September 4, 2007 – The Project on Scientific Knowledge and Public Policy (SKAPP) says that the failure of FDA and other public health agencies to respond promptly and decisively to a report of bronchiolitis obliterans in a popcorn consumer indicates a disturbing decline in our nation’s public health system.

Until recently, the lung disease bronchiolitis obliterans had been identified only in workers exposed to the artificial butter flavoring chemical diacetyl through the manufacture of flavorings and food items. In July, Dr. Cecile Rose, the chief occupational and environmental medicine physician at National Jewish Medical and Research Center, wrote to the FDA, CDC, EPA, and OSHA, informing the agencies of a patient she had recently identified “with significant lung disease whose clinical findings are similar to those described in affected workers, but whose only inhalational exposure is as a heavy, daily consumer of butter flavored microwave popcorn.”

In a post on the public health blog The Pump Handle, SKAPP Director David Michaels explains, “One would expect the relevant federal agencies to respond quickly to what may be the first documented case of lung disease caused by consumer exposure to artificial butter flavor.” The agencies did not act on this information, though, and Michaels considers their inaction “a sign that something is seriously wrong with our public health system.”

Dr. Rose’s letter follows other attempt by health advocates to spur the FDA to action on diacetyl. In September of 2006, SKAPP petitioned FDA to revoke diacetyl’s “generally regarded as safe” (GRAS) status. In May 2007, Congresswoman Rosa L. DeLauro (D-CT), chair of the House of Representatives Appropriations subcommittee that funds the FDA, urged the agency “to consider revoking the generally safe designation for diacetyl and removing it from the market until further testing is completed.” FDA Commissioner Andrew von Eschenbach refused to commit the FDA to do anything other than monitor the situation. Congresswoman DeLauro then added language to the report that accompanied the Agriculture Appropriations Bill, directing the FDA to submit a report on its diacetyl research plan to the committee within 90 days of enactment.

After she wrote FDA about her patient's case, Dr. Rose reports that agency attorneys asked that she resubmit her letter to the docket that has been created for SKAPP's petition. Michaels notes that FDA and other agencies could have responded to Dr. Rose's letter by issuing an alert and requesting information from lung disease specialists about symptoms in patients who are heavy consumers of popcorn; by meeting with popcorn manufacturers' technical directors to discover what they know about consumer exposures and levels of diacetyl released by microwaving popcorn; or, at minimum, by asking Dr. Rose for more information.

"None of the agencies did anything like this," Michaels states. "Their failure to respond adequately is a sign that our public health protection system is in dire need of repair."

Read more:
Diacetyl case study
Background on diacetyl
Documents related to diacetyl
Posts about diacetyl on The Pump Handle blog