4.1: Consumer Safety and Health

The idea of protecting the safety and health of consumers isn’t new. From the beginnings of civilization, people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813.

The revolting condition of the meat-packing industry that Upton Sinclair captured in The Jungle (right) led to a meat inspection law and a comprehensive food and drug law, now known as the Food Drug and Cosmetic Act (FDCA) of 1906. In this chapter, we will examine some of the most significant regulations, explore how regulations come to pass, and discuss the role of the Food and Drug Administration (FDA) in regulations of consumer products.

The FDA's authority to regulate products has changed over time significantly. The agency has inherited new product areas and lost others. New laws and court rulings have reshaped the FDA's powers over these product areas. Transformations in the marketplace have created new regulatory challenges. Advancements in science have provided new tools to protect the public health. At times, public health crises have compelled urgent changes, and at other times, reform has taken place slowly through a length and controlled administrative process. Through it all, FDA's steadfast commitment to protecting the public health has remained at the core of all regulatory action.

History of Regulation in the Pharmaceutical Industry

The aim of pharmaceutical regulation is to ensure objective characteristics such as safety, effectiveness, honesty in labeling, accurate reporting of side effects (if any). Regulations do not apply to subjective characteristics such as taste, color, or texture. There are no regulations, for example, that dictate all aspirin tablets to be blue in color. Most of us take quality for granted these days. It was not so long ago that substances such as cocaine could be used as ingredients in soda (Coca-Cola) or over-the-counter tonics (Wikipedia, 2016).

The FDA outlines major milestones of product regulation: www.fda.gov/about-fda/fdas-evolvingregulatory-powers/milestones-us-food-and-drug-law-history

Some of the better-known incidences and the regulations that arose, as a result, are as follows:

• The original Food Drug and Cosmetic Act (FDCA) of 1906. The FDCA is intended to prevent the sale of unacceptable foods and drugs rather than regulate safety or effectiveness.
• The Durham-Humphrey Amendment, passed in 1951, was the first federal law requiring a physician’s prescription for drugs “unsafe for self-medication.”
• The requirement that drugs are proven to be both safe and effective and is supported by "substantial evidence" is the mandate of the Kefauver-Harris Amendments.
• The Orphan Drug Act amended the FDCA as of January 4, 1983, is an act calling for incentives to companies producing orphan drugs (which may benefit only a small number).
• The Drug Price Competition and Patent Term Restoration Act, passed in 1984, made generic drugs more readily available at the same time as providing a way for manufacturers to recoup some amount of pre-patent research costs by factoring research time into the patent life of the drug
• ClinicalTrials.gov was founded in 1999 to provide the public with updated information on enrollment in federally and privately supported clinical research.

Explore!

Go here to explore more FDA law milestones. List any laws put in place after 2005. Why do you think they were put into law? Are there any unusual laws?

What Causes the Enactment of Regulations?

There are two major influences which trigger the enactment of regulations:

1. Consumer tragedy (serious injury, death) resulting from the use of a product
2. Advancements in science and technology

Once alerted to either of the above conditions, our lawmakers respond through legislation, and enforcement is assigned to the appropriate government agency. The issue of enforcement is not always clear-cut. Several agencies may enforce regulations in certain sectors – for example, GMOs, which we will discuss in a later chapter. Authority for oversight and regulation of the pharmaceutical industry, however, is quite clear - the primary agency is the Food and Drug Administration (FDA).

Explore!

Go here to learn how consumers can report problems with FDA-regulated products. Look to the Q&A on the left-hand panel - what kinds of products *doesn’t* the FDA handle?