Overview of Food and Drug Law

Every product regulated by the U.S. Food and Drug Administration (FDA) must meet exacting requirements under the Federal Food, Drug, and Cosmetic Act. These rules govern safety and efficacy testing, labeling accuracy, and manufacturing standards across product categories from prescription drugs to packaged foods.

When a product is mislabeled, adulterated, or sold without proper premarket approval, the FDA can take swift enforcement actions. For consumers, the consequences can mean unexpected health risks. For businesses, violations can bring inspections, warning letters, and costly recalls.

Because the stakes are so high, individuals and companies need experienced legal guidance. A food and drug law attorney can help you respond effectively before small problems become major liabilities.

What Is Food and Drug Law?

As interstate commerce grew in the United States, a need for federal regulation on food and drug safety also grew. The first federal law to address this need was the Pure Food and Drug Act of 1906. This was the era when Upton Sinclair’s classic novel, The Jungle, brought to light unsanitary and dangerous conditions of the meat-packing industry.

This law was just the first step. In 1927, the Bureau of Chemistry was renamed to the Food, Drug, and Insecticide Administration. This organization eventually became the FDA that we are familiar with today. The FDA regulates most food and food ingredients sold. It also heavily regulates all pharmaceutical products, both those requiring a prescription and those sold over the counter (OTC).

The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) was enacted to regulate public health by overseeing a broad range of products’ safety, efficacy, labeling, and marketing. Under the FD&C Act, the FDA must ensure that drugs, devices, and other regulated products are both safe for consumers and effective for their intended uses.

Adulterated products are those contaminated or improperly manufactured, posing health risks. A product is misbranded when the labeling or packaging is false, misleading, or incomplete. A food is adulterated if it’s produced under insanitary conditions or contains harmful substances. Cosmetics are adulterated if they contain poisonous or decomposed substances, are unsanitary, or use unsafe containers.

The Role of the Food and Drug Administration (FDA)

The FDA, part of the U.S. Department of Health and Human Services (HHS), is entrusted with protecting and promoting public health. It also plays a critical role in advancing regulatory science and facilitating innovation in medical products. It ensures consumers have accurate, science-based information to support informed use of medical products and food.

A primary function of the FDA is to approve new drugs and medical devices before market entry. In addition to product regulation, the FDA performs inspections of manufacturing facilities.

When violations are reported or identified, the FDA may take several action:

• Request a recall if a product is found to be unsafe or mislabeled
• Issue warning letters for serious violations
• Leverage enforcement tools to address biologics or promotional practices violations, including “untitled letters” for less severe infractions

How Are Foods and Drugs Regulated?

The FDA requires drug manufacturers to submit a New Drug Application (NDA) demonstrating safety and effectiveness before marketing a new drug.

A landmark piece of legislation impacting drug regulation is the Kefauver–Harris Amendments of 1962. These drug amendments established that pharmaceutical manufacturers must prove a drug’s effectiveness, not just safety, before marketing it. These amendments also established that drug manufacturers must obtain informed consent for patients participating in clinical trials.

Drug products like medical devices are regulated based on risk classification:

• Class I devices are general products that are exempt from premarket regulatory processes
• Class II devices require premarket notifications
• Class II devices are subject to rigorous premarket approval processes.

The 1976 Medical Device Amendments established this classification system, enhancing the FDA’s regulatory authority over device safety and effectiveness. Foods with additives and dietary supplements are regulated with safety evaluations.

Manufacturing Standards

A large responsibility of the FDA is regulating drug manufacturing standards. Current Good Manufacturing Practice (CGMP) regulations ensure that drugs are consistently produced and controlled to meet quality standards.

Violation of CGMP results in the drug being considered adulterated under the FD&C Act. The FDA can request voluntary recalls or enforce seizures or injunctions when CGMP violations occur.

Medical devices are subject to Quality System Regulation (QSR), which outlines the requirements for design, manufacturing, packaging, testing, installation, and servicing.

Dietary supplements and cosmetics comply with GMPs specific to that industry under the Dietary Supplement Health and Education Act of 1994 (DSHEA). While not FDA-approved, cosmetics must also meet basic GMP and safety standards to avoid adulteration or misbranding.

Post-Marketing Standards

The FDA uses the FDA Adverse Event Reporting System (FAERS) and MedWatch to collect and monitor trends in drug safety and device issues post-approval.

Sponsors must report serious or fatal adverse drug events within 15 days and other events quarterly. MedWatch also encourages voluntary reports from health professionals and consumers.

Outside parties can report regulatory misconduct. The FDA conducts inspections and may issue warning letters, recall requests, or civil enforcement actions across product categories. Enforcement aims to address safety threats and ensure compliance, including in cases of misbranding, adulteration, or manufacturing violations.

Understanding Product Labeling and Marketing Rules

Accurate product and food labels are essential for protecting consumer safety. Clear, easy-to-understand nutrition labeling helps consumers make informed decisions. It helps to prevent harmful misrepresentations, such as overstating benefits or overly downplaying risks.

Food labels must include:

• A statement of identity
• Net quantity
• Manufacturer’s name and address
• Ingredient list
• Nutrition facts
• Allergen declarations in the information panel

Over-the-counter medication labels must clearly display the active and inactive ingredients, drug uses, warning statements, and dosage instructions for safe use. Labels must also comply with regulatory format and organization regulations.

Prescription drugs must have labeling that includes the recommended dosage, method, and timing. The label must also include usage warnings.

Cosmetic products are required to comply with specific labeling regulations. The label must clearly identify the product, manufacturer, or distributor details, net quality, and ingredients. If there are appropriate warnings, these must also be included. Ingredients must be listed properly, with trade secrets petitions where applicable.

Misbranding and Misleading Claims

A misbranding is when a product has false, misleading, or incomplete labeling. Unapproved claims are prohibited in the promotion of drugs or medical devices. These are claims that haven’t been preapproved before being used in marketing.

Terminology is crucial in FDA regulatory enforcement. Prescription drug marketing must adhere to a “fair balance” approach, meaning the benefits and risks must be equally displayed.

Your Legal Rights as a Consumer

Individuals have the right to shop for consumer products without fear. The food supply should be safe for consumption. If someone is harmed by a defective, contaminated, or mislabeled product, they have a right to seek recovery.

Practical Next Steps

There are several steps consumers can take to protect themselves and their rights:

1. Preserve the product and packaging from the item that causes the injury. Do not return it to the store where it was bought or to the manufacturer. Do not throw it away.
2. Seek medical care and document everything (labels, receipts, lot numbers, photos of injury/packaging).
3. Reported the incident to the FDA. In some situations, there may need to be a larger investigation that could result in a recall to prevent injury to others.

Speaking with a lawyer is helpful in understanding the next legal steps and developing a strategy. If a product injures a large number of consumers, then a class action lawsuit may be more appropriate. A law firm will represent all similar claims in a single legal action to aggregate the claims.

When To Speak with a Food and Drug Law Attorney

If you’ve suffered an injury from a product, speaking with a lawyer can help you protect your right of recovery. The sooner you speak with a lawyer, the better they are able to help you gather and preserve evidence.

A lawyer can help you determine the best path for pursuing recovery by identifying relevant claims. Once hired, an attorney can draft the necessary pleadings and advocate on their client’s behalf. Counsel can help assess whether claims should be brought individually or as part of a class action.

For companies that must comply with FDA regulations, early attorney involvement helps reduce liability and penalties. Legal guidance helps structure proper premarket filings, ensure compliant manufacturing systems, and train staff on post-market obligations.

Find Legal Help

Hiring a lawyer can help you understand the key FDA rules, your rights as a consumer, and why legal counsel is often critical when navigating this complex area of law.

Use the Super Lawyers directory to find a lawyer knowledgeable in food and drug laws.