Disease Treatment Claims For Nutritional Products?

Industry should consider looking for legislative approaches.

By Todd Harrison

Without Congress or Court intervention, the answer to the question, “Will FDA ever permit direct disease treatment claims for nutritional products?” is unfortunately a resounding “NO!” As discussed in the last column, FDA rejected the saw palmetto health claim petition that would have permitted a disease treatment claim for saw palmetto and the amelioration of certain signs and symptoms of BPH. FDA set forth several different reasons for its decision. However, the driving force behind FDA’s decision is the agency’s desire to protect the new drug approval process and to relegate disease treatment claims to the narrow class of foods known as medical foods. Because of the widespread availability of dietary supplements, it is doubtful that a company will want to expend its resources on obtaining a new drug approval for a particular natural remedy. In other words, the potential gains are probably outweighed by the cost of receiving a new drug approval because the company that receives the approval will not be able to eliminate its competitors from the marketplace, although it will be able to make drug claims for its product.

As for medical foods, while they do not require prior approval by FDA, the universe of foods or supplements that would qualify is limited because medical foods are required to be for the dietary management of a disease or health related condition. Moreover, the person that is inflicted with the disease or health related condition must have distinct nutritional needs that are being met by ingesting the medical food. The distinct nutritional need must be established through recognized scientific principles. Thus, if a particular food achieves its effect based on a pharmacological effect rather than a nutritional effect, the food does not qualify as a medical food. In regard to herbs, it may be difficult to convince FDA that it is achieving its effect through nutritional means rather than pharmacological. Accordingly, the medical food category is a possible means of making disease treatment claims for a particular product, but its actual usefulness for a wide variety of dietary and food ingredients may be limited.

The saw palmetto health claim petitioners are presently challenging FDA’s denial of the health claim in the U.S. District Court for the District of Columbia. It is difficult to assess whether the petitioners will ultimately be successful in their court challenge and any decision for or against will likely be appealed. Thus, it is quite possible a judicial resolution of this matter will take two to three years. In the meantime, the industry should start focusing on other means of making express disease claims. In this regard, DSHEA’s safe harbor for publications is of some use to the industry. However, the publication cannot refer to specific dietary supplement products. Although companies are developing strategies to make use of this safe harbor, the ex­ception appears to be more valuable to retailers, direct marketers and online companies than companies that merely market their products through the retail shelf. Thus, it is time for the industry to start considering legislative remedies.

A Legislative Solution

There have been a couple of Congressional bills introduced that would permit disease treatment claims on the label and labeling of dietary supplements. One of the proposed laws would give exclusivity of the disease treatment claim to the company or group of companies that first file clinical studies with FDA that substantiate the disease treatment claim, while the other law would permit a disease treatment claim based on the minimum of scientific support as long as it was properly disclaimed. Both of these approaches are difficult to justify. For instance, in the former situation, a company that is first to submit its successful clinical trial for saw palmetto to FDA would be permitted to make a BPH treatment claim to the exclusion of all other products even though the other products are equivalent to the saw palmetto product used in the clinical trial. In the latter situation, a company would be able to make a disease treatment claim for its product even though the available scientific evidence overwhelmingly suggests that the disease treatment claim is misleading. Such a result is not what the industry should be striving for. Rather, the industry should work together and draft legislation that is intended to permit truthful and nonmisleading disease treatment claims for dietary supplements that are known to have medicinal benefits. One approach that should be considered is the development of a monograph system for dietary products.

Indeed, a sound monograph system would permit companies to make truthful and nonmisleading disease treatment claims for their products without fear of FDA taking adverse regulatory action. Permitting disease treatment claims for products rather than vague structure/function claims would help ensure that the general public understands whether the particular product is appropriate for them. For example, marketers of St. John’s Wort are limited to vague claims such as “helps promote a healthy mental outlook.” This claim suggests that St. John’s Wort will help promote a healthy mental outlook regardless of whether a person has severe depression or is not depressed at all. Thus, the claim is potentially misleading to a large number of consumers because companies are not permitted to inform consumers that St. John’s Wort is helpful in individuals that are suffering from mild depression. To avoid the potential misleading nature of the claim, companies should be able to state on product labels that St. John’s Wort is indicated for mild depression. Moreover, the monograph system would require that products meet certain specifications and contain appropriate warnings. Products that do not meet the specifications set forth in the applicable monograph are not permitted to make disease treatment claims.

The exact contours of a monograph system would need to be spelled out in any legislation to avoid potential problems down the road. However, one hallmark of a monograph system would be to permit the sale of these natural remedies over-the-counter as long as the remedy is not represented for the cure or treatment of serious illnesses such as heart disease, cacer and disease. Regardless of the specific contours of a monograph system or something similar to it, it is in the interest of the general public that the shackles that hinder the free flow of information be removed and be replaced with a system that permits natural remedies that have known medicinal values to make truthful and nonmisleading disease treatment claims.

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].