FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register notice and subsequently has been included in the Code of Federal Regulation (21 CFR 104.20) even though the policy was never subjected to notice and comment rulemaking and does not qualify as a legally binding “rule,” but rather as agency “guidance.”  From the beginning, FDA’s fortification policy has been designed to discourage the “indiscriminate addition of nutrients to food” and “establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods.”

The new Guidance restates and elaborates upon the food fortification principles stated in the established 1980 fortification policy.  The Guidance does not reference a specific provision of the Federal Food, Drug & Cosmetic Act (FDCA) as the basis for its authority to maintain or enforce the fortification policy, but signals the agency’s readiness to rely on the misbranding provisions of the statute in taking enforcement actions against fortified snack foods. Notably, the “Statement of Purpose” for FDA’s established fortification policy in 21 CFR 104.20(a) attempts to draw a link between the fortification policy and FDA’s authority to prevent deceptive or misleading claims under its misbranding authority without elaboration or support:  “[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 new Guidance further addresses the potential for “inappropriate” fortification to result in misbranding violations in the context of fortified snack foods and suggests that fortification of “snack foods could mislead consumers to believe that substitution of naturally nutrient dense foods with fortified snack foods would ensure a nutritionally adequate diet.”   The new Guidance goes on to suggest that “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.”  The new Guidance does not cite any quantitative or qualitative research for the notion that fortification of snack foods will result in consumer confusion.

While recognizing explicitly that the FDA fortification policy does not establish “legally enforceable responsibilities,” the new Guidance urges food manufacturers that elect to add nutrients to a food for human consumption to follow the principles of the fortification policy, including the following guidelines:

• Principles of “Rational Fortification.” The Guidance states that there are four primary “principles of rational fortification,” which were also part of the established 1980 fortification policy.  Those principles permit the addition of essential nutrients to food for purposes of:
  • Correcting a dietary insufficiency;
  • 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.

The Guidance cites as an example of rational fortification the addition of calcium to a soy beverage because a soy beverage would be a reasonable vehicle for people who do not drink milk, such as those who are lactose intolerant, but wish to obtain calcium, and essential nutrient (mineral).

• Conditions that Added Nutrient Should Satisfy.  The Guidance states that, before a nutrient is added to food, manufacturers should ensure that the nutrient is:
  • Stable in the food under customary conditions of storage, distribution, and use;
  • Physiologically available from the food.
  • Added at an “appropriate level to avoid excessive intake of that nutrient, considering cumulative amounts from all sources in the diet” (e.g., level does not exceed an existing upper intake level (UL) established by the Institute of Medicine (IOM));
  • The nutrient is “suitable for its intended purpose” and complies with FDA safety requirements (e.g., GRAS or approved food additive).

• “Inappropriate Fortification.”  The Guidance states that “it is not appropriate to fortify certain foods, such as” fresh produce, meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.  As noted above, the Guidance also states that it is inappropriate to fortify unsweetened carbonated beverages, low-calorie and calorie-free snack foods (e.g., low calorie or fat free cookies), and alcohol beverages.
• “Essential Nutrients.”  The Guidance states that only the addition of “essential nutrients” to food is covered by FDA’s fortification policy.  “Essential nutrient” refers to the vitamins and minerals assigned Reference Daily Intakes (RDIs), and to protein and potassium which have been assigned Daily Reference Values (DRVs).
• “Mandatory” and “Voluntary Fortification.”  The Guidance states that FDA uses the principles in the fortification policy in issuing regulations requiring nutrients to be added to food, such as standards of identity regulations that require folic acid to be added to various enriched grain products (mandatory fortification).  In addition, the Guidance states that manufacturers “should also follow the fortification policy” described in the Guidance for “voluntary fortification” of foods, including when the following types of foods are fortified:
  • Foods that do not have a standard of identity;
  • Nutritionally modified versions of foods that have a standard of identity (e.g., orange juice with added nutrients);
  • Foods that qualify for a “healthy” claim as a result of added nutrients.
• Excluded Foods. The Guidance states that FDA’s fortification policy does not apply to animal foods, infant formulas, or dietary supplements.
• Enforcement.  The Guidance states that FDA’s fortification policy is primarily used as “guidance,” but has incorporated by reference the provisions of the fortification policy into the nutrient content claim regulations for two nutrient content claims: (1) “more” claims (and synonyms “fortified,” “enriched,” “added,” “extra,” and “plus”; and (2) “healthy” claims (and related claims “healthful,” and “healthier”).  If a fortified food does not comply with FDA’s fortification policy and is marketed with express or implied “more” or “healthy” claims,  the Guidance suggests that “FDA may issue a warning letter and take enforcement action.”

FDA issued the guidance as a final guidance, rather than as a draft guidance to be finalized as a letter date.  As it typically does with non-draft guidance documents, FDA is accepting written comments without a specified deadline for submission of comments.

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