Because the US FDA currently has not issued final regulations for the medical foods category, legal expert Christopher A Brown says companies have the opportunity to shape those regulations and drive the market

Labels for foods—whether conventional foods such as milk, dietary supplements, such as vitamin C, or functional foods such as Benecol—may bear only so-called 'structure/function' claims to describe a food's health benefit unless the US Food and Drug Administration (FDA) authorises a health claim. However, there is one food category that may make health benefit claims on its labels without first having to obtain FDA approval. Such foods are called medical foods.

Medical foods, as defined by the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)], are foods formulated to be consumed or administered enterally (taken by mouth or administered through a tube) under the supervision of a physician. They are also intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognised scientific principles, are established by medical evaluation.

FDA, in its proposed regulations [21 C.F.R. § 101.9(j)(8)], states that in order to qualify as a medical food, a product must be specially formulated and processed to provide nutritional support as part of an ongoing physician-supervised dietary management programme to treat a specific therapeutic or nutritional need.

Medical foods do not have to include nutrition information on their labels, and their claims do not need to meet specific standards. Currently, FDA is exploring ways to more specifically regulate medical foods. This might include mandating safety evaluations, specifying claims standards and requiring specific information on the labels.

Medical foods are often confused with foods for special dietary use, such as hypoallergenic foods. Medical foods are different in that they are intended to be used by people with specific dietary needs that arise due to a disease or condition, whereas foods for special dietary use are intended to be used by people with dietary needs for reasons other than a disease or condition.

Additionally, FDA, by regulation, exempts medical foods from its nutrient content claims and health claims regulations, as well as its dietary supplements labelling requirements; foods for special dietary use are not exempt. Therefore, manufacturers may make claims, without obtaining FDA approval, as to how a medical food addresses a patient's distinct nutritional requirements that exist because of a disease or condition.

Note that Federal Trade Commission rules still require that all advertising claims be truthful and not misleading. Thus, manufacturers must have on file competent and reliable scientific evidence that supports any health benefit claim that appears in advertising.

Although FDA has not issued any final rules governing medical foods, in 1996 FDA issued an advanced notice of proposed rulemaking (ANPR). The agency stated that medical foods are not meant to be used by the general public and may not be available in stores or supermarkets. FDA believes that, if medical foods were available over the counter, consumers who were not under the supervision of a physician would use them.

Furthermore, FDA stated that it believed Congress had intended foods for special dietary use to be a broader category of foods for people with special dietary needs or desires, whereas Congress intended medical foods to be a narrower category of foods for people with particular diseases or conditions who have distinctive nutritional requirements. FDA recognised that medical foods are targeted at diseased populations but that medical foods are not required to be pre-approved to ensure that they are safe and effective for those patients. Yet, since 1996, FDA has not finalised its rulemaking on medical foods.

In fact, FDA, other than defining medical foods, has not issued any final rules detailing specific requirements for product formulation and manufacturing, or set standards for claims, safety, efficacy and labelling. Therefore, FDA's views of medical foods are not law—the statutory and regulatory definition of medical foods is the only law governing this category.

Because medical foods are exempt from many FDA regulations, they have received little attention by FDA. Traditionally, most medical foods are liquids or mixes that have been available through hospitals and clinics and used for patients with specific medical needs. For example, burn patients' bodies consume a lot of extra nutrients during the time it takes to repair tissue damage. TraumaCal liquid, a specially formulated nutrient drink, is often given to burn patients to help ensure that those patients receive the optimal amount of nutrients they require for recovery.

However, the little attention given to medical foods by FDA has created an environment wherein manufacturers, taking advantage of an opportunity not to have to get FDA approval, have begun to market a variety of food products as medical foods—whether or not those products really qualify as such.

For example, Baker Norton Pharmaceu-ticals has marketed a medical food called Zbar, which is available over-the-counter and claimed to help maintain stable blood sugar levels overnight. It was not designed to treat people suffering from hypoglycaemia, but rather it was designed to help prevent it. Because FDA does not believe that medical foods should be sold in stores or supermarkets, FDA would likely not consider Zbar to be a medical food. However, Zbar could qualify as a medical food under the statutory definition of a medical food, because the statute requires only that a medical food be taken orally or enterally under the supervision of a physician for the dietary management of a disease—all of which Zbar could meet. Just because a medical food is available over-the-counter does not mean that it is not used under a physician's supervision. In fact, physicians often instruct patients to use particular over-the-counter drugs for indications in their labelling.

Zbar represents the conundrum facing the food industry. Many manufacturers are reluctant to enter the medical foods market because of the lack of definitive regulations. Manufacturers do not want to risk investing their time and money developing and marketing a medical food only to have the FDA issue final rules that could eliminate products from the market. On the other hand, many manufacturers see the lack of regulations as an opportunity to market products without FDA interference. The reality is that the current legal environment contains both risks and opportunities.

Additional risks lie in marketing high-risk products targeted to populations with life-threatening diseases. For example, marketing complete nutritional products to those in intensive care units brings with it the risk that a product that is sub- or super-potent may cause a potentially life-threatening hazard to a patient. If FDA does issue rules concerning formulation, safety and efficacy for medical foods, those rules will certainly apply to these types of products, and FDA will be more likely to take action against manufacturers.

Opportunities, on the other hand, lie in marketing low-risk products to low-risk populations. For example, physicians often instruct pregnant women to take a specially formulated multivitamin to help ensure foetal health. These multivitamins are often sold over the counter. Thus, if FDA were to finalise its rule wherein it believes that medical foods should not be available over the counter, the Agency could take action against marketers of such vitamins. However, because those vitamins are low risk and are not being marketed to anyone with a life-threatening condition, it is less likely that FDA would take enforcement action against manufacturers of those vitamins. In either example above, currently, both types of products could be legally marketed.

Therefore, the medical foods market, while a narrow market, is nonetheless one with opportunities for manufacturers of low-risk products that wish to make health benefit claims without obtaining FDA approval. Because FDA has yet to finalise any regulations governing medical foods, companies that are in the medical foods market for the time being have the opportunity to help shape those regulations and drive the market in the future.

Christopher A Brown is an attorney in Sonnenschein Nath & Rosenthal's food and drug practice group.
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