Abstract
The Food and Drug Administration (FDA) is facing a flurry of new products coming to market over the next few years that will be based on biotechnology. The agency will have to deal with state-of-the-art drugs and devices utilizing biotechnology as the developmental base. Also, many universities and companies are exploring the potential uses of biotechnology in developing new foods and food additives. This article will examine how the FDA is presently regulating medical device, and food and food additive biotechnology and the challenges confronting the agency in these areas in the future.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
See Rogers,Medical Device Law—Intent and Implementation,36 Food Drug Cosm. L. J. 4 (1981).
21 USC § 360c(a)(l)(A)(1982)
Id. § 360c(a)(l)(B).
Id. § 360c(a)(l)(C).
Id. § 360c(f)(l).
Id. § 360(k).
Kahan,Premarket Approval versus Premarket Notification, Different Routes to the Same Market,39 Food Drug Cosm. L. J., 510, 517 (1984). For a full explanation of the medical device approval processs and appellate options when adverse approval decisions are received,see O’Reilly,Food and Drug Administration, § 18–17 (1984).
H. R. Rep. 893, 94th Cong, 2d Sess.36 (1976).
Bozeman,The Regulation of Hybridoma Products, from the proceedings of the Health Industry Manufacturers Association conference, entitled,Impact of Hybridoma Technology on the Medical Device and Diagnostic Product Industry, at 75–76 (1982);see also Miller,The Impact of New Technology on Regulation by the FDA: Recombinant DNA Technology,36 Food Drug Cosm. L. J., 345 (1981).
H. R. Rep. No. 893, 94th Cong., 2d Sess.36 (1976).
See Commercial Biotechnology, An International Analysis,3 (Office of Technology Assessment, 1984).
See Shanks,The Regulation of Biotechnology Products as Toxics, HealthSpan 21 (Feb. 1985); Comments,Regulation of Genetically Engineered Foods Under the Federal Food, Drug, and Cosmetic Act,33 AM. U.L. Rev. 899, 913 (1984).
21 USC §§ 301et seq. (1982).
See 4b9 Fed. Reg. 50,856 (1984).
For the circuitous definition of food,see 21 USC § 321(f)(1982).
21 USC § 321(s)(1982).
Id. § 348(a).
Id. § 342(a)(2)(C).
Id. § 321(s).
21 CFR § 170.30(f)(2)(1985).
At one time, the FDA had proposed that a “significant alteration” would be a 10% or greater increase in a toxicant or a 20% or greater reduction in a nutrient. Spiher,The Growing of GRAS,10(3)Hort. Science 3,4 (1975). These numerical criteria were not adopted, leaving uncertainty as to the extent to which nutrient and composition can change without forfeiting GRAS status.
21 USC § 343(a)(1982) (“A food shall be deemed to be misbranded—(a) If its labeling is false or misleading in any particular”);see also id. § 331 (prohibited act to cause introduction or delivery into interstate commerce of a misbranded food).
21 CFR Part 110 (1985).
49 Fed. Reg. 50,856. 50,879 (1984) (“Substances used in animal feeds, other than drugs, that are produced by recombinant DNA technology, are considered to be food additives and require approval of a food additive petition (FAP). Other products of new biotechnology may also be considered to be food additives”). For a full explanation of the food additive approval process and appellate options available in the event of adverse FDA decisions,see O’Reilly,Food and Drug Administration, § 11.08 (1984).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Kahan, J.S., Gibbs, J.N. Food and drug administration regulation of medical device biotechnology, and food and food additive biotechnology. Appl Biochem Biotechnol 11, 507–516 (1985). https://doi.org/10.1007/BF02798644
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF02798644