By: April Carson
Earlier this month, the FDA issued a safety communication regarding the improper marketing of amniotic fluid eye drops for dry eye disease, as part of their efforts to fight against companies selling unapproved stem cell products. While the drops may provide some temporary relief for symptoms of dry eye, they can also carry health risks. The agency is advising consumers to avoid using any products claiming to contain amniotic fluid as a treatment for dry eye and other medical conditions.
Two (Regener-Eyes and StimulEyes) were previously informed that their products would require an approved Biologics License Application (BLA) to remain on the market, or healthcare providers would need an Investigational New Drug (IND) application to provide them to patients. The communication pertains to earlier letters.
The FDA stated in a safety communication that there are no guarantees that the products are safe and effective to treat any disease or condition. Additionally, there are currently no FDA-approved amniotic fluid eye drops available to treat, alleviate, or cure any eye diseases or conditions.
Both products seem to be easily purchasable on the Internet as there are various options available on Google Shopping. Although M2 Biologics, the manufacturer of StimulEyes, has stated on its homepage that the product cannot be ordered online at the moment, it is still possible to buy it through other means. Therefore, the FDA is warning consumers not to purchase or use any eye drops containing amniotic fluid.
It is uncertain whether the companies made any alterations to their products or marketing after receiving previous letters from the FDA. In October, Harrell and Regener-Eyes received a letter with no title stating that their company's website claimed their product was made of placental-derived biomaterials and was a biological product used for treating dry eye disease.
The FDA has determined that the products are classified as drugs and biological products, and therefore require a valid biologics license before they can be marketed. "We have not approved any products containing amniotic fluid as a drug or biological product," said FDA Commissioner Dr. Stephen Hahn. "The use of these unapproved products can potentially lead to serious health risks and should be avoided."
The FDA is cracking down on companies that sell products labeled as "birth tissue" and claim to contain stem cells and other biological materials from the placenta and umbilical cord. The agency is asserting that these products are biological and must be subject to regulation.
According to Leigh Turner, executive director of the bioethics program at the University of California Irvine, numerous businesses offer stem cell products derived from allogeneic birth tissue, but only a few advertise "regenerative" amniotic fluid eye drops for dry eye disease and other conditions. "Regulatory-wise, it's a massive red flag," Turner said. "The FDA has not approved any of these products for sale or use in the United States."
Regener-Eyes was informed by the FDA in a letter that the company described their product as "acellular," indicating it does not have stem cells. However, it's uncertain what exactly businesses are implying when they assert such products have regenerative abilities, according to Turner.
Turner said that the use of the excitement and popularity surrounding regenerative medicine is being used to advertise supposed treatments.
"These companies are preying on the public's ignorance of what regenerative medicine is, and making false claims about how treatments can 'heal' diseases," Turner said. "It's irresponsible and dangerous."
According to Paul Knoepfler from the University of California Davis, who has been monitoring the stem cell industry, these products may still contain growth factors and other substances that could potentially affect the eyes. "It's important to note that the FDA is not saying these products are ineffective, but rather that their safety and effectiveness have not been proven," Knoepfler said.
Knoepfler warned that using drugs in the eye might have risks beyond the eye due to systemic circulation. Moreover, there is a risk of infection. He emphasizes treating such products as drugs and requiring extensive clinical trials before releasing them to the market for sale.
In light of these warnings, Knoepfler advises people to use only FDA-approved drugs or products for their eye care needs. While the stem cell industry is promising and growing, consumers should be safe rather than sorry when it comes to their health. Taking extra caution with untested products may save you from potential health risks in the long run.
The FDA has instructed healthcare providers to report any negative effects related to the use of amniotic fluid eye drops to its MedWatch program. Thus, it is important to be aware of potential side effects such as eye irritation, redness, and vision changes.
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April Carson is the daughter of Billy Carson. She received her bachelor's degree in Social Sciences from Jacksonville University, where she was also on the Women's Basketball team. She now has a successful clothing company that specializes in organic baby clothes and other items. Take a look at their most popular fall fashions on bossbabymav.com
To read more of April's blogs, check out her website! She publishes new blogs on a daily basis, including the most helpful mommy advice and baby care tips! Follow on IG @bossbabymav
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