The FDA issues warning letters to 8 companies for manufacturing/marketing unapproved ophthalmic drug products

The FDA has issued warning letters to 8 companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.

These warnings come amidst an increased amount of complications and issues caused by unapproved eye drops, as the FDA states they are trying to “protect Americans from potentially harmful ophthalmic products.”¹

As stated in a press release from the FDA, the products being addressed in these letters are “illegally marketed to treat conditions such as conjunctivitis (pink eye), cataracts, glaucoma and others.” While some of the letters also cite certain companies for quality issues related to product sterility.¹

According to the FDA, concern is heightened because these “illegally marketed, unapproved ophthalmic drug products” pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.¹

For instance, the FDA states that some of the eye products are labeled to contain “silver,” which may be characterized as as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause arygyria, a condition caused by excessive exposure to chemical compounds of the element silver, or to silver dust, which can cause the skin to permanently turn gray or blue-gray.

Jill Furman, JD, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research discussed the letters in the press release.

“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,” said Furman. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”

The 8 companies the FDA issued letters to, as well as the products are:

Boiron Inc.²

• Optique 1 Eye Drops

CVS Health³

• CVS Health Pink Eye Relief Drops

DR Vitamin Solutions⁴

• Vision Clarity Eye Drops
• Life Extension Brite Eyes III
• Can-C Eye Drops
• Longevity Science Visual Ocuity

Natural Ophthalmics, Inc.⁵

• Women’s Tear Stimulation Dry Eye Drops
• Allergy Desensitization Eye Drops
• Ortho-K Thin (Daytime) Eye Drops
• Ortho-K Thick (Night) Eye Drops
• Tear Stimulation Forté Dry Eye Drops
• Cataract Eye Drops with Cineraria

OcluMed LLC⁶

• OcluMed Eye Drops

Similasan AG/Similasan USA⁷

• Similasan Dry Eye Relief
• Similasan Complete Eye Relief
• Similasan Allergy Eye Relief
• Similasan Kids Allergy Eye Relief
• Similasan Red Eye Relief
• Similasan Pink Eye Relief
• Similasan Kids Pink Eye Relief
• Similasan Aging Eye Relief
• Similasan Computer Eye Relief
• Similasan Stye Eye Relief
• Similasan Pink Eye Nighttime Gel
• Similasan Dry Eye Nighttime Gel
• As well as sterility issues

TRP Company, Inc.⁸

• Dryness Relief
• Pink Eye Relief
• Allergy Eyes Relief
• Red Eye Relief
• Eye Strain Relief
• Eye Lid Relief
• Aging Eye Relief
• Blur Relief
• Floaters Relief
• Twitching Relief
• Stye Relief
• Dryness Relief PF

Walgreens Boots Alliance, Inc.⁹

• Walgreens Allergy Eye Drops
• Walgreens Stye Eye Drops
• Walgreens Pink Eye Drops

Regarding all these products, the FDA said they were “especially concerning from a public health perspective.” The FDA stated that the products are “not generally recognized as safe and effective (GRASE) for [their] referenced uses and, therefore, [are] a ‘new drug.’”²

The FDA stated the companies must respond within 15 working days of receipt of the letter, stating the specific steps taken to correct these issues, with failure to adequately address the matter potentially resulting in “legal action including, without limitation, seizure and injunction.” The FDA has also placed some of the companies on “import alert” to stop their products from entering the US and reaching consumers.

The FDA also warned consumers currently using eye products included in the warning letters to speak to a health care professional.

References:

1. FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products. Press Release. Released September 12, 2023. Accessed September 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products

2. Boiron, Inc. Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/boiron-inc-663402-09112023

3. CVS Health Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023.https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cvs-health-663246-09112023

4. DR Vitamins, LLC dba DR Vitamin Solutions Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dr-vitamins-llc-dba-dr-vitamin-solutions-663127-09112023

5. Natural Ophthalmics, Inc. Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natural-ophthalmics-inc-663758-09112023

6. OcluMed LLC Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023
   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oclumed-llc-663525-09112023

7. Similasan AG Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/similasan-ag-658878-09112023

8. TRP Company, Inc Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trp-company-inc-663037-09112023

9. Walgreens Boots Alliance, Inc. Warning Letter. FDA. September 11, 2023. Accessed September 12, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walgreens-boots-alliance-inc-663404-09112023