These two sentences from a Feb. 9 New York Times article on the peanut salmonella crisis stuck out to me: “Interviews and government records show that state and federal inspectors do not require the peanut industry to inform the public—or even the government—of salmonella contamination in its plants. And industry giants like Kellogg used processed peanuts in a variety of products but relied on the factory [Peanut Corporation of America in Blakely, GA] to perform safety testing and divulge any problems.”

Anyone who travels via plane or has a child in school knows that peanut allergies are one of the most common food allergies. In fact, peanut allergies affect approximately 2% of American adults and 8% of American children—that’s nearly 2 million people, according to the American Academy of Allergy, Asthma, & Immunology.

It’s therefore shocking to me that the peanut industry is not more regulated in terms of being required to report contamination to agencies such as FDA. One would think that the government would take extra precaution with such a large food industry (traces of peanuts can be found in multiple foods such as chocolates, crackers, cereals, health bars, oils, etc.)  and one that can potentially harm so many individuals’ health. PharmTech’s editor-in-chief attended the BIO CEO and Investors Conference this week where panelist Scott Gottlieb of the American Enterprise Institute (former FDA Deputy Commissioner for Medical and Scientific Affairs) noted that FDA is bad at regulating “low probability, high impact events” such as contamination in a food component or something that gets into the blood supply (a contaminating virus, say) that doesn’t show up in the population until five years later. Perhaps this is a lesson learned.

The second comment from the article regarding Kellogg relying on the factory to perform safety testing is also shocking to me. I understand we’re talking about the food industry here, not the pharmaceutical industry, where it has been hammered in lately that the manufacturer is the one ultimately responsibly for a product’s safety—no matter where the product is actually manufactured, in part or full. Perhaps the food industry does not have the same standards for its manufacturers (please leave a comment if you know the answer).

Another lesson here for pharma is that there is a clear reason industry groups, FDA, and ICH have been pressing that the manufacturer take responsibility for its products and its contract facilities. Relying on someone thousands of miles away to tell you if there may be a problem at the plant is not going to cut it. The manufacturer needs to visit its sites, audit its sites, and take charge of all aspects of its manufacturing chain. Recent drug recalls and supply-chain contamination also have illustrated this requirement. Perhaps it’s time to listen.