The Complete Patient

You’d think that after taking nearly four months to answer a few questions posed by Michigan Sen. Carl Levin about the Family Farms Cooperative (FFC) case, the federal Food and Drug Administration (FDA) would at least provide some clarification.

Instead, it only seems to have added to the regulatory and legal confusion around the matter. Here are some key bones of contention:

--Terminology. The FDA in its two-page response to Sen. Levin refers alternately to the “sale” and “distribution” of raw milk . Early on in its letter, it refers to its “activities in enforcing regulations governing the interstate sale of raw milk,” and then concludes by saying it “prohibits the sale of unpasteurized milk…in interstate commerce.” The reason that terminology is so important to FFC is that the co-op argues its use of cow share agreements for co-op members makes the transport of raw milk from Indiana to Michigan a fulfillment of a lease agreement rather than any kind of “sale.”

--The question not answered. Sen Levin inquired about the status of the FDA’s investigation of Indiana farmer David Hochstetler, who provides the FFC’s raw milk and requested that it “provide information regarding the timeline, procedures, and appeal rights under this process.” The FDA’s response explains that it investigated Hochstetler at the request of the Michigan Department of Agriculture (MDA) and that it issued a warning letter that “requests that Mr. Hochstetler notify FDA in writing, within 15 working days, of the specific steps he has taken to correct the noted violations…” But interestingly, nothing is said about “appeal rights under this process.” Maybe because there are no appeal rights?

--Cow-share agreements. A third source of confusion comes from the FDA’s failure to offer any insights into its attitude about cow-sharing agreements. In answer to a question from Sen Levin of whether “the FDA previously investigated interstate cow-sharing agreements,” the agency cites two cases—Dee Creek Farms in Washington and Double O Farms in Kentucky. But in neither case does FDA offer any insight into its views about how cow-share agreements mesh with prohibitions on raw milk in interstate commerce, except by inference—if we investigated them and wrote warning letters, we feel they’re wrong.

So if you thought that by taking its time, the FDA would offer insights, you were wrong. Just more of the same, including its throwaway about ensuring that “people living in Michigan and Indiana are protected from the dangers of raw milk.”