September 27, 2023
As a trusted global health care brand for more than 40 years, the health and safety of our customers is and always has been of the greatest importance to our people both here in the US, and in Switzerland, where our products have always been manufactured with Swiss precision and quality.
It is important to note that the issues raised with our products and manufacturing are not due to any consumer safety issues or incidents. Similasan products have been available across the US since 1987, and more than 100 million bottles have been sold. To our knowledge we have experienced zero cases of adverse events linked to the use of Silver Sulfate as a preservative. Pending resolution of the FDA concerns, we have voluntarily suspended the sale and distribution of all Similasan eye drop products to US retailers.
We are aware of recent concerns involving some competitors’ eyecare products, where flaws in product design and manufacturing resulted in a number of documented adverse events; however, those products and issues are completely unrelated to our Company, our processes, our products or our ingredients.
The FDA has categorized homeopathic over-the-counter drugs as “unapproved drugs” since May of 1988 when Compliance Policy Guide 400.400 was published. Similasan has historically complied with appropriate regulations related to the homeopathic “unapproved drug” classification and will continue to do so as instructed by the FDA.
We understand that the FDA shares our values of health and safety, and we are engaging with them to better understand the issues raised and provide updated documentation around our manufacturing processes. We are cooperating with the FDA and hope to have this matter resolved quickly.
FDA - FAQ
Why did Similasan receive a warning letter?
During a routine facility inspection, the FDA noted some issues at our manufacturing facility. Additionally, the FDA has expressed concern with homeopathic ophthalmic marketing claims which historically have been used throughout the industry.
Is this related to the eye products recalled this year that caused death and blindness?
No. Similasan is not affiliated and does no business with the company involved in the recall earlier this year. Those products and issues are completely unrelated to our Company, our processes, our products and our ingredients.
Is there a safety issue with Similasan products? Were they safe in the past?
The issues raised at our products and manufacturing facility are not due to any consumer safety issues. Similasan products have been available across the US since 1987, and more than 100 million bottles have been sold.
Is Similasan recalling product? Can I use the bottle of Similasan eye drops that I have at home?
There has been no product recall. While Similasan believes in the safety of its products, we have voluntarily suspended the sale of our eye drop products. We recommend that you discontinue the use of those products until we resolve our discussions with the FDA.
Are Similasan products manufactured in the US or imported?
Similasan products are manufactured at a facility in Switzerland. The production facility is audited every year by various regulatory authorities.
What is Similasan doing now, what are the next steps?
We understand that the FDA shares our values of health and safety, and we are engaging with them to better understand the issues raised and provide updated documentation around our manufacturing processes. We are cooperating with the FDA and hope to have this matter resolved quickly.
Can I still purchase Similasan products? When will your products be available again?
Pending resolution of the FDA concerns, we have voluntarily suspended the sale and distribution of all Similasan eye drop products to US retailers. We are cooperating with the FDA to quickly resolve this matter. We will continue to update our valued customers as we have more clarity.
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