Module 4: Nutrient Labeling/Content Claim

Implied Nutrient Content Claim

A claim by a manufacturer which does not directly indicate a required "nutrient" is present/absent/in a particular amount but instead describes a food or ingredient has a particular quality which infers qualities about a nutrient. (e.g. an implied claim doesn't say "high in fiber" instead it might say "high in oat bran" or would not say "low in fat" but instead may say "baked not fried") These may require analyzing the entire label for context. Manufacturers still cannot mislead consumers by making statements that imply false truths (e.g. our "banana is cholesterol free" would be misleading because cholesterol is an animal product and ALL bananas are cholesterol free or claiming a product is "Baked not fried" when regardless of the cooking method a product contains high amounts of fat.

National Labeling and Education Act (NLEA) 1990

Amended the FDCA to allow health claims for foods and dietary supplements under limited conditions and mandated changes to labels including provisions about sulfites, sweeteners, colors, spices, non dairy and allergenic substances, net contents, metric labeling and serving sizes to reflect what people actually eat. (Prior to 1990 health claims were not permitted.) (USDA promulgated nutritional labeling requirements for meat and poultry which parallel FDA requirements for other foods.) *NLEA does not cover advertising but FTC indicated it may apply the same criteria as FDA and USDA-FSIS do.

FDA Modernization Act (FDAMA) 1997

Amended the FDCA to permit health claims based on an "authoritative statement" which linked a nutrient to a disease provided it was made by a scientific body. (FDA requires companies to petition to "authorize" "qualified health claims.")

Expressed Nutrient Content Claims

An explicit claim by a manufacturer which states the level or range of a nutrient in food. (e.g. low sodium, fat free or 100 Calories.) These expressed claims sometimes also include implied claims that a food, due to its expressed nutrient content, may be useful in maintaining healthy dietary practices. (e.g. healthy, contains 3 grams of fat.)

Relative Nutrient Content Claims

Claims which "compare" a required nutrient level to the amount found in an appropriate reference food using terms -light, reduced, less or fewer, more. For less/fewer and more claims the reference food may be dissimilar or similar. For light, reduced, added, extra, plus, fortified, and enriched claims the reference food shall be similar. For light claims the reference food shall be representative of the type of food. For claims other than light the reference food may be the same manufacturer or another similarly situated.

% Daily Value (DV)

Designation on food label which combines Daily Reference Value (DRV) and Reference Daily Intakes (RDI). Used on a food label to inform consumers the proportion of a nutrient/required label component represents in their diet per day

McDonald's Corp. (dubbed McFat cases)

Federal District Court found that McDonald's advertising was not objectively deceptive (causing the plaintiff's consumption of unhealthy food which caused plaintiff's obesity.) Note - in response 20 states have enacted "hamburger shield laws" which ensure that restaurants cannot be sued for making someone fat." This case consisted of numerous post case procedural maneuvers which ultimately ended with a settlement for the plaintiffs and a stipulated (agreed upon) dismal.

Disclosure Statements for foods that exceed specific nutrient content requirements

For foods (other than meal, main dish or intended for infants/children under 2) which exceed specific requirements (contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium per reference amount customarily consumed, per labeled serving...) a disclosure statement indicating "see nutrition information for _____ content" must be bold type, easily legible and conspicuous.

Labels for Modified Standardized Foods

If a food has a nutrient content level which is used to describe a standardized food a manufacturer must ensure that the food is not nutritionally inferior to the traditional standardized food unless the modified food is labeled "imitation" or with specific limitations regarding the products use or function (e.g "not suitable for baking")

Medium size package Nutrition Fact Panel Format

If a food package has 2-40 square inches the nutrition facts panel may be tabular or linear with permitted abbreviations. The package eliminates the requirement for footnotes except the "Percent Daily Values are based on a 2000 Calorie diet."

Small package Nutrition Facts Panel Format

If a food package has less than 12 square inches of space nutritional information is optional unless there is a nutrient content or health claim. Small packages must include address or telephone number for consumers to obtain information.

Calorie Labeling of Articles of Food in Vending Machines

If vending machines are operated by persons who own or operate 20 or more machines, operators must put a sign close to article of food or button with the amount of calories in clear, conspicuous manner unless purchaser can examine Nutrition Facts Panel before buying or if otherwise available. If an operator is not governed by FDCA (less than 20 machines) must make an election to be governed by federal rules instead of state or local (unless the state/local rules are identical to federal rules) by registering every other year.

Daily Reference Value (DRV)

Numerical quantity which allows consumers to assess whether their diet exceeds maximum recommendations for a variety of macronutrients. DRVs are listed for macronutrients including energy contained nutrients (fat, saturated fat, total carbohydrate-including fiber, protein) and sodium and potassium. DRVs are based on % of Calories consumed per day compared to a recommended 2000 Calorie diet.

Reference Daily Intake (RDI)

Numerical quantity which reflects the daily intake level of a nutrient that is considered to be sufficient to meet the requirements of healthy individual in every demographic in the US. RDI is based on Recommended Dietary Allowances (RDA) which are determined by the National Academy of Sciences.

Simplified Nutrition Facts Panel Format

Permitted format if food contains an insignificant (or less than 1g/serving for total carbohydrate, dietary fiber, and protein) or zero amount of 8 or more of the mandatory nutrients and total Calories . (For children under 2 food must contain an insignificant amount of 6 or more of Calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A/C, calcium and iron) If simplified format is used the label MUST include total Calories, total fat, total carbohydrates, protein and sodium even if insignificant, other nutrients must be listed if present AND nutrients which are added must always be listed.

Dual Column Nutrition Facts Panel Format

Recommended format for nutrition facts panel for food items which require preparation before consumption (for consumer comparison as packaged and as prepared). Also used when alternate ways to list nutrients are available.

Trans Fat Labeling

Required to label trans fats in packaged foods under saturated fats on nutrition facts panel unless the less than .5 grams per serving (unless a claim is made about fat, fatty acids, or cholesterol amounts) *Partially hydrogenated Oil has lost its Generally Recognized as Safe status and must be removed from products by Jun 18, 2018.

Nutritional Labeling of Standard Menu Items in Restaurants (20 or more locations, same name, substantially similar items) and Similar Retail Food Establishments

Requires Calories (adjacent/associated with name of standard menu item), statement which puts Calories in context of recommended total daily Calorie intake, additional nutritional information must be made available upon request with prominent, clear, conspicuous statement that information is available, and number of calories/item adjacent to self-service food and food on display, plus calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars and protein. If not governed by FDCA (less than 20 locations) must make an election to be governed by federal rules instead of state or local by registering every other year.

Patient Protection and Affordable Care Act (ACA)

Requires limited nutrition labeling of standard menu items at chain restaurants, similar food establishments and chain vending machine operators and non-chain operators may elect to be treated similarly if register every other year.

Nutrient Content Claims/ Nutrient Level Descriptors

Requires that a claim on a label/labeling made about a food which characterizes the level/amount of any nutrients must be one which is explicitly defined by FDA (free, good source, healthy, high, lean and extra lean, less and fewer, light, low, more, reduced) about a nutrient and that the claim must be true. Any person can petition the FDA to define a new expressed or implied nutrient content claim or synonyms. However, FDMA amended this requirement to add an exception that for claims that are NOT explicitly defined by FDA in a regulation may be permitted if the claim was recognized by a scientific body of the US government (NIH, CDC, NAS) in a published authoritative statement but a manufacturer must notify FDA 120 days before distributing food with such claim (FDA can either reject or recognize the claim within the 120 days.) Exceptions to nutrient content claim rules include- 1) brand names used before Oct 21, 1989 until FDA defines a term, 2) "diet" soft drinks before Oct 25, 1989 as long as not misleading, 3) if a "statement of identity" exists for a particular food item (here the statement of identity rules control instead of nutrient content e.g. "low fat milk.")

Standard Nutritional Facts Panel Format

Requires the nutrition facts be in a box, in black or another contrasting color as well as other regulations. The shortened format permits eliminating certain nutrients which are in insignificant levels. If a package contains more than one variety and aggregate display with each variety are listed in separate columns.

Serving Size

Rounded to the nearest whole number (if rounding indicate by the word "about") and must be listed in both common household units (cup, tablespoon, teaspoon, piece, fraction, tray, jar) AND metric units (ounces may ONLY be used when a common household unit is not available.)

Exemptions to Nutrition Facts Labeling

Small business (either small volume or total sales <$500,000 or food sales <$50,000), no nutritional significance (e.g. water, coffee beans), dietary supplements, medical foods, bulk shipments, raw fruits/vegetables, small packages, bulk containers (but must have available info at point of purchase). (All exemptions are lost if a nutrient content claim or health claim is made.)

Reference Amounts Customarily Consumed (RACC)

The RACC is a reference amount used for labels for 139 categories of food typically eaten per occasion based on an amount reported on national food consumption surveys. *Special rules apply to special categories e.g. pie, cake, cereal, flour Also, if food appears in a discrete unit (cookie, bar etc.) the serving is the whole unit that most closely approximates the reference amount in the following percentages less than or = 50%, 50%-67%, 67-200%, 200%+ of the RACC. If < or = 50% use the X number of discrete units closest to 1 for a serving size. If 50%-67% use the serving size is 1 or 2 discrete units. If 67% to less than 200% the serving size is 1 discrete unit. *If a multi-serving container has 100g or 100 mL servings and the discrete unit contains 150%-200% of the reference amount the manufacturer may use 1 or 2 servings *If an individual container has less than 200% RACC the items equals 1 serving

Public Citizen and CSPI

Under the NLEA if a nutrient content claim or health claim is made for a menu food at a restaurant, the Nutritional Facts labeling requirements must be met.