Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny …

Cord for Life also fared poorly on an F.D.A. inspection in November, according to the letter, which listed numerous deficiencies in sanitation, like employees wearing the same non-sterile smocks for up to two weeks, not changing gloves and not cleaning equipment properly.

The F.D.A. gave the company 15 days to present a plan for correcting the deficiencies, and noted that failing to act on the problems could result in seizure and/or injunction by the agency.

Donald Hudspeth, general manager of Cord for Life, said the company had already corrected the problems identified in the inspection. Mr. Hudspeth also said that Cord for Life was unaware that the F.D.A. expected it to submit more proof of completion.

In addition, he said the company had not received any reports of adverse reactions from its products in its 25-year history.

The F.D.A. did not release the names of the recipients of the other 20 letters.

In their statement, Dr. Gottlieb and Dr. Marks dismissed claims by some stem cell businesses that they are exempt from F.D.A. regulations because their practitioners extract stem cells from a patients own fat or bone marrow and then return the cells to the same patient. The cells do not qualify as drugs and do not need regulation, the clinics argue.

The two officials disagreed: Stem cell products can create unique and serious risks depending on how theyre manipulated once theyre taken from the body and how they are used once theyre reinserted in the body.

The statement also noted that the F.D.A. was halfway through a three-year period of what it calls enforcement discretion, meaning that in 2017 it put stem-cell clinics on notice that their treatments were likely to come under F.D.A. authority, but that instead of cracking down immediately it was giving them time to learn what rules applied to them and to comply.

So far, though, the industrys response has been modest, the agency said, adding that once the three-year period is over, in November 2020, well step up our oversight.

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Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny ...

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