Penis enlargers and constricting rings to maintain erections can be seized at U.S. borders, U.S. regulators said Thursday, citing inadequate safety labels.
The devices have inadequate directions for use and can have harmful effects, from rupturing blood vessels to causing
gangrene of the penis, the Food and Drug Administration said in guidance to import inspectors posted on the agency’s Web site. The guidance was a revision to guidelines on "external penile rigidity devices" the FDA published in 2004.
“Basically, the labeling of these devices falsely states or implies they will treat impotence, prolong erection, and increase the dimensions of the penis,” the FDA said in the new notice.
http://www.star-telegram.com/business/story/849736.html
Link to FDA memo:
http://www.fda.gov/ora/fiars/ora_import_ia7801.html