From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 58
Final Thoughts
Therapeutic honey-impregnated dressings offer the promise of an effective wound
antiseptic with broad-spectrum antibacterial activity.18 Unlike antibiotics used to treat
wounds, honey would not require laboratory evaluation of susceptibility before begin-
ning treatment. Fortunately, honey does not adversely affect human tissue it may, in fact,
promote healing. Honey relies upon the release of hydrogen peroxide for its therapeutic
effect and may prove to be an important adjunct for wound care in light of the burgeon-
ing incidence of bacterial resistance to antibiotics. The availability of honey-impregnated
dressings is indicative of the agency’s creative product approval process.
References
1. Sherman M. “Maggots and leeches—are they medical devices?” Regulatory Affairs Focus. 2004 9(10):36-39.
2. Trump EF. “Sweet salve”. The Washington Post. 7 August 2007.
3. Hutt PB. “A history of government regulation of adulteration and misbranding of medical devices.” Food Drug
Cosmet Law J. 1989:44:99-117.
4. Pub L No. 75-717, 52 Stat 1040 (1938), as amended at 21 U.S.C. §§et seq.
5. Op cit 3.
6. Op cit 4.
7. Pub L No. 94-295, 90 Stat 539 (1976).
8. Op cit 1.
9. Harris G. “Age-old cures, like the maggot, get U.S. hearing.” The New York Times. 25 August 2005.
10. Root-Bernstein R and Root-Bernstein M. Honey, Mud, Maggots and Other Medical Marvels. Houghton Mifflin,
Boston, 1997.
11. Morse S. “Bee benefits downplayed.” The Washington Post. 15 August 2007.
12. Ibid.
13. Lusby PE et al. “Honey—a potent agent for wound healing?” J Wound Ostomy Continence Nurs. 2002
29:295-300.
14. White JW et al. “The identification of inhibine, the antibacterial factor in honey, as hydrogen peroxide and its
origin in a honey glucose-oxidation system.” Biochim Biophys Acta. 1963 73:57-70.
15. Op cit 13.
16. Tonks AJ et al. “Honey stimulates inflammatory cytokine production from monocytes.” Cytokine.
2003 21:242-7.
17. Op cit 13.
18. Cooper RA et al. “The sensitivity to honey of Gram-positive cocci of clinical significance isolated from
wounds.” J Applied Microbiol. 2002 93:857-63.
Published in Regulatory Focus, January 2008. Copyright © 2008 Regulatory Affairs Professionals Society.
Final Thoughts
Therapeutic honey-impregnated dressings offer the promise of an effective wound
antiseptic with broad-spectrum antibacterial activity.18 Unlike antibiotics used to treat
wounds, honey would not require laboratory evaluation of susceptibility before begin-
ning treatment. Fortunately, honey does not adversely affect human tissue it may, in fact,
promote healing. Honey relies upon the release of hydrogen peroxide for its therapeutic
effect and may prove to be an important adjunct for wound care in light of the burgeon-
ing incidence of bacterial resistance to antibiotics. The availability of honey-impregnated
dressings is indicative of the agency’s creative product approval process.
References
1. Sherman M. “Maggots and leeches—are they medical devices?” Regulatory Affairs Focus. 2004 9(10):36-39.
2. Trump EF. “Sweet salve”. The Washington Post. 7 August 2007.
3. Hutt PB. “A history of government regulation of adulteration and misbranding of medical devices.” Food Drug
Cosmet Law J. 1989:44:99-117.
4. Pub L No. 75-717, 52 Stat 1040 (1938), as amended at 21 U.S.C. §§et seq.
5. Op cit 3.
6. Op cit 4.
7. Pub L No. 94-295, 90 Stat 539 (1976).
8. Op cit 1.
9. Harris G. “Age-old cures, like the maggot, get U.S. hearing.” The New York Times. 25 August 2005.
10. Root-Bernstein R and Root-Bernstein M. Honey, Mud, Maggots and Other Medical Marvels. Houghton Mifflin,
Boston, 1997.
11. Morse S. “Bee benefits downplayed.” The Washington Post. 15 August 2007.
12. Ibid.
13. Lusby PE et al. “Honey—a potent agent for wound healing?” J Wound Ostomy Continence Nurs. 2002
29:295-300.
14. White JW et al. “The identification of inhibine, the antibacterial factor in honey, as hydrogen peroxide and its
origin in a honey glucose-oxidation system.” Biochim Biophys Acta. 1963 73:57-70.
15. Op cit 13.
16. Tonks AJ et al. “Honey stimulates inflammatory cytokine production from monocytes.” Cytokine.
2003 21:242-7.
17. Op cit 13.
18. Cooper RA et al. “The sensitivity to honey of Gram-positive cocci of clinical significance isolated from
wounds.” J Applied Microbiol. 2002 93:857-63.
Published in Regulatory Focus, January 2008. Copyright © 2008 Regulatory Affairs Professionals Society.