Pharmacy

History of the FDA

3 months ago  •  Add Comment  •  by Donna Bliss

FDA Fundamentals

What is the Federal Drug Administration exactly and what is its origin? The FDA ensures that consumer-based products are safe to use. This is important most important when it comes to drugs that are constantly undergoing new research and that contain new ingredients.

Where did the FDA come from? Here’s a brief history of the FDA that shows why it’s such an important organization for modern consumer-based applications.

The FDA: A Basic History

The Beginnings of Food and Drug Regulation

Around 1848, it started becoming increasingly clear that mass-produced food and drugs needed to be regulated to keep consumers safe. This is because unregulated food meant that consumers might be subjected to consumables that could potentially make them sick. At the same time, unapproved drugs were being misbranded and consumers were unaware of potential side effects.

As a result, the federal government began using chemical analyses to ensure that agricultural products marketed to a large group of people were safe to consume. In 1862, the Department of Agriculture took over this responsibility which was eventually given to the FDA.

Although it wasn’t called the FDA at the time, the organization ensured that produce met the necessary safety standards.

The Formation of the FDA

While politicians were stumping for a law, Samuel Hopkins Adams, a journalist exposed in graphic detail the hazards of the marketplace. Almost simultaneously, Upton Sinclair, an American writer of social issues, gained visibility in 1906 with his novel The Jungle, which exposed the deplorable conditions of the U.S. meat-packing industry.

In 1906, President Roosevelt signed the Food and Drugs Act, known simply as the Wiley Act, a significant step in the Progressive era. This act, which the Bureau of Chemistry was charged to administer, prohibited the interstate transport of unlawful food and drugs under penalty of seizure and prosecution. 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.

The new law also prohibited the addition of any ingredients in foods or drugs that might 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 contain false or misleading claims and had to list the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine.

However, the following notorious cases proved the need for increased food and drug regulations:

Because of these incidents and many others, entire groups were formed to ensure safety standards regarding food and drugs. Eventually, the Bureau of Chemistry was entirely reorganized in 1927 into a foundation focused on approving these standards. This organization was called the Food and Drug Administration (FDA). And in 1937, the Elixir Sulfanilamide tragedy which took the lives of more of more than 100 people in 15 states, led to the passage of the 1938 Food, Drug, and Cosmetic Act, which increased FDA’s authority to regulate drugs.

The FDA In A Modern Era

Today the FDA still upholds and enforces the Pure Foods and Drugs Act. It exists to ensure people are kept safe and that they can consume mass produced products, knowing that they’re protected. With changing views regarding safety, the FDA now approves cosmetic products as well.

As social, legal, political & economic changes have occurred, the FDA has evolved to suit modern needs. This has also included moving their focus towards the AIDS epidemic as well as the rise in opioid usage.

Overall, the FDA strives for consumer safety. The organization is a necessity that adapts to ensure that consumers are continuously protected.

How Does the FDA Approve Drugs?

Although the Center for Drug Evaluation and Research (CDER) doesn’t test drugs, the facility does research drugs to determine which ones are safe as well as effective. The CDER is also responsible for establishing over the counter (OTC) and prescription drugs.

In order to have a drug classified as OTC, it must be approved. This can be done by submitting a new drug application (NDA) or by checking an OTC monograph. This is accomplished by looking at a list of approved ingredients to determine that the drug is safe to use. If a product matches a monograph but isn’t FDA approved, it can still be marketed commercially.

Before You Go

The FDA has been part of US history for decades and the work it does towards ensuring consumer safety is essential. For over 110 years, this organization exists to Protecting America’s Health.

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