Educate Before you Regulate

Dr. Robert Califf, the commissioner of the U.S. Food and Drug Administration (FDA), recently testified before the U.S. House of Representatives Energy and Commerce Committee on the agency’s priorities and budget for the upcoming fiscal year. During his testimony, he touched on tobacco regulation and the coming release of the characterizing flavor rule, which should spark concern among premium cigar manufacturers, retailers, and enthusiasts. 

One of the key issues with Dr. Califf’s testimony is the apparent hypocrisy in regulating tobacco products. On the one hand, he acknowledges that “enforcement is a key issue” and that the FDA is “moving into an era where enforcement is critical.” Yet, he also advocates for “educating before regulating” and expresses concern about the due process taking too long. Independent experts have been critical of the FDA’s regulating-before-educating mentality and speeding up the rule-making process, claiming it doesn’t lead to more inclusivity, especially regarding public participation. It is still being decided if he intends to forgo the proper due process to speed up enforcement, if he plans to work with the Department of Justice (DOJ) more closely to speed up delays, or if he intends to have the FDA enforce rules themselves.  

Dr. Califf also said, “… we are seeing supply chain issues and shortages in every industry we regulate except tobacco and vaping,” which is misleading and inaccurate as it relates to premium cigars. The premium cigar industry has been affected by supply chain issues, including the pandemic-related delays in shipping and production and the changes in workforce patterns due to the pandemic. This statement is even more questionable as Dr. Califf later admits that the agency lacks detailed data on supply chains.  

In addition, Dr. Califf’s comments on the upcoming summit with the Justice Department on the Reagan Udall Foundation reports “all government issue” raises concerns about the influence of government entities on the FDA’s decision-making process. The FDA desperately needs better oversight by Congress, not joining forces with other government agencies to expand power and authority. It wasn’t the congressional intent for the FDA to have the power it currently yields now, let alone an expansion of powers that diminishes the agency’s accountability. 

In conclusion, Dr. Califf’s testimony raises serious concerns about the FDA’s path forward, its views on the regulatory process, its vision for handling problems within the agency, and its fundamental understanding of regulated industries. The agency must take the time to educate itself and the public on the actual impacts of regulations before rushing to implement them. The premium cigar industry is a vital part of the economy. It should not be subject to arbitrary regulations that could harm its businesses, national economies, and consumers.  

19m50s to 21m Tobacco discussion  

31m20s “Educate before you regulate” Dr. Califf  

42m17s “Enforcement is a key issue. We are seeing supply chain issues and shortages in every industry we regulate except tobacco and vaping” Dr. Califf  

42m35s Upcoming summit with the Justice Department on the Reagan Udall Foundation reports ‘all government issue’ 

43m10s (FDA is) moving into an era where enforcement is critical  

47m30s Potential restructure to enforcement to still have due process. Califf complained that the due process takes a long time and he is concerned about fentanyl in vape products 

48m20s Califf confirms that CTP and FDA are on track to finalize flavor rule August of 2023  

52m40s Supply chain issues in every sector except tobacco  

1h1m Representative Carl – Flavored tobacco – Illegal market, and cross border sales due to otp and sales tax, why not with flavored products?  

1h3m Flavor ban will strengthen cartels – Rep. Carl 

1h10m “People assume we (The FDA) have a lot of detailed data on supply chains, we do not” Dr. Califf  

1h15m “Take things one step at a time, and educate before you regulate” Dr. Califf  

1h37m “Make a commodity unavailable to the public and that’s a real risk with some of these idealistic views, would actually make it impossible to have an industry that produces a product” Dr. Califf