Medical Foods — Has Their Time Come?

Attempting to understand a poorly defined category.

By Todd Harrison

At a recent FDA meeting, there was a discussion of whether NLEA’s health claims provisions permit the agency to authorize the use of disease treatment claims on the label and labeling of food products. The specific claim at issue was the use of saw palmetto as a means of treating BPH. Without addressing this issue, however, there is another statutory mechanism that would permit the use of this claim without FDA approval. I am referring to “Medical Foods.” Medical foods have been around since the early 1970’s and have generally been regulated by FDA on a case by case basis. In 1989, as part of the Orphan Drug Act, Congress codified FDA’s policy regarding medical foods. Under the codification, Congress specifically exempted medical foods from NLEA’s nutrition labeling and health claims provisions. In the Orphan Drug Act of 1988, Congress created a distinctly different category of food known as “medical foods.” Congress further exempted “medical foods” from NLEA’s nutrition labeling, nutrient content claims and health claims provisions. In essence, this means that product labels for medical foods may refer to specific diseases without the products being considered drugs by FDA. For example, the following claim would be permissible for a medical food:

“Provides the unique nutritional re­quirements for the dietary management of heart disease”
To be considered a medical food, the product must:
(1) be a food;
(2) be formulated to be consumed or administered enterally;
(3) be administered under the supervision of a physician; and
(4) be intended to provide dietary management of a disease or health related condition that has specific nutritional requirements, based on recognized scientific principles, as established by medical evaluation (21 U.S.C. § 360ee).

As with food and dietary supplements, medical foods do not require preapproval by FDA before they are marketed. However, unlike dietary supplements and conventional foods, “disease” related claims for medical foods do not require prior approval by FDA.

Outside of this definition and FDA’s November 29, 1996 Advanced Notice of Propose Rulemaking (ANPR) regarding Medical Foods, 61 Fed. Reg. 60661, neither Congress or FDA has provided much guidance regarding the type of ingredients that may be used in medical foods or the level of safety.

At a minimum, there is little doubt that the inactive components of medical foods would be subject to the FD&C Act’s food additive provisions. Indeed, in this re­spect, there is no reason to treat medical foods any differently from functional foods or dietary supplements. As to the active ingredients in the medical food, neither the FD&C Act or the Orphan Drug Act require that medical foods be approved for use by FDA prior to their addition to food. This is not to say that active ingredients in a medical food do not have to be GRAS. Indeed, they do. Rather, the FD&C Act only requires medical food ingredients to be generally recognized as safe for their intended patient population (see FD&C Act § 409).

For example, L-arginine is an essential amino acid for the proper functioning of the heart. Studies suggest that individuals with heart disease have extremely low levels of L-arginine in their heart and that supplementing a heart patient’s diet with L-arginine may be necessary. However, significantly high levels of L-arginine may have adverse effects in healthy individuals because L-arginine may increase the body’s nitric oxide content. While this may be a positive effect in individuals with heart disease, it could be considered an undesirable effect in the general population. Thus, the addition of high levels of L-arginine to the diet of healthy individuals may not be considered GRAS for use in the general population, but its addition to the diet of individuals with heart disease may very well be considered GRAS.

As stated earlier, medical foods are exempted from the requirements of the Nutrition Labeling and Education Act (NLEA), including NLEA’s nutrition labeling, nutrient content claim and health claims provisions. In essence, this means that product labels for medical foods may refer to specific diseases without the products being considered drugs by FDA. For example, the claim “provides the unique nutritional requirements for the dietary management of heart disease” would be a permissible claim for a medical food if the food meets all the conditions set out in the statute. The label, however, as part of its statement of identity, should identify the product as a medical food and that it should only be eaten under the supervision of a physician. Moreover, a medical food should not be promoted for use by the general population or to a population that is only at risk of a particular disease. To do so, arguably, takes the food outside the definition of a medical food set out in 21 U.S.C. § 360ee.

Medical foods are a special category of food that are designed to meet the special nutritional requirement of individuals that are afflicted with a particular disease. In its ANPR, FDA states that medical foods that do not meet the special nutrient needs of its intended patient population are adulterated and misbranded. Under any other view, the medical foods category would merely create a safe harbor for fraudulent claims targeted at those who are most vulnerable in society. Indeed, because physicians rely on the claims made for medical foods as a significant factor in deciding whether to recommend a particular medical food in the treatment of a patient, it is essential that the claims made for such products present an accurate interpretation of the scientific evidence concerning the usefulness of that product or specific formulation. Thus, a strong standard of substantiation is required for such products.

FDA believes, at the very least, that the standard for substantiation should be no less demanding than NLEA’s “significant scientific agreement” standard for health claims. Further, because medical foods are intended for use in the clinical management of people who are ill, FDA believes it may be more appropriate to apply a more stringent standard than the significant scientific agreement standard to support medical food claims. Indeed, FDA’s view is that the scientific standard contained in the statutory definition of medical foods may require some of the same types of data as are needed to support a new drug application. FDA, however, has not provided any detail on the types of data it would require to support a claim for medical foods.

As more and more companies attempt to market medical foods, the pressure on the agency to define a standard will be­come greater. Indeed, FDA could see a proliferation of these types of products if it decides that “disease treatment” claims are not permissible health claims under NLEA. Thus, it may be in the agency’s interest not to take a restrictive view of the type of health claims permitted under NLEA and allow a “disease treatment” health claim, especially when dietary management of a disease could have a strong impact in the management of a particular disease.

Outside of the ANPR, FDA has provided little guidance to companies regarding the marketing of medical foods. Thus, it is most likely in the best interest of a company wishing to develop a medical food to contact FDA and work closely with the agency in order to avoid potential regulatory problems down the road.

NW

Todd A. Harrison is a senior associate with the law firm Keller & Heckman, Washington D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on food and dietary supplement adulteration, labeling and advertising issues. He can be reached at Keller & Heckman, 1001 G. St. NW, Suite 500 W, Washington D.C. 20001; 202-434-4244; Fax: 202-434-4646; E-mail: [email protected].