President, Strategic Communications, LLC

Tuesday, November 27, 2012

Finally, FDA Acts Before More Poeple Die

How many deaths did it take for FDA to flex a little muscle? How many more people will end up in the emergency rooms or die due to consumption of products with no caffeine ingredient disclosures. How many more thousands of hours will the FDA spend in trying to calculate how many angels dance on the front panel lettering of food products, despite no one but a Registered Dietitian understands the information? How many of man-hours will be spent in endless meetings debating whether parents have an obligation to turn off "offensive" television advertising to children or leave it to the federal government to set rules governing what food companies can tell what consumers at what time of the day?

To to give the devil his due,yesterday the Food and Drug Administration halted operations of Sunland Peanut Butter, the country's largest organic peanut butter processor, that supplies product to companies such as Trader Joe's, Whole Foods, Safeway, Target and other large grocery chains after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the plant in Portale. FDA cracked down on salmonella poisoning for the first time with new enforcement authority the agency gained in a 2011 food safety law, although other legal experts claim the agency could have acted much soonerf it has showed  a little backbone.

FDA is an agency that lives in black-and-white. It cannot distinguish shades of gray and therefore the agency waited until Congress gave it new authority to suspend a company's registration when food manufactured or held there has a "reasonable probability" of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company's registration. To a non-lawyer, presenting a reasonable case to a judge that a plant was producing food that had "reasonable probability"of killing people was not a high legal hurdle.

A few years short and many deaths later, Michael Taylor, the FDA's deputy commissioner for foods, said the agency's ability to suspend a registration like this one is a major step forward for the agency.
"Consumers can be assured that products will not leave this facility until we determine they have implemented preventive measures that are effective to produce safe products," Taylor said. I'm confident Taylor's new found enthusiam will be of great comfort to those families that lost parents, children, aunts, and uncles and who know that FDA fiddled as Rome burned.

In the Washington world or regulation, FDA typically looks for a deep pocket company on which to enforce new statutory authority.

During a month-long investigation, after the outbreak linked to processor Sunland and to Trader Joe's, FDA inspectors found samples of salmonella in 28 different locations in the plant, in 13 nut butter samples and in one sample of raw peanuts.The agency also found improper handling of the products, unclean equipment and uncovered trailers of peanuts outside the facility that were exposed to rain and birds.The FDA said that over the past three years, the company shipped products even though portions of their lots, or daily production runs, tested positive for salmonella in internal tests. The agency also found that the internal tests failed to find salmonella when it was present. FDA inspectors found many of the same problems – including employees putting their bare fingers in empty jars before they were filled, open bags of ingredients, unclean equipment, and many other violations – in a 2007 inspection. Similar problems were recorded by inspectors in 2009, 2010 and 2011, though government officials didn't take any action or release the results of those inspections until after the illnesses were discovered this year.

Sunland's president and chief executive officer, Jimmie Shearer, denied the company knowingly shipped tainted products.

So, does this tell us? FDA knew for a very long time the Sunland plant was a problem. They collected data but took no action. Then, armed with new legislative authority. It swooped in and shut the plant down and issued a press release. How many people died in the meantime?

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