185.
[21] Note that “oils” are not considered a “food group” for purposes of food group equivalents but are considered a category of individual foods.
[22] This table appears in the proposed rule at 21 C.F.R. § 101.65(d)(3)(ii).
[23] Id. at 59,190-91.
[24] This table appears in the proposed rule at 21 C.F.R. § 101.65(d)(3)(iii)(B).
[25] Id. at 59,190.
[26] Note that for individual products and mixed products the Proposed Rule uses “per RACC,” while main dish products and meal products use “per labeled serving” instead of “per RACC.”
[27] This table appears in the proposed rule at 21 C.F.R. § 101.65(d)(3)(iv)(B).
[28] Id. at 59,190.
[29] This table appears in the proposed rule at 21 C.F.R. § 101.65(d)(3)(v)(B).
[30] Id. at 59,176.
[31] Id. at 59.177.
[32] Id. at 59.178.
[33] Id. at 59,179.
[34] Id. at 59,179-80.
[35] Id. at 59,181.
[36] Id. at 59,184.
[37] Id. at 59,184.
[38] Id. at 59,185.
[39] Id. at 59,191.
[40] Id. at 59,189.
[41] Id. at 59,189-90.
[42] Id. at 59,193-94.
[43] Id.
[44] Id. at 59,182.
[45] Id. at 59,183.
[46] Id. at 59,195.
[47] Id. at 59,197.