Dear Mr. Hochstetler:
A joint investigation by the U.S. Food and Drug Administration, the Indiana Board of Animal Health, and the Michigan Department of Agriculture, has documented violations of the Public Health Service Act (PHS Act) and a Federal regulation promulgated under the PHS Act.
Our investigation determined that your firm distributes unpasteurized raw milk and cream in interstate commerce, in finished form for human consumption. Such distribution is a violation of the PHS Act, 42 U.S.C. § 271(a), and the regulation codified in Title 21, Code of Federal Regulations (CFR), section 1240.61(a) The regulation prohibits the delivery into interstate commerce of milk and milk products in final package form for direct human consumption unless they have been pasteurized. The milk and cream you produce in Indiana and distribute to Cooperatives in Michigan and Illinois for further distribution to their Co-op members is in final package form for direct human consumption. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29,509 (Aug 10, 1987).
The above observation is not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act and implementing regulations. You should take prompt action to correct this deviation and prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice.
In addition to the violation above, we have several comments concerning the lack of labeling of your raw milk and cream products. First, we note that your raw milk and cream products do not contain labeling that specifies the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). We also note that your raw milk and cream products do not contain a principal display panel bearing a declaration of the net quantity of contents (21 CFR 101.105). Lastly, we note that your raw milk and cream products fail to have labels that declare their ingredients (21 CFR 101.4).
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to Judith A. Jankowski, Compliance Officer, at the above letterhead address. If you have any questions regarding any issues in this letter,please contact Ms. Jankowski at 313-393-8125.
Last Friday (March 26, 2010), FDA announced the following:
The FDA is collaborating with the Michigan Department of Community Health (MDCH), the Illinois Department of Public Health, the Indiana State Board of Animal Health and the Indiana State Health Department, to investigate the outbreak. MDCH reports that, as of March 24, 2010, it received reports of 12 confirmed cases of illness from Campylobacter infections in consumers who drank raw milk. The raw milk originated from Forest Grove Dairy in Middlebury, Ind.
In addition to the 12 confirmed cases in Michigan, three Indiana residents also have been infected with this Campylobacter strain.
Several readers have commented on my earlier posts regarding the risks inherent in drinking raw milk in general, and the implications of this current Campylobacter outbreak in particular.
One reader said, "Phyllis Entis' suggestions that the cowshare milk wasn't fresh because it traveled through several states is typical of the hyperbole and misstatements of the public health establishment. She ought to look at a map, and see how close northeast IL, northwest IN, and southern MI are to each other."
Another reader said, "If you are a city dweller, it is not practical and against zoning laws to keep your own horse or cow in your condo or townhome. You board your cow with a farmer in the country, and you get your rightfully owned milk secreted by your own cow."
I ran a Google mapping of the distances between Middlebury, Iowa (where the milk originated), Vandalia, Michigan (the location of the distributor) and Wayne County, Michigan (where some of the Campylobacter cases were reported. From Middlebury to Vandalia is just 29 miles; from Vandalia to Wayne County is an additional 190 miles. From Middlebury to Chicago (where some of the milk was shipped, according to the Illinois Department of Public Health) is 118 miles. That's a long way to go for a glass of milk!
A reader commented, "It is legal for anyone to possess, consume, and cross state lines with the milk. The federal law against interstate shipment only applies to milk that is in commerce, which means it has to be sold or given away. This milk was always owned by the shareholders, and it was never sold or given away."
I would point that reader to the Webster's New World Law Dictionary, which defines commerce as "The exchange of goods, materials, products, and services or the travel of people." As for interstate commerce, the same dictionary describes it as "Commerce that involves the transport of goods, materials, products, services, and people within the United States but across state boundaries."
The last time I checked, boarding an animal in exchange for money is providing a service. Milking somebody's cow for him in exchange for money is providing a service. This is commerce. When the customer is in Michigan and the supplier of the service is in Indiana, this is interstate commerce. And it comes under FDA's jurisdiction.
I have no quarrel with anyone who prefers to consume raw milk. But let's keep the discussion grounded in fact – not flimflam.
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