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Does the FDA Do More Harm Than Good?

Is it time to shut down the FDA?

Just days after the Food and Drug Administration released a report acknowledging its failings in the baby formula shortage, a group of former FDA employees and policy experts gathered at an InsideSources roundtable to debate the question. Dr. Richard Williams, who spent 27 years working on food safety at the FDA, said he was surprised by his own answer.

“Maybe we can make more progress if we break it up.”

It is not just formula-seeking families frustrated by the FDA’s performance.  The agency, which regulates 20 percent of the U.S. consumer economy, has been at the center of some of the biggest public policy fiascos of the past five years. Critics say it needlessly delayed the rollout of COVID testing in the early days of the pandemic. Its bureaucracy has slowed the progress of potentially life-saving drugs to market. It has misinformed smokers about the benefits of switching from combustible cigarettes to alternatives like vaping. And a new investigation by Politico found that, despite having the word “food” in its name, the FDA is routinely failing at keeping unsafe foods off the market.

Williams, an economist with the Mercatus Center at George Mason University, is the author of  “Fixing Food: An FDA Insider Unravels the Myths and the Solutions.” He said that even as the FDA’s performance has lagged, its budget has soared — more than doubling between 2010 to 2021 to $6.4 billion. And in the face of its recent fumbles, the agency is asking for another 30 percent budget hike. Worse, said Williams, the FDA is using its recent failings to support its requests for more money, claiming they need more resources to enforce more regulations.

“I was working on infant formula in the early 1980s when the Infant Formula Act was passed,” Williams said. “And I asked, ‘Why are there only six firms making infant formula?’ The answer was, ‘We discourage anybody else from coming into the market. We don’t want more plants to inspect, so we don’t have as much control.'”

“And how many firms are in the infant formula market today? Six.”

Chalfont pediatrician Dr. Marion Mass sees the same issue.

“This shutdown unmasked an even bigger problem — there are so few baby formula plants in the United States that a single shutdown can have major consequences, as we’ve been seeing,” she wrote for the New York Post. “That doesn’t mean we need new legislation mandating more baby-formula manufacturers and plants. In fact, the right answer is that we need less government, not more.”

Mass, who is with the group Free2Care, told DVJournal the FDA is supposed to make sure food and drugs are safe. However, with many drugs or their precursor chemicals being manufactured in China, the FDA is less able to be vigilant.

“Among the most striking effects of the overhead built into the annual national cost of our dysfunctional healthcare system, has been the outsourcing to China of the manufacture of many pharmaceuticals and medical supplies used here at home,” she said. “The effect on the quality of the supplies in America’s medicine chest has been alarming. Shortages and contaminated products are chronic and constitute a slowly unfolding healthcare crisis for the United States.”

Panelist Jack Kalavritinos, a health communications expert who has worked at both Health and Human Services and the FDA said the core issue is leadership. “Leadership matters and specific changes need to be made.”

“Right after the public health emergency was called for in January [2020] the FDA put out an odd blog,” said Kalavritinos. “It talked about how COVID tests should be limited and how there should be less authority for the private sector through expedited approval processes.”

When that was brought to HHS Secretary Alex Azar’s attention, “the secretary stepped in, he overruled that [FDA guidance], and thus began the process of unleashing the private sector,” Kalavritinos said. “It makes the point that a federal agency, at a key moment in time, should not be making policy and law through a blog post.”

And lack of leadership was part of the baby formula shortage failure, he added.

“When you shut down a plant like this, the new FDA commissioner should literally drive over to the West Wing — and bring the HHS deputy secretary with you — and say, ‘If we work fast, it will still take months to get this factory back online. But if we don’t take extraordinary actions, there will be shortages.'”

“That takes leadership, and that didn’t happen,” Kalavritinos said.

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An Open Letter From Ex-Smokers to Tobacco Control: You’re Killing Us. Literally

I smoked for 41 years and then finally quit smoking with vaping more than eight ago. I’ve owned and operated a vape shop for nearly seven years, helping more than 2,000 people in my small community to quit smoking with the help of flavored vapor products.

And I have a message for the Food and Drug Administration and its “Tobacco Control” allies: Your treatment of vaping is killing people. And you need to stop Tobacco Control, by which I mean the legislatures, regulatory bodies, policymakers, academia and research, the public “health” lobby groups and, of course, a complicit media. I’m painting all of you with the same brush because, from my perspective, all that matters is the end result.

You’ve trained the public to despise smokers. You even trained us to despise ourselves. And now you want to do the same again for vaping? Why?

Why would you want to prevent smokers from moving off a deadly, lifelong addiction to vastly safer vaping? Why would you put up barriers? Is this what you would want for your friends, your family?

You tax, punish and segregate us from the rest of society. You pass laws against us, not for us. Your only “Tobacco Control” message? Quit, or die.

And so smokers die, 480,000 of us every year.

Your policy and regulatory response to vaping is deadly, bald-faced prohibition; your loudest voices are chilling in their utter disdain for our lives; and your prevailing narrative on nicotine vaping is nothing short of a fairytale.

Thanks to regulators at the federal and state level, vape shops and the independent vapor industry are being systematically eliminated and our products banned. We are being driven back to smoking by the very people we entrusted to help us to quit. And we are dying.

FDA regulatory authority over electronic cigarettes ultimately stems from the Tobacco Control Act. Electronic cigarettes don’t contain tobacco, yet you apply a greater regulatory burden on vapor products used for cessation than that applied to deadly tobacco products themselves. The message to the public? Quitting smoking with vaping is more dangerous than smoking.

That is a deadly lie.

The result is people like me who use vaping to quit smoking face a hostile public. Our friends and family have been misinformed and whipped into a moral panic. Other businesses and industries are being pressured by regulation and a misinformed public to sever ties with independent vapor and vape shops, to carpet-bomb our supply chain, and to convince the public we are addicting and killing their children. National campaigns now depict us as monsters, selling depression sticks to children.

You lie, you mock mental illness and depression. You deter people from quitting smoking and force those of us who’ve quit back to smoking. And you’ve increased cigarette sales for the first time in two decades. That did not need to happen, COVID, or no COVID.

Few, if any, of the people in Tobacco Control have ever set foot in a vape shop. They appear to have no idea what we do. Yet, you are eliminating us and our products and are sending our clients back to smoking and dying.

Thousands of vape shops like mine are currently the human face of tobacco harm reduction in this country, providing the products, personal service and support currently keeping millions of Americans smoke-free. We’re not just an industry selling a product; we are a community working together, helping millions to quit smoking, and we do it far better than you ever have and ever will.

Electronic cigarettes are proven safe and effective cessation products employed by hundreds of millions of consumers over the last 18 years with no significant harm and have reduced both adult and youth smoking rates.

The scientific and statistical evidence, the consensus of the world’s experts and the global population experience of millions of successful ex-smokers suggest that vaping can be easily, safely and inexpensively regulated with a set of common-sense manufacturing and marketing standards, coupled with the message that vaping is for old guys like me to quit smoking, not for young people to start. Put me on your anti-vaping posters and watch youth use disappear. Standards that we’ve been begging for as an industry, for years.

If you can’t see that, I think you’re in the wrong business. If you’re focused on the mythical harms of an equally mythical youth vaping epidemic, you’re definitely in the wrong business. If you think the public benefits from taxing, banning, restricting and lying about the most effective and popular means of smoking cessation ever devised, you need to get out of our way because we are saving lives and you are now taking them.

The bottom line: Tobacco Control has become a clear and present danger to public health.

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STROUD: National Consumer Protection Week Underscores Need for Harm Reduction

The Biden administration has recently declared the week of March 6-12 as National Consumer Protection Week. In its declaration, the administration remarks that “it is important that consumers are fully informed about their rights and the potential risks in the marketplace.”

While the declaration specifies certain consumer issues including “price gouging, stealing money, harvesting personal information,” as worth addressing, there is one major consumer category that has not been afforded the same type of transparency in the name of consumer protection: tobacco harm reduction.

Despite killing half of their users, combustible cigarettes remain for sale across the country. And despite decades of public health campaigns raising awareness of the dangers caused by smoking, an estimated 34.1 million American adults continue to smoke to this day.

While public health groups only promote medical treatments and/or the failed “Quit or Die” approach to helping smokers quit, numerous tobacco harm reduction products, including e-cigarettes, smokeless tobacco and snus, and heated tobacco products have emerged over the past two decades. The products offer adult consumers access to nicotine without the harmful effects associated with combustible cigarettes.

Decades of research indicate that it is the smoke in combustible cigarettes — not nicotine — that causes the most harm. Combustible cigarettes contain nearly 600 different ingredients and when lit on fire produce more than 7,000 chemicals. Tobacco harm reduction products offer consumers nicotine without the deadly smoke.

Despite this, many manufacturers and even retailers are prohibited by federal law from relaying the public health consensus of the reduced harms of tobacco harm reduction products to adult consumers.

In 2016, the Food and Drug Administration deemed several products as tobacco products, including e-cigarettes and other novel products. Under these deeming regulations, all products introduced to market after 2007 must have submitted applications to the FDA by September 2020 to currently be sold legally in the United States.

Per the deeming regulations, no manufacturer and/or retailer may claim that e-cigarettes (or other novel tobacco products) are less harmful than combustible cigarettes, unless they are issued an order by the FDA. This is despite the fact that numerous public health groups have found e-cigarettes to be less harmful.

In 2015, a landmark report by Public Health England found e-cigarettes to be “around 95 percent safer than smoking.” The agency reiterated the reduced harm finding in 2018. In 2016, the Royal College of Physicians declared that vaping is “unlikely to exceed 5 percent of the risk of harm from smoking tobacco.” In 2018, the National Academies of Sciences, Engineering, and Medicine found that “using current generation e-cigarettes is less harmful than smoking.”

Again, retailers and manufacturers of such products are not allowed to pass along this information to consumers.

Deeply problematic is that the National Consumer Protection Week’s announcement comes six months after the FDA issued market denial orders to nearly 1 million e-cigarette products, while the agency continues to stall on authorizing any of the remaining premarket tobacco product applications.

Consumers not only should be informed of less harmful tobacco alternatives but these products ought to be promoted, not subject to draconian regulatory processes that have effectively shut out more than 99 percent of the market. The costs associated with a premarket tobacco product application are estimated by the FDA to be “in the lower to mid hundreds of thousands of dollars.”

This NCPW, consumers ought to retake the very technology they created to solve the smoking problem, and the federal government should lessen regulatory burdens that harm consumers of tobacco harm reduction products.

Follow us on social media: Twitter: @DV_Journal or Facebook.com/DelawareValleyJournal.