FDA Boxed in on Interstate Ban

For some time now, enforcement on the interstate ban of raw milk and raw milk products by the United States Food and Drug Administration (FDA) has looked to be an exercise in futility (only raw cheese aged 60 days or more is legal in interstate commerce). Thousands of otherwise law-abiding citizens violate the ban in this country on a regular basis. FDA has stated that it will not enforce the ban against individuals transporting raw milk across state lines for their own consumption; to the FDA, it is dangerous when someone is transporting raw milk for consumption by a group of people but is somehow safe when it is only for an individual.

FDA’s last enforcement action against a raw milk producer, concluded over five years ago, has not deterred demand; more consumers want raw dairy products than ever. FDA has never publicly acknowledged that the ban has been a failure but once again it has the opportunity to do so and respect consumer freedom of choice. There are currently two petitions before FDA on the regulation (21 CFR 1240.61) establishing the interstate ban—one filed by Organic Pastures Dairy Company (OPDC) and the Farm-to-Consumer Legal Defense Fund (FTCLDF) and the other filed by the Real Food Consumer Coalition (RFCC). Repeal of the interstate ban is long overdue; granting of the two petitions would be a significant step toward making that a reality. No matter what FDA decides, it is going to have to answer once again why it has not repealed a law that does not work.

On June 22, 2016, FDA received a petition from OPDC and FTCLDF requesting that FDA lift the interstate ban on raw butter. FDA’s only response to date has been a December 13, 2016 letter stating it needed more time to reach a decision on the petition. Federal law requires that FDA respond to a citizen petition within six months of its filing; unfortunately, the courts regard a statement from the agency that it needs more time as a satisfactory response.

More than anything the raw butter petition is a request to FDA that the agency obey the law; in establishing the raw butter ban, FDA violated and continues to violate the Federal Food, Drug, and Cosmetic Act (FFDCA). The FFDCA contains a statute governing standards of identity for foods. Standards of identity are requirements prescribing what a food product must contain to be marketed under a certain name in interstate commerce. For instance, the standard of identity for milk in final packaged form requires that it be pasteurized or ultra-pasteurized and that it contain not less than 8.25% non-fat milk solids and not less than 3.25% milkfat.¹ FDA’s long held position is that the pasteurization requirement can be part of the standard of identity. Standards of identity are intended to promote honesty and fair dealing for the benefit of consumers.

Congress has given FDA power to issue regulations establishing standards of identity for most foods, but there are exceptions and one of those is butter. The FFDCA specifically prohibits FDA from establishing a standard of identity for butter; Congress has passed a law defining butter that serves as a standard of identity for the product. That definition does not require butter to be pasteurized. The petition asks FDA to abide by the statutory standard of identity and to stop breaking the law in the name of the law.²

FDA justifies the ban on the grounds that it has the power to regulate communicable disease, a claim the federal government’s own statistics show has no foundation. If raw butter can be banned under this power, just about any other food could be, as well. The citizen petition notes that since the Centers for Disease Control (CDC) created the Foodborne Outbreak Online Database in 1998, not even one foodborne illness outbreak has been attributed to the consumption of commercially produced raw butter.³ There is one 2007 outbreak in Utah where homemade butter was listed as a possible cause for an outbreak as were raw milk and homemade soft raw cheese; given butter’s food safety history, it is likely that the milk or cheese was the cause.

The irony is that possibly more than any other raw dairy product, consumers purchase raw butter for its health benefits. FDA can do better than violate the law by banning a product that doesn’t make people sick.

The RFCC petition, sent to FDA on April 26, 2017, requests that:

“FDA exercise its enforcement discretion to avoid taking, and to cease taking, enforcement action against those who distribute unpasteurized milk and milk products in interstate commerce when the milk products bear labels that include in conspicuous bold face type prominently displayed on the statement of identity for the product: (1) a warning regarding the health risks of unpasteurized milk and milk products; and, when applicable, (2) instructions for safe handling, including self-pasteurization.”⁴

There is a precedent for the warning label requirement; another regulation, 21 CFR 101.17(g) requires that there be a warning label with a specific statement for juice that has not been pasteurized. The warning label and safe handling statements are intended to provide information and education to the consumer to address FDA’s concern that the agency needs to protect people from themselves.

The petition notes that the request it is making is in line with presidential executive orders issued earlier this year to reduce the regulatory burden on a Regulatory Reform Task Force that is required “at a minimum” to identify regulations that “eliminate jobs, or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency. . .”⁵ The quote is a good description of the interstate raw milk ban.

The RFCC consists of members of some of the bigger food buyers clubs around the country obtaining raw milk, including many mothers who will do whatever it takes to access the foods they believe best for their children’s health, even if that means violating ill-conceived regulations banning foods they have a legal right to consume.

The two petitions are pushing FDA to reevaluate the ban and do the right thing by repealing it. It is time for the FDA to honor freedom of choice and get rid of a regulation a federal judge once described as being in a state of “desuetude,”⁶ a word meaning “not being used.” A law not worth enforcing is not worth having on the books.

FTCLDF Code of Regulations states that a goal of the organization is “overturning the federal regulation banning the interstate shipment of raw milk (and raw milk products) for human consumption.” That day is getting closer. Thanks to  your support, FTCLDF and other raw milk advocates are winning this battle. Help us continue our push towards ending the ban by attending our fundraiser or by making a donation.

Footnotes:
¹ Farm-to-Consumer Legal Defense Fund. Raw Butter Is a Communicable Disease. June 23, 2016. Posted online at https://www.farmtoconsumer.org/blog/2016/06/23/raw-butter-communicable-disease/
² Mark McAfee and Farm-to-Consumer Legal Defense Fund. Citizen Petition to Lift Interstate Ban on Raw Butter. p. 5 Posted online at
https://www.farmtoconsumer.org/wp-content/uploads/2016/06/1-CitPetFDA-Butter-062216-1.pdf
³ Centers for Disease Control and Prevention. Foodborne Outbreak Online Database. Posted online at https://wwwn.cdc.gov/foodborneoutbreaks/
⁴ Emord & Associates. Citizen Petition to Exempt from 21 C.F.R. § 1240.61(a) Certain Unpasteurized Milk and Milk Products if Properly Labeled. Posted online at http://hartkepr.com/wp-content/uploads/2017/05/2017-4-26-RFCC-Petition-GoFundMe.pdf
⁵ Ibid.
⁶ Judge Mark Bennett. Memorandum Opinion and Order Regarding Plaintiffs’ Motion to Amend Judgment. May 1, 2012. [PDF]