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 of melatonin.
4.8 FDA’S FORTIFICATION POLICY
FDA has written rules to established uniform set of principles for the rational addition of nutrients to foods.102 Desirable nutrient levels and quality in the food supply is an important public health objective. The uniform fortification of foods was one of the great public health achievements of the twentieth century, eliminating the nutrient deficiency diseases of pellagra, beriberi, rickets, and scurvy.
However, random fortification of foods could result in over‐ or underfortification and create nutrient imbalances in consumers’ diets. This could undermine the public health achievements through uniform fortification. It could also result in deceptive or misleading claims for certain foods.
As stated in the FDA’s fortification principles, “The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food… . The policy set forth in this section is based on U.S. dietary practices and nutritional needs and may not be applicable in other countries.”103
FDA finds fortification of certain listed nutrients may appropriately be added to a food appropriate under the following circumstances104:
to correct a dietary insufficiency recognized by the scientific community to exist and known to result in nutritional deficiency disease if the food is suitable vehicle for the added nutrients; or
to restore nutrient(s) to a level(s) representative of the food before storage, handling, and processing under good manufacturing practices.
The fortification rule lists a number of limits and controls, such as the food cannot be fortified in a way contrary to any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions (such as standards of identity), nutritional quality guidelines established in federal regulation, and common or usual name regulations. Adding a nutrient is also appropriate only when the nutrient is stable in the food under customary conditions of storage, distribution, and use; is physiologically available from the food; and the level will not result in an excessive intake of the nutrient.
NOTE
