DSHEA broadened the regulatory definition of dietary supplements beyond essential vitamins, minerals, and amino acids, and even beyond other food constituents proposed to optimize nutrition. The definition includes, with some exceptions, any product intended for ingestion as a supplement to the diet, including vitamins, minerals, amino acids, herbs, botanicals, other plant-derived substances, and concentrates, metabolites, constituents, and extracts of these substances. Although regulated as dietary supplements, with associated labeling requirements that limit disease-related claims, some supplement products are marketed in third party “literature and information” for pharmacological, rather than nutritional, purposes, as “natural” treatments for diseases such as cancer, heart disease, AIDS, arthritis, diabetes and multiple sclerosis. Similar promotions make distinctions between nutritional and pharmacological properties especially difficult for some herbal products. Herbal teas are regulated as foods, and herbs promoted for pharmacological properties (in third party literature) may appear in products such as beverages, bars, and other foods.
Conventional foods and dietary supplements are not intended to treat disease. Dietitians’ recommendations should be for the purpose of improving nourishment (with essential nutrients as well as other potentially beneficial food components that may help prevent disease). For products intended to treat disease, registered dietitians must evaluate whether their academic preparation and scope of practice (including state licensing regulations for dietitians and other health care professionals) qualifies them to provide advice advocating the use of such products. Recommendations of dietary supplements to treat disease should be under a physician’s supervision, but dietitians must know about these products to help answer client questions, identify potential food and drug interactions, and document client use.
Dietetics professionals must recognize when to make appropriate medical referrals for the diagnosis and treatment of disease. For example, in the United States, St. John’s Wort (Hypericum) is marketed to help mood and depression. The supportive evidence for this product has been sufficient to justify several randomized, placebo-controlled, double-blind clinical trials now underway to evaluate the effectiveness of Hypericum in comparison with established antidepressant medications. At the same time, concerns have been raised about drug interactions with Hypericum, including the undesirable use of this supplement by HIV-infected patients treated with certain protease inhibitors. This product may be shown to be safe and effective under some conditions. But even though neighbors, friends, or sales personnel can recommend such a product, professional recommendations should be made only by professionals trained to differentially diagnose and treat depression, skills which are not in the training or scope of practice of dietetics.
Certain foods, statutorily classified as “medical foods” under the Food, Drug and Cosmetic Act (FDC Act), are intended and can be used as therapeutic dietary adjuncts to medical treatment. However, such products must provide a distinctive nutritional need that is related to the disease or medical condition that is based on sound science, and the products must be used under the care and advice of a physician. Formulas and foods that are low or absent in phenylalanine and oral rehydration solutions are examples of such medical foods.
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