This research paper seeks to discus the progression of the current food legislation of the United States starting from the Pure Food and Drugs Act and Meat Inspection Act of 1906 to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The importance of discussing each law is to be able to determine the standards that are in effect and regulations that are prevailing that must be conformed to. It is important to discuss each law because there is no one single law that codifies all the standards that should be met for regulation process. In fact there is no one agency that implements the food laws of the USA.
There are several government agencies that implement the food legislation. The agencies tasked with the duties are the Food and Drugs Administration, the Food Safety and Inspection Service, and the Environmental Protection Agency. The roles of each agency as well as the laws implemented by each will be discussed in Chapter 3 of this research paper. It is important to know the roles of each agency as well as the jurisdiction of each with respect to food law in order to determine which agency is responsible for the implementation of a specific food law and which regulations are the prevailing regulations.
Chapter 2: History of United States Food Legislation 1800’s The earliest trace of food legislation in the United States can be rooted from the 1800s in the U. S. Patent Office. It all started when the Patent Office created an Agriculture Division to deal with the advances in the growing technologies in agriculture. Around twenty years later, back in 1862, the US Department of Agriculture was established, absorbing the staff of the Agriculture Division of the US Patent Office.
The responsibilities of this new office included those that belong to today’s food regulatory agencies (FDA 2007). It is in this same period (1800s) where Dr. Harvey Wiley campaigned for the enactment of federal laws to address food safety issues based on the results of his extensive research on food handling and preparation. However, due to the inability to respond quickly by the federal government, it is the local governments who first enacted such laws to address the issues of food safety.
This however caused problems for interstate food business for each state had varying requirements that should be met. In 1905, Upton Sinclair’s “The Jungle” which describes the meat condition of the packing industry was published. This is the stimulus that prompted Congressional action from the Federal Government (FDA 2007). 1906 In 1906, the first major federal legislations on food were enacted. These are the Pure Food and Drug Act and the Meat Inspection Act. Both Acts will be discussed in detail below.
Although these two pieces of legislation have been amended or have been modified by subsequent complimentary legislation, these two laws still remain to be the foundation of current food laws. The Pure Food and Drugs Act The Pure Food and Drugs Act was enacted for the purpose of the “prevention of the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes. (Section 1, Pure Food and Drugs Act)”.
According to Section 7 of the same act, the following shall be deemed adulterated in violation of the Act: In the case of food: First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength. Second. If any substance has been substituted wholly or in part for the article. Third. If any valuable constituent of the article has been wholly or in part abstracted. Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed. Fifth.
If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this Act shall be construed as applying only when said products are ready for consumption. Sixth.
If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter (Section 7, Pure Food and Drugs Act of 1906). The Pure Food and Drug Act was enacted initially merely to concern itself with the labeling of drugs and food products. This, however, eventually lead to the outlawing of certain products due to its inefficaciousness or due to the harm that it can cause to a person.
An example of this is the case of Coca Cola in United States v. Forty Barrels and Twenty Kegs of Coca-Cola (241 U. S. 265). In the above mentioned case, the issue was whether or not Coca Cola was an adulterated product due to the use of artificial caffeine which was also found to be excessive. It was also alleged in the complaint that Coca Cola is misbranded because the two medicinal ingredients originally indicated that it possessed were removed at that time.
Although the judge ruled in favor of Coca Cola, the latter was forced to settle out of court by lowering the caffeine content of their products due to the exorbitant costs of litigation. The above mentioned law was entrusted to be enforced and administered by the FDA (then Bureau of Chemistry). It mainly sought to prohibit the illegal interstate transport of food and drugs by seizing of the questionable products and/or prosecuting the party responsible. Unlike the present law, the focus of the Pure Food and Drugs Act is on the labeling of the products, rather than the premarket approval of the substances used in the products (FDA 2007).
The Meat Inspection Act This Act charged the United States Department of Agriculture (USDA) with the duty to inspect meat products and to ascertain whether or not the meat is safe and not misbranded, adulterated, or mislabeled. The responsibilities of USDA include the inspection of the animals before and after they are slaughtered, the inspection of facilities used for slaughtering and processing, the inspection of the meat products, and the approval of the product labels of the processed meat.
The above mentioned law authorized the Secretary of Agriculture to oversee and order the inspection of meat and to prevent those that are found to be unfit for human consumption from being sold or consumed. The spirit of this law is aimed towards the protection of the diet of the American people unlike the previous laws which were enacted for trade purposes with European Nations. Another important contribution of this act is the focus on the accuracy of the ingredients indicated on the label (FDA 2007).
Subsequent to the enactment of the two aforementioned pieces of legislation, the focus of food law was shifted from state government to federal government. This however did not leave the states without any role in food safety. Post 1906 Notwithstanding these two legislative enactments, several food safety issues still continued to arise. This prompted attempts to revise these laws, especially the Pure Food and Drugs Act.
The problem with the above mentioned laws is that even if they provided provisions that prohibited certain acts, they failed to specify the guidelines or requirements that should be followed for purposes of compliance. An example of this is the use of labels. The meat inspection act provides that if a person uses a label, everything stated therein must be truthful. It however made no mention about things that should be stated such as weight or measurement. It just provided that, should one decide to use a label, the contents written therein must be truthful.
It even failed to specify the mandatory things that should be stated therein. The effect of this is if there is a harmful ingredient used, the manufacturer may just opt not to put it on the label or may not attach a label at all. Another example is the failure of the 1906 statute to provide for the definition of adulterated and misbranded. This prompted the US Supreme Court to interpret these by themselves without basis from the laws (FDA 2007). 1938 Food, Drug, and Cosmetic Act
Due to the public clamor for a new law to replace the Pure Food and Drugs Act, the Food, Drug, and Cosmetic Act was enacted in 1938. This law basically emasculated the powers of the FDA and broadened the definitions of terms from the old law which, prior to the enactment of the latter law, were not sufficiently defined by statute. The provisions of the above mentioned law include the following: • the authorization of the FDA to establish identity standards for food; • the authorization of the FDA to inspect food processing facilities provided that it be done during normal working hours;
• the prohibition of false statements pertaining to food items; the prohibition of the use of misleading containers; • the broadening of adulteration and misbranding laws; • the shifting of the burden of proof in adulteration cases from the FDA to the industry; • the requiring of additional label for dietary food; and the addressing of labeling of imitation food. Basically, this law grants the FDA the authority over the production, processing, packaging, holding, and storage of food products, domestic or imported, thatare not meat, poultry, egg, or some food product of the above mentioned.
It is the FDA’s duty to ensure that the above mentioned food products are safe, fit for human consumption, and adequately labeled. The law also required the food industry to have new substances which would be made to be used in contact with the food product to be pre approved first by the FDA (FDA 2007). Post 1938 Although the Food, Drug, and Cosmetics Act and the Meat Inspection Act remained as the primary food laws, subsequent laws or amendments were enacted to address additional issues that were not covered by the above mentioned laws.
The first of which is the Poultry Inspection Act of 1957 as amended on 1968 (21 USC Sections 451-471; 9 CFR Part 381). Poultry Inspection Act Under the above mentioned law provides for the inspection of all poultry products sold in intestate commerce to ensure that they are not /deemed unfit for human consumption. The said law also provides for the reinspection of imported poultry for the same purpose as mentioned above. This law was enacted as a recognition of poultry and poultry products as an important source of the Nation’s food supply by the State (21 USC Section 351).
As such, it is essential for the interest of the public that these food products be inspected before sold to the public to assure that they are not adulterated, and properly marked, labeled, and packaged for the health and welfare of the consumers. Like the meat inspection act, the law deals with the inspection of food products to ensure that they food product to be sold is safe for consumption. Unlike the previous law however, this law concentrates on poultry and poultry products (FDA 2007). Food Additives Amendment of 1958, This was the first amendment introduced on the Food, Drug and Cosmetic Act of 1938.
The amendment exempted two groups of substances from the regulation process of additives as mandated by law. The first group is composed of substances that have been determined by the FDA or USDA as safe for use prior to this amendment. These additives are designated as prior-sanctioned substances. The other group of additives that were exempted from the regulatory process are GRAS or safe substances. These are the substances that are generally known to be safe by experts and those that are scientifically proven to be harmless such as salt, sugar, vitamins etc..
If a substance has not yet been considered as GRAS, manufactures may request the FDA to examine the substance to have it listed as GRAS (FDA 2007). Color Additives Amendment of 1960 Color additives are used in everyday items consumed by an individual. It makes things more appealing, attractive, and appetizing. It is also used to allow the consumers to identify a certain product such as the colors used in capsules to identify a certain pill. The second amendment introduced to the Food, Drug and Cosmetic Act is the Color Additives amendment of 1960.
This amendment prohibited the use of color additives that may cause cancer to the consumer regardless of the amount (FDA 2007). Fair Packaging and Labeling Act of 1966 This is the next food legislation that was enacted subsequent to the Food, Drug and Cosmetic Act of 1938. The Fair Packaging and Labeling Act (15 USC 1451-1461) is the law requiring labels to be attached on food products. It is mandated by the said law that the food products must be labeled and the label should include the following information:
1) The identity of the product; 2) The business name and place of business of the manufacturer, packer, or distributer; and 3) The net quantity of the contents of the package in both metric and U. S. customary units. Unlike the previous law which required the contents of a label to be truthful at all times if decided to be used, the Fair Packaging and Labeling Act made it mandatory for food products to use labels and also provided for the mandatory information that should be included or indicated in the label (FDA 2007).
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