Update Nov Dec 2013 - (Page 28)

Enforcement * No use of a national drug code (NDC) number - Medical food labeling should not include an NDC number because a medical food is not a drug. * Medical food ingredients - All ingredients must be safe and suitable, as well as one of the following: (1) a food additive, (2) a color additive, (3) generally recognized as safe, or (4) authorized by prior FDA sanction. * Inborn Errors of Metabolism - These diseases may, in some cases, be managed with a medical food (e.g., phenylketonuria and other inborn errors of metabolism involving metabolism of amino acids, proteins, organic acids, or fatty acids). In other cases, such a disease may be managed with drug therapy or normal dietary modification (e.g., reducing lactose and galactose ingestion for galactosemia). Therefore, some, but not all, inborn errors of metabolism are suitable for treatment with a medical food. * Pregnancy - FDA does not consider pregnancy to be a disease, and dietary modification can often provide the necessary nutrition for pregnancy. A medical food may be appropriate for a specific disease or condition that results from pregnancy, however. * Type 1 or Type 2 Diabetes Mellitus - A medical food is not appropriate for these conditions. These patients can use diet therapy and/or drugs to manage their condition. * Nutrient deficiency diseases - These diseases (e.g., scurvy resulting from lack of vitamin C) are caused by inadequate nutrient 28 Update November/December 2013 intake and are not suitable for us of a medical food. The Future of Medical Food The FDA revisions to the Draft Medical Food Guidance were long awaited and provide important clarifications. A medical food is just one type of product in a physician's armamentarium for treating a particular disease or condition. A medical food that is marketed with scientific and medical evidence that establishes the linkage between the medical food, disease or condition, and nutritional deficiency can be an important part of an overall medical care plan if a physician deems such a product suitable for a particular patient. However, the latest revisions would appear to place significant limitations on the future use of medical foods in specific disease areas. FDA's position that a medical food will be appropriate for some inborn errors of metabolism, not for pregnancy (but perhaps for a pregnancy-related condition), and not for Diabetes Mellitus may significantly hamper the development of new and innovative products for these particular conditions. FDA's revisions also raise a related unresolved issue: How much dietary modification is required before FDA recognizes that use of a medical food is justified? Diet can be easily modified in some cases by limiting the types and quantities of foods, and finding the right combination of vitamins, minerals, and dietary supplements. Diet can also be modified in the extreme, by eliminating entire food categories or exponentially increasing the intake of a particular type of food in the diet. FDA has not addressed how much dietary modification is actually considered realistic before FDA will accept that a condition has a specific nutritional component that warrants treatment with a medical food. From a compliance standpoint, dietary modification must be attainable and sustainable. If a patient cannot attain and sustain a dietary regimen, then the dietary modification cannot be considered realistic. Industry guidance and patient education about the development and safe use of a medical food as a treatment option is crucial for improved understanding of a medical food and its potential benefits. Time will tell if industry concludes that FDA's revised Draft Medical Food Guidance provides necessary clarity, dampens innovation, or renders medical food as a legally regulated category obsolete. 1. 2. 3. 4. 5. 6. 7. 8. 9. FDA, Draft Guidance for Industry - Frequently Asked Questions About Medical Foods; Second Edition (August 2013), available at http://www.fda.gov/ downloads/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/MedicalFoods/UCM362995.pdf (last visited Sept. 6, 2013). Letter from Alan K. Parver, Counsel, Healthcare Nutrition Council, to Shawne K. Suggs-Anderson, Center for Food Safety and Applied Nutrition, FDA (Sept. 17, 2013), available at http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-0880 (last visited Sept. 20, 2013); Letter from Douglas MacKay, Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition, to Division of Dockets Management, FDA (Sept. 13, 2013), available at http://www. regulations.gov/#!docketDetail;D=FDA-2013-D-0880 (last visited Sept. 20, 2013). 21 U.S.C. § 360ee(b)(3). 21 U.S.C. § 321(f) (FFDCA § 201(f)). 21 U.S.C. § 321(ff) (FFDCA § 201(ff)). 21 U.S.C. § 350(c)(3) (FFDCA § 411(c) (3)); 21 C.F.R. Part 105. 21 U.S.C. § 321(z) (FFDCA § 201(z)). Structure/function claims, which apply to conventional foods and dietary supplements, do not apply to medical foods. Orphan Drug Amendments of 1988, Pub. L. No. 100-290, 102 Stat. 90 (codified at 21 U.S.C. §§ 301 note, www.fdli.org http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/UCM362995.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/UCM362995.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/UCM362995.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/UCM362995.pdf http://www.regulations.gov/#!docketDetail;D=DFA-2013-D-0880 http://www.regulations.gov/#!docketDetail;D=DFA-2013-D-0880 http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-0880 http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-0880 http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-0880 http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013