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Q&A with Azim Chowdhury, Partner-FDA Group (Tobacco, E-Vapor, Food, Packaging) at Keller and Heckman LLP

Posted by Venus on

Q&A with Azim Chowdhury, Partner-FDA Group (Tobacco, E-Vapor, Food, Packaging) at Keller and Heckman LLP

Azim Chowdhury is nationally recognized as an expert on FDA issues as they relate to the tobacco and e-vapor industries. He represents tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance, and spearheaded Keller and Heckman’s FDA tobacco and e-cigarette practice group. Keller and Heckman LLP, founded in 1962, has a broad practice in regulatory law and related litigation and business transactions. Keller and Heckman's comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices and dietary supplements before the FDA uniquely positions the firm to guide tobacco, e-cigarette and e-liquid companies through the myriad of statutory and regulatory requirements that will soon be applicable to these products.

In the anticipation of Keller and Heckman’s *2018 E-Vapor and Tobacco Law Symposium, spoke with Chowdhury about what to expect at the second annual event.

For our readers who don’t know, can you talk a little bit about how you got into vaping law/education as a specialty?

The first time I came across a vapor product was back in 2009. While shopping at the mall, I came across a kiosk selling Smoking Everywhere cigalikes. I had been practicing law for a few years at that point and was focusing on medical devices and FDA regulations. I was immediately intrigued by the so-called “electronic cigarettes,” and started researching. When and how FDA was going to regulate vapor products was very much uncertain — the Tobacco Control Act had just become law, giving FDA the authority to regulate tobacco products, but the agency had already come out against e-cigarettes (the first time) arguing that they were unauthorized drug delivery devices. I wrote one of the first law articles on what FDA might do and how it would impact the burgeoning vapor industry for the Food and Drug Law Institute’s Update magazine (which you can findhere). I continued to write articles following the Sottera lawsuit, began speaking at conferences and attending vape expos, edited a couple of books, and quickly came to be recognized as a legal expert on vapor products.

In March 2010, I joined Keller and Heckman, a firm best known for its nationally-ranked FDA practice that includes lawyers as well as scientists, and spearheaded theE-Vapor Law Practice here. Now, we represent dozens of vapor businesses in the U.S. and around the world, including trade associations, manufacturers, suppliers, distributors and retailers in matters of federal, state and global regulatory compliance, as well as litigation, business and intellectual property issues.

This year is the second E-Vapor and Tobacco Law Symposium. Can you talk about how this year’s agenda came into play and how it changed from last year’s?

Last year we launched the inaugural E-Vapor and Tobacco Law Symposium from our offices in Washington, D.C. It was an experiment to see how this industry, which is mostly used to vape expos, trade shows and advocacy events, would react to a legal training seminar. Keller and Heckman’s well-established food, packaging and environmental practices have a long history of hosting these types of seminars, so this is right up our alley. Because the Deeming Rule had just become effective, we knew it was the right time to bring this type of event to the vapor industry to help companies understand how to stay in compliance.

With the success of last year’s Symposium, we decided to take the event “on the road” to Irvine, Calif., to reach a broader audience and make it easier for businesses on the West Coast to attend. With all the changes with the new administration, a new FDA commissioner and new policies that seem to indicate a shift in the agency’s view of these products (we hope), we are covering a lot more material at this year’s event. In addition to our Keller and Heckman experts, we are particularly excited for our guest speakers, several coming from overseas, who will be presenting on topics including good manufacturing practices, state laws, EU and UK laws, and vapor device standards.

Stepping further into that, what are some of the biggest challenges that vapers and business owners need to be aware of this year?

Companies must understand that even though the deadline for premarket applications for products on the market today has been delayed until 2022, the Deeming Rule is still in effect, and there are several fast-approaching deadlines for requirements such as ingredient reporting and HPHC testing that companies need to comply with in the meantime. We are expecting FDA to ramp up enforcement and inspections of facilities, so being prepared for that is critical. We will also be addressing the elephant in the room — Premarket Tobacco Product Applications (PMTAs) — and how companies might be able to work together to save money and submit applications to FDA.

Beyond FDA, more states are passing legislation impacting this industry, including new taxes and licensing requirements. Much of this will be covered at the Symposium. We are also seeing more companies get notices from state environmental regulators regarding how they are storing and disposing of nicotine and other hazardous chemicals. We think that is going to be a big issue in 2018 and moving forward.

Finally, if you’re looking to expand your business beyond the U.S. to the EU or Asia, we are going to have a lot of great presentations on how to do that.

Have there been any wins within the law that you’ve seen for our industry?

There have been a lot of victories at the state level by advocacy organizations such as SFATA, VTA and the Smoke-Free Associations fighting for vaper’s rights. We also had a huge victory last year on behalf of the Right to be Smoke-Free Coalition in Indiana, where we got the Seventh Circuit Court of Appeals to strike down the unconstitutional parts of Indiana’s e-liquid law (seehere). The industry should also consider FDA’s extension of the PMTA deadline as a victory that resulted from everyone’s lobbying efforts, as well as the threat from the lawsuits.

One topic we will be discussing at the Symposium is the appeal of the Nicopure and Right to be Smoke-Free challenge to the Deeming Rule, and how companies can still help with that effort.

The symposium schedule is jam packed and really looks like a must-attend event. Can you talk further about the importance of this two-day event?

I do believe this is a must-attend event for businesses who truly are interested in complying with the law and staying around for the long-term. This will also be a great opportunity to network with Keller and Heckman attorneys and other experts, as well as with other businesses. So far, we have over 100 registered attendees that include some of the biggest names in the industry, but also a lot of smaller companies who are looking to do things the right way.

*Seating is limited, but it is still not too late toregister! Keller and Heckman is also exploring options for next year’s Symposium, and may take it to the Midwest or back to the East Coast.