As nutrition continues to drive innovation, the ever-present question is simple: What claims can I make? There are many practical challenges from a product development/palatability standpoint in regards to developing new or reformulated foods with added nutrients such as calcium, omega-3 fatty acids, fiber and chromium picolinate. Although consumers seek incremental ways to improve the nutritional quality of their diet, at the same time, most are unwilling to compromise taste and value. Innovation is thus tied to communication. But incentives to innovate are stymied when marketers are prevented or significantly restrained from communicating the benefits realized through innovation.

Since the roll-out of nutrition labeling rules by the Food and Drug Administration (FDA or the agency) in 1993, it has been understood that statements about the level of a nutrient (“nutrient content claim”) or the health benefits associated with the level of a nutrient or food (“health claim”) require regulatory approval. Claims such as “light,” “low-fat,” and “good source” are useful to consumers but—from a communications standpoint—offer a tired message.

In the name of innovation, there often are calls to “think outside the box.” In the regulatory arena, such creativity all too often is constrained by the regulatory parameters within which food marketers must operate. Food labeling regulations define the box. While the contours of the box are sometimes fuzzy, when a claim puts the marketer decidedly outside the box, the negative consequences of adverse regulatory action can be substantial.

This article highlights several threshold legal principles that govern what nutrients may be added to which foods and at what levels. In turn, the significant developments that have arisen over the past year shed some light on the positive avenues and dead-ends food marketers face in effectively communicating nutritional innovation to consumers as they relate to health claims and related messages.

Rational Fortification: Adding Beneficial Nutrients to Conventional Foods

Food labeling regulation encompasses two key concepts that determine whether one can add a given nutrient (or ingredient) to a food in order to achieve a desired health benefit. First, there must be a lawful basis for the addition of the nutrient or ingredient and, second, such an addition must constitute “rational fortification” as envisioned by the FDA and its counterpart at the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS).

Food ingredients generally fall into one of three legal categories: color additives, food additives and generally recognized as safe (GRAS) ingredients. Color and food additives are not permitted unless approved for use by FDA. Such approvals may be restricted to specified categories of foods, with specific limitations on the maximum allowed level that can be added. In other instances, FDA's food additive regulations are more flexible and allow use of a food additive at unspecified levels consistent with good manufacturing practices.

Exempt from the definition of a food additive are substances that are GRAS. GRAS status of an ingredient can be established by common use in foods or by scientific evidence that demonstrates the safety of an ingredient for an intended use. An ingredient can be considered GRAS based on common use in the food supply prior to 1958. GRAS status can be affirmed by FDA or self-determined by an individual company. So-called GRAS notifications have allowed a more flexible and timely way for FDA to review and object or not object to a firm's GRAS determination when submitted to FDA. Regardless of the legal path, there must always be a legal basis for use of a nutrient in the food to which it is added. Unfortunately, the complex process in making such determinations and the regulatory processes involved are beyond the scope of this article.

Unlike the rules governing the legal use of ingredients, the notion of what constitutes “rational fortification” is not specified by regulation. Based on its general legal authority to prohibit false or misleading claims on a food label, the FDA developed a fortification policy that set the basis for policy and practice at both the FDA and USDA. The policy is widely recognized by the agency and most others as antiquated and in need of updating. Nevertheless, there are certainly underlying principles that remain valid, including whether the food and added nutrient are appropriate as a vehicle for encouraging consumption of the particular nutrient. It is prudent to carefully consider these underlying policies when determining if fortification of a food is appropriate.

The USDA long has prohibited the direct fortification of meat and poultry products, whether single ingredient cuts of meat/poultry, or a further processed, multi-ingredient product that is prepared in an inspected establishment. The prior label approval process for meat and poultry products has enabled USDA to keep a tight rein on the addition of nutrients. As a consequence, the ability to provide nutritional benefits in multi-ingredient meat or poultry products has been impeded. While there is the possibility of modest flexibility in USDA's approach that companies should consider, FDA and USDA officials widely acknowledge the value and need to revamp their fortification policies. In the meantime, marketers will be well-served to adopt rational approaches to fortification.

Added Nutrients for Health Benefits: Qualified Health Claims on the Decline

In response to court rulings and a desire by FDA to facilitate consumer access to reliable diet and health information, the agency developed a “qualified health claim” policy whereby the limitations of the underlying science would be disclosed to the consumer as part of a health claim. Prior to the emergence of this policy in 2003, the FDA had only approved unqualified health claims supported by the gold standard of “significant scientific agreement.” While the developments were prompted by dietary supplement company initiatives, the process and types of claims have been considered by many as appropriate for qualifying food products as well.

The qualified health claim policy reflects the FDA's attempt to balance the courts' mandate for providing more, not less, information to consumers as contemplated under the First Amendment. In some circles, the health benefits of lycopene in tomatoes, green tea/extract and chromium picolinate are generally accepted. Whole grain and omega-3 fatty acids are two more mainstream food components understood to offer health benefits, although the regulatory treatment of such health-related claims is still under development.

The fate of health claims made just a few years ago relating to the use of green tea and cancer prevention foreshadowed what has become a very gloomy picture for many new, fashionable nutrient/food components. The FDA responded to a green tea health claim petition after evaluating 223 published scientific studies, finding there was not “credible evidence” to support the claim for many of the cancers identified in the petition. In two instances, the agency concluded that a qualified health claim was appropriate with limitations that would sink any marketer's ship while still docked. The claim:

Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.

The “highly unlikely” effect of green tea on cancer prevention is also highly unlikely to ever appear on a food label. Marketers may well have other ways to tout the general healthful properties of green tea/extract, but not by focusing on cancer.

Chromium picolinate and its purported effects on improving insulin resistance met a similar fate. The FDA found “very limited credible evidence” for the benefit of chromium picolinate and insulin resistance and a reduced risk of type 2 diabetes. The qualified health claim that can appear on food labels must include the cautionary statement that the claimed health benefit “is highly uncertain.”

Other claims, including a petition for a qualified claim touting the benefits of calcium and a variety of abnormal menstrual cycle conditions, were rejected outright by the FDA. Finding “no credible evidence,” the FDA determined that the health claim could not be presented to consumers regardless of any attempts to qualify the nature of the underlying science. One can imagine that those considering filing a qualified health claim petition or awaiting an FDA decision on a pending petition (which remain non-public until the agency issues a formal response) have abandoned or are rethinking such efforts where the science is not demonstrably superior to the science that has largely been rejected by the agency.

The Glass is (at least) Half-full

Touting the levels of omega-3 fatty acids is an area where FDA has moved to allow a number of related claims. (See chart “FDA Broadens Permitted Omega-3 Claims.”) These petitions are based on authoritative scientific statements of the federal government (so-called FDAMA claims as authorized under the FDA Modernization Act) which allow for health claims and nutrient content claims. FDA has reviewed and accepted requests for nutrient content claims for ALA, DHA, EPA and combinations of DHA and EPA. There are somewhat different criteria for each of these claims whereby qualifying products can make claims such as “excellent source of.” One example: “Excellent source of ALA omega-3. Contains Xmg ALA per serving, which is X% of the Daily Value for ALA (1.3g).”

The benefits of whole grains are undeniably a message that can be delivered in many different ways. Both USDA and FDA have issued guidance surrounding such claims as “100% whole grain” (allowed), whole grain and reduced risk of coronary heart disease and certain cancers (allowed if approved health claim is used), and “good source of whole grain” (USDA will not approve a label with this claim, viewed as unapproved nutrient content claim).

But there is no reason to delay consideration of whole-grain claims before the regulators in Washington get everything figured out. One clear path to developing marketing claims is close consultation of the Dietary Guidelines and MyPyramid. Indeed, the detail and level of scientific rationale underlying the most recently issued Dietary Guidelines provides a great deal of information that can provide the basis for nutrition-focused claims for foods formulated with the particular nutrient.

Health claims that reference the dietary impact on particular diseases are likely to continue to diminish in use as the latest wave of petitions have met with less than resounding success. Other nutrients, such as omega-3 fatty acids and ingredients like whole grains, provide just two examples of where marketers and their product development counterparts may focus their energies. Beyond health claims, there are many other avenues to explore for communicating useful nutrition and health information. So-called structure-function claims, MyPyramid-based claims and others suggest that the communication of innovation will find its way onto food labels.

Steven Steinborn, Hogan & Hartson LLP, represents food and dietary supplement companies on a range of product development, marketing and regulatory compliance, and enforcement issues involving the FDA, the USDA, the FTC and Consumer Products Safety Commission. His e-mail is: