Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. The Agency released its draft policy in January 2015, which we previously summarized. Such website reviews and warning letters do not result from the same inspection‑483-warning letter protocol as a GMP inspection; when FDA finds noncompliant website language it can and does issue warning letters immediately. Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure. People with type 1 diabetes must regulate their blood glucose levels by checking their levels with a glucose meter multiple times daily, calculating how much insulin is needed to lower their blood glucose levels, and administering the necessary dose using a syringe or insulin pump. For example, 21 C.F.R. Walmart, ConAgra Foods, and Subway restaurants are among those pledged to make sodium reductions in their menus.
Among the latest round of new draft guidance, FDA is offering new insight on how to develop generics for Novartis’ blockbuster cancer and transplant treatment Afinitor (everolimus), which does not have any generic competitors and was first approved by FDA in 2009. (v) It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food. Americans eat about 1½ teaspoons of salt daily, or 3,400 milligrams. Currently, the majority of U.S. medical food products (51 of 82) on the market are for metabolic diseases. Protein-based medical foods are the most common. Patients who will use software for determining an insulin dose must be aware of a potential dosing error and then the patient must take over. The Council for Responsible Nutrition (CRN) has commented on the draft guidance, stating that FDA’s conclusion that medical foods may be marketed only for diseases or conditions the “dietary management of which cannot be achieved by modification of the normal diet alone” (as stated in 21 CFR 101.9(j)(8)(ii)), is unduly restrictive, not in the best interest of public health and inconsistent with the statutory definition of medical foods. Companies and trade associations have commented that FDA lacks authority to redefine medical foods, specifically adding new criteria that would prohibit the marketing of medical foods to diabetic because the disease can be managed through changes in the normal diet. It will be interesting to see if the “modification of the normal diet alone” stipulation is removed from the final guidance in response to comments from stakeholders.
Others have commented that the emphasis on medical supervision implies that the products should be distributed by physicians and should not be available in stores. This would severely restrict the sale of medical foods like Ensure® and Pedialyte®, which have been available on the supermarket shelf for decades. Imagine the consequences of making products like Pedialyte® only available through a doctor’s office! This will only lead to higher prices and reduced access for a safe product that has benefitted millions of children. Australia and New Zealand are almost there already — their spreadable cream cheese contains 348 mg of sodium per 100 grams. The guidance further states that diseased patients may be used in studies to assess safety or tolerability in a susceptible population, but “an investigation intended to evaluate the effects of a medical food on a disease would require an IND.” Thus, the guidance contains conflicting statements about medical foods and INDs. A product that claims to enhance a user’s athletic performance by providing suggestions based on the results of relative lactic acid testing, when the product uses venipuncture to obtain the blood samples needed for testing. In order to show that a medical food is effective for specific dietary management of a disease or condition, clinical studies must be performed in people that have the disease or condition.
By requiring INDs for such studies, FDA is forcing all new medical foods that have not yet been tested in humans as drugs, even though they also state in the guidance that clinical investigations intended to evaluate the nutritional effects of a food (including medical foods) would not require an IND. Any ingredient added to a medical food should be: a food additive used in accordance with FDA’s food additive regulations (see 21 C.F.R. Medical foods will be branded as drugs as soon as the IND (Investigational New Drug) application is filed. FDA is clearly overstepping its authority by requiring INDs for clinical studies performed on medical foods, and should revise the guidance to be in accordance with section 5(b)(3) of the Orphan Drug Act (21 U.S.C. FDA calls these devices “mobile medical apps”. Perhaps the intent of the guidance was to prohibit use of medical foods for diseases other than the disease that requires the nutritive benefit from the medical food; if so, the guidance should be revised to read “an investigation intended to evaluate the effects of a medical food on a disease would require an IND (other than the disease which would require the nutritive benefit from the medical food).” This would limit the use of the medical food to a specific condition and curb off-label use for other conditions. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.
As such, FDA concluded the product was not a medical food as the term is defined in the statute. So, we are left with a guidance document that, if enforced, will severely limit development of new foods and availability of medical foods that are currently on the market. To better regulate the medical food category, FDA is taking a proactive stance, in addition to its usual reactive policy of issuing warning letters. By requiring submission of an IND for clinical investigations on the structure or function of the body, it effectively channels all studies for medical foods designed to be used for purposes other than nutrition into the drug category, branding them as drugs. A central theme to the new guidance is “intent” or purpose. If the purpose of the study is to examine the safety or nutritive value of a food ingredient, then an IND is not required. So, in order to conduct clinical trials without an IND, design clinical studies on medical foods with these caveats in mind.
Developers of functional foods should consider whether their food could fall under the definition of a food for special dietary use, as this definition has not been officially declared extinct by either Congress or FDA. The medical food arena will no longer be an option unless FDA revises their definition of a medical food.  Greene, H. L., Prior, T. and Frier, H. I (2001). After such a long wait, little may have changed.
Obesity Research 9 (Suppl. In practice, the burden it puts on device developers to address expected users and use environ-ments means that a wide range of users and use environments should, logically, be included in the mandated research—in initial research such as contextual enquiry and in user verification and validation testing of prototypes and/or the final device (described in draft guidance sections 9 and 101).