Tobacco Enforcement Counsel

Navigating FDA Tobacco Facility Inspections and Managing Enforcement Risk

At MyFDALawyers.com, PC, our tobacco enforcement counsel is a skilled, solutions-focused advocate for businesses. We assist companies in navigating FDA Tobacco Facility inspections, which can pose significant risks across multiple U.S. federal agencies. If you have any specific questions or concerns about tobacco regulations or enforcement, or the related regulatory obligations, we are here to help. Contact our FDA lawyers today to set up your confidential, no-obligation consultation.

Tobacco Companies are Subject to FDA Inspections

Tobacco is a major industry in the United States, with total sales expected to exceed $100 billion in 2025. It is also a heavily regulated industry. Tobacco manufacturers, importers, distributors, and retailers are subject to premarket obligations, as well as marketing, labeling, manufacturing standards, and facility inspections under the Family Smoking Prevention and Tobacco Control Act. These inspections assess compliance with restrictions applicable to regulated tobacco products, including e-cigarettes, cigars, smokeless tobacco, and novel nicotine products.

We Help Companies Manage and Navigate FDA Inspections

FDA conducts Tobacco Facility inspections both in-person and virtually (through online surveillance and examination of websites). At MyFDALawyers.com, PC, we help clients (1) understand what to expect during FDA inspections, (2) prepare, and (3) respond competently to manage the legal and financial risks. Our services include:

• Documentation Requirements: We help audit and structure internal systems to ensure accuracy, completeness, and readiness for these encounters, so that you can be prepared because all tobacco companies must maintain organized records required by FDA regulations, including product listings, labeling, ingredient submissions, and sales restrictions compliance.
• Facility Readiness: We conduct pre-inspection compliance walkthroughs to enhance facility readiness and address potential compliance issues.
• Employee Protocols: We develop tailored employee training so that staff understand (1) how to interact with FDA inspectors, (2) what information should be shared and what information can remain confidential, and (3) how to document inspection activities and to respond to inspectors.

Responding to an FDA Enforcement Action

If the FDA finds a violation during an inspection, the agency’s response will depend on the nature and severity of the violation and the company’s compliance history. It is common for FDA to issue a Form 483, a Warning Letter, or a Civil Money Penalty order. We guide clients through the response and remediation process, negotiating settlements to minimize the business impact.

Understanding the Inter-Agency Risks (Tobacco Industry)

The FDA is not the only federal agency that regulates the tobacco industry. Other agencies, such as the Federal Trade Commission (FTC), U.S. Customs and Border Protection (CBP), and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) can also participate. A compliance issue flagged by one agency can trigger investigations or enforcement actions by other agencies. We help tobacco businesses adopt a coordinated compliance strategy to reduce regulatory risks.

How Our Tobacco Enforcement Counsel Can Help

Our attorneys Bill Senior and Rick D. Quinn bring decades of FDA experience to provide proactive and personalized advocacy. We are ready to:

• Listen to your concerns and answer your questions;
• Explain your rights, responsibilities, and options;
• Assist in gathering and preparing all supporting documentation; and
• Develop a strategy focused on obtaining the best possible outcome.