UNAPPROVED EYE PRODUCTS
The U.S. Food and Drug Administration (FDA) has taken decisive action by
dispatching warning letters to eight companies, casting a spotlight on their illicit
manufacture and marketing of unapproved ophthalmic drug products, a flagrant
violation of federal law. These warning letters are emblematic of the FDA’s
unwavering commitment to shielding the American populace from potentially
perilous eye-care offerings.
The eye products that have incurred the FDA’s stern rebuke have been
surreptitiously hawked as remedies for a spectrum of ocular ailments, ranging
from the common conjunctivitis, famously known as “pink eye,” to more serious
conditions such as cataracts and glaucoma. However, these claims are not only
unsubstantiated but are also in contravention of established regulations. In a
particularly damning twist, some of these FDA warning letters also serve as a
reprimand for the companies’ reckless disregard for the vital element of product
sterility. This reprehensible lapse in quality control raises serious concerns
regarding the safety of these ophthalmic products, jeopardizing the well-being of
unsuspecting consumers.
These actions by the FDA underscore its commitment to maintaining the integrity
of ophthalmic products on the market and to safeguarding the vision and health
of the American public.
The US FDA’s Role in Regulating and Ensuring Safety of Ophthalmic Eye Drops
Regulatory Oversight: The FDA oversees the approval, manufacturing, and
distribution of ophthalmological eye drops in the United States.
Product Approval: The FDA evaluates the safety and efficacy of new eye
drop products through a rigorous review process before granting marketing
approval. This ensures that only safe and effective medications reach
consumers.
Quality Control: The FDA sets and enforces quality standards for eye drop
manufacturing, including Good Manufacturing Practices (GMP) to ensure
product consistency and quality.
Labeling and Packaging: The FDA regulates the labeling and packaging of
eye drops to ensure that consumers receive clear and accurate information
about usage, side effects, and storage.
Post-Market Surveillance: After approval, the FDA continues to monitor
the safety and efficacy of eye drop products in the market. This includes
evaluating adverse event reports and taking action if safety concerns arise.
Generic Approvals: The FDA also reviews and approves generic versions of
ophthalmic eye drops once the patent for the original product expires,
increasing accessibility and affordability for consumers.
Research and Innovation: The FDA encourages research and innovation in
the field of ophthalmology by providing guidance to developers and
facilitating the development of new treatments and technologies.
What’s the issue?
The big concern here is that the FDA is worried about some eye products that are
being sold illegally and without their approval. These products are a big risk
because when you put drugs in your eyes, they can get around the body’s natural
defenses.
What’s even more concerning is that some of these products claim to have silver
in them, which can be labeled as silver sulfate, silver sulphate, or argentum. If you
use these silver-containing drugs for a long time, it can actually turn parts of your
skin, including your eyes, permanently gray or blue-gray – a condition called
“argyria.” That’s definitely not what anyone wants.
And here’s the kicker: these unapproved drugs say they can cure, treat, or prevent
serious eye conditions. But that’s not proven, and it might make people skip
treatments that the FDA has already checked and found safe and effective.
The FDA has sent warning letters to eight companies for illegally making or
promoting unapproved drugs for specific eye conditions. Here are the companies
in question:
Boiron Inc.
CVS Health
DR Vitamin Solutions
Natural Ophthalmics, Inc.
OcluMed LLC
Similasan AG/Similasan USA
TRP Company, Inc.
Walgreens Boots Alliance, Inc.
A warning letter is like a wake-up call from the FDA. When the FDA discovers that
a manufacturer has seriously broken the rules, they send a notification, which
usually comes in the form of a Warning Letter. This Letter spells out exactly what
the violation is, whether it’s related to how the product is made, misleading
claims about what the product can do, or incorrect usage instructions. It’s a clear
message that the company needs to fix the problem.
The letter also lays out the steps the company needs to take and how quickly they
need to do it. The FDA keeps a close eye on the company to make sure they
actually make the necessary corrections. In other words, it’s the FDA’s way of
saying, “You’ve got a problem, and you need to fix it, immediately.”
What to Do if a Patient Uses These Products?
Seek Professional Advice: Consumers currently using eye products
mentioned in these warning letters should consult with their healthcare
provider.
Report Adverse Reactions: The FDA strongly encourages both consumers
and healthcare professionals to report any adverse reactions through the
agency’s MedWatch program.
Deadline for Company Response: The FDA has given the companies 15
days from receiving the letters to outline their plans for correcting the
violations. Failure to act promptly may lead to legal actions by the FDA,
including product seizure and court orders to halt production and
distribution of unapproved products.
Import Alert: To prevent these products from entering the U.S. market, the
FDA has placed certain companies on import alert, safeguarding
consumers.
Ongoing Investigation: The FDA’s inquiry into eye products is ongoing, and
the agency remains ready to take further regulatory or enforcement
measures as necessary.
And these eye products are:
In each of the eight warning letters, a range of issues have been identified
concerning unapproved eye products.
Boiron Inc.
o Optique 1 Eye Drops
CVS Health
o CVS Health Pink Relief Drops
DR Vitamin Solutions
o Vision Clarity Eye Drops
o Life Extension Brite Eyes III
o Can-C Eye Drops
o Longevity Science Visual Ocuity
Natural Ophthalmics, Inc.
o Women’s Tear Stimulation Dry Eye Drops
o Allergy Desensitization Eye Drops
o Ortho-K Thin (Daytime) Eye Drops
o Ortho-K Thick (Night) Eye Drops
o Tear Stimulation Forté Dry Eye Drops
o Cataract Eye Drops with Cineraria
OcluMed LLC
o OcluMed Nutritional/Lubricant Eye Drops
Similasan AG/Similasan USA
o Similasan Dry Eye Relief
o Similasan Complete Eye Relief
o Similasan Allergy Relief
o Similasan Kids Allergy Relief
o Similasan Red Eye Relief
o Similasan Pink Eye Relief
o Similasan Kids Pink Eye Relief
o Similasan Aging Eye Relief
o Similasan Computer Eye Relief
o Similasan Stye Eye Relief
o Similasan Pink Eye Nighttime Gel
o Similasan Dry Eye Nighttime Gel
TRP Company, Inc.
o Dryness Relief Eye Drops
o Pink Eye Relief Eye Drops
o Allergy Eyes Relief Eye Drops
o Red Eye Relief Eye Drops
o Eye Strain Relief Eye Drops
o Eye Lid Relief PM Ointment
o Aging Eye Relief Eye Drops
o Blur Relief Eye Drops
o Eye Floaters Relief Eye Drops
o Eye Twitching Relief Eye Drops
o Stye Relief Eye Ointment
Walgreens Boots Alliance, Inc.
o Walgreens Allergy Eye Drops
o Walgreens Stye Eye Drops
o Walgreens Pink Eye Drops
IN CONCLUSIONS:
“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 Jill Furman, director of the
Office of Compliance for the FDA’s Center for Drug Evaluation and Research.
“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.”