Federal Guidelines for Teeth Whitening

Please note: FDA approval is not necessary for over the counter cosmetic products, which is what Revolution Whitening™ products are.

The following is to show that these are cosmetic products, and do not need FDA approval.

FDA : RULES, GUIDANCE, REGULATIONS AND CLASSIFICATIONS:

Q.  What is an ultraviolet activator?

A. It is a device that produces ultraviolet light intended to polymerize

or take off resinous dental pit and fissure sealants or restorative material by transmission of light through a rod.

The scope of this guidance includes devices that use light sources such as quarts-tungsten-halogen lamps, light emitting diodes (LED's), and xenon-plasma arcs, as well as laser energy sources.

RULE : The FDA guidance does not include heat or light sources intended exclusively for tooth bleaching procedures. These are classified under 2CFR 872.6475, Heat Source for Bleaching Teeth, product code EEG. These devices are exempt from the pre market notification procedures in subpart E of part 807 of this chapter, subject to the limitations of 872.9. (This action being considered cosmetic)

Q.  What is FDA's authority over cosmetics?

A. It is very important to understand that Congress passes the laws and govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including the FDA to create and enforce the rules and regulations, but only those as authorized under the law. A change in FDA's statutory authority over cosmetics would require a full congressional vote.

( It would take an act of Congress )

Additional information is also available at (FD&C Act, sec. 201(i)).

21 CFR 872.6070 Ultraviolet Activator for Polymerization