Leigh Turner, executive director of the bioethics program at the University of California Irvine, who has long been tracking stem cell companies, said that while "hundreds" of businesses sell such allogeneic birth tissue-derived stem cell products, a "much smaller number of companies advertise purported 'regenerative' amniotic fluid eye drops for dry eye disease and other indications." The agency has argued that these are biological products that need to be regulated as such. The FDA has been getting tougher on "birth tissue" companies, which market products that allegedly contain stem cells and other biological materials that are derived from the placenta and umbilical cord. Although StimulEyes maker M2 Biologics states on its homepage that online ordering of the product is currently unavailable, the product appears to be available for purchase through other channels. "There are no assurances that the products are safe and effective for any disease or condition," FDA said in its safety communication, adding that there are "currently no FDA-approved amniotic fluid eyedrops to treat, mitigate, or cure eye diseases or conditions."īoth products appear to be readily available for sale on the internet, with plenty of options on Google Shopping.
#Amniotic fluid images license
The communication links to earlier letters to two manufacturers - makers of Regener-Eyes and StimulEyes - warning that the products would need an approved Biologics License Application (BLA) to stay on the market, or health care providers would need an investigational new drug (IND) application to deliver them to patients. In its ongoing battle against companies selling unapproved stem cell products, the FDA issued a safety communication earlier this month about amniotic fluid eye drops being improperly marketed for dry eye disease.
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