FDA, 1990 In 1989, FDA investigators made several inspections of D'Plume
manufacturer Carol Block. These inspections uncovered "serious
violations of the Federal Food, Drug, and Cosmetic Act,"
including:
 No approved clearance to market by
510(k)
Illegal export of an unapproved device
Misbranding the device as permanent
Illegal references to FDA in sales
material
Inadequate directions for use
Inadequate labeling regarding potential
hazards, especially eye injury
Failure to follow Good Manufacturing
Practice
FDA says about the D'Plume PhotoEpilator efficacy:
The training manual and promotional material contain statements
which represent and suggest that the devices are adequate and
effective for the permanent removal of hair,, which statement
is false or misleading or otherwise contrary to fact, since
these devices are not adequate and effective for such purpose."
Source: FDA Regulatory Letter CHI-499-90 (April 12, 1990)
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hair removal
facts
for consumers
