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AOA, CIBA oppose FDA’s plan to rule plano tinted lenses cosmetic
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WASHINGTON — The U.S. Food and Drug Administration is considering a plan to reclassify tinted contact lenses that do not correct vision as cosmetic devices rather than medical devices. In response, the American Optometric Association expressed to Tommy Thompson, secretary of the U.S. Department of Health and Human Services, that this action raises serious health concerns.
In a letter to Sec. Thompson, J. Pat Cummings, OD, AOA president, said, “the very real health considerations associated with improper fit and wearing of lenses apply equally to both non-corrective and corrective power lenses. On behalf of the nation’s 30,000+ doctors of optometry and their patients, we urge your immediate intervention to prevent implementation of this ill-founded proposal.”
Congressman Henry A. Waxman, ranking majority member of the House Committee on Government Reform, also wrote in a letter to Sec. Thompson, “FDA’s plan to deregulate colored contact lenses may prove to be a financial windfall for some companies, but it will penalize real people, including teenagers, who will wind up with severe eye infections, painful corneal disease and even blindness.”
CIBA Vision has voiced its opposition to this plan and its support of continued FDA regulation of color contact lenses. The company has also recently filed a lawsuit in the U.S. District Court for the Northern District of Georgia in Atlanta against two Georgia companies, alleging illegal distribution and sale of color contact lenses.
The lawsuit was filed Sept. 12 against C&C Trading Company Inc., of Doraville, Ga., and MAS Wholesale & Retail and its owner Michelle Signh of Riverdale, Ga. It claims that these companies are engaged in the sale and distribution of color contact lenses without prescriptions, without providing instructions for use and without medical advisories required by law.
Currently, all contact lenses — regardless of whether they are intended for vision correction or only cosmetic purposes — are regulated as medical devices by the FDA, and Georgia law specifically prohibits the sale of any contact lens without a prescription.