Why Is Clotted Cream Illegal in the U.S.? – Unveiled Reasons

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Clotted cream, an esteemed dairy product traditionally associated with British culinary practices, has found its way into various international markets. However, its presence in the United States has been notably constrained due to stringent regulatory frameworks governing dairy imports and food safety. This discourse aims to elucidate the underlying legalities that render the sale and importation of traditional clotted cream illegal in the U.S., examining the implications of such regulations on both consumers and potential importers. The exploration will include an analysis of relevant food safety laws, with a particular focus on pasteurization requirements as mandated by federal agencies.

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What is Clotted Cream?

Clotted cream, scientifically referred to as “clouted cream” in certain regions, is a thick, rich dairy product characterized by its high-fat content, typically in the range of 55% to 64%. This cream is produced predominantly in the southwest of England and is integral to British tea-time traditions, often served with scones and jam. The production of clotted cream involves the indirect heating of unpasteurized cow’s milk which then cools slowly for several hours, allowing a thick layer of cream to rise to the surface and “clot.”

This process not only imparts a distinctive texture and flavor but also positions clotted cream in a unique category within dairy products, distinguishing it from butter, whipped cream, and other cream derivatives. The traditional method of production, which eschews pasteurization prior to the clotting stage, is pivotal in achieving the desired consistency and flavor profile associated with genuine clotted cream.

The legal importation and sale of clotted cream in the United States are impeded primarily by regulations enforced by the Food and Drug Administration (FDA). The FDA stipulates rigorous standards for the safety of all dairy products entering the U.S. market, prominently featuring requirements for pasteurization. Under these regulatory provisions, the FDA mandates that all milk and cream, whether domestic or imported, must undergo pasteurization as a safeguard against pathogens potentially harmful to public health.

Given that traditional clotted cream is made from unpasteurized milk, its standard production method does not comply with FDA requirements. The pasteurization law, codified under the Pasteurized Milk Ordinance (PMO), aims to minimize health risks associated with raw milk products, which include a higher susceptibility to bacterial contamination, such as that from Mycobacterium bovis, Listeria, and E. coli.

In addition to pasteurization mandates, the importation of clotted cream is further complicated by labeling and standard identity regulations, which ensure that all dairy products sold in the U.S. conform to predefined compositional standards. As clotted cream does not have a designated standard of identity under U.S. law, any deviation in its traditional production process aimed at compliance with FDA regulations may lead to a product that legally cannot be labeled as clotted cream.

Consequently, the strictures imposed by U.S. food safety laws have significantly restricted the availability of authentic clotted cream, influencing both the market dynamics and consumer accessibility to this quintessentially British dairy product.

Pasteurization and U.S. Dairy Laws

The legal framework governing the pasteurization of dairy products within the United States is anchored in an array of federal regulations and guidelines, primarily enforced by the Food and Drug Administration (FDA). The Pasteurized Milk Ordinance (PMO), which sets forth these requirements, mandates that all milk and milk-derived products distributed commercially must undergo pasteurization. This statutory requirement aims to eradicate or significantly reduce the presence of pathogenic bacteria, thereby enhancing the safety of dairy products for public consumption.

The PMO defines pasteurization as the process of heating every particle of milk or milk product, in properly designed and operated equipment, to one of the temperatures specified in the ordinance and held continuously at or above that temperature for at least the corresponding specified time. Variations in this process, such as ultra-pasteurization or ultra-high temperature (UHT) processing, further underscore the FDA’s commitment to mitigating public health risks associated with the consumption of raw dairy products.

Implications for Import and Sale

The rigorous enforcement of pasteurization laws has significant implications for the importation and sale of dairy products like clotted cream, which traditionally is made from raw milk. The FDA’s stringent requirements preclude the entry of such products into the U.S. market unless they conform to the safety standards prescribed. This effectively bars the import of authentic clotted cream from regions where it is traditionally made using non-pasteurized methods, unless it undergoes pasteurization prior to import, which aficionados argue would compromise its authenticity and quality.

For distributors and retailers within the U.S., this creates a considerable barrier. The legal inability to import traditional clotted cream not only limits product offerings but also affects market competition and consumer choice. Importers and sellers may face legal repercussions, including fines and sanctions, if they attempt to bypass these regulations.

Given the constraints imposed by U.S. dairy laws, stakeholders in the dairy industry have explored various alternatives and legal substitutes to traditional clotted cream. One approach has been the local production of clotted cream using pasteurized milk compliant with FDA standards. While this method adheres to safety regulations, some consumers note differences in taste and texture compared to the traditional product.

Additionally, manufacturers may market products under names that evoke the essence of clotted cream without claiming the traditional label, such as “cream spreads” or “thickened creams.” These products are designed to mimic the texture and flavor of clotted cream but are made with legally compliant ingredients and processes.

Furthermore, technological advancements in dairy processing have led to the development of treatments and additives that can simulate the qualities of clotted cream while ensuring compliance with FDA regulations. These innovations provide consumers with safer alternatives, although purists might still prefer the original product made through traditional methods.

In conclusion, while the U.S. dairy laws restrict the availability of traditional clotted cream, they also foster a market for innovative substitutes that meet legal standards, thereby ensuring public health safety while attempting to cater to consumer preferences for specialized dairy products.


In sum, the prohibitive status of traditional clotted cream in the United States underscores a broader regulatory ethos that prioritizes public health and safety through strict adherence to pasteurization laws. These regulations, while restrictive, are emblematic of the FDA’s mandate to minimize health risks associated with the consumption of raw milk products. Consequently, the market adaptation in the form of domestically produced or modified products that comply with these legal standards, while not identical to their traditional counterparts, reflects an equilibrium between regulatory compliance and consumer demand for specialty dairy products.


Can clotted cream be made legally in the U.S.?

Yes, clotted cream can be legally made in the U.S. using pasteurized milk, adhering to all relevant FDA regulations, though it may differ slightly from traditional British clotted cream in taste and texture.

Are there any legal consequences for importing traditional clotted cream into the U.S.?

Yes, importing traditional clotted cream that has not undergone pasteurization can lead to legal penalties, including fines and import bans, as it violates FDA regulations.

What are some legal substitutes for traditional clotted cream available in the U.S.?

Legal substitutes include pasteurized versions of clotted cream produced domestically, as well as other products like cream spreads or thickened creams that simulate the texture and flavor of traditional clotted cream.


  1. Food and Drug Administration (FDA). “Grade ‘A’ Pasteurized Milk Ordinance (PMO) – M-I-03-4: Questions and Answers on Pasteurization Requirements of the PMO.” FDA, 2021.
  2. U.S. Department of Agriculture (USDA). “Dairy Programs – Milk Safety.” USDA, 2021.
  3. International Dairy Foods Association. “Regulations and Guidance on Dairy Imports/Exports.” IDFA, 2021.
  4. Smith, J. & Davis, R. “Dairy Technology: Advances in Milk Processing.” Journal of Dairy Science, 2020.
  5. National Center for Biotechnology Information. “Public Health Impacts of Raw Milk and Raw Milk Products.” NCBI, 2019.

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