In this capacity, the FDA is charged with protecting the health of the US public, to ensure the quality of its food, medicine, and cosmetics. Before this time, the United States government had no formal oversight of these products and left issues of quality and purity to the individual manufactures, or at times, individual states. This lack of regulation was not much of a concern during the early years of the country, as most people made their own goods, or purchased them from locally owned shops who would make their own products.
However, as more people moved into cities to work in factories and other urban jobs, pre-made goods were needed as city dwellers could not produce these themselves. As these types of products gained in popularity, horrific stories regarding both workplace and product safety came to light.
Over the years, the act has been expanded and modified, and today the FDA is the major government agency involved in the oversight of prescription medications, including how these are advertised to the public. A closer look at important dates in the history of the FDA provides a direct link between the claims made on medical trade cards of the past, and those featured within modern direct-to-consumer drug advertisements. Look at the timeline below to learn more about the people, legislative acts, and legal cases that contributed to the evolution of the FDA, the pharmaceutical industry, and direct-to-consumer-advertising.
Harvey W. Wiley, U. Chief Chemist Wiley became the U. Chief Chemist and expanded the U. Bureau of Chemistry's food adulteration studies. He was a staunch advocate for enacting federal regulations to ensure the quality and safety of food and medicine throughout the country. He retired from government service in and died in Prior to this Act, medications such as Mrs.
Winslow's Soothing Syrup for teething and colicky babies did not need to disclose that its product contained ingredients such as morphine and alcohol. Johnson that the Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug. The Sherley Amendment provided language that prohibited the intentional labeling of medication bottles or packaging with false therapeutic claims.
For instance, due to this amendment the FDA was able to prosecute the manufacturers of Mrs. Summary of the misbranding charges brought about by the FDA for fraudulent claims made by the manufacturer's of Mrs. Since , nearly bills had been introduced in Congress to regulate food and drugs; on 30 June President Roosevelt signed the Food and Drugs Act, known simply as the Wiley Act, a pillar of the Progressive era. The basis of the law rested on the regulation of product labeling rather than pre-market approval.
Drugs, defined in accordance with the standards of strength, quality, and purity in the United States Pharmacopoeia and the National Formulary, could not be sold in any other condition unless the specific variations from the applicable standards were plainly stated on the label. Foods were not defined according to analogous standards, but the law prohibited the addition of any ingredients that would substitute for the food, conceal damage, pose a health hazard, or constitute a filthy or decomposed substance.
Interpretations of the food provisions in the law led to many, sometimes protracted, court battles. If the manufacturer opted to list the weight or measure of a food, this had to be done accurately.
Also, the food or drug label could not be false or misleading in any particular, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine, had to be listed. The bureau's regulatory emphasis under Wiley centered on foods, which he believed posed a greater public health problem than adulterated or misbranded drugs. Wiley generally held a dim view of chemical additives to foods, championing an approach that considered most to be unnecessary adulterants.
On this he clashed often with Secretary of Agriculture James Wilson, and on occasion President Roosevelt himself had to decide government policy on food regulation. Wiley's personal administrative authority under the act was diluted early on when Wilson created a Board of Food and Drug Inspection in to establish agency policy in enforcing the law.
Similarly, the creation of the Referee Board of Consulting Scientific Experts in the following year to advise the department on safety issues associated with food additives undercut Wiley's scientific authority.
The bureau had been developing informal standards for many foods in collaboration with outside experts since , an activity that continued after the act.
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