Food Regulation. Neal D. Fortin

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Outraged at the conditions described in The Jungle, President Theodore Roosevelt sent his own investigators to the Chicago packinghouses. They found the situation as revolting as Sinclair had described, including witnessing a carcass falling into a latrine, being hauled back out, and put back uncleaned with the other meat.¹⁰ Even though leaders within the meat industry were ready for new rules, Congress refused to pass a bill. President Roosevelt had held back his investigators’ report, but when Congress would not act, he released the report to the newspapers. Soon Roosevelt had his bill.¹¹

On June 30, 1906, President Theodore Roosevelt signed both the Pure Food and Drug Act¹² and the Meat Inspection Act¹³ into law. Passage of these two statutes began the modern era of U.S. food regulation. While neither act could be considered comprehensive, both responded to the concerns of the day.

      The Pure Food and Drug Act added regulatory functions to the U.S. Bureau of Chemistry. The Meat Inspection Act of 1906 required the U.S. Department of Agriculture (USDA) to inspect all cattle, sheep, swine, goats, and horses when slaughtered and processed into products for human consumption. The primary goals of the Meat Inspection Act were to prevent adulterated livestock from being processed into food, and to ensure that meat was slaughtered and processed under sanitary conditions.

      1.2.3 Evolution of the Food Statutes

      Not long after passage of the Pure Food and Drug Act, legislative battles began to expand and strengthen the law. For instance, the act did not prohibit false therapeutic claims, but only false and misleading statements about the ingredients or identity of a drug. Therefore, the Food and Drug Administration (FDA) could take no action against snake oil with an illegitimate claim to cure cancer so long as the product actually was oil from snakes. In addition, leaders in the food industry called for more stringent product quality standards to create a level playing field. Members of Congress called for better safety standards and fair dealing.

However, major revision of the food law stalled until a precipitous event fell while a significant segment of the public was paying attention. Sulfanilamide, one of the new sulfa drugs, was being used effectively to treat strep throat and other bacterial diseases. To increase the palatability of the bad tasting drug, a drug company mixed the antibiotic with diethylene glycol, a sweet‐tasting liquid. The mixture was called Elixir of Sulfanilamide and shipped in the fall of 1937 (Figure 1.1). Within weeks, deaths were reported to FDA. At least 107 died in an often‐agonizing death. Many of the dead were children who received the elixir for strep throat.¹⁴

FIGURE 1.1 Elixir of sulfanilamide.

      Source: Image source: FDA.

      The manufacturer admitted it had performed no safety tests. None were required. Therefore, the company could not be prosecuted for selling a product with a poisonous ingredient. Ultimately, the company was convicted of misbranding because their product did not meet the definition of “elixir” because diethylene glycol was substituted for alcohol. The company received just a fine, and there was no jail time.

However, the tragedy spurred legislative action, and in 1938, the Food, Drug, and Cosmetic Act (FD&C Act) was enacted. The FD&C Act required premarketing approval and proof of the safety of drugs. The act also:

       extended government control to cosmetics and therapeutic devices,

       provided that safe tolerances be set for unavoidable poisonous substances in food,

       authorized standards of identity, quality, and fill‐of‐container for foods,

       authorized factory inspections, and

       added court injunctions to the previous penalties of seizures and prosecutions.

      NOTE

      1 1.1 Jamaican Ginger Paralysis. “Jake Leg Blues,” “Jake Walk Papa,” other songs from 1929 and the early 1930s lamented paralysis caused by drinking Jamaican ginger extract, commonly called “Jake.” The ginger extract typically contained 70–80 percent alcohol, and during Prohibition, some imbibed it for the alcohol. The extract avoided the alcohol prohibition by being sold as medicine. Jake Leg, a paralytic illness, was caused by intentional adulteration with tri‐orthocresyl phosphate (TOCP), added to avoid prohibition detection while producing a more palatable alcoholic beverage. However, TOCP is a slow‐acting neurotoxin. Over 1930 and 1931, this disease affected tens of thousands of Americans with estimates as high as 100,000. In 1930, the paralytic illness was traced to a single company, Boston‐Hub Products. No law required ensuring the safety of ingredients, so the company had violated no law by adding a poisonous substance. Ultimately, Hub president, Harry Gross, and his brother‐in‐law and part owner, Max Reisman, were charged with violations of the Prohibition Act and for selling “Ginger Extract USP” that differed from the USP standard. Each was fined $1,000 and given a two‐year suspended prison sentence. Jake Leg was caused by a single company, but due to the scandal, the many companies that sold ginger extract saw their market collapse and disappear. John Parascandola, The Public Health Service and Jamaica Ginger Paralysis in the 1930s, 110 PHS CHRON., No. 3, 361–63 (May–June 1995).

      The food laws continued to evolve based on the concerns and issues of the times. In the 1950s, concerns over synthetic food additives, pesticides, and cancer were high. Consequently, in 1958, the Food Additives Amendment to the FD&C Act was enacted, requiring the evaluation of food additives to establish safety. The Delaney Clause forbade the use of any food additive that was found to cause cancer in humans or animals. In 1960, the Color Additive Amendment to the FD&C Act was enacted, which required manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.

      After a number of well‐publicized outbreaks of botulism food poisoning from canned foods, the FDA issued Low‐Acid Food Processing Regulations in 1973. After deaths from cyanide placed in Tylenol capsules, FDA issued the Tamper‐Resistant Packaging Regulations in 1982. In 1983, Congress passed the Federal Anti‐Tampering Act, which makes it a federal crime to tamper with packaged consumer products.

      Throughout the 1980s, there was a growing interest in the effect of nutrition on health along with increased marketing of foods to fulfill health concerns. At the same time, food processing continued a trend toward becoming nationally distributed rather than local. Various states implemented nonuniform laws to regulate health and nutrition claims, which the national industry found hindered interstate commerce. In 1990, Congress enacted the Nutritional Labeling and Education Act (NLEA), which requires nearly all packaged foods to bear nutritional labeling. The act also requires nutritional and health claims for foods to be consistent with terms defined by the FDA.

      Then, impetus grew for enhanced food safety regulation over several years of high‐profile food recalls, foodborne illness outbreaks, and consumer advisories. In 2006, fresh spinach sickened over 200, and the fresh greens industry suffered huge losses. In 2007, nearly 2,000 pet food products were recalled due to melamine adulteration of gluten. In 2007, more than 600 people became ill from contaminated peanut butter. In 2008, imported peppers sickened over 1,400, but not before tomatoes were misidentified, causing huge losses to the tomato industry. In 2009—in what may have been the precipitating event—nine deaths and hundreds of illnesses were traced back to peanut paste from the Peanut Corporation