FDA Review Finds Storage Problems at Food Supplement Regulator CFSAN



The US Food and Drug Administration (FDA) has announced that it has found still more vials of improperly stored hazardous substances in one of its labs, just weeks after the agency announced that it had found dozens of other vials of hazardous substances, including the smallpox virus.


In July 2014, FDA and the National Institutes of Health (NIH) announced they had discovered previously unknown vials containing variola—the virus which causes smallpox—as well as dengue, influenza, Q fever and rickettsia.

The vials, more than 300 in all, were discovered during the relocation of FDA’s Center for Biologics Evaluation and Research (CBER), which for decades had been located on the same Bethesda, MD campus as its original parent agency, the NIH.


The smallpox virus in a 1975 electronmicrograph. (CDC via AP)

“These things were stored in locations where they should not have been stored,” said Alfred Johnson, director of the NIH’s office of research services, which is coordinating a “clean sweep” of the agency’s labs.

While FDA took control of CBER in 1972, the massive storage rooms located within CBER were evidently never properly inventoried, leading to the 2014 discoveries of the vials. While many of the found pathogens are known to be deadly, none are considered more so than variola, a virus thought to have been all but eradicated in the late 1970s. Prior to FDA’s discovery, the virus was thought only to exist in two high-security storage facilities: One in the US, and the other in Russia.

FDA said the vials had likely been in the facility since between 1946 and 1964, when CBER was still an office of the NIH.



In the wake of the findings, FDA officials pledged to undertake a thorough audit of their facilities and report any additional problems they found.

And on Friday, the agency quietly reported they had discovered still more problems, though less severe than ones discovered previously.

In an email to Regulatory Focus, FDA confirmed it had uncovered several vials of staphylococcus enterotoxins (SE) which had been improperly stored in an unregistered biosafety level 2 laboratory maintained by the Center for Food Safety and Applied Nutrition (CFSAN). The laboratory was not registered with the Center for Disease Control and Prevention’s (CDC) Select Agent Program (SAP), the agency said.

The agency is allowed, per federal regulations, to work with SE in quantities less than 5 mg. The substance is known to cause food-borne illnesses, but is notably less dangerous than other substances found previously by the agency. The excess amounts have since been destroyed, FDA said.

In statement to Focus, FDA said it “will continue its efforts to diligently search its labs to ensure the safe handling of all potentially hazardous materials of concern and compliance with all applicable regulations.”

Separate reports indicated that a similar search by the NIH resulted in far more troubling findings. The Washington Post, Associated Pressand Natureall reported that NIH discovered ricin and the pathogens which cause tularemia, the plague, botulism and meloidosis.



By Alexander Gaffney