From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 46
exploring ways to more specifically regulate medical foods, which could include safety
evaluations, standards for claims and specific information on the labels. FDA will hold
a public hearing to decide whether functional foods require unique regulations, but no
similar action has been taken for medical foods.
References
1. FDA website http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MedicalFoods/default.
htm. Accessed 24 January 2012.
2. Chew NJ: Food for thought. Biopharm 1991, 19:10-12.
3. U.S. Congress 1988. 100th Congress. Orphan Drug Amendments of 1988, P.L. 100-290. Amendment of Section
526(a)(1) of the Federal Food, Drug and Cosmetic Act
4. U.S. Congress 1990. 102nd Congress. Nutritional Labeling and Education Act of 1990. P.L. 101-535. Amendment of
Section 403 of the Federal Food, Drug and Cosmetic Act.
5. 21 CFR Part 105.3
6. Federal Register Vol 61, Number 231, 29 November 1996.
7. Federal Register Vol 68, Number 77, 22 April 2003.
8. Personal Communication, Drug Information Branch, 14 September 2006.
9. http://limbrel.com/limbrel.php. Accessed 24 January 2012.
10. Graham DJ: “COX-2 inhibitors, other NSAIDs, and cardiovascular risk.” JAMA, published online 12
September 2006.
Published in Regulatory Affairs Focus, January 2007. Copyright © 2007 Regulatory Affairs Professionals Society.
exploring ways to more specifically regulate medical foods, which could include safety
evaluations, standards for claims and specific information on the labels. FDA will hold
a public hearing to decide whether functional foods require unique regulations, but no
similar action has been taken for medical foods.
References
1. FDA website http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MedicalFoods/default.
htm. Accessed 24 January 2012.
2. Chew NJ: Food for thought. Biopharm 1991, 19:10-12.
3. U.S. Congress 1988. 100th Congress. Orphan Drug Amendments of 1988, P.L. 100-290. Amendment of Section
526(a)(1) of the Federal Food, Drug and Cosmetic Act
4. U.S. Congress 1990. 102nd Congress. Nutritional Labeling and Education Act of 1990. P.L. 101-535. Amendment of
Section 403 of the Federal Food, Drug and Cosmetic Act.
5. 21 CFR Part 105.3
6. Federal Register Vol 61, Number 231, 29 November 1996.
7. Federal Register Vol 68, Number 77, 22 April 2003.
8. Personal Communication, Drug Information Branch, 14 September 2006.
9. http://limbrel.com/limbrel.php. Accessed 24 January 2012.
10. Graham DJ: “COX-2 inhibitors, other NSAIDs, and cardiovascular risk.” JAMA, published online 12
September 2006.
Published in Regulatory Affairs Focus, January 2007. Copyright © 2007 Regulatory Affairs Professionals Society.