By Wes Siegner –
The article “‘Medical Foods’ and Supplements for Brain Health Advance” that recently appeared in The Wall Street Journal provides important insights into a growing industry that is focused on offering a wider range of healthcare options. However, the article contains common misconceptions about these products and the increasingly important role that they play in public health.
The article opens with the common misstatement that medical foods “aren't regulated by the Food and Drug Administration” and further demeans the category by implying that the data supporting efficacy is insufficient. In fact, FDA regulates these products to assure that they are safe and manufactured in compliance with detailed “good manufacturing practice” regulations, and both the FTC and FDA regulate the claims for these products to assure that they are truthful and supported by competent and reliable scientific evidence.
The regulatory scheme for these products is appropriately less stringent than for drugs because the products, by their nature, are safe and therefore require less government oversight to permit more innovation and consumer choice. Congress has appropriately authorized FDA to remove medical food and dietary supplement products from the market that are exceptions to the “inherently safe” rule and that do not meet FDA’s “good manufacturing practice” regulations. As the article states, these products are not intended to cure diseases. Such claims would make the product a “drug” requiring premarket approval. The consequences of making illegal drug claims and violating the requirements intended to assure product safety can be severe, including criminal prosecution.
The article also misrepresents the amount and type of data that are required to support disease management claims for medical foods, stating that lab tests on cells are often the only basis cited. While it is true that clinical testing of drugs is appropriately more stringent than for medical foods or dietary supplements, this does not mean that the claims for these products can be supported without clinical testing. Disease management claims for medical foods are closely policed and, if found lacking in clinical support, are likely to be challenged by a wide range of groups, including the FDA, the FTC, the NAD (an industry self-regulatory arm of the BBB), state attorneys general, and plaintiffs' class action lawyers. The potential penalties for failure to substantiate claims with well-controlled human studies include large financial penalties and prosecution.
The level of FDA regulation of these products, as with other FDA-regulated products like drugs and devices, is based on a balance of risks and benefits to the public health. Where the risks are low because the products are inherently safe, as with foods and dietary supplements, it is a waste of government resources and an unnecessary barrier to innovation to require premarket approval, as is required for most drugs. The article’s discussion of medical foods for Alzheimer's illustrates how the more limited regulation for medical foods and dietary supplements opens the door to innovation and the development of important products that act as adjuncts to other treatments, thus providing a greater range of less expensive healthcare options to many patients who are affected by serious diseases.