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Noncorrective contact lenses, such as those with colors and
special designs, pose the same health risks as clear contact
lenses that correct vision. Without appropriate care and medical
supervision, consumers wearing noncorrective lenses can suffer
eye infections, scarring, and blindness.1Children who have
purchased these products illegally have suffered injuries severe
enough to require corneal transplant.2Until recently, the Food
and Drug Administration (FDA) has publicly claimed jurisdiction
over all contact lenses, including noncorrective lenses, as
medical devices. Medical devices must be screened by the FDA
before marketing and are subject to rigorous requirements to
ensure their safety. On April 4, 2003, however, the FDA
announced that it now considers noncorrective lenses to be
cosmetics,3a classification that eliminates most of the safety
requirements imposed on medical devices. According to legal and
eye care experts, the FDA’s decision to regulate noncorrective
lenses as cosmetics places the public at risk from unsafe
products and could undermine confidence in all contact lenses.
Here are several key points on FDA’s new policy: • Regulating
noncorrective contact lenses as cosmetics risks eye injuries
Medical device regulation is the most protective level of
oversight FDA can apply to any product that is not a drug. FDA
must review the safety and effectiveness of devices before they
are ever sold to the public. Companies must follow standardized
1See, e.g., R. Snyder, M. Brenner, L. Wiley, et. al., Microbial
Keratitis Associated with Plano Tinted Contact Lenses, Contact
Lens Association of Opthalmologists Journal, 252-5 (1991);Myron
Yanoff and Jay S. Duker, Opthalmology (1999). 2Health Concerns
Tinge Use of Contact Lenses, Los Angeles Times (Aug. 26, 2002).
365 CFR 16520–16522.
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FDA’S NEW POLICY ON NONCORRECTIVE CONTACT LENSESmanufacturing
processes to reduce the risk of injury or infection to
consumers. FDA can require that a device be available only by
prescription. If adverse events occur, companies must report
them quickly to FDA. FDA can also require specific labeling,
including directions for safe use. By comparison, FDA’s
authority to regulate cosmetics is quite limited. FDA does not
review cosmetics for safety or effectiveness before they are
sold to the public. While the agency can detain suspect imported
cosmetics prior to sale, FDA can only take action against
products manufactured domestically after they have already been
marketed. The agency cannot require cosmetic manufacturers to
test for safety problems, cannot set “good manufacturing
practices” for cosmetics, cannot require reporting of adverse
events, and cannot require that cosmetics carry directions for
safe use. FDA cannot require that cosmetics be used under the
supervision of an eye care professional. Unlike for medical
devices, FDA does not even have a formal mechanism to learn of
the existence or location of cosmetics manufacturers. • When
noncorrective contact lenses are cosmetics, related products do
not need to pass safety standards Prior to FDA’s April 4
announcement, all solutions used to clean and preserve contact
lenses were automatically regulated as medical devices by FDA.
This classification allowed the agency to impose manufacturing
standards to assure sterility and safety. FDA’s decision to
reclassify noncorrective contact lenses as cosmetics, however,
has opened the door for manufacturers to market solutions only
for the cosmetic lenses. FDA would not be able to apply any
safety standards to these products prior to marketing, risking
additional eye injuries. • FDA’s recent actions to protect the
public from noncorrective contact lenses can be challenged and
evaded While FDA recognizes the danger posed by noncorrective
lenses in the absence of strict oversight, it can only take half
measures to protect the public under cosmetics law. On April 4,
FDA issued an import alert to allow for the detention of
decorative contact lenses.4The agency cited three grounds for
the action: (1) the products are adulterated by the matrix of
the contact lens; (2) the products may contain color additives
not specifically approved for use in cosmetics; and (3) the
instructions for use may be inadequate. All of these grounds may
be challenged in court. A company could argue that the matrix of
the lens is no different from the matrix in approved device
lenses and therefore cannot be physically adulterated. It could
show that all of its color additives are approved, and it could
add some instructions for use to the package. The products might
then be sold 465 CFR 16520–16522 2
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FDA’S NEW POLICY ON NONCORRECTIVE CONTACT LENSES3without safety
standards for manufacturing, adverse event reporting and without
necessary medical supervision. Moreover, FDA’s ability to detain
cosmetics prior to sales is limited to imports. A domestic
company manufacturing decorative lenses could market dangerous
products first and then force FDA to seek a court order to stop
them after consumers have already been injured. The ensuing
proceeding could be expensive and time-consuming, and the burden
of proof on FDA could be high. Meanwhile, the lenses would
remain on the market.• With FDA unwilling to reverse its
judgment, a new law is urgently needed FDA’s justification for
changing the regulatory status of noncorrective lenses relates
to a separate debate over classification of products in food and
drug law. Others outside the agency disagree with the FDA’s
position. Regardless, with FDA unlikely to reverse course on its
own, Congress should pass a law clarifying that all contact
lenses are medical devices. Such a step would maintain the level
of safety oversight that has existed until now and could be
crafted to be neutral on the legal dispute over the
classification ofproducts in food and drug law. Unless Congress
acts, noncorrective, colored contact lenses could become widely
available over-the- counter without any assurance that they have
been properly manufactured or that they can be used safely. |