Today, everyone is looking for easy and delicious ways to eat snacks that are healthy, and one popular trend to help consumers do so is to replace nutrient-void snacks with fortified snack foods. Many fortified snacks currently are on the market, including candies fortified with vitamins and minerals, potato chips with added protein, and brownies and cookies with added fiber. However, companies eager to market fortified snack foods should be mindful of FDA’s fortification policy, which is set forth in 21 CFR § 104.20.
The fundamental objective of the policy “is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods." As stated in its policy, the agency’s concern regarding the addition of nutrients to food is twofold: “[R]andom fortification of foods could result in over- or under-fortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims for certain foods."
The principles of “rational fortification" permit the addition of essential nutrients to food for purposes of:
- Correcting a dietary insufficiency that is recognized by the scientific community;
- Restoring nutrient levels to those prior to storage, handling and processing (the restoration principle);
- Providing a balance of vitamins, minerals and protein in proportion to the total caloric content of the food (nutrient-to-calorie balance principle); and
- Preventing nutrient inferiority in a food that replaces a traditional food in the diet.
In its policy, FDA takes the position that it is inappropriate to fortify snacks and sugary and snack foods that are not naturally nutrient-dense, such as cookies, candies, cakes, chips, and sweetened and unsweetened carbonated beverages. In a recently published guidance reaffirming the agency’s position regarding the fortification of foods, FDA elaborated on its displeasure of using snack foods as a vehicle for delivering added nutrients: “Fortification of these types of snack foods could mislead consumers to believe that substitution of naturally dense foods with fortified snack foods would ensure a nutritionally adequate diet. Moreover, the fortification of such snack foods would disrupt public understanding about the nutritional value of individual foods and thereby promote confusion among consumers, making it more difficult for them to construct diets that are nutritionally adequate."
However, FDA offered no evidence of such consumer confusion.
The agency actually does not have legal authority to prohibit the fortification of foods unless it can be shown that fortification renders that particular food unsafe for consumption. In a case involving a sugar product fortified with vitamins and minerals that were lost in the refinement of cane juice during manufacturing, a U.S. District Court stated: “The basic flaw in the Government’s case against the product is that it is seeking, under the guise of misbranding charges, to prohibit the sale of a food in the marketplace simply because it is not in sympathy with its use. But the Government’s position is clearly untenable. The provisions of the Federal Food, Drug, and Cosmetic Act did not vest in the Food and Drug Administration or any other federal agency the power to determine what foods should be included in the American diet; this is the function of the marketplace." (United States v 119 Cases …“New Dextra Brand Fortified Sugar," 231 F. Supp 551 (D. Fla 1963), aff’d per curiam, 334 F. 2d 238 (5th Cir. 1964))
FDA’s fortification policy is non-binding guidance that the agency can do no more than “urge" the industry to follow. That is unless certain nutrient content claims are made in the marketing of a fortified food.
There are three nutrient content claim regulations that specifically incorporate FDA’s fortification policy, thereby making failure to comply with the guidance subject to enforcement action. The “healthy," “more/plus" and “high-potency" nutrient content claim regulations provide that, if compliance with the requirements for making such claims is based on a nutrient that has been added to a food, such addition must be in accordance with FDA’s fortification policy. FDA has issued numerous warning letters to companies making nutrient-content claims on their fortified snack foods for failing to comply with the agency’s position that snack foods should not be fortified. There have also have been class-action lawsuits alleging non-compliance with the nutrient-content claim regulations for failure to comply with FDA’s fortification policy, as well as enforcement action by state regulators on snack food fortification matters.
In the preamble to the final rule regarding “high potency" nutrient content claims, the agency expressed its concern with allowing nutrient-content claims on snack foods: “FDA has previously stated that fortifying a food of little or no nutritional value for the sole purpose of qualifying that food for a health claim is misleading … Indiscriminate fortification of such foods with one nutrient would not make such foods consistent with dietary guidelines and may encourage over-fortification of the food supply (e.g., vitamin or mineral addition to soft drinks)(62 FR 49868 (September 23, 1997))."
Companies considering the addition of a fortified snack food to their product line should make certain that the product’s label and labeling (including website) do not contain express or implied “healthy," “more/plus," or “high potency" claims. Also, companies should ensure that any nutrient addition is safe and suitable for the food being fortified. This would include not only ensuring that the nutrient is stable in the food under customary conditions of storage, but also that the nutrient is added at an appropriate level to avoid excessive intake of the nutrient, taking into account the cumulative amounts from all sources in the diet. In making this assessment, upper levels of intake should be considered when available, such as the tolerable upper intake level (UL) established by the Institute of Medicine (IOM). Lastly, companies should verify that the nutrient being added is suitable for its intended purpose and complies with applicable regulations governing the safety of the substance in food, as some food additive or GRAS (generally recognized as safe) regulations have limitations on what nutrients can be added to what foods and at what levels.
The industry will continue to innovate with new, improved snack food products that strive to be health- conscious while also remaining appealing to consumers. Thus, industry should be mindful of FDA’s fortification policy and its authority to enforce such a policy through regulations on certain marketing claims.
Jacqueline Kuler, senior counsel at Amin Talati, assists companies in complying with the various legal requirements applicable to the manufacture, marketing and distribution of foods, dietary supplements, drugs, medical devices and cosmetics. She works with companies in preparing legally compliant labels and marketing materials, including helping to develop substantiation, and advises in all matters relating to the manufacture and distribution of FDA-regulated products, including registration and listing requirements, GMP (good manufacturing practice) standards, adverse event and recall matters, and import/export issues.