FDA Drafts Guidelines to Improve Labeling of Hydrogen Peroxide Contact Lens Care Products

Regulatory news

| August 17, 2022 | By Ferdous Al-Faruque

(Source: Pexels)

The United States Food and Drug Administration has developed draft guidance for manufacturers of hydrogen peroxide (HPCP) contact lens care products to consider when labeling their solutions in response to a number of adverse events, including cases where consumers lost their sight.

On August 17, the FDA released draft guidance titled “Hydrogen Peroxide Contact Lens Care Products: Labeling Recommendations for Consumers – Premarket (510(k)) Notification Submissions.” . The document comes more than five years after the agency convened its expert group on ophthalmic devices and its advisory committee on risk communications to discuss how to communicate potential HPCP risks.

“The safety and effectiveness of HPCPs when used as directed has been well established over the past decades; however, the FDA has become aware of an increase in the number of adverse event reports related to the misuse of these products,” the agency said. “Consumers have reported adverse effects ranging from irritation to severe burning and stinging of the eyes and even blindness with the use of HPCP.”

Like other lens care products, HPCPs can clean and disinfect contact lenses by breaking down and removing debris, proteins, fatty deposits and microorganisms. However, unlike other solutions, HPCPs tend to be preservative-free, which means they can be used by people who are allergic or sensitive to preservatives. Although the products are generally considered low risk, misuse of the product can have serious consequences.

The public meeting on HPCP in March 2017 covered several issues and the experts on the panel offered multiple suggestions for improving communication, including proper labeling and packaging, and clear communication of the risks of product misuse. They stressed that product labeling should be simple and clear in terms of warnings and instructions for use, and that manufacturers should ensure that their HPCP bottles have red end caps and caps to further distinguish them. clearly from other lens cleaners.

In the proposed guidelines, the FDA follows the advice of its advisory group on the use of red caps and guidance, although the agency leaves some of the recommendations up to companies to decide whether to implement.

“While not within the scope of these guidelines, the panel also suggested changing the shape, size, color, tactile characteristics or other characteristics of the bottle that would distinguish HPCPs from other products in the bottle. ‘caring for contact lenses that do not contain hydrogen peroxide’, advice says. “Although the FDA does not intend to recommend the type of bottle to be used to contain HPCP solutions, the FDA recommends, whenever possible, that containers be separate from those of multipurpose solutions or other products without hydrogen peroxide, which could minimize potential product selection errors and misuse of the product.

The FDA noted that the panel also called on manufacturers to redesign and standardize HPCP labeling so they stand out from other products.

“Based on adverse event reports and feedback obtained at the March 2017 panel meeting, misuse of the device may be exacerbated if the instructions for use and any warnings or precautions on the labeling of the device are unclear,” the agency noted. “The FDA believes that these issues can be mitigated by emphasizing and simplifying the important warnings and instructions for use on the labeling of bottles and cartons for HPCP solutions…The FDA believes that the design and Appropriate standardization of labeling would help inform consumers of the risks associated with devices, thereby increasing the likelihood of appropriate use of the device and helping to mitigate misuse of the device.”

The guidelines go on to make other recommendations, such as ensuring manufacturers include the contraindications of HPCP products on their labeling and prominently display the known potential hazards associated with the solutions.

“These warnings can alert consumers to the possibility of serious adverse reactions, situations which, if not avoided, could result in death or serious injury, and what action to take if they occur,” said regulators. They added that general warnings should feature prominently in all types of labeling, such as package insert labeling, carton labeling and bottle labeling. Additional warnings, they added, should be included in the leaflet.

Additionally, the FDA said manufacturers should include non-product-specific warnings that consumers should follow their ophthalmologist’s instructions and all labeling instructions for proper use while taking care of various product components. such as the lens case, or risk serious injury.

In terms of educating consumers about potential adverse effects, the FDA said the information should be on the package insert and list reactions associated with HPCPs such as corneal ulcers that can lead to loss of vision. The agency also said consumers should be advised to remove their lenses immediately if they experience symptoms such as stinging and burning, eye discomfort or excessive tearing.

“Statements should be added to the package insert informing the consumer of lens removal instructions, thereby reducing the risk of eye damage,” the FDA said. “The package insert labeling should also include statements that consumers contact their eye doctor immediately if problems persist or worsen, to seek immediate professional care, and to report all adverse events to the manufacturer.”

“A statement should be added informing the consumer that they can also report adverse events to FDA Medwatch,” the agency added. “This is important for diagnosing or documenting any adverse events associated with the product.”

The draft guidelines also include a glossary and sample label appendices that manufacturers can use as templates for their products.

Stakeholders can comment on the draft guidelines through October 17 at www.regulations.gov under the docket number. FDA-2022-D-0986-0001.

© 2022 Society of Regulatory Affairs Professionals.

About Marion Alexander

Check Also

Warby Parker Inc. (NYSE: WRBY) Receives Medium “Holding” Rating from Analysts

Shares of Warby Parker Inc. (NYSE: WRBY – Get Rating) received a consensus rating of …