U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Inspections and Investigations
  5. Regulatory News, Stories, and Features
  6. I Am ORA
  7. I am ORA Profile: Audra Lenhart
  1. I Am ORA

I am ORA Profile: Audra Lenhart

U.S. Public Health Service Commissioned Corps Officer
Lt. Commander Audra J. Lenhart, Senior Regulatory Officer

 

Audra Lenhart
Lt. Commander Audra J. Lenhart

Hi. I’m U.S. Public Health Service Commissioned Corps Officer Lt. Commander Audra J. Lenhart. In my role as a Senior Regulatory Officer in ORA’s Tobacco Operations, I help to ensure tobacco products sold in the United States and on the market, are legally allowed, and that tobacco manufacturers and retailers are following the law and regulations designed to reduce the health burden of tobacco use for Americans.  

Tobacco application rules 

To legally manufacture, sell, or distribute new tobacco products in the United States, a premarket tobacco product application must be submitted to the FDA, and a company must receive a written marketing order from the agency before it can sell and market its product to consumers. I work to ensure tobacco companies follow the FDA’s tobacco rules by inspecting and following up with firms who have not submitted a proper tobacco application to the agency. If a tobacco application has not been submitted, and a company is marketing or selling a tobacco product, I instruct companies on how to voluntarily remove their tobacco product from the market until they come into compliance.

Tobacco compliance and routine inspections 

I also conduct compliance inspections to determine if a previously inspected tobacco firm has made corrections to violations the agency previously found. For example, I follow up with companies that have been issued a Tobacco Retailer Warning Letter and fail to promptly and adequately correct all violations, and comply with applicable laws and regulations. These violations may lead to enforcement actions, including Civil Money Penalties. Since 2009, our office has worked diligently in the field collecting the evidence needed to issue more than 670 warning letters to manufacturers, importers, and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes—all measures intended to protect Americans, including our youth, from tobacco harms.

Additionally, I conduct routine inspections of tobacco firms that have no previous compliance history with the agency to make sure they are following applicable tobacco rules and regulations.  

Tobacco products and reducing the health burden of tobacco use 

The FDA regulates all tobacco products, including any component, part, or accessory of a tobacco product. These products include e-liquids, electronic nicotine delivery systems, such as e-cigarettes and vaping products, smokeless products, such as snuff and chewing tobacco, hookahs, and cigars. During my inspections and investigations, I collect evidence when I discover any violations of the​​​​​​​ Tobacco Control Act, which is designed to reduce the health burden of tobacco use. This includes looking to see if a tobacco product is being sold to or marketed to minors, looking at tobacco warning labels, and tobacco claims, such as reduced harm claims like “light,” “low,” or “mild.”

#IAMORA  

I love my job, even with the challenges of a rapidly changing tobacco landscape. While I’m constantly learning and have to remain adaptable as the industry changes and new products are introduced, I’m up to the challenge. As a former nurse, I influenced positive health habits for patients directly impacted by tobacco use. Now, my regulatory expertise is used to increase awareness of the health risks on the population - - not just on individual users, with respect to initiation and smoking cessation.  

#IAMORA and I protect public health from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products.

Back to Top