FDA Issues Alert: Dangers of Unapproved Eye Products

Eight businesses received warning letters from the U.S. Food and Drug Administration on September 12 for producing or advertising illegal ophthalmic medication items in contravention of federal law.

The agency's ongoing campaign to safeguard Americans against potentially dangerous ophthalmic goods includes these warning letters. The eight warning letters discuss the illegal marketing of eye products for the treatment of diseases such as conjunctivitis, also known as "pink eye," cataracts, glaucoma, and others.

A few FDA warning letters also name the firms for sterility-related product quality problems.

Because medications applied to the eyes circumvent some of the body's natural defenses, the FDA is especially concerned that these illegally marketed, unapproved eye products provide a heightened risk of injury to consumers.

According to their labels, several eye products include silver, which can eventually even lead to argyria. The condition results in persistent graying or blue-graying of some bodily tissues, including the eye.

Furthermore, unapproved eye products that claim to cure, treat, or prevent dangerous illnesses may lead patients to postpone or discontinue medical procedures that have been shown to be secure and efficient by the FDA review process.

The following businesses received letters of warning from the agency:

  • Boiron Inc.
  • CVS Health
  • DR Vitamin Solutions
  • Natural Ophthalmics, Inc.
  • OcluMed LLC
  • Similasan AG/Similasan USA
  • TRP Company, Inc.
  • Walgreens Boots Alliance, Inc.

The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.

- Jill Furman, Director of the Office of Compliance for the FDA's Center for Drug Evaluation and Research

Furman adds that they will keep looking into possibly dangerous eye goods and working to get unlawful products off the shelves so that people may continue taking their necessary medications without worry.

Note
Customers who have already been using eye products included in these warning letters should consult their doctor.

The FDA's MedWatch program welcomes consumer and medical professional reports of unfavorable effects. Within 15 days of receiving the letters, the FDA has requested a response from the corporations outlining how they plan to fix the problems.

When necessary, the program will release safety alerts for goods under FDA regulation based on the information it receives from the general public.

The FDA may take legal action, including product seizure and a court order forcing a corporation to stop producing and marketing an unapproved product if the infractions are not swiftly corrected.

A few of these businesses have also been placed on import alert by the government to prevent their goods from entering the country and reaching customers. The FDA is still looking into eye products; if necessary, it may take more regulatory or enforcement measures.


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