Ullman Opines on Characterization of Synthetic Glycans

September 9, 2021 | Compliance Investigations & White Collar

Marc Ullman was interviewed for the Nutraingredients-USA article, “Synthetic glycans developer issued warning over failure to file IND in COVID-19 trials.”

The Food & Drug Administration (FDA) issued a warning letter to Kaleido for the way they set up trials for its synthetic glycans product. The FDA’s position was that the trials were attempting to prove the product could be a treatment, and therefore Kaleido should have filed an Investigational New Drug application. The FDA’s warning letter also noted that it appeared Kaleido was trying to position the synthetic glycans as a “medical food,” treatment for COVID-19.

Addressing the medical food issue, Marc noted that the line between medical foods and dietary supplements has been blurred from the outset. “You are supposed to be supplying something that is nutritionally essential for the management of that disease. One of the issues that FDA is confronting is that there are products that really should be dietary supplements and people try to shoehorn them into the medical foods category so that they can make claims on them.

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