FDA’s Mission: Protecting Public Health or Maintaining State Secrets?

Getting information out of the U.S. Food and Drug Administration isn’t like pulling teeth. It’s more like getting teeth pulled in a long, painful process with no end in sight.

It all started three months ago, when I learned about a November warning letter sent by FDA to Harmless Harvest, an early purveyor of coconut water. The firm looked at thermal aseptic processing, then looked away five years ago and opted for high pressure processing (HPP) to pasteurize the beverage without destroying nutrients and creating flavors that make people cry “Yech!!!”

Like other coconut water sellers, Harmless Harvest sourced its juice from Thailand, where the firm built a processing facility three years ago. FDA took issue with Harmless Harvest’s HACCP plan and its failure to validate a 5 log reduction of Clostridium botulinum. I didn’t think anaerobic bacteria were a concern in a fresh refrigerated product, but okay. Maybe it was just an example of FDA flexing its FSMA muscles and knuckling down on imported products.

Then things got interesting. Harmless Harvest dropped HPP altogether, and other firms with HPP systems started telling me that FDA inspectors were ordering them to do the same. Concern over low-acid juices with a pH above 4.6 seemed to be the sticking point.

Protecting public health is the point of FDA, so I initiated an inquiry about the new policy and what prompted the change. Coconut water is a big deal, it seems, and not just in the U.S. In the UK market, sales top $130 million, with a 120 percent annual growth rate. Had a botulism outbreak occurred?

The seven-week anniversary of the first call and e-mail to FDA came and went. To mark the occasion, another in a series of calls and e-mails was placed to the FDA official in charge of ignoring me. The silence is deafening.

In the meantime, makers of HPP presses have tackled the C. bot danger head on. Avure Technologies commissioned a study to determine if coconut water above 4.6 pH can support the growth and toxin production of proteolytic and non-proteolytic strains of C. bot at 4° and 10° C, or about the temperature of a functioning refrigerator and a malfunctioning one. The conclusion: fresh coconut water inoculated with various spore strains of the pathogen and stored for 45 days failed to germinate, grow and produce toxin.

What makes the finding even more compelling is where the study was conducted: the Institute for Food Safety and Health (IFSH) in Bedford Park, Ill. Before it became an institute, IFSH was the National Center for Food Safety and Technology (NCFST), where much of the primary research and validation work on HPP was conducted. Originally conceived as a partnership between private industry, academia and regulatory experts, IFSH continues to host scientists from Illinois Institute of Technology (IIT) and—get ready for it—the FDA.

Avure’s resident microbiologist plans to draft a detailed paper on the study and seek publication in a peer-reviewed journal. Until then, FDA’s scientists might consider walking across the hallway and make a few discreet inquiries. Those staff scientists include Guy Skinner, whose bio says his research focus is C. bot and extended shelf life foods—you know, products like refrigerated coconut water.

Guy will be a panelist at the upcoming IFT Conference. The Topic: “Can High Pressure Processing in Combination with Heat Serve as a Safe Alternative to Inactivate Clostridium botulinum Spores?” Spoiler alert: in 2009, FDA accepted a filing petition from NCFST, IIT and Avure for the commercial use of pressure-assisted thermal sterilization in the production of low acid foods. Specifically, the process authority evaluated mashed potatoes.

Of course, science isn’t static, and new research may contradict earlier conclusions. If so, FDA, please share.

In the meantime, another shot of Novocain, please, as I continue to wait.