Page 92 - Summer2008

The licences with independent tests come back • When there is an outbreak, test raw milk

committee • negative and no one is getting sick. products rst, and test them in the home
When there is an outbreak, use food ques-
setting rather than from the shelf. If a per-
needs to be tionnaires that leave out likely vectors of son is infected and has handled a raw milk
aware of the disease but always include raw milk. In a product, the product will test positive for the
double recent outbreak in Pennsylvania, one mem- organism. Omit testing other foods or raw
milk products on the shelf (not handled by
ber who got sick reported receiving a call
standard from the health department. The department the consumer) but report a positive lab result
applied to wanted to know whether she had drunk raw for the raw milk product. This method has
raw milk milk. She replied that she hadn’t but that she been used to implicate Mexican style raw
milk cheese in numerous reports.
suspected undercooked chicken from a local
compared to restaurant. But once she replied negatively • Omit subjects who got sick but did not drink
other foods. to the question on raw milk, the department raw milk. The 2001 Wisconsin outbreak
was not interested in pursuing the question- cited on the CDC website is a good example
ing further, not interested in tracking down of this. People who got sick but did not drink
the chicken. raw milk were not admitted to the hospital

CALIFORNIA & OPDC FEDERAL GRAND JURY INVESTIGATION

One example of FDA’s now more active role against raw milk can be seen in the agency’s activities carried out in
California. In 2004 from April 5-9, FDA conducted an inspection of Organic Pastures Dairy Corporation (OPDC) in Fresno,
California. Through that inspection and the subsequent investigation, the agency determined that OPDC was distributing
unpasteurized milk and milk products in interstate commerce for human consumption. On February 24, 2005, the agency
sent a warning letter to Mark McAfee (CEO of OPDC) warning him that such distribution was in violation of federal law
[21 CFR 1240.61]. The law prohibits unpasteurized milk and milk products in final package form in interstate commerce
for human consumption; however, there is no prohibition on raw pet dairy products in interstate commerce. McAfee
responded to the warning letter by sending the agency a copy of the labels he intended to affix to unpasteurized dairy
products shipped in interstate commerce. The labels indicated that the products were for “cat or dog food only.” The
agency answered McAfee’s response by referring him to an FDA guidance document on marketing a pet food product.
The document stated that “there is no requirement that pet food products have premarket approval by FDA.” The agency
had no other response to the labels McAfee submitted; in effect FDA gave its tacit approval for OPDC to proceed with
shipping raw dairy products in interstate commerce with the new labels. FDA did not tell OPDC that the company must
drop all out-of-state customers known to be purchasing for human consumption nor did it tell OPDC to verify whether
future customers were purchasing for pet consumption only. Nor did FDA tell the dairy that it would be violating the law if
it sold product labeled for pet consumption to out-of-state customers when it had knowledge that those customers would
be using it instead for human consumption.
On March 19, 2008 (more than three years after responding to FDA’s warning letter), Mark discovered that OPDC
was the subject of a federal grand jury investigation, an investigation instigated by FDA and centered primarily on the
company’s sale of raw pet dairy products in interstate commerce. On that day, two OPDC employees, who had earlier
received subpoenas to testify before a US District Court grand jury in Fresno, were paid a visit at their homes by two FDA
special agents from the agency’s Office of Criminal Investigations. The agents questioned the employees about the dairy’s
sale of raw milk and colostrum in interstate commerce (colostrum can legally be sold in interstate commerce as a dietary
supplement for human consumption). The agents asked one of the employees to wear a wire; the employee refused.
Mark responded to the news of the investigation by contacting David Gumpert who, in turn, posted a story about
the grand jury investigation on his blog (www.thecompletepatient.com), “Of Nighttime Agent Visits, Phone Tapes, and Se-
cret Wires: Now OPDC Is Target of a Grand Jury Investigation into Raw Milk” (March 20, 2008). Shortly thereafter, Mark’s
attorneys contacted the US Attorney’s office in Fresno offering to share documents and other exculpatory evidence in an
attempt to dissuade the US Attorney from continuing the grand jury investigation. Apparently in response to the offer, the
US Attorney cancelled the grand jury testimony of the two employees and temporarily suspended the proceedings of the
grand jury. As of this time, the grand jury remains suspended.
It appears that FDA is trying to have Mark prosecuted for misbranding under the Federal Food, Drug and Cosmetic
Act. “Misbranding,” in this case under FDA’s apparent interpretation of the law, would be knowingly selling products for
human consumption that were labeled for pet consumption only. What is unjust about FDA’s action is that in 2005, it made
it apparent to McAfee that he was in compliance with the law as long as he labeled his products for pet food only.
90 Wise Traditions SUMMER 2008