Marc C. Sanchez - Food Law and Regulation for Non-Lawyers

Contract In-House Counsel & Consultants, LLC, Washington, DC, USA

Marc C. Sanchez

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Readers may arrive to this textbook from a broad range of experiences and backgrounds, but we all share the common experience of food and drink . To some extent that makes us all experts in food regulations . Whether that experience is legal or regulatory or simply our daily meals and snacks we have all encountered a food label or fought a bout of mild food poisoning . We have all developed expectations about what our food should beorganic , local, or free range for exampleand maintain a keen interest in news of outbreaks or instances of new or hidden ingredients , such as pink slime. This textbook will take that experience and peel back the curtain for the reader to gain a deeper insight into the basics of the U.S. system of food safety laws and enforcement mechanisms . This text will explore both the legislative history of this system and the contours of current law and the case precedent that shapes its interpretation.

Understanding the food enforce ment agencies is vital given the size of the industry. The U.S. Food and Drug Administration (FDA ) estimates a person spends 75 cents of every dollar on a FDA regulated products (CFSAN That means consumers spend roughly 57 cents of every dollar on products they consume. Still unaccounted for are their purchases on United States Department of Agriculture (USDA) regulated meat products . As can be seen the consumer relies on the food safety system to protect a bulk of the purchases one may make. This places food law and regulation as an area of paramount importance.

In its broadest terms food law is about protecting the public. Nearly everyone in modern society relies on someone else growing or making the vast majority of the food we eat. We trust this food will not make us sick and will be exactly as declared on the label . In food we trust. This protection against harmful products in the enforcement or post-market surveillance context is known as adulteration . The safeguards against fraudulent products, those whose labels do not accurately describe what the product contains, are known as misbranded in the enforcement context. Prior to an enforcement action both are considered under a broader umbrella known as the pre-market approval process. The overarching aim remains the sameprotect the consumer. The primary mechanism to achieve this goal is to ensure the agencies tasked with enforcing food safety laws can inspect facilities and use enforcement tools to remove harmful or fraudulent products from the market. The enforcement tools also act as a deterrent. Deterrence and inspection together build trust and allow consumers to shop with confidence. The two also protect a brands reputation.

Food law also plays an important function for society as a whole. The U.S. lacked a robust system of product liability laws and enforcement for much of its history. Prior to 1906 the main power consumers wielded lay in organizing boycotts. Consumers thus could indirectly influence players in food production through the power of bad publicity, protests, and weakened sales. It is widely noted meat sales fell by nearly half following Upton Sinclairs The Jungle (FDA The new system of laws and bureaucracy added public confidence to the market by introducing an element of accountability to bad actors.

Accountability not only means responsibility to those who were directly harmed, but to those indirectly harmed or burdened by the action. Economist call such indirect costs externalities that is the ripples created from an action (See Fig. These ripples far from Jensen Farms are what the current system of laws and enforcement tools works to control.

The FDA s authority over food derives from the Food Drug and Cosmetic Act (FD&C ). The Act at the center of the FDAs authority stands at the end of a long history beginning in 1906. Understanding this history is important to gain insight into the drafters intent as to what provisions and definitions mean and how the Act should be construed. This is an exercise routinely undertaken by courts .