Food and Drug Administration law, or FDA law, is the body of law that regulates food, cosmetic, and drug manufacturing and sale in the United States.
The goal of FDA law is to make food and drugs safe for public consumption.
The goal is to provide consumers with honest information about the contents of a product so that consumers can make informed choices.
FDA law also exists to regulate how food and drug manufacturers maintain the right to profit from their creations in a way that’s both fair to the company and to the public.
What Is the FDA?
The FDA is the U.S. Food and Drug Administration.
The FDA is the government agency that’s tasked with creating, implementing, and enforcing regulations that relate to the sale and marketing of food and drugs.
The FDA oversees a wide variety of products, including:
- Food
- Drugs
- Medical Devices
- Devices that Emit Radiation
- Vaccines
- Blood Safety
- Biological Products
- Cosmetics
- Animal and Veterinary Products
- Tobacco
The FDA says that its goal is to protect public health.
They say that ensuring the safety of the food and drug supply is important for national security and public health.
They say that it’s important to help the United States defend itself from attacks on the food supply from foreign and domestic sources that may wish to harm the supply.
What Does FDA Law Regulate?
FDA law regulates the way that food manufacturers and other product producers must label their products.
Essentially, FDA laws exist to make sure that consumers receive honest information about a product before they purchase and consume it.
FDA laws ban selling misbranded or adulterated foods across state borders.
As many as 25 percent of consumer products fall under the regulatory authority of the FDA.
The Development of Food and Drug Regulations in the United States
Food and drug regulation in the United States didn’t begin until the mid-1800s.
The Pure Food and Drug Act of 1906 established the Bureau of Chemistry under the auspices of the U.S. Department of Agriculture.
The Bureau of Chemistry was tasked with enforcing the Pure Food and Drug Act.
The Bureau of Chemistry became the U.S. Food and Drug Administration in 1930.
An additional Meat Inspection Act was assigned to the Food Safety and Inspection Service as a part of the U.S. Department of Agriculture.
Early legislation focused on requiring truthful labels on food and drug products.
Manufacturers are required to identify products that contain substances that the government deems dangerous including alcohol, morphine, and marijuana.
Likewise, a product can’t contain these labels if it doesn’t contain the substance.
Manufacturers must clearly state active ingredients on a product’s label.
Throughout the 20th century, lawmakers continued to pass regulations that impacted the development and sale of food and drugs in the United States.
Other major pieces of legislation include:
- Food Additive Amendment of 1957
- Delaney Clause of 1958
- Food, Drug, and Cosmetic Act of 1938
- Kefaurer-Harris Drug Amendments of 1962
- Nutrition Labeling and Education Act of 1990
Prescription Drugs
The FDA began restricting drug sales in 1938.
The FDA began focusing on drug restrictions in 1938, and the 1951 Durham-Humphrey Amendment restricted sales of certain drugs under the care of a physician or requiring a prescription.
Regulations also require testing to prove that a drug has the effect that its manufacturer claims it has.
In Alberty Food Products Co v. United States, the courts ruled that a manufacturer can’t avoid liability for making incorrect claims about a drug by simply leaving the information off the label.
The Commerce Clause
Congressional authority to regulate food and drug sales in the United States comes from the commerce clause of the U.S. Constitution.
The commerce clause gives Congress the authority to regulate activities that impact economies between states.
The courts have interpreted the commerce clause broadly.
Even if a food or drug sale that falls fully within one state might indirectly impact sales between states, the federal government has the authority to regulate it.
The FDA relies on authority from the commerce clause to broadly regulate the many types of products within their purview.
Challenging FDA Regulations
Both the FDA and product manufacturers can take to the courts to challenge and enforce FDA regulations.
In fact, an important body of work for lawyers who work in the field of FDA law is litigation that defines, challenges, and interprets regulations.
For the most part, courts narrowly define FDA regulations.
Policy Making
Lawyers who practice FDA law for the Food and Drug Administration or for the U.S. Department of Agriculture find themselves grappling with a great deal of policymaking questions.
They must strike a balance between too many regulations that can prevent a needed drug from reaching the market in a timely manner with the need to make sure that a drug is safe before the public has access to it.
For example, in the 1990s, individuals and policy groups expressed concern that too many individuals died prematurely because the FDA refused to approve potentially lifesaving drugs to treat AIDS and AIDS complications.
For lawyers who work for the government, a great deal of their work is making judgment calls about policies and about courses of action as they relate to the release of foods or drugs into the public market.
Recent Changes and the Opioid Epidemic
As companies continue to invent and market new pharmaceuticals, the regulatory nature of the FDA changes.
In 2017, the FDA charted new territory by asking Endo Pharmaceuticals to remove an opioid drug from the market because of the effects of drug abuse.
The action marked the first time that the FDA asked a drug maker to take a drug off the market because of abuse.
Conflicts Between Federal Law and State Policies
Lawyers who work in the field of FDA law often have to navigate conflicts between federal law and state policies.
A lawyer may advocate for their client’s position to navigate these conflicts.
For example, many states have laws and policies regarding marijuana that are more lenient than federal law.
A state may bring an action in a court to clarify, narrow, or try to nullify an FDA decision or regulation.
Who Practices FDA Law?
FDA lawyers practice in a variety of settings both public and private.
FDA lawyers work in private practice advising private corporations about how to comply with FDA regulations.
Private practice lawyers also help their clients litigate and attend regulatory hearings if conflicts arise.
Many lawyers also work directly for the companies that make food and drugs.
Lawyers who specialize in FDA law also work for the FDA itself.
They investigate compliance and bring enforcement actions.
FDA lawyers also work to create recommendations for lawmakers and compliance procedures in order to shape public policy on the issues surrounding FDA law.
Private lawyers may also work in a lobbying capacity.
Food and drug companies depend on lawyers to bring issues to the attention of lawmakers to ask for change.
Food and drug lobbyists help lawmakers understand why laws are flawed.
They help their clients approach lawmakers to help them understand their position and advocate for desired outcomes.
Most FDA-related lobbying takes place on a federal level.
A Large Practice Industry
Most companies that develop food and drugs work on a large scale.
They tend to look to large firms or in-house counsel to meet their needs.
Lawyers who practice FDA law gravitate towards larger law firms and government agencies instead of small firms and solo practice.
Why Become an FDA Lawyer?
Lawyers who work in FDA law have the opportunity to have a great deal of influence over the way Americans live.
The regulation of food and drugs in the United States has developed primarily in the past century.
These policy decisions have greatly impacted the way that Americans test, market, and profit from foods and drugs.
Whether a lawyer works for the FDA or on behalf of a company that makes food or drugs, an FDA lawyer has great potential to make a lasting difference in national public policy.
A career in FDA law can also be lucrative and stable for those who practice it.
Large food and drug manufacturers have ongoing needs.
They’re often constantly seeking assistance with compliance and help for enforcement actions on an ongoing basis.
Food and drug companies are often large.
Their size can mean a steady book of business for the lawyers who work in the field.
Federal FDA workers also typically enjoy steady employment with benefits.
Working Towards Food and Drug Safety
FDA law is the law with national significance.
A lawyer who practices FDA law has the potential to impact practices and policies throughout the United States.
FDA law involves policymaking, compliance, and enforcement procedures.
Lawyers in the business work to make products safe as well as accessible to the public.
Lawyers specializing in FDA law work with pharmaceutical companies, food manufacturers, and medical device companies to help them meet compliance standards and navigate the FDA approval process.