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The Pitfalls and Burdens of Claims

By: Marie Alice Dibon, PharmD
Posted: February 2, 2010, from the February 2010 issue of GCI Magazine.

page 9 of 9

Editor’s note: The author would like to thank THOR Personal Care SAS (147, rue Irène Joliot Curie, BP 90875—La Croix Saint Ouen, F-60208 Compiegne Cx—France), notably applications scientist Géraldine Louvet-Pommier de la Prade, for input and insight on the status of parabens in the European Union.

a Additional information on FDA actions and warning letters is available on its Web site ( The two examples in this feature were examples the FDA chose to point out to the author during her research.

b In 2007, three letters were issued addressing topical skin care preparations bearing drug claims and being marketed as cosmetics, while one was sent in 2006, two in 2005 and one in 2004.

c In his article “Labeling Claims—Untangling the Rules” in the September issue of GCI magazine (available online at and originally published in the August 2009 issue of Cosmetics & Toiletries magazine), David Steinberg outlines the negative impact caused by “free from” labels.

Marie Alice Dibon, PharmD, is the principal at Alice Communications, Inc., helping companies in the life science sector to develop innovative technologies.