March 4, 2024

The Food and Drug and Administration has issued an advisory against the use of cosmetic colored contact lenses that are not registered with the agency.

In an advisory posted on its social media account and website on Oct. 31, the FDA warned the public against the purchase and use of Maxi Eyes Spectroflex Color Lens, which is sold online.

Based on its post-marketing surveillance, the FDA said it cannot guarantee the product’s quality and safety as it has not undergone the agency’s evaluation process.

The FDA directed concerned establishments not to advertise or sell the product until a product registration certificate is issued.

Local government units have also been asked to ensure that the product is not sold in stores in their areas of jurisdiction.

The Bureau of Customs has also been asked to restrain the entry of the product into the country.

In its website, Maxi Eyes Spectroflex Color Lens, maker of cosmetic contact lens, claims to have been issued a CE mark or that it has met European safety, health and environmental protection requirements, it is certified in the U.S. to sell graded lens, and is approved for purchase using a HSA (health savings account), which are valid in the U.S., but not in the Philippines.

The Food and Drug Administration Act prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, use, promotion, advertising, or sponsorship of health products without the proper authorization from the FDA. – Rimaliza A. Opiña