Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

  • Philip Saddik Long Island University
  • John Pappan

Abstract

Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.

Keywords: Drugs; Cosmetics; FDA; EMA; EU Cosmetics; Approval process; PIF; CPSR.

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References

1. International Trade Administration. 2016 Top Markets Report Pharmaceuticals (p2) [Internet]. U.S. Department of Commerce; 2016 [Cited 2018 Mar 05]. Available from:
https://www.trade.gov/topmarkets/pdf/Pharmaceuticals_Executive_Summary.pdf
2. Hall M, Hill D, Pave G. Global Pharmaceuticals 2016 industry statistics [Internet]. Hardman and Co.: London; 2017 Mar 02 [Cited 2018 Mar 25]. Available from:
http://www.hardmanandco.com/docs/default-source/sector-docs/life-sciences-documents/02.03.17-global-pharmaceutical-industry-2016-statistics.pdf
3. European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures (p4 & 7) [Internet]. EFPIA: Belgium; 2017 [Cited 2018 Mar 15]. Available from:
https://www.efpia.eu/media/219735/efpia-pharmafigures2017_statisticbroch_v04-final.pdf
4. Hanan MT and Freeman J. Structural Inertia and Organizational Change. American Sociological Review [Internet]. 1984 Apr [cited 2010 Mar 12]; 49(2):149-64. Available from:
http://www.jstor.org/stable/2095567
5. US Food & Drug Administration. Drugs @FDA Glossary of Terms. [Internet]. USFDA; 2017 Nov 14 [Cited 2018 Mar 11]. Available from:
https://www.fda.gov/drugs/informationondrugs/ucm079436.htm#D
6. European Medicines Agency. About the website, Glossary [Internet]. EMEA; 2018 [Cited 2018 Mar 10]. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/glossary.jsp&mid=&startLetter=M
7. Federal Institute for Drugs and Medical Devices. Medicinal Products: Evaluating benefit. Minimising risks [Internet].BfArm; 2013 [Cited 2018 Mar 13]. Available from:
https://www.bfarm.de/EN/Drugs/_node.html
8. US Food & Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) [Internet]. USFDA; 2002 Jul 08 [updated 2012 Apr 30; cited 2018 Mar 15]. Available from:
https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
9. US Food & Drug Administration. Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph [Internet]. Federal Register; 2003 May 29 [cited 2018 Mar 16]. Available from:
https://www.federalregister.gov/documents/2003/05/29/03-12783/oral-health-care-drug-products-for-over-the-counter-human-use-antigingivitisantiplaque-drug-products
10. US Food & Drug Administration. The Drug Development Process [Internet]. USFDA; 2018 Jan 04 [cited 2018 Mar 10]. Available from:
https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm
11. US Food & Drug Administration. Drug Approval Process. [Internet]. USFDA [cited 2018 Mar 18]. Available from:
https://www.fda.gov/downloads/drugs/resourcesforyou/consumers/ucm284393.pdf
12. DR. G. Renner. Legislation of Cosmetics in the EU, Key Features of Regulation 1223/2009/EU (multiple pages) [Internet]. EU:2009 [cited 2018 Mar 19]. Available from:
https://www.cosmeticseurope.eu/files/6214/7643/4067/Key_features_of_the_CPR.pdf
13. Cosmetics Europe. Understanding the Cosmetics Regulation [Internet]. EU:2018 [cited 2018 Mar 11]. Available from:
https://www.cosmeticseurope.eu/cosmetics-industry/understanding-cosmetics-regulation/#
14. Cosmetics Europe (2015, March). From Cosmetics Europe guidelines on the product information file (P.I.F.) Requirement [Internet]. EU:2018 [cited 2018 Mar 11]. Available from:
https://www.cosmeticseurope.eu/download/cEw5VFdiMDh5VTB4cHh6OU9VRWo0QT09
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How to Cite
Saddik, P., and J. Pappan. “Differentiation Between the Regulatory Paths Placed on Mouthwashes in the US and EU”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 8-13, doi:https://doi.org/10.22270/ijdra.v6i2.229.