Hearing Wrap Up: FDA Must Eliminate Red Tape, Promote Innovation to Root Out Illicit Products and Restore Trust in the Agency 

WASHINGTON—Today, the House Committee on Oversight and Government Reform held a hearing on “Restoring Trust in FDA: Rooting Out Illicit Products.” During the hearing, members exposed how the U.S. Food and Drug Administration (FDA) stumbled from crisis to crisis during the Biden Administration, failing in its core mission. Bureaucratic red tape, inefficiencies, and weak oversight have led to a surge in harmful products, food safety violations, and counterfeit drugs infiltrating the legitimate supply chain. Members praised the Trump Administration for taking action to ensure FDA adheres to its mission and Make America Healthy Again and pledged to work with the administration to further this goal.

Key Takeaways:

The FDA stumbled from crisis to crisis during the Biden Administration, failing in its core mission. Bureaucratic red tape, inefficiencies, and weak oversight have led to a surge in harmful products, food safety violations, and counterfeit drugs infiltrating the legitimate supply chain.

• Guy Bentley, Director of Consumer Freedom at the Reason Foundation, testified how the FDA’s regulatory bottleneck is allowing illicit products to flood the market: “Under the current FDA regulatory landscape, it is easier to introduce a new cigarette to the market than an e-cigarette, nicotine pouch, or heated tobacco product, all of which the agency acknowledges are safer alternatives to smoking […] “Thanks to the FDA’s regulatory bottlenecks, illicit products have flooded the market to satisfy demand, with almost 90% of e-cigarettes sold being illegal, mainly consisting of disposable products from China. There are around 18 million adult vapers, accounting for a third of all tobacco and nicotine users. Facing few satisfying choices in the legal market, adult vapers are opting to purchase products that are unregulated and unaccountable to the FDA.”

• Shabbir Imber Safdar, the Executive Director for the Partnership for Safe Medicines, testified how counterfeit medicine poses a threat to public health and safety, which has only worsened since the COVID-19 pandemic: “Counterfeit medicines pose a significant threat to public health and safety, and to our national security. Unfortunately, counterfeit medicines have been around almost as long as medicine, but its growth has been dramatically rising over the past several years due to increased volumes of drugs, longer supply chains, drug shortages, technological developments making it easier to counterfeit drugs, and the involvement of international organized crime […] During the COVID-19 pandemic, Americans moved their purchasing power to e-commerce platforms at an accelerated rate, including buying unverified and counterfeit medicines from unlicensed sources.”

• Chairman James Comer (R-Ky.) stated in his opening statement, “President Biden’s FDA pushed burdensome gender identity requirements on clinical trials that made compliance more expensive. They turned a blind eye to the Chinse Communist Party targeting our children by flooding our streets with illicit tobacco and nicotine products. They neglected infant formula facility inspections that led to mothers and fathers across the country being unable to buy the formula their children needed. And they failed to work hand in hand with U.S. Customs and Border Protection to root out illicit pharmaceuticals, food, tobacco, and CBD. We are facing a national epidemic of chronic disease, mental health, and obesity and the FDA under the previous administration sat on its hands.”

• Jonathan Miller—General Counsel at the Hemp Roundtable and Partner-in-Charge at Frost, Brown, Todd—testified about the consequences of FDA’s failure to issue consistent guidelines for the U.S. hemp industry: “Unfortunately, lack of uniform quality control standards for hemp products at the federal level has forced responsible farmers and small business owners to compete against unscrupulous actors who generate headlines by distributing poorly manufactured products that are sometimes inappropriately marketed to children and can be confusing to adults. Reports persist of Chinese manufacturers selling purely synthetic cannabinoids – those that have no relation to the hemp plant – in the marketplace, endangering public health and safety.”

The FDA must regain the trust of the American people and put their health, not bureaucracy, first. This includes reducing red tape and barriers to innovation to ensure the agency adheres to its mission.

• Dr. Richard Williams— Board Chair at the Center for Truth in Science and Senior Affiliated Scholar with the Mercatus Center—testified that FDA must focus on regaining the trust of the American people and produce results: “Rather than using its regulatory authority to exercise the maximum amount of control over a massive amount of the economy, the FDA must refocus on regaining the trust of the American people. To do so, the FDA needs to take advantage of advances in technology and focus on their programs that achieve real results. We have been increasing funding for food safety and nutrition for decades and not getting the results consumers should expect. It is time to demand results but results, such as making food safer, have not been demanded of FDA.”

• Guy Bentley, Director of Consumer Freedom at the Reason Foundation, emphasized the need to streamline approvals for safer alternatives to tobacco: “Streamlining the PMTA process is the safest and most effective way to achieve a coherent marketplace that protects youth while offering adult smokers safer nicotine alternatives and disrupting the illicit market. Application costs should be radically reduced, and reviews must be completed within the statutorily mandated 180 days. These goals can be achieved within the bounds of the TCA as presently structured.”

• Dr. Richard Williams also testified that cultural changes are needed to improve FDA’s outcomes: “In addition to making the United States more competitive in world trade, particularly against our enemies, the answer is to reshape the FDA’s culture and programs. This will require the agency to focus on research and sharing information on best practices, encouraging invention and innovation, rethinking their approach to regulations, and focusing on targeted risk-based compliance. These sweeping cultural changes within the agency and Congressional oversight of FDA’s outcomes will do much to restore America’s faith in the FDA.”

• Jonathan Miller—General Counsel at the Hemp Roundtable and Partner-in-Charge at Frost, Brown, Todd—stated: “We are hopeful that new leadership at the FDA will reverse the past course of inaction and take deliberate action leveraging their current authorities to robustly regulate hemp products. This issue is precisely in line with the new Administration’s focus on providing adult consumers the freedom to make health care choices on behalf of their own families, with holistic solutions that are grown on American farms.”

President Trump and his administration are taking decisive action to Make America Healthy Again and Congress will work alongside them to further this goal.

• Chairman James Comer (R-Ky.) stated in his opening statement, “Thankfully President Trump and Secretary Kennedy are taking action to Make America Healthy Again. Soon after his return to office, President Trump signed an executive order removing unscientific pseudoscience compliance burdens for clinical trials. FDA recently restarted approvals of safer alternatives to traditional tobacco products, and I’m hopeful more will come soon to bring greater clarity to the market. Secretary Kennedy announced Operation Stork Speed which will provide families with access to safe infant formula for their babies and prevent shortages going forward. And President Trump’s efforts to re-secure the southern border have returned law enforcement’s ability to stop the influx of illicit pharmaceuticals, food, tobacco, and CBD coming into the country.”

Member Highlights:

Chairman Comer discussed with an expert witness how the FDA has failed to approve safer tobacco and nicotine alternatives, which has created a thriving market for unsafe products.

Chairman Comer: “The FDA’s refusal to approve new tobacco products created a thriving market for illegal and unsafe products, often from China. These products are often targeted at children. What should FDA be doing to prevent these illicit Chinese products targeting our kids?”

Mr. Bentley: “FDA have set up a multi-agency Task Force is particularly the partnership with DOJ and CBP to try and track and halt the importation of products from China, but at the end of the day this will be nothing really more than a bandage, unless its own internal processes can be reformed, which also, fortunately, don’t require more staff or more funding.”

Additionally, Chairman Comer discussed with an expert witness how the Biden FDA failed to prevent the infant formula crisis.

Chairman Comer: “Mr. Williams, this Committee investigated the infant formula crisis extensively last Congress and found several failures at FDA including a failure to encourage competition and resiliency in the market. Can you talk through how the FDA failed to prevent the crisis and what needs to be done to improve competition and resilience to ensure such a crisis never happens again?”

Mr. Williams: “Yes, one of the main problems, particularly with supply, was that we would have manufacturers write to FDA and say, ‘we’re thinking about getting into the infant formula business.’ FDA would respond with, ‘please, don’t.’ They wanted to keep the number of suppliers down to six, and they did that. So consequently, when we had one plant that had a problem—that actually had been investigated—when it had stopped production, that’s when we hit a huge supply problem. But there was one other problem […] when FDA passes regulations on infant formula, that raises the price of infant formula for people who can’t get it for free. And what happens is less well-off consumers extend the infant formula with water, and there’s nothing more dangerous than the primary source of nutrition being extended with water for infants.”­

Rep. Glenn Grothman (R-Wis.), the chairman of the Health Care and Financial Services Subcommittee, discussed with an expert witness how special interests are increasing bureaucratic red tape and driving up food costs.

Rep. Grothman: “Americans have been grappling with high inflation, especially food inflation, during the Biden Administration. Grocery prices rose 22%. Would you simplify the FDA’s food regulatory structure to lower prices, and can you give me some examples of what could be done?”

Mr. Williams: “Yeah, I believe that is exactly what I would do. I think a lot of the problem with FDA food regulations, from my expertise, and it really is now going on over 40 years and I continue to look at it, is that too many of FDA’s regulations were not being made because it was going to keep food safer or because it was going to help nutrition. A lot of it is because of some firms controlling FDA, saying ‘we want regulations to put our competitors at a disadvantage.’ All those regulations have to be complied with, and all of that compliance by those firms raises prices. They don’t pay for the regulations. This is a big misunderstanding, particularly in FDA.”

Additionally, Rep. Grothman discussed with expert witnesses how providing safer alternatives could increase Americans’ life expectancy.

Rep. Grothman: “America does spend a great deal on medicine, and a lot of that is on drugs. Nevertheless, our life expectancy seems to be less than other developed countries. Can you comment on that?”

Mr. Bentley: “Congressman, my expertise is basically in tobacco policy, but I will say that an easy way to increase life expectancy and reduce cancer is have more authorized, safer alternatives to cigarettes onto the market, which FDA has been stymying for the last five years.”

Mr. Miller: “I would just add that when it comes to holistic products, products made from American agriculture, like hemp, these give alternatives to the pharmaceuticals, that a lot of Americans find tremendous relief in. We should be promoting them, but we should also, and as I’ve been saying, regulate them strictly.”

Rep. Scott Perry (R-Pa.) discussed how the U.S. has the lowest life expectancy in the developed world despite spending the most on pharmaceuticals. He also questioned witnesses about the importance of domestic manufacturing of critical medicine.

Rep. Perry: “The average life expectancy for the average American is 78 years despite spending more than every other developed country that has an expectancy of 82 years. Six in 10 Americans have at least one chronic disease. More than 40% of American children are suffering from at least one health condition.”

Rep. Byron Donalds (R-Fla.) criticized the Biden Administration for its bureaucratic approval process, which allowed illegal vaping products to flood the market to meet consumer demand.

Rep. Donalds: “To be clear, I’m not against Americans who want to use vaping products or tobacco products. I think it is important for the American people to understand that the previous administration did not do the job of making sure that there were products on the shelf where they could clearly understand what they were consuming or ingesting. And then you have products like this [illegal vape] that have hit the shelves in the United States, primarily because the previous administration was derelict in their duty and making sure that they were approving applications of companies in America who could supply the demand from the American consumer.”

CLICK HERE to watch the hearing.