In November 2015, the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) released new guidance on fortification of foods. The purpose of the guidance document is to help the food industry better understand and comply with the fortification policy for various food products. In this article, we focus on five important elements of the updated guidance, providing additional information to help clarify FDA’s fortification policy.
Is my fortification in the food product a rational addition?
The fundamental purpose of FDA’s regulation on food fortification is to emphasize rational addition of nutrients in foods. But what is a rational addition and what is not? As the new guidance summarizes, fortification should be performed to 1) correct a dietary insufficiency or meet a demonstrated health need; 2) restore nutrient levels to those prior to storage, handling, and processing; 3) provide a balance of vitamins, minerals, and protein in proportion to the total caloric content of the food; and 4) prevent nutrient inferiority in a food that replaces a traditional food in the diet.1 The guidance states that you cannot fortify fresh produce, meat, poultry or fish products, sugars or snack foods such as cookies, candies, cakes, chips, or carbonated or alcoholic beverages. FDA mentions a few examples of rational additions, such as adding folic acid to enriched grain products to prevent neural tube deficiency or adding calcium to soy beverages because it is a reasonable vehicle to provide calcium to people who do not drink milk. The guidance should have further explained the “reasonable vehicle” concept to preempt fortification of unreasonable vehicles. While the document clearly states that carbonated beverages or snack foods such as cookies, candies, cakes, and chips cannot be fortified, it makes no mention of FDA’s stance on fortification of tea, coffee or snack bars, leaving it up to the manufacturer to produce a convincing, science-based rationale as to why fortification of these foods should be permitted.
Is it appropriate for a particular nutrient to be added to the food product?
The guidance affirms that only essential nutrients with recommended daily intakes (RDIs) or Daily Reference Values (DRVs) listed in 21CFR104.20 or 21CFR 101.9 (see Table 1) are allowed to be used for fortification.1 Any other ingredients are prohibited from fortification in foods. It is somewhat confusing to have the essential nutrients listed under two regulations. In fact, the two lists are almost identical, except that several nutrients including vitamin K, manganese, selenium, chromium, molybdenum and chloride are listed as essential in 21CFR 101.9 (c) 8 (iv), but not in 21CFR 104.20 (d)(3). As clarified by the new FDA guidance, the list of essential nutrients in 21CFR 101.9 (c) 8 (iv) used to be the same as the one in 21CFR 104.20 (d)(3), but it was amended in 1995 and included several more nutrients as described above. Therefore, 21CFR 101.9 (c) 8 (iv) is a more complete reference for essential nutrients. In March 2014, FDA published a Proposed Rule that will add an RDI for choline at 550 mg/day. Once the rule is finalized, choline may be fortified in food via an amendment to 21CFR 101.9 (c) 8 (iv), although the exact timeframe for the amendment is unpredictable.
Due to controversies and inconsistencies in nutritional standards across different countries, one foreseeable consequence is misbranding of fortification in imported foods. For instance, fluoride is on the European Food Safety Authority (EFSA)’s list of approved added nutrients but is not on FDA’s lists. Thus, a food with a fluoride fortification claim that is legal in the European Union may be considered misbranded in the U.S. when the food is imported. It is important for the industry to pay attention to such differences to avoid impoundment at the port of entry or a possible recall if the product reaches the market.
Can I fortify products in order to make a health claim?
As mentioned in the guidance document, under 21 CFR 101.14 (e)(6), also called the “jelly bean rule”, a food subject to a health claim must contain, without fortification, at least 10% of the RDI or DRV of vitamin A, vitamin C, iron, calcium, protein, and fiber. In recent years there have been some widely publicized cases of food manufacturers violating this rule. In 2009, the Center for Science in the Public Interest (CSPI) filed a lawsuit against Coca-Cola for deceptive and unsubstantiated claims on Vitamin WaterÒ. Vitamin WaterÒ was in violation of the jelly bean rule, as it did not contain 10% of the RDI or DRV of the nutrients mentioned in 21 CFR 101.14 (e)(6) without fortification and contained 33 grams of sugar per bottle. In October of 2015, Coca-Cola agreed to change the label and stop making the violative claims for the product and pay up to $2.73 million to cover fees and expenses of the plaintiffs’. An FDA warning letter was issued to Quest Nutrition, LLC, on July 29th, 2015, stating that their BBQ flavored protein chips violated fortification policy and nutrient requirements for use of the term “healthy”. The company replied that their product was a newly invented food product that is not fortified, complies with the nutrient requirements for “healthy”, and should not be considered a snack. The company will likely have to take FDA to court in order to resolve the matter.
Despite increased vigilance by the FDA, consumers and watchdogs, instances of “jelly bean rule” violation abound. A simple search on the internet identifies numerous comments and complaints from consumers about mineral-fortified soda and vitamin-added candies that mislead the public to believe they are healthy due to the nutrients added. Although food manufacturers may insist that their fortified products contain more than 10% of the RDI or DRV of the six nutrients mentioned above and meet every requirement for nutritive content, they need to remember that the jelly bean rule is predicated on the grounds of food without fortification. Therefore, as a rule of thumb, fortification of snack foods and carbonated beverages in the absence of a compelling scientific rationale for doing so is a potentially violative act, and action may well be taken by the FDA to rectify the infraction.
Can I fortify foods with standards of identity?
Although the guidance mentions that 1) certain foods with standards of identity require fortification and 2) foods with a standard of identity that do not include the addition of a particular nutrient could potentially be fortified, it does not provide any examples of successful or disallowed fortifications for the latter case and refers the reader to 21 CFR 130.10 for additional information. Regulation 21 CFR 130.10 states that for ingredients not present in the standardized food, the label shall identify the ingredient with an asterisk, followed by the words “*ingredient not in regular (fill in name of the traditional standardized food).” A recent visit to the local store reveals that most orange juice manufacturers are compliant with this labeling provision; however, some are exploiting use of the term “ingredient” in the regulation to include substances like probiotics and omega-3 fatty acids, which are not nutrients or substances otherwise permitted to be added to standardized foods by 21 CFR 130.10.
How much is not too much to add?
Regarding amounts to add, the guidance document mentions that nutrients: 1) can be added to restore the nutrient to levels representative of the food prior to storage, handling and processing; 2) should be added in proportion to the food’s caloric content; and 3) should be added at appropriate levels to avoid excessive intake.1 While it is important to ensure that the actual amount of nutrients meets claimed values over the shelf life and is not out of balance with caloric content, particular attention should be paid to the potential risks of adding vitamins or minerals at levels that exceed their Tolerable Upper Intake Levels (ULs). Caution should be taken when adding the nutrients whose RDI and UL values are close. For example, the UL of folate is only 2.5 times its RDI, and folate overdose may mask vitamin B12 deficiency, potentially leading to irreversible neuropathy. Furthermore, the RDIs of some essential minerals for adults (e.g. zinc) may be higher than the ULs for 4- to 8-year old children. When devising an overage to account for nutrient loss, make sure to take calories per food serving, the age of the intended consumer and ULs of the nutrients for all ages into account. Remember that the food could be consumed as soon as is placed on the shelf, not just at the end of its shelf-life, so manufacturers should not over-fortify to compensate for potential nutrient loss during the shelf life of the product.
Challenges and opportunities for fortifying foods
It has been more than three decades since the food fortification policy was first introduced in the 1980s. It is important for the food industry to comply with this policy for the sake of maintaining the nutrient sufficiency and balance for the US population. Violation of the policy may lead to FDA warning letters and misbranding lawsuits.1 One prominent trend is that the food fortification policy is often violated by companies attempting to make healthier alternatives to traditional snack foods. For foods that can be easily defined as snacks, fortification is banned by the FDA. The outcome of the BBQ flavored protein chips case above is worth watching, as it may set a precedent for new types of snacks.
Before fortifying your product, think about the identities of the added nutrients and the product base, as well as the amounts added. The guidance poses special emphasis on rational addition and nutrient sufficiency and balance. The manufacturer must show that the addition is permitted, reasonable, and within acceptable limits. For more information, consult the references provided below or contact Burdock Group.
*The authors have Doctor of Philosophy degrees in Nutritional Science and Toxicology; they are not attorneys, and do not represent this article as providing legal advice.
Table 1. Nutrients that can be used to fortify foodNutrientDRV or RDI* Amount per 100 calories Upper limits (ULs)Protein a50 g2.5 gNEVitamin A a,b5,000 IU250 IU3,000 mg or 10,000 IUVitamin C a,b60 mg3 mg2,000 mgCalcium a,b1 g0.05 g2.5 gIrona,b18 mg0.9 mg45 mgVitamin D a,b400 IU20 IU50 µg or 2,000 IUVitamin E a,b30 IU1.5 IU1,000 mg or 1,111IUVitamin Kb80 mg4 mgNEThiamin a,b1.5 mg0.08 mgNERiboflavin a,b1.7 mg0.09 mgNENiacin a,b20 mg1 mg35 mgVitamin B6 a,b2.0 mg0.1 mg100 mgFolate a,b400 µg20 µg1,000 µgVitamin B12 a,b6.0 µg0.3 µgNEBiotin a,b0.3 mg0.015 mgNEPantothenic acid a,b10 mg0.5 mgNEPhosphorus a,b1.0 g0.05 g4 gIodine a,b150 µg7.5 µg1,100 µgMagnesium a,b400 mg20 mg350 mg dZinc a,b15 mg0.8 mg40 mgSelenium b70 µg3.5 µg400 µgCopper a,b2.0 mg0.1 mg10 mgManganese b2.0 mg0.1 mg11 mgChromium b120 mg6 mgNEMolybdenum b75 µg3.75 µg2,000 µgChloride b3,400 mg170 mg3,600 mgPotassium a3,500 mg175 mgNE
DRV = daily reference value, IU = international units; NE = not established, RDI = recommended daily intake.
*DRVs for protein and potassium; all others are RDIs. DRVs and RDIs are for adults and children 4 or more years of age. The amount per 100 calories was calculated by dividing the RDI or DRV by 20, based on 2000 calorie total intake as a daily standard.
a DRVs or RDIs and amount per 100 calories are from 21CFR 104.20 (d)(3).
b RDIs are from 21CFR 101.9 (c) 8 (iv).
c The UL values are for adults 19 or more years of age. Values were obtained from http://iom.nationalacademies.org/Activities/Nutrition/SummaryDRIs/~/media/Files/Activity%20Files/Nutrition/DRIs/ULs%20for%20Vitamins%20and%20Elements.pdf. ULs were converted as follows: (1) Vitamin A from µg to IU as retinol, (2) Vitamin D from µg to IU, and (3) Vitamin E from µg to IU as d,l-alpha-tocopherol based on equations in the NIH Dietary Supplement Ingredient Database, available at http://dietarysupplementdatabase.usda.nih.gov/ingredient_calculator/equation.php
d magnesium represents intake from a pharmacologic agent only and does not include intake from food and water.
 FDA. Guidance for Industry: Questions and Answers on FDA’s Fortification Policy. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm470756.htm. Published November 2015. Accessed January 26, 2016.
 FDA. Proposed Changes to the Nutrition Facts Label. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm Published March 2014. Accessed January 26, 2016.
 Fluoride is mandatorily fortified in drinking water in the U.S., which is regulated by the Environmental Protection Agency (EPA).
 Burros, M. FDA Imposing Stricter Rules on Food Labels. The New York Times. http://www.nytimes.com/1994/05/05/us/fda-imposing-stricter-rules-on-food-labels.html Published May 5, 1994. Accessed January 26, 2016.
 Stempel, J. Coke to Change Vitaminwater Labels to Settle U.S. Consumer Lawsuit. http://www.reuters.com/article/coca-cola-vitaminwater-settlement-idUSL1N1211HX20151001 Published October 1, 2015. Accessed January 26, 2016.
 FDA. A Warning Letter to Quest Nutrition, LLC for Food Labeling/Misbranded. http://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm460915.htm Published July 29, 2015. Accessed January 26, 2016.
 FDA. Quest Nutrition, LLC. – Company Response Letter. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm461541.htm Published August 10, 2015. Accessed January 26, 2016.
 The nutrient to calories balance principle emphasizes the proper amount of nutrients per unit of calories, based on a diet with 2000 calories a day (Table 1). Thus, the amount of fortified nutrients should be calculated based on their RDI or DRV values and the calories per food serving.
 Bryan, R. H. Are we Missing Vitamin B12 Deficiency in the Primary Care Setting? Journal for Nurse Practitioners. http://www.medscape.com/viewarticle/726357_1 Published July, 2010. Accessed January 26, 2016.