Contact Lens Bill Reversing Regulation As Cosmetics Pushed By Optometrists

Legislation addressing the regulation of decorative contact lenses has a strong chance of being considered this fall when Congress returns from its recess Sept. 2.

Referred to the House Energy & Commerce Committee before the August break, the bill (HR 2218) is garnering Republican support, according to staffers.

The legislation would reverse FDA's decision to regulate noncorrective contact lenses as cosmetics rather than medical devices. Co-sponsored by Reps. John Boozman (R-Ark.) and Henry Waxman (D-Calif.), the bipartisan bill was introduced May 22 (¹ (Also see "Plano Lens Cosmetics Classification Countered In Boozman-Waxman Bill" - HBW Insight, 2 Jun, 2003.), p. 6).

FDA announced in April its belief that decorative contact lenses should be regulated as cosmetics. Despite stakeholder objection, the agency says it is unwilling to overturn its decision absent congressional intervention.

The bill would amend FD&C Act Sec. 520 by adding "both corrective and noncorrective contact lenses and similar articles shall be considered devices" under Sec. 201(h). Should it succeed, efforts to strengthen prescription requirements for contact lens sales could be welcomed by FDA, congressional aides say.

One such initiative is the National Contact Lens Enforcement Petition, led by Medina, Ohio optometrist Tim Milburn. Signed by 1,186 optometrists and endorsed by the Virginia State Board of Optometry, the petition urges FDA not to allow Internet retailers to substitute, change, fill or sell lenses without a valid prescription.

"Only the FDA can act to regulate a medical product involved in interstate commerce," the June 18 petition says. "Yet, the agency has left it up to states to handle this problem. The result has been that consumers are not being protected from unscrupulous companies."

The petitioners state that they are unaware of any prosecution against distributors selling without a prescription. "To our knowledge, the FDA has failed to enforce and prosecute a single case of illegal contact lens sales involving interstate commerce," they assert.

However, the Securities & Exchange Commission could press charges against distributor 1-800 Contacts, the petitioners say. The firm described its passive Rx verification system to the Federal Trade Commission last year at the agency's behest.

In the company's most recent 10-K filing, 1-800 Contacts explains that federal regs qualify contact lenses for an exemption from certain device labeling requirements. Devices falling within the exception must contain a labeling statement restricting the products to sale "by or on the order of a licensed practitioner."

"However, a device...dispensed without a prescription may be considered misbranded by the FDA," the firm says. Although potential misbranding penalties include seizure, injunction or prosecution, "to date, the FDA has not taken any such action," 1-800 Contacts states.

Consequently, the petitioners ask FDA to enforce existing regulations to prevent the unlawful sale of contact lenses without a valid, actively verified prescription from a licensed eye care professional.

Although they concede that alternative distributors would suffer financially because of the inconvenience imposed on consumers, who would have to send a copy of their prescription to a mail order or Internet firm, the petitioners maintain "in no way do [they] wish to inhibit online, mail-order or interstate sales of contact lenses."

"However, Internet contact lens sales must be held to the same strict standards as non-Internet...sales," the group maintains, urging doctors to report every contact lens related injury to FDA.

Rep. Waxman has been working on the lens issue since Fashion Wear Services, a UK-based maker of the disputed products, met with FDA last summer (² (Also see "Colored Contact Lens Deregulation Lacks Precedent – Rep. Waxman" - HBW Insight, 2 Sep, 2002.), p. 8).

In the UK, an attempt to introduce plano lens legislation failed in June, but the effort instead resulted in the circulation of a General Optical Council letter among optical bodies stating that "the fitting and sale of cosmetic contact lenses should be supervised by qualified health professionals [to] avert the risks of permanent eye injury to consumers buying such lenses without professional supervision." The Royal College of Ophthalmologists opted not to sign the document, but sent a letter of support to the UK government.