Update Nov Dec 2013 - (Page 29)

Enforcement 10. 11. 12. 13. 14. 15. 16. 17. 360aa note, 360bb, 360ee; 42 U.S.C. § 236 note). Regulation of Medical Foods, 61 Fed. Reg. 60,661, 60,662 (Nov. 29, 1996); Rani H. Singh, The Enigma of Medical Foods, 92 molecUlar geneticS and metaboliSm 3, 4 (2007). Miscellaneous Drugs; Release of Evaluation Reports; Drugs for Human Use; Drug Efficacy Study Implementation, 37 Fed. Reg. 18,105 (Sept. 7, 1972). 21 U.S.C. § 360ee(b)(3). 21 C.F.R. § 101.9(j)(8)(ii). Draft Medical Food Guidance, at 9-12. 21 C.F.R. § 101.9(j)(8)(i)-(v). Regulation of Medical Foods, 61 Fed. Reg. 60,661, 60,669-6,0670 (Nov. 29, 1996). Withdrawal of Certain Proposed Rules and Other Proposed Actions, 69 Fed. 18. 19. Reg. 68,831, 68,834 (Nov. 26, 2004). FDA, Compliance Program Guidance Manual 7321.002, Medical Foods Program - Import and Domestic (FY 06/07/08) (implementation date August 24, 2006), available at http://www.fda. gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073339.pdf (last visited September 6, 2013). Letter from Celeste M. Corcoran, Acting District Director, Seattle District, FDA, to John P. Troup, Chief Science Officer, Metagenics, Inc. (Aug. 13, 2013), available at http://www. fda.gov/ICECI/EnforcementActions/ WarningLetters/2013/ucm367142.htm (last visited Sept. 20, 2013); Letter from Emma R. Singleton, Director, Florida District, FDA, to Richard H. Mann, President, Realm Labs, LLC (Apr. 11, 2013), available at http://www.fda.gov/ ICECI/EnforcementActions/WarningLetters/2013/ucm351906.htm (last visited Sept. 20, 2013). 20. Food Allergen Labeling and Consumer Protection Act of 2004, Title II, Pub. L. No. 108-282, 118 Stat. 891 (codified at 21 U.S.C. §§ 301 note, 321, 343, 343-1, 374a; 42 U.S.C. §§ 242r note, 243 note, 300d-2 note). 21. Interestingly, a drug that requires the supervision of a physician must contain "Rx only" on the labeling. 21 U.S.C. § 353 (b)(1), (4) (FFDCA § 503(b)(1), (4)). In the case of a medical food, which requires a physician's supervision, "Rx only" is not permitted. MODIFY YOUR Career DNA Earn a Master of Biotechnology Enterprise and Entrepreneurship or an MS in Regulatory Science from Johns Hopkins University. > Earn your graduate degree part-time > Take courses online or on-campus in Rockville, MD > Advance a strong science foundation beyond the laboratory > Develop a foundation in biotechnology commercialization and regulatory affairs > Learn from a world leader in science education and research Get started here FDLI biotechnology.jhu.edu November/December 2013 Update 29 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm351906.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm351906.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm351906.htm http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073339.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073339.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073339.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073339.pdf http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm367142.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm367142.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm367142.htm http://biotechnology.jhu.edu

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

Update Nov Dec 2013