In a recent letter addressed to Dr. Kevin Geraci, president of AMC/NOMA, Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner of the Food and Drug Administration, responds to the concerns that the AMC/NOMA expressed in a letter to the FDA regarding the regulatory status of plano soft contact lenses marketed solely to change the appearance of the eye in a decorative fashion. The FDA shares the concerns about the risk of eye injury presented by these products if they are distributed without the involvement of a qualified eye care professional and is aggressively exercising all appropriate authority to ensure that the American public is protected from unsafe products.
The FDA intends to exercise maximum permissible regulatory control over decorative contact lenses because of the safety concerns these products present. First, the FDA has issued a press release and public health Web notification warning against the use of decorative contact lenses that have not been prescribed and fitted by an eye care professional. Secondly, they have issued an import alert warning instructing FDA and Customs officials to detain all decorative contact lenses presented at United States ports of entry and intended for distribution without health professional involvement. The products will not be admitted unless and until their compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act) is demonstrated to the FDA’s satisfaction. Third, using its cosmetics authority, the FDA will ensure that all manufacturers of decorative contact lenses marketed over the counter have substantiated the safety of their products before marketing. Fourth, the FDA plans on initiating seizure actions against decorative contact lenses currently on the market of OTC distribution in violation of federal law. The FDA believes these actions will enable the agency to fully protect the public health from the risks presented by decorative contact lenses distributed without a prescription and professional fitting.
Concern for already distributed products was addressed. The FDA is actively investigating reports that decorative contact lenses may have already been introduced to the United States market in violation of the FD&C Act. Firms responsible for distributing the products will be held accountable to the fullest extent of the law.
The FDA has received reports of corneal infections associated with wear of decorative contact lenses in excess of the recommended period. In some cases, use of the products may result in corneal scarring and blindness. Decorative contact lenses may also reduce the wearer’s visual acuity, contrast sensitivity, and other visual functions, resulting in interference with driving and other activities. FDA’s enforcement of the FD&C Act with respect to decorative contact lenses would be strengthened by even more data concerning the ocular health risks presented by these products and welcome submissions from contact lens and eye care professional organizations documenting the substantial health risks associated with use of decorative contact lens products without learned intervention. Submissions should be directed to: James Saviola, O.D., Center for Devices and Radiological Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-460, Rockville, Maryland 20850.
The letter concludes by assuring AMC/NOMA that the FDA has no intention of modifying the existing legal requirements applicable to or otherwise “deregulating” contact lenses and is using the full range of enforcement tools available to ensure that decorative contact lenses are not commercially distributed in the United States without appropriate involvement of eye care professionals.