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

  • Philip Saddik Long Island University
  • John Pappan


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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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:10.22270/ijdra.v6i2.229.