Unlike China, which has special standards for the use of nutritional fortifiers, the United States manages food fortification by formulating nutritional fortification principles and product-specific standards. Next, Foodmate provides a detailed introduction to the regulation of nutritional fortifiers in the United States.

Regulations related to nutritional fortification

The FDA in the United States is responsible for the regulation of fortified foods, managing the nutrition enhancement of foods by establishing nutrition enhancement principles and specific product standards. The nutrition enhancement principles are guiding policies for voluntary food fortification, mainly used to guide the fortification of foods without specific product standards. The principles and regulations regarding fortified elements, fortification levels, and claims made for fortified products are clearly stated in the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act.

SEC. 411 of the Federal Food, Drug, and Cosmetic Act does not set maximum limits on natural or synthetic vitamins or minerals in food, does not limit the combination and quantity of various natural or synthetic vitamins, minerals, and other food ingredients in food, and stipulates that product standards shall be established to ensure product quality.

The Dietary Supplement Health and Education Act clarifies that both fortified foods and dietary supplements may use FDA-approved health claims, such as the claim that "Calcium helps to maintain bone density".

Principles of Nutritional Enrichment

The Principles of Nutritional Fortification are a set of guiding policies on the proper fortification of foods, primarily used to guide fortification of foods for which there are no product-specific standards, and the Principles provide clarity on the circumstances in which fortification may be allowed. 21 CFR 104.20, ‘NUTRITIonAL QUALITY GUIDELINES FOR FOODS’, states that the FDA discourages the indiscriminate addition of nutrients to foods, and believes that fortification of fresh produce, meat, poultry, or fish products, sugars, and recreational foods such as candy, carbonated beverages is inappropriate. Fortification of these types of snack foods can mislead consumers into believing that fortified snacks can be used as a substitute for naturally nutrient-rich foods to obtain a nutrient-rich diet.

Foods can be fortified in the following ways: (1) to correct dietary deficiencies, e.g., the School Lunch Program requires that milk contain a certain amount of vitamin D; (2) to restore nutrients to levels prior to storage, handling, and processing, e.g., fortified flour; (3) to balance nutrients in proportion to the total caloric content of the food; (4) to replace traditional foods to avoid nutrient deficiencies in the food.

Enhanced product standards

For nutritionally fortified foods with specific product standards, manufacturers must follow FDA's requirements. In the process of serving customers, Foodmate found that some enterprises have misunderstanding about the management of fortified foods in the U.S. Some partners, thinking that wheat flour in the U.S. must be nutritionally fortified. In fact, it is not true. 21 CFR 137 specifies the requirements for grain flour and related products, which include both the requirements for ordinary grain flour and those for fortified grain flour. For example, §137.165 specifies requirements for fortified flour, which, in addition to meeting requirements such as the definitions and characterization criteria specified for flour in §137.105, should contain 2.9 mg thiamine hydrochloride, 1.8 mg riboflavin, 24 mg niacin, 0.7 mg folate, and 20 mg iron per pound of fortified flour, with the option of fortified flour having an added 960 mg/lb of calcium in addition. It should also be ensured that the vitamin and mineral content of fortified flour is compliant throughout the expected shelf life. In contrast, §137.105 Flour does not have a nutritional fortification requirement.

For products that are not fortified, FDA has given manufacturers the right to selectively fortify a nutrient in the product standard. If a manufacturer chooses to fortify a product with a particular nutrient, the fortification must comply with the product standard. For example, §131.112 Fermented Milk Standard specifies that manufacturers may choose to fortify with vitamin A and vitamin D. If they do so, they are required to ensure that the amount of vitamin A is not less than 2,000 IU and the amount of vitamin D is not less than 400 IU per quart (946 mL) of product.

These are all the contents shared by Foodmate on the regulation of nutritional fortification in the U.S. If have any questions, please feel free to contact us via global_info@foodmate.net.