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On May 10, FDA announced that it will reevaluate regulations concerning nutrient content claims (NCCs), including the definition of “healthy.”

An NCC is a claim on a food product label that directly or by implication characterizes the level of a nutrient in a food (e.g., “low fat,” “high in fiber,” “healthy”). A food with a “healthy” NCC claim must contain specific low levels of total fat, saturated fat, cholesterol, and other nutrients. However, members of the food industry have pointed to current nutrition guidance that state that a healthy diet includes foods that are high in certain fats, such as almonds, avocados, and salmon.

On November 6, 2015, the Food and Drug Administration (FDA) issued long-awaited guidance on its fortification policy for adding nutrients to foods in the form of a Questions and Answers Guidance for Industry. The FDA originally issued the fortification policy more than 30 years ago, in 1980, to “promote the rational addition of nutrients to foods in order to preserve a balance of nutrients in the diet of American consumers.” The fortification policy was then amended in 1993 to conform to the Reference Daily Intakes and Reference Daily Values issued by the FDA. However, this new announcement is the first time since 1980 that the FDA has provided guidance specifically on the fortification policy. The underlying principle of the fortification guidelines is to provide a uniform nutritional benefit to consumers without misleading consumers to believe that the fortified food will provide a complete and nutritionally sound diet.

The policy provides guidance on how to properly fortify food with vitamins and minerals, so as to avoid indiscriminate fortification of foods. For example, the FDA has issued Warning Letters stating that it is inappropriate to fortify snack foods and carbonated beverages. Additionally, the new guidance states that fortification of snack foods, including unsweetened carbonated beverages and low-calorie and calorie-free snack foods, “could mislead consumers to believe that substitution of naturally nutrient dense foods with fortified snack foods would ensure a nutritionally adequate diet.” For the same reason, FDA states it is inappropriate to fortify alcoholic beverages.

Confirming what coffee and tea connoisseurs have long known, the European Food Safety Authority (EFSA) in January declared that 400mg of caffeine per day is not a safety concern. A 98-page draft assessment indicates the same for a single dose of up to 200mg for adults ages 18–65, even when consumed less than two hours before strenuous exercise. For pregnant women, caffeine intakes of up to 200mg per day additionally raised no safety concerns. And, finally, for all junior coffee lovers (ages 3–18), a dose of 3mg per kg of body weight per day is considered safe. Although the report confirmed that a dose of 100mg may affect sleep patterns, the report’s overall message appears to show that European regulators may be less concerned with caffeine intake than their U.S. counterparts.

As food industry observers know, caffeine has become an increasingly hot topic in U.S. food regulation. For example, the Institute of Medicine conducted a 2013 workshop on caffeine in food and dietary supplements that presented statements, recommendations, and opinions of individual participants on (1) regulation of caffeine in the United States, (2) intake and exposure to caffeine, (3) safety signals and surveillance, (4) safe caffeine exposure levels for vulnerable populations, (5) caffeine’s effects on the cardiovascular system, (6) caffeine’s effects on the central nervous system and behavioral effects associated with caffeine consumption, and (7) other compounds impacting caffeine’s effects.

What recourse do businesses have when their products are incorrectly identified as the source of a foodborne illness outbreak? For the time being, it appears that the answer to that question is “very little.” In a recently dismissed lawsuit concerning FDA’s 2008 warnings linking tomatoes to a Salmonella outbreak in New Mexico and Texas, which proved to be wrong, a federal court held that the government’s error did not constitute a regulatory “taking” under the Fifth Amendment, even though the warnings had significant financial impact on the marketplace. Despite the court’s decision, and its impact on prospective regulatory takings claims, a compensation provision under the Food Safety Modernization Act (FSMA) provides a potential avenue of recourse for farmers, and it is likely that litigants will test this compensation theory in the future.

Throughout 2013, the FDA issued several Warning Letters to manufacturers of medical foods, suggesting that the FDA’s final guidance may narrow its interpretation of the definition of “medical foods.” The details and implications of these Warning Letters are discussed in a Food Industry LawFlash from our FDA Practice.

It remains important for the medical food industry to monitor the status of the guidance and any continued enforcement efforts in order to determine whether the agency will be revise its interpretation of the medical food category or continue to enforce the more limiting criteria set forth in the nutritional labeling regulations.