DV Journal

Advertisers sometimes stretch the truth. But small-business owner Ketan Vakil got in trouble for the opposite reason: He wanted to put correct information about his meat broths and spice blends on product packaging.

His New York company, Gourmend Foods, uses ingredients that are low FODMAP, an acronym for difficult-to-digest sugars. People with sensitive stomachs look for low FODMAP options when they shop, so Vakil decided to make things easy.

He designed labels that clearly and accurately described the contents as “low FODMAP.” The claim is not just slick marketing. Vakil’s products are laboratory tested and independently certified as low FODMAP.

No one disputes the fact. Yet, when Vakil expanded his product line to include beef broth, the Department of Agriculture forced him to remove any mention of FODMAP from the label. He could not even say “digestible” or “gut-loving.” The USDA also alerted the Food and Drug Administration, which has jurisdiction to regulate Vakil’s chicken broth and seasoning mixes.

Packaging for these products already included the “low FODMAP” claim. Now Vakil must worry about an FDA crackdown. The reason has nothing to do with truth in advertising.

Regulators ban using “low FODMAP” and similar language on food labels because federal agencies follow an outdated list of preapproved “nutrient content claims.” No one can call any product “low FODMAP,” regardless of the ingredients, until the government catches up with consumer demand and expands its menu of permissible descriptions.

Vakil and his customers cannot wait. Tens of millions of citizens suffer from digestive disorders, including Vakil. He started his business in 2021 to fill a market gap after spending years searching for low FODMAP options for himself. Finding packaged foods with the information he needed proved difficult, he developed his recipes and eventually launched Gourmend Foods. That’s when he discovered the problem was government censorship, not market resistance.

Rather than accept the restrictions on his speech, Vakil and Nevada customer Michelle Przybocki fought back with a First Amendment lawsuit filed in March 2023. Our public interest law firm, the Institute for Justice, represents them.

The case hinges on the constitutional right to convey truthful, factual, verifiable information without government permission.

The war on FODMAP labeling is just one example of abuse. Regulators tried to stop Florida creamery owner Mary Lou Wesselhoeft from calling her skim milk “skim milk” in 2014. They said she had to call it “imitation” skim milk, ironically because she refused to add artificial vitamins. Wesselhoeft had to go to the 11th Circuit Court of Appeals to defeat the government censors.

Daniel Staackmann, the founder of plant-based food company Upton’s Naturals, fought his own First Amendment battle in Mississippi. State lawmakers, acting at the behest of the meat lobby, told him in 2019 he could not call his veggie burgers “veggie burgers.” He could not call his meatless hot dogs “meatless hot dogs.” And he could not call his vegan bacon “vegan bacon.” The state did not back down until Staackmann sued in federal court.

A similar feud has continued for years over the right of plant-based milk producers to use the word “milk.” Actress Aubrey Plaza sided with Big Dairy on April 20 when she starred in a satirical ad for “wood milk.”

The backlash from her fans was swift. For now, at least, they can continue buying plant-based milk products with accurate and easy-to-understand labels. Draft guidance from the FDA, released in February, rejects the dairy industry’s push to criminalize common terms like “almond milk,” “coconut milk,” “soy milk” and “oat milk.”

This conclusion should never have been in doubt. Like low FODMAP foods, the First Amendment is easy to digest. The underlying concept is simple: Businesses have a right to tell the truth, and customers have a right to hear it.

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How can Americans lead healthier lives?

Solutions include reforming the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), along with replacing cigarette smoking with safer nicotine delivery systems.

InsideSources recently hosted the “Common Sense Public Health Roundtable” at the National Press Club in Washington, D.C., where three public health professionals laid out simple solutions that could pack a real public health punch.

“I would replace the FDA’s human food program, and I would replace it with something that would give both producers and consumers a better choice,” said Dr. Richard Williams. “And that would address food safety and nutrition problems that are plaguing us.” Williams, author of “Fixing Food: An FDA Insider Unravels the Myths and the Solutions,” worked at the FDA for nearly 30 years. “We treat FDA like it’s a revered institution when in fact, it’s like an old company that’s selling outdated products.”

The FDA is 117 years old, Williams noted, and “things are going on that they can’t keep up with.” He said while the most recent problem was the infant formula shortage, there have been a variety of other issues, especially with food safety and nutrition.

Thanks to a lack of innovation and little pressure from the public to improve, the results are underwhelming.

Every year, the FDA goes to Congress and asks for more money, making the same claims: 48 million people are getting sick from food-borne diseases, 128,000 are hospitalized, and 3,000 die Williams noted.

“Nobody ever says, ‘You’ve been saying the same thing every year, and we keep giving you more money, and nothing’s happening,’” said Williams. “They write regulations… They’re out of ideas, and unfortunately, we all pay for this” with taxes, higher food prices, illness, and death.

“Should almond milk be called milk? They spent a couple of years trying to figure that out,” said Williams

“Nutrition is a bigger problem,” he said. “Four out of 10 people are obese in this country.” Half the population will be obese by 2023. And food labels don’t help. Since they started labeling in 1973, “half of us now are diabetic or pre-diabetic. Heart disease and cancer are going up.”

“In 2020, COVID killed 350,000 people in this country. Poor nutrition killed 500,000,” said Williams. And the FDA still uses “old science.”

He suggested the FDA use a model like DARPA (Defense Advance Research Projects Agency) where the bureaucracy is minimal, and the agency can “develop new ideas.”

Among the steps, Williams suggested: Foods made in 3D printers; using robots in food production and intelligent packaging to signal that food is spoiled; and wearable nutrition devices that tell you what to eat and how much.

Clive Bates, editor of “The Counterfactual,” offered a basic yet bold public health policy. “Get rid of all smoking.”

About 480,000 people die from smoking each year, Bates noted, which is a huge number compared to other public health issues. And, he added, “another 16 million live in misery” from smoking-related diseases. Because smoking rates are far higher among lower socio-economic groups, targeting it also adds to social justice efforts. “If you can do something about smoking, you can do something about health disparities, which is a good thing.”

Bates argued the U.S. could do something about it. But it is just choosing not to, as a matter of public health policy.

Since 2010, there have been alternatives to what public health pros call “combustible cigarettes,” new products that provide nicotine without combustion.

“If you get rid of the smoke, you get rid of almost all the toxicant exposure,” said Bates. “People will continue to use nicotine but at much, much lower risk.” Government authorities in Great Britain have pegged the health risk from e-cigarettes, vaping, and other similar products at about 95 percent lower than smoking.

But instead of encouraging smokers to switch to lower-risk alternatives, as the U.K. has done, the FDA has been funding major marketing efforts targeting vaping and e-cigarettes, convincing smokers there is no health benefit from making the change.

As a result, most Americans incorrectly believe vaping is as dangerous as smoking.

One problem, Bates said, is that the FDA doesn’t know how to regulate something that comes with some risk but is far safer than the alternative. He said that vaping isn’t food or medicine; it is more like beer or coffee. It’s something people consume because they enjoy it.

“They don’t really know what they’re doing with these (smoking replacement) products,” he said. It would be better to consider them like coffee or moderate alcohol consumption. It’s pleasurable. It’s fun… It’s a harm reduction strategy. For people to use the products, they have to be appealing. Regulators have problems with that.”

And no, Bates added, the “F” in “FDA” does not stand for “fun.”

Dr. Brian Miller is a fellow at the American Enterprise Institute and a doctor at Johns Hopkins University. He used his real-world experience to discuss the CDC’s failures in the fight against COVID-19.

“I worked on COVID wards, and normally during a pandemic, you go to the CDC for advice,” Miller said. “Well, you’re in the middle of a global pandemic, and people are confined to their homes. You look up the CDC guidance, and the webpage hasn’t been updated. Or they don’t know.”

A pandemic caused by a communicable disease is the CDC’s reason for existence, and yet it wasn’t ready when the real thing happened. Why?

“The CDC’s mission has drifted,” he said. The agency started focusing on “current events” and health issues like the environment or addressing issues like racism and gun violence. Those healthcare issues keep the agency in the headlines but have little to do with the CDC’s job.

“Having an organization that is trying to be all things to all people all the time means that it cannot perform its basic functions, as we discovered during the pandemic.”

For Miller, the first step is obvious. “We should be directing our dollars to policy levers that work,” Miller said. “We should think about directing the CDC’s resources to its core mission and then some of those other funds and staff (could go to other agencies),” he said.

Also, the public should have the right to comment on CDC’s regulations.

“Public opinion still matters,” he said. “And public input matters.”

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.

Part of that historic shift has been a change in the sourcing of the active pharmaceutical ingredients (APIs) that go into our medicines and vitamins. In the 1990s, 90 percent of the world’s APIs came from the U.S., Europe, and Japan. China is now the largest global supplier of APIs.

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. But a national security threat of incalculable measure has developed out of our country’s reliance on China for drugs, protective equipment, and medical supplies.

By driving up all of the costs of needless overhead in our healthcare system, we compelled our manufacturing sector to seek lower labor costs in China. We now see that this manufacturing must be brought home or placed within the borders of staunch allies. Despite the many obstacles that stand in the way of doing that, it would be a supreme, historic folly to delay. We cannot wait until the next pandemic to address this threat.

In 2022, China has become the source of approximately 40 percent of the world’s Active Pharmaceutical Ingredients (APIs), the chemical building blocks that are critical to making drugs. Few in the United States, even among physicians, are fully aware of just how drastic our dependence has become.

Here are just a few examples. Approximately 97 percent of antibiotics used in the United States, including drugs as basic as penicillin and amoxicillin, now come from China. And almost all of the contrast dye needed for many diagnostic procedures originates in a single facility in Shanghai, which recently closed because of a COVID-related lockdown. Putting all our eggs in one or a few baskets concerning medically related supplies demonstrated severe consequences, as across the United States, physicians now warn that rationed and deferred diagnostic procedures as a result of this closure, will inevitably have medically unfortunate consequences.

Much of the personal protective equipment (PPE), so much in the forefront of the news during the worst of the pandemic in 2020, also originates in China. The country where the pandemic erupted suddenly needed the PPE in short supply in the United States.

But of equal seriousness to the risks associated with reductions in or cutoffs of these desperately needed supplies exported from China is the chronically vexing question of the quality and safety of those exports.

A few examples:

Chinese-made KN95 masks were found to be substandard during the pandemic. Just before COVID-19 struck, eight million Chinese-made surgical gowns were recalled for not having been produced under sterile conditions.

In 2019, three commonly used blood pressure medications manufactured in China were found to be tainted with carcinogens.

In 2008, news reports compelled the Food and Drug Administration (FDA) to acknowledge that 81 deaths from contaminated heparin—made in China and sold worldwide—had been produced in a facility the FDA had not inspected. 81 Given the dramatic shift by the United States to foreign-made medications and supplies, it is not surprising that the FDA has struggled to keep up with its legally required inspections of manufacturing facilities overseas. And when the pandemic hit, inspections stopped.

The implications for public health and national security are staggering. By inspecting only a small fraction of Chinese manufacturing plants and their output, the FDA fails to perform its primary duty of ensuring drug and product safety. This puts Americans in harm’s way.

Medications with ingredients from China are used in the United States for routine surgeries, common and less-common infections, psychiatric disorders, cancer, and seizures. Those with chronic diseases who must take medication and the young who have years ahead of taking these medications are most at risk of developing cancers and other long-term complications from possibly tainted products that have not yet been detected.

In May 2020, Sen. Marco Rubio (R-Fla.) and Sen. Elizabeth Warren (D-Mass.) introduced the bipartisan “Strengthening Supply Chains for Service Members and Security Act” (H.R.6374). The bill would implement the recommendations from a previous Department of Defense Office of Inspector General (DOD OIG) report to address the nation’s overreliance on foreign-made pharmaceuticals.

Tariffs imposed during the Trump years and sustained, at least so far, by the Biden administration were a step in the direction of stimulating domestic production of the class of products discussed above.

America must reclaim the manufacture of its medical supplies and critical drugs made from safe APIs. Those who shape our trade policy and create the ground rules that have driven the decisions of American corporations to send manufacturing abroad must act now to reverse course. The FDA must strengthen its staffing for auditing foreign manufacturers that are significant vendors in our supply chain.  Any foreign country’s refusal to allow free and timely access to production facilities must be fined and either suspended or terminated as a vendor.

The proverbial Sword of Damocles dangles above us. To the greatest degree and by any policy and regulatory means, including taxation rates, the United States must bring home the production of the ingredients that go into a revitalized domestic manufacture of the tools we use to care for our sick. Posthaste.

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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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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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