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MEDICAL FOOD PRE-REGISTRATION AND POST-MARKETING SURVEILLANCE REQUIREMENTS

Executive Summary

MEDICAL FOOD PRE-REGISTRATION AND POST-MARKETING SURVEILLANCE REQUIREMENTS should be established through new legislation, FDA Center for Food Safety and Applied Nutrition's (CFSAN) Regulatory Affairs Staff Chief David Hattan proposed at a Food and Drug Law Institute (FDLI) meeting November 2. Hattan suggested that new legislation should "establish a regulatory definition that we all can agree would be an appropriate one." A new law also should, he said, employ a "pre-registration ]approach[ where the company would submit to the FDA before marketing the product quality assurance and control information . . . examples of their labeling . . . the claims they are going to make . . . information on clinical testing . . . and adequate instructions for use of the product." Additionally, Hattan said, "there would be some sort of post-marketing surveillance activity . . . to avoid adulteration of the products and . . . redress what we consider to be inappropriate market activities by the revocation of registration." Short of new legislation, Hattan outlined several other alternatives for tighter regulation of medical foods. For example, FDA could establish a compliance program to confirm product composition labels and watch for contamination, as well as defining review authority between CFSAN and the Center for Drug Evaluation and Research. A final alternative would be to leave current regulation as it stands, but Hattan noted deregulation would "encourage companies that may not have the expertise in this particular area to become involved and . . . increase the potential of disaster." Under the terms of the Orphan Drug Amendments of 1988, a medical food is defined as food labeled for the dietary management of a disease or condition to be consumed or administered enterally under the supervision of a physician. Because medical foods often include labels with health claims, they fall into a gray area between FDA food and drug regulators. Hattan's suggestions indicate a desire by the agency to clarify the regulatory status of medical foods. CFSAN Office of Nutrition and food Sciences Deputy Director Edward Scarbrough pointed out similarities between medical foods and infant formula, which was more strictly regulated in the wake of fatalities associated with those products in 1979. That background "has caused us to look at the medical foods industry as a possible extension of the infant formula kinds of considerations and has caused is to think about this problem of additional regulation . . . much more seriously." Hattan mentioned that the infant formula market, the technological forerunner of medical foods, "is one of the most sophisticated and rigorously regulated segments of the food industry." Medical foods, he added, "are of equal sophistication," and arguably would require comparable regulation. Speaker Scott Bass (Bass and Ullman) offered a definition of medical foods as "foods formulated for the sustenance of persons with diseases of specific medical conditions." In an effort to distinguish medical foods from drugs, he added, "We are not talking about preventing or treating disease . . . but sustaining patients who have a disease or condition . . . delivering nutrition and nothing more." "You're going to have a stampede of people who make health food or health claims into this market," Bass warned. "All industry companies argue against more labeling restrictions or stricter GMP's," he continued, "but, in this case, it is very short-sighted because, unless there are stricter GMPs and possibly pre-market notification . . . there will be no way to prevent the wrong type of company from coming into this industry, the wrong type of claims being made," and pre-market approval regulations will be the result. Charles Raubicheck (Davis Hoxie Faithfull & Hapgood) suggested adoption of a monograph approach to improve medical food labeling whereby labels would reveal certain information beyond what is required for standard food approvals. These include precautions, statements about supervision under a licensed practitioner, and possibly additional nutrition information. He also suggested that companies voluntarily provide to the FDA, upon request on a case by case basis, "some evidence of administration of the product in humans showing how the product supplies" the dietary need it claims to satisfy. The medical foods industry is currently valued at $ 500 mil., and with an 11% annual growth rate, is expected to reach $ 1 bil. by the 1990's, according to Hattan. Currently there are over 180 medical foods products on the market. A representative of the enteral Nutrition Council noted that the enteral foods industry is comprised of 20 companies, with seven owning a combined market share of 95%, including Bristol-Myers, Clintec Nutrition Co., Kendall McGaw, Norwich Eaton Pharmaceuticals, Ross Labs, Sandoz Nutrition Corp. and Sherwood Medical Co.
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