FDA Releases Draft Guidance on Labeling for Hydrogen Peroxide Cleaners for Contact Lenses

The guidance comes as a result of an increase in eye injury.

The FDA has released draft guidance for labeling hydrogen peroxide-based contact lens care products meant to prevent misuse that may result in serious injury to eyes.1 The guidance is a result of an increase in adverse event reporting to the agency, including eye irritation, severe stinging or burning, and blindness. Many reports noted that it was not easy to distinguish hydrogen peroxide-based contact lens care products from products that don’t have the same potential risk for severe injury.

In addition to the general guidance that labels should be not exceed an eighth-grade reading level, labels should address 4 important questions:

  • How does the product work?
  • What is the correct use for the product?
  • What are the product’s risks?
  • Who should be contacted if a problem occurs?

Adverse events, as well as risks and benefits, should be indicated in a balanced way using lay language. Statements about performance that are either misleading or unsubstantiated should not be made on packaging. This current guidance will supersede the recommendations made in 2010 guidance on labeling for contact lens products with hydrogen peroxide-based contact lens care products.

Recommended warnings and guidance that should be present include only using in provided cases, a warning that unneutralized disinfecting solution should not be placed into the eye, what to do if unneutralized solution comes in contact the eye, and strong warnings against the reuse of the neutralizing solution, rinsing the contact lens with labeling hydrogen peroxide-based care, and putting the hydrogen peroxide-based contact lens care solution into eyes.

Comment is welcome until October 17, 2022 at regulations.gov in docket #FDA-2022-D-0986-0001.

Reference

  1. Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions. Draft Guidance. FDA. Issued August 17, 2022. Published August 23, 2022.