In particular, statements about the saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, calories from fat, or calories from saturated fat are prohibited.
4.7.8 Exemptions
Brand Names
Undefined nutrient descriptors used in brand names established before October 21, 1989, can continue to be used in the name until FDA may define the term.93 Any brand names first used after 1989 must comply with nutrient content claim rules, and undefined nutrient descriptors are prohibited.
Diet Soft Drinks
A soft drink that used the term “diet” as part of its brand name before October 25, 1989 (and in compliance with other FDA rules) may continue to use diet as part of its brand name, provided that its use of the term is not false or misleading.94 “Diet” is not an approved nutrient descriptor, and therefore, is not permitted in other uses.
Terms in Standardized Food Names
Where a statement of identity established a descriptor in the standardized name of a food, the statement of identity rule applies rather than the rule for the nutrient content descriptor.95
4.7.9 Statements That Are Not Implied Claims
A number of specific uses of terms are not considered implied nutrient content claims when it is clear that they are not made in a nutrient context.96
1 A claim that a specific ingredient or food component is absent for food allergies, food intolerance, religious beliefs, or dietary practices such as vegetarianism or other non‐nutrition‐related reason (e.g., “100 percent milk free”).
2 A claim about a substance that is non‐nutritive (e.g., “contains no preservatives,” “no artificial colors”).
3 A claim about the presence of an ingredient that is perceived to add value to the product (e.g., “made with real butter,” “made with whole fruit,” or “contains honey”).
4 A statement of identity for a food in which an ingredient constitutes essentially 100 percent of a food (e.g., “corn oil,” “oat bran,” “dietary supplement of vitamin C 60 mg tablet”).
5 A statement of identity (e.g., “corn oil margarine,” “oat bran muffins,” or “whole wheat bagels”), unless such claim is made in a context that suggests that a nutrient is absent or present in a certain amount.
6 A statement of special dietary usefulness in compliance with 21 C.F.R. part 105.
4.7.10 New Nutrient Content Claim Approvals
Any person can petition the FDA to define a new nutrient content claim.97 Petitions may also be submitted for use of new synonyms for already defined terms. In addition, petitions may be submitted for permission to use implied nutrient content claims. The procedure and format for submitting petitions is available at 21 C.F.R. § 101.69.
Authoritative Statement (FDAMA) Claims
The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the FD&C Act to allow nutrient content claims not defined by FDA in regulation if the claim was recognized by a scientific body of the U.S. government in a published authoritative statement.98 These scientific bodies include the National Institutes of Health, the Centers for Disease Control and Prevention, and the National Academy of Science.
To use such a claim, a notification to FDA must be made of the intention to use the claim at least 120 days before distributing food with the claim. The FDA must reject or recognize the claim within 120 days.
Choline Content Claims
In 2001, FDA recognized the following nutrient content claims to characterize the level of choline99: “Good source of choline,” “Contains choline,” “Provides choline,” “Excellent source of choline,” “Rich in choline,” and “High in choline.” These claims would include one of the following statements “Contains [X mg] choline per serving, which is [X%] of the Daily Value for choline (550 mg),” or “Contains [X%] of the Daily Value for choline per serving. The Daily Value for choline is 550 mg.” The area within the brackets would be filled in with the specific percentages of the DV and milligram amounts of choline in the product.
The following relative claims are also recognized: “Added choline,” “More choline,” “Enriched with choline,” “Fortified with choline,” “Extra choline,” and “Plus choline.” The relative claims would also include the statements “[Percentage 10% or greater] more of the Daily Value for choline per serving than [reference food]. This product contains [X mg] choline per serving which is [X%] of the Daily Value for choline (550 mg). [Reference food] contains [X mg] choline per serving.” The area within the brackets would be filled in with the specific percentages of the DV and milligram amounts of choline in the product and a description of the reference food.
Omega‐3 Nutrient Content Claims
In 2014, FDA recognized nutrient content claims for conventional foods and dietary supplements containing alpha‐linolenic acid (ALA).100 The claims permitted are the following:
| Nutrient content claim for ALA | Conditions for making the claim101 |
|---|---|
| High | ≥ 320 mg of ALA per RACC (≥ 20% of 1.6 grams/day) |
| Good source | ≥ 160 mg of ALA per RACC (≥ 10% of 1.6 grams/day) |
| More | ≥ 160 mg of ALA more per RACC than an appropriate reference food (≥ 10% of 1.6 grams/day) |
Note, however, nutrient content claims for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega‐3 fatty acids are prohibited.
4.7.11 Nutrient Content Claims Absent a Daily Value
Nutrient content claims characterize the level of a nutrient, and therefore, these claims are not permitted unless a DV has been established for that nutrient. For example, “High in Melatonin” is an illegal nutrient content claim. To qualify for a “high” nutrient content claim, FDA requires there be at least 20 percent of the DV of the nutrient per serving and per reference amount. There is no DV for melatonin; therefore, no nutrient content claims can be made for the substance.
Alternately, a truthful statement may be made that specifies only the amount of the nutrient per serving and does not characterize the level, such as implying that there is a lot or a little of that substance in the food. For example, “x mg of melatonin per serving” would not be considered a nutrient content claim so long as nothing else characterizes the level