Criminal Exposure Under the FDCA and Controlled Substances Act: Defending Against Allegations of Manufacturing or Distributing Dangerous Substances
Federal authorities have significantly intensified their efforts to investigate and prosecute individuals and companies involved in the illicit manufacturing or distribution of hazardous substances. These efforts frequently focus on violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA).
Whether you are a Florida physician, pharmacist, business owner, chemical supplier, or someone else caught in the government’s crosshairs, being investigated under either statute can lead to serious criminal consequences, including lengthy prison sentences and substantial fines.
At Trombley & Hanes, our Tampa criminal defense attorneys defend individuals and businesses facing high-stakes federal investigations or indictments. Understanding the government’s approach to these prosecutions is essential to protecting your rights and future.
Understanding the FDCA and CSA: Two Powerful Federal Statutes
The FDCA was enacted to protect the public from adulterated or misbranded drugs, medical devices, and cosmetics. It gives the U.S. Food and Drug Administration (FDA) broad authority to oversee and regulate the safety and labeling of products distributed in interstate commerce.
Violations of the FDCA can become criminal when they involve intentional misbranding, false statements, or the introduction of harmful products into the marketplace.
The CSA is designed to regulate controlled substances by categorizing drugs and chemicals into different “schedules” based on their potential for abuse and medical use. The law applies to manufacturers, distributors, and medical professionals and includes strict licensing, reporting, and handling requirements.
Unlawful production, possession, or distribution of substances such as fentanyl, oxycodone, or methamphetamine can result in severe penalties, especially when the government alleges intent to distribute or involvement in a criminal conspiracy.
When allegations involve counterfeit pills, misbranded substances, or unlawful prescribing or dispensing, federal prosecutors may pursue charges under both statutes. These investigations often involve multiple agencies, including the DEA, the FDA’s Office of Criminal Investigations, and U.S. Attorneys’ Offices.
Who Is at Risk of Criminal Charges?
The targets of FDCA and CSA investigations are not limited to street-level dealers.
Increasingly, federal agents focus on:
- Physicians, pharmacists, and pain management clinics are suspected of unlawful prescribing or dispensing.
- Chemical suppliers are accused of providing precursor substances used to manufacture fentanyl-laced pills.
- Companies involved in the import or distribution of misbranded or unapproved drugs.
- Online pharmacies and telehealth platforms are operating outside regulatory compliance.
Even legitimate businesses and licensed professionals can become involved in enforcement actions when regulatory requirements are misinterpreted, poorly documented, or not followed properly. Once a criminal investigation begins, it can escalate quickly, especially if investigators believe a public health risk is involved.
Building a Strategic Defense Against Serious Allegations
Federal drug and healthcare prosecutions are highly complex and aggressively pursued. At Trombley & Hanes, our Tampa criminal defense attorneys understand the unique challenges of FDCA and CSA cases. We evaluate each client’s circumstances to identify early defense strategies, challenge overbroad or unsupported charges, and protect their rights at every stage of the investigation and trial process.
Our team includes former federal prosecutors who understand how these cases are built and how to dismantle them. Whether negotiating with the government, challenging expert testimony, or preparing for trial, we aim to minimize your exposure and secure the best possible outcome.
If you are being investigated or have been charged under the FDCA or Controlled Substances Act, contact Trombley & Hanes at 813-229-7918 or online for a confidential consultation. Early intervention is critical. Let us use our experience and insight to help you.
