FDA, 1990 (regulatory letter)

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)