The lawsuit, which was filed at the US District Court in the Eastern District of California last week, is seeking a Writ of Mandamus to order the FDA to take final agency action on Organic Pastures’ 22 December 2008 petition to amend regulation CFR 1240.61.
The lawsuit cites FDA commissioner Margaret Hamburg and Kathleen Sebelius, the secretary of the US Department of Health and Human Services, as defendants.
CFR 1240.61 currently prohibits the distribution of dairy products made from un-pasteurised milk across US state lines. Organic Pastures requested that an exception be made to the rule.
“Raw milk that is tested, state inspected, state regulated, carries a ‘government warning statement’ and labelled for retail sale in one state may be transported to another state if that other state allows the sale of raw un-pasteurised milk and or dairy products,” read the 2008 requested amendment.
Under federal law, the FDA has up to 180 days to respond to a written petition. Nearly four years have passed since Organic Pastures filed its original petition with FDA.
No final FDA action
“FDA has had nearly four years to take final agency action on Organic Pastures’ petition yet as of this date has failed to take any final action,” said the filed lawsuit.
According to Organic Pastures, the FDA failed to respond to its petition within 180 days. On 17 July 2009 - after the deadline - the FDA issued a letter that did not give a “tentative response” to the petition.
In July 2012 - more than three years later - Organic Pastures sent a letter to FDA seeking final agency action on its petition. FDA responded on 29 August 2012, claiming that it was “developing a response to the petition.”
The next day, Organic Pastures sent an email to the FDA asking when the “developing response would be forthcoming” – to which the FDA stated it could not “be any more definite about a date for a response.”
“To this day, nearly four years later, FDA has failed to take final agency action on Organic Pastures’ petition,” said the court document.
“Organic Pastures has no other remedy to force FDA to take action on its petition than to obtain a Writ of Mandamus from this Court,” it added.
Serious health risks
The FDA has long warned about the dangers posed by raw milk.
“Milk and milk products provide a wealth of nutrition benefits. But raw milk can harbour dangerous microorganisms that can pose serious health risks to you and your family,” said a recent FDA warning. “This raw un-pasteurised milk can carry dangerous bacteria such as Salmonella, E.coli, and Listeria, which are responsible for causing numerous foodborne illnesses.”
Despite the concern, some US states do still permit the intra-state sale of raw milk for human consumption.