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October 31, 2013
WASHINGTONThe Council for Responsible Nutrition (CRN) submitted comments to FDA lauding the agency's efforts to set and enforce boundaries for the marketing of medical foods, but argued the agency has been too narrow and inconsistent with the statutory criteria for what constitutes a medical food. The comments were aimed at the Draft Guidance for Industry, Frequently Asked Questions About Medical Foods; Second Edition, which FDA revised in August 2013 and provided for a 60-day comment period.
"CRN appreciates FDAs attention to the medical foods category and believes that FDAs regulation of medical foods should simultaneously foster development of these important products while also maintaining the integrity of the medical foods category and its distinction from conventional foods and dietary supplements," wrote Steve Mister, president and CEO of CRN. However, he further expressed concern over FDA's interpretation of the medical foods category, which is "is overly narrow and inconsistent with the statutory definition of medical foods."
Based on the definition of a medical food established by Congress in the Orphan Drug Act Amendments of 1988, CRN explained a medical food must:
be formulated to be consumed or administered enterally,
be consumed or administered under the supervision of a physician,
be intended for the specific dietary management of a disease or condition for which there are distinctive nutritional requirements, and
these nutritional requirements must be based on recognized scientific principles as established by medical evaluation.
"CRN agrees with FDA that the statutory definition of medical foods is narrow; only products meeting all four statutory criteria may be lawfully marketed as medical foods," Mister wrote. However, FDA has never defined medical food for regulatory purposes, nor has the agency issued any regulations specifically for medical foods. FDA has, though, implemented a statutory exemption for medical foods from the Nutrition Labeling and Education Act (NLEA) of 1990Congress has previously exempted medical foods from various nutrition labeling and claims requirements.
CRN noted under existing statutes, medical foods must follow all the requirements placed on other food products, including good manufacturing practices (GMPs) and facilities registrations, and must also comply with all food labeling requirements, except any exempted NLEA requirements. Mister explained medical foods are allowed to feature claims about helping to meet the distinctive nutritional requirements of patients suffering from diseases or health-related conditions for which distinctive nutritional requirements have been established, as well as claims about providing nutritional support for such patients. On the other hand, a medical food cannot be claimed to diagnosis, cure, treat, or prevent disease.
Mister noted the guidance allows for the marketing of medical foods only for diseases or conditions that cannot be managed solely by modification of the normal diet. "This criterion circumscribes the category of medical foods in ways not contemplated by the statutory definition of 'medical food' and is not in the best interest of the public health, and thus unduly narrows the product category," Mister argued, urging FDA to, instead, delete the modification of the normal diet alone" criterion and more closely adhere to the statutory definition of medical food.
"This regulatory limitation is not in the statutory text," he wrote. "If Congress had intended to limit the category of medical foods in this way, then it would have included such a limitation in the statutory definition of medical foods. This is particularly so where Congress was otherwise incredibly precise with respect to the criteria for defining medical foods."
Mister explained FDA's use of this "extra-statutory criteria" is rooted in 21 CFR 101.9(j)(8), but CRN argued this section only provides for the exemption from NLEA requirement, not as a regulatory definition outside of the exemption requirement. "FDAs use of the section 101.9(j)(8) exemption from nutrition labeling as a definitional regulation to limit an entire product category is unsupported by the regulation itself and inconsistent with the statutory definition of medical foods," Mister argued. He further noted FDA relied solely on a 1990 Life Sciences Research Office of the Federation of American Societies for Experimental Biology (LSRO/FASEB) report for its application of the "modification of the normal diet alone" criterionthis LSRO report was, itself, based mostly on a draft Codex report.
"The agencys decision to limit the category of medical foods in this way ignores the importance of medical foods in making the dietary management of many diseases and conditions easier, more convenient, and less expensive," Mister contended. He noted people with type II diabetes are typically unable to normally metabolize dietary carbs, but medical foods can be specifically formulated to overcome this digestive limitation. "Such dietary management of type II diabetes is based on recognized scientific principles and is managed under the supervision of a physician, as diabetics are typically under a doctors care, because the disease is not one that can be self-diagnosed or self-treated," Mister said, adding that under FDA's revised draft guidance on medical food FAQs, a medical food could not be labeled or marketed for type II diabetes, because a regular diet can be modified to meet, theoretically, the nutritional needs of diabetes patients.
"FDA ignores the fact that compliance with treatment plans for chronic illnesses, including changes to diet and lifestyle, are adhered to only about fifty percent of the time," Mister countered. "As a group, patients with diabetes are particularly prone to regimen adherence problems." He argued medical foods can be a useful tool in such cases, and FDA's continued application of this extra-statutory criteria will "stifle medical food innovation and deny patients access to safe and healthful products that can greatly improve their ability to manage the diseases and conditions from which they suffer."
CRN also suggested the draft guidance may be violating the First Amendment by restricting commercial speech. "FDA has placed an outright prohibition on the marketing of certain medical foods intended for use in the dietary management of particular diseases and conditions, such as diabetes," CRN said, in its comments. "FDA may restrict commercial speech in this way only if it can show that doing so is necessary to directly advance a substantial governmental interest, and that the means chosen to restrict the commercial speech are narrowly tailored." CRN does not feel FDA can show a government interest in restricting truthful and non-misleading commercial speech on lawful products, and the agency's blanket prohibition on medical foods for certain populations/diseases is not narrowly tailored.
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