Government investigators announced Thursday June 9th, 2016 that the FDA still has not implemented a recall of peanut butter and almond products despite the fact that advanced DNA testing showed confirmation of salmonella contamination more than three months previously.
The Food and Drug Administration has been dragging its feet to force a recall of the manufacturers of the tainted products, even though they have new legal powers and the technology to trace the fingerprint of the source or pathogens of the contamination, confounding the inspector general’s office at the Department of Health and Human Services. The FDA’s delays in the food-safety investigations have definitely put the American consumers at risk for serious illness and even death.
The inspector general’s office, in what is an unusual urgent warning stated that they were calling an, “early alert” and that the FDA needed to pay “immediate attention” to the situation, and in fact that the FDA needed to follow new standards of protocol and procedure to force manufacturers to get the recall done promptly. George Nedder, a lead investigator is quoted as saying, “Months and weeks when peoples’ lives are on the line? It needs to be done faster.”
The response from the FDA’s top food and safety official was that the inspector general’s report was selective and only singled out “a very selective sample” of recalls that did not happen in a timely manner (in a matter of days) calling them “outliers”. But the Deputy Commissioner, Stephen Ostroff stated that the FDA had put in place a group of officials from food safety to oversee cases on a weekly basis that did not seem to be getting the traction they should be accomplishing, which indicates there is a real concern here. Ostroff said, “That way we will be able to take action much more quickly in circumstances where there seems to be some reluctance at the firm.”
Typically the FDA has relied on manufacturers voluntarily recalling tainted products and removing them from the shelves, citing that this is the fastest route. But the government was not satisfied with that protocol and in 2011 a law gave the FDA the necessary power to order recalls when the case had the potential for serious harm to the public. To further enhance these powers and to be more precise the government introduced whole genome sequencing, which is precise DNA mapping. This technique gave the FDA the ability to trace bugs from the people who got sick with the samples of products or the manufacturing plant.
The inspector general was disturbed to find that the new powers granted to the FDA did not seem to have much of an impact on the FDA’s procedures, making note of two cases in 2014 in particular. Those two cases are just two examples of the review the inspector general has been making of 30 recalls between 2012 and 2015, to which the results of will be made public later.
The call for the review stems from the two cases that were considered a serious public health hazard one of which involved nSpired Natural Foods Inc. who voluntarily recalled peanut butter and almond products on August 19, 2014 after 14 people in 11 states became ill and sought treatment from the ER. However, the recall came some 165 days after the FDA first knew that salmonella contamination in samples taken from the manufacturing plant and samples taken from patients who got sick were identical, or to quote the FDA, “indistinguishable”. The company made a voluntary recall more than three months after the FDA did DNA mapping tying the sick patients/consumers to the nSpired Natural Foods Inc. manufacturing facility.
FDA official Ostroff spoke in defense of the allegation and said, “It was the first time FDA had used DNA mapping in an investigation, and “it just isn’t accurate” to suggest that the agency did nothing for three months after making a definitive link.
“I won’t tell you this went as quickly as we would like it to go,” he said. “Now that we have more experience with this technology, we hope we don’t see similar timelines.”
The other case that prompted the inspector general to investigate was that of a voluntary recall by Oasis Brands Inc. on three different instances in 2014 that involved numerous cheese products. In this case an infant died as a result of the tainted products and at least nine people in six states were ill enough to need treatment at their local hospital.
The final recall from Oasis came 81 days after the Agriculture Department of Virginia had notified the FDA that there was listeria in one of the company’s cheese products. During those 81 days the FDA inspected the manufacturing facility and found listeria during both of those inspections.
According to Nedder, the inspector general heading the investigation, the problem occurred multiple times because during the first two recalls the company did not get all the potentially tainted products in the recalls. It was not until the final recall in October of 2014 that all potentially contaminated products were removed from the shelves. Nedder was quoted as saying in response to this negligent action, “If you were playing Russian roulette with three bullets in the chamber, would you feel safe if you took one or two of them out?” Nedder asked. FDA’s Ostroff responded that the agency was acting on the best available information at the time.
Rep. Rosa DeLauro, D-Conn. A leading backer of food safety legislation said the situation with the FDA was “mind boggling” and that “it is even more astounding” that the FDA given its authority and new powers to mandate recalls and yet seems unwilling to yield its authority in the interest of the public.
