On July 12, 2001, the Florida District Office of the FDA sent a letter to Tend Skin regarding health claims made in promotional literature.
</font><blockquote><font size=“1” face=“Verdana, Helvetica, sans-serif”>quote:</font><hr /><font size=“2” face=“Verdana, Helvetica, sans-serif”> The drugs are also misbranded [Section 502(f’)(1 ) of the Act] because the labeling fails to bear adequate directions for use. The labeling is false and misleading as it suggests the products are safe and effective for their intended uses when, in fact, this has not been established [Section 502(a) of the Act].
The products are also misbranded because you have failed to register with the FDA as a drug manufacturer and have failed to list the drug products you manufacture [Section502(0) of the Act].
</font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>They were cited for many violations, although their claims for razor bumps and ingrown hair were not cited.
Consumers who are concerned about the safety of this product should consider other exfoliating options such as Bikini Zone and other over-the-counter products to resolve irritation from shaving and waxing.