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FDA head Dr Alexander "Mack" Schmidt rules pasteurization for all interstate milk sales in 1973

FDA head Dr Alexander "Mack" Schmidt rules pasteurization for all interstate milk sales in 1973

Intrastate raw milk sales are governed by the states, view the raw milk law map. The first raw milk bans were enacted in cities and states, starting with Chicago in 1914.

The ban on interstate raw milk sales was enacted by The FDA in 1987, following less sticky eras of prohibition, using its administrative authority granted by Congress through The Federal Food, Drug, and Cosmetic Act.

Alexander “Mack” Schmidt, MD, Commissioner of the Food and Drug Administration (FDA) from 1973 to 1976, played a formative role in banning interstate sales of raw milk. Here’s his journey:

Key events in Dr. Schmidt’s career

1960-1973: Early Career

Schmidt, a physician and public health expert, worked at the National Institutes of Health (NIH) and later became Director of the Bureau of Medicine at FDA.

1973: Appointment as FDA Commissioner

President Richard Nixon appointed Schmidt as FDA Commissioner, tasking him with addressing food safety concerns. The U.S. Public Health Service convened a conference in 1969 to address milk safety issues, emphasizing pasteurization. In 1970, FDA Commissioner Herbert Ley stated that “raw milk is a hazardous food” and announced plans to require pasteurization.

Dr Schmidt entered his role as FDA Commissioner in the midst of this existing dialogue and executed the first federal action on raw milk sales.

Milk Safety Review

Schmidt initiated a comprehensive review of milk safety, considering scientific evidence, public health risks, and industry practices.

Proposal to Ban Raw Milk Sales

Schmidt proposed a rule to ban interstate sales of raw milk, citing concerns about milk-borne diseases like tuberculosis, brucellosis, and salmonellosis.

Public Hearings

The FDA held public hearings, allowing stakeholders to provide input. Schmidt considered comments from dairy farmers, processors, consumer groups, and public health experts.

March 1973: Final Rule

Schmidt issued the final rule (38 FR 3586) requiring pasteurization of milk and milk products in interstate commerce, effectively banning raw milk sales.

1973-1976: Implementation and Enforcement

Schmidt oversaw implementation and enforcement of the rule, working with state and local authorities to ensure compliance.

Differences between the interstate ban of raw milk sales in 1987 vs the order of 1973

The 1987 ban differed from 1973 in several ways:

  1. Statutory Authority: The 1987 ban was enacted through the FDA’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA), whereas the 1973 ban was enacted through the FDA Commissioner’s rulemaking authority.
  2. Regulatory Language: The 1987 ban was codified in the Code of Federal Regulations (21 CFR Sec. 1240.61), providing clearer and more specific language regarding the prohibition.
  3. Exceptions: The 1987 ban included exceptions for:
    • Cheese made from raw milk, aged at least 60 days
    • Raw milk used for processing into pasteurized products
    • Intrastate sales (within a state)
  4. Enforcement: The 1987 ban strengthened enforcement by:
    • Increasing penalties for non-compliance
    • Authorizing FDA inspections and seizures
    • Requiring record-keeping and labeling
  5. Public Comment and Hearings: The 1987 ban followed extensive public comment and hearings, ensuring stakeholder input.
  6. Scientific Justification: The 1987 ban cited updated scientific evidence on milk-borne disease risks.
  7. State and Local Involvement: The 1987 ban encouraged state and local authorities to adopt similar regulations.
  8. International Trade Implications: The 1987 ban considered international trade agreements and potential impacts.

The 1987 ban built upon the 1973 foundation, providing clearer regulations, stronger enforcement, and updated scientific justification.

Industry groups involved

The mandate for milk pasteurization leading to the ban on interstate sales of raw milk in 1973 was supported by various groups, including:

  1. National Milk Producers Federation (NMPF)
  2. International Dairy Foods Association (IDFA)

Some notable figures also opposed the ban:

  1. Senator George McGovern (D-SD): Advocated for raw milk sales.
  2. Representative Steve Symms (R-ID): Opposed federal overreach.

How farmers feel about the interstate raw milk ban

Opinions range depending on the concerns and ambitions of the farmer. Some larger raw milk farms are chomping at the bit to stock shelves nationwide. Some have a more modest vision, but would like the option to sell across their state’s border which might be just a few miles away.

Some farmers who are established in states, whose needs are met through intrastate commerce, might prefer the effectively protectionist barricade across state lines.

More about Dr Alexander “Mack” Schmidt

From The FDA

Alexander McKay Schmidt, the tenth person to head the modern FDA (7/20/1973 – 11/30/1976), was born in Jamestown, North Dakota, in 1930. He received a Bachelor’s degree from Northwestern and earned an M. D. from the University of Utah in 1955. After spending two years in the army, Schmidt returned to the University of Utah College of Medicine as a member of the faculty. From 1967 to 1968 he became an administrator of the Regional Medical Program of the National Institutes of Health, then he was appointed to a deanship and faculty post at the University of Illinois College of Medicine in Chicago.

HEW Secretary Caspar Weinberger appointed Schmidt Commissioner of Food and Drugs in July 1973. Under Schmidt, the agency pursued a wide range of initiatives, including the banning of red dye no. 2, increased attention to patient package inserts for prescription drugs, the early phase of the over-the-counter drug review, comprehensive medical device legislation, the institution of a policy board, and the formalization of administrative regulations. In addition, the agency was buffeted by frequent congressional hearings into a variety of operations and policies.

Schmidt left FDA in November 1976 and returned to Illinois, where became vice chancellor for health affairs. In 1987 he was named chair of the University Hospital Consortium in Oakbrook Terrace, Illinois, a consulting group for academic health care institutions. Schmidt died in 1991.

Sherwin Gardner, deputy commissioner from 1972 to 1979, acted as commissioner on three separate occasions, for a total of approximately 12 months, between the tenures of Charles Edwards, Alexander Schmidt, Donald Kennedy and Jere Goyan.

The Gerald R. Ford Presidential Library & Museum has a collection of Alexander M. Schmidt’s papers, which include documents related to his time as Commissioner of Food and Drugs ¹. These papers cover topics such as food and drug regulatory policy, the drug approval process, and food safety.

Obituary in the Chicago Tribune: Alexander Schmidt, 61, Activist FDA Chief in `70s (archive)

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