By Ricardo Carvajal -
A fight that started as a citizen petition asking FDA to permit the interstate sale of raw milk under limited circumstances is now being waged in federal court. In 2008, raw milk advocates and the Organic Pastures Dairy Company ("OPDC") petitioned FDA to amend the regulatory ban on interstate sale of raw milk to incorporate the following exception:
Raw milk that is tested, state inspected, state regulated, carries a “government warning statement” and labeled for retail sale in one state may be transported to another state if that other state allows the sale of raw un-pasteurized milk and or dairy products.
Last December, OPDC sued FDA to compel a response to the citizen petition. On February 26, 2013, FDA denied the citizen petition in emphatic terms, and subsequently filed a motion for judgment on the pleadings based on a number of affirmative defenses (lack of standing, ripeness, and failure to state a claim upon which relief can be granted). OPDC responded by filing a motion to amend its complaint to address those issues. The court granted that motion, and dismissed FDA’s motion for judgment on the pleadings as moot. OPDC recently filed an amended complaint alleging that FDA’s denial of its citizen petition is arbitrary and capricious in part because FDA has taken no action to ban the interstate sale of other foods, including pasteurized milk and produce, associated with outbreaks that have sickened or killed many consumers.
In the interim, FDA has deployed other tools to advocate its position, including a consumer advisory on the dangers of raw milk. FDA’s campaign received support from the CDC, which issued its own consumer advisory. CDC staff also partnered with state health agency staff to publish a report on a recent outbreak of foodborne illness linked to raw milk produced by a dairy with a state-issued unpasteurized milk permit and “minimal deficiencies identified during inspection” – illustrating, in the words of the authors, “the ongoing hazards of unpasteurized dairy products.” Some states have been clamping down on efforts to circumvent their restrictions on the sale of raw milk (see here). Not surprisingly, outbreaks linked to raw milk have also drawn the interest of the plaintiffs’ bar (see here).