Custom Services International.
This article was originally published in The Gray Sheet
Executive Summary
Petitions FDA to revise its Sept. 30 final rule on natural rubber latex containing devices. The firm requests that the agency eliminate the requirement that condom manufacturers must print the statement: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" on individually wrapped condoms. Echoing concerns initially expressed by the Health Industry Manufacturers Association in October 1996, the petition notes that the additional statement "cannot be placed on the principal display panel...without regulatory relief as to some other required statement, or a waiver for further decrease in the type size" ("The Gray Sheet" Oct. 6, p. 3). The firm believes the existing warnings printed on the packaging are sufficient...