Did Utah GOP congressional candidate Bruce Hough ‘beat the FDA?’ Here’s what happened.

The images of Bruce Hough standing under Utah’s Mount Olympus looking westward, strolling side-by-side with a voter and sporting a John Deere hat in a farmer’s field, has flitted across tens of thousands of phone screens as he asks Utahns to vote to send him to Congress.

In another scene from his ad, titled “Washington D.C. is Broken!,” a narrator tells viewers over an image of gloved hands measuring a turmeric-colored substance in a lab, “He helped save his industry when he sued FDA regulators and won,” adding that he fought to save thousands of in-state jobs.

A candidate in Utah’s 2nd Congressional District special election to replace retiring Rep. Chris Stewart, Hough describes himself as a “movement conservative” — those who want to shrink the administrative state and are anti-regulation.

The businessman co-founded and acted as president of Nutraceutical, a Park City-based company selling herbal and nutritional supplements, for nearly a quarter of a century. He’ll face fellow Republicans Celeste Maloy and Becky Edwards in a primary competition Tuesday.

But the video — among Hough’s most viewed ads on YouTube and Facebook — tells just a fraction of the story behind his lawsuit challenging a Food and Drug Administration rule made after thousands of people reported adverse effects from a nutritional supplement, and several high-profile athletes died in connection with it.

The start of a regulation

At 23 years old, pitcher Steve Bechler was at Baltimore Oriole spring training at Fort Lauderdale, Florida, in February 2003 — hoping to make the team’s bullpen for the upcoming season. During conditioning drills, he collapsed and was taken to a local hospital, where he died from multiple organ failure the next morning. His wife was pregnant and gave birth to a daughter two months afterward.

A Broward County medical examiner linked Bechler’s death to an increasingly popular nutritional supplement used for energy and weight loss: ephedra.

In 2001, three football players — two in college and one playing professionally — died while using the supplement, The Washington Post reported. Its use was soon prohibited in college athletics and the National Football League, as well as in the Olympics. The U.S. Army also made the substance off-limits for soldiers after more than 30 died while taking it, according to CBS News at the time.

Bechler’s death and the medical examiner’s conclusion were the last straw for the FDA, and it opened an inquiry into ephedra, ultimately banning it nearly a year later.

Ephedra is derived from a Chinese herb called ma huang, and when taken has effects similar to the drug speed. According to a summary of the supplement’s dangers published by Harvard Medical School, dangerous reactions reported in association with ephedra include heart attacks, strokes, seizures and sudden deaths.

Within a few months of the FDA announcing its decision, Nutraceutical — which sold the supplement — filed a lawsuit in federal court, alleging that the agency had failed to show that the substance was dangerous at low doses, and was abusing its authority by imposing a total ban.

“Most of the products that caused the controversy were products that were of extraordinarily high doses and/or were adulterated or spiked with other products,” Hough told The Salt Lake Tribune. “So anytime that you do not properly label a product or you do not include what’s actually in it, the FDA has absolute authority for removing it from the shelves.”

He continued, “There were a number of very high-profile news reports that came out, but if you read the follow-on stories and toxicology reports, you would find that ephedra was not a leading indicator to any safety issue, but it did have potential safety issues if it’s taken beyond its ... dosage levels that were recommended by legitimate packages.”

Nutraceutical was not among the companies sued in dozens of product liability lawsuits that emerged around the country, and according to court records contained less than 10 milligrams of ephedra in its supplements. Overall, the FDA “collected information on about 19,000 complaints or adverse events from (ephedra) use,” court records say.

A U.S. district court judge in Salt Lake City ruled in Nutraceutical’s favor, temporarily putting the supplement back on the market in Utah. Hough told The New York Times at the time that the company didn’t have plans to resume selling its supplement, and that its goal in the lawsuit was to check the FDA’s power to establish rules affecting the wellness industry.

The FDA asked for the ruling to be re-examined, and the case came in front of the 10th Circuit U.S. Court of Appeals.

That appeals court sided with the government, writing, “We find that the FDA correctly followed the congressional directive to analyze the risks and benefits of (ephedra) in determining that there is no dosage level of (ephedra) acceptable for the market.”

Nutraceutical in turn asked the U.S. Supreme Court to take on the case, but, as the Associated Press reported, the high court turned it down without comment. Ephedra remains banned in the U.S.

The local U.S. Attorney’s office and the Department of Justice, who litigated the case, declined to comment on Hough’s characterization of the suit’s resolution in saying he “beat the FDA,” and now-retired counsel on the case contacted by The Tribune said they have little memory of it.

The number of calls to poison centers related to ephedra poisonings peaked at 10,326 in 2002, a correspondence in the New England Journal of Medicine found, and in the years since the ban was put in place steadily declined to 180 by the end of 2013.

Hough maintains that the case was a victory for the dietary supplement industry because he pushed back against the way the FDA was assessing the risks of supplements against their benefits. While the FDA allows companies to include some health claims on supplement labels, packaging and advertisements cannot infer that a supplement will treat, prevent or cure disease.

“Since the dietary supplement industry cannot actually enunciate any specific health benefits, then any risk could be deemed as too high risk,” Hough said.

Hough’s congressional campaign — to which he has personally loaned nearly $400,000 — has so far reported spending $1,500 to advertise on Facebook, according to the latest Federal Election Commission filings.

As primary election day gets closer, Meta’s Ad Library estimates the campaign has now spent nearly $35,000, with most of that ad spending in the last month.

The FDA did not respond to multiple requests for comment on Hough’s advertising that he “beat” the agency.

Hough’s mistrust of the FDA remains

At a summit for the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation in January, former FDA commissioner Scott Gottlieb — who was appointed by former President Donald Trump, and served as an advisor on his campaign — warned against politicians stoking mistrust against the agency he previously helmed.

“We’re going to go through a political cycle where there will be multiple national politicians campaigning against public health,” Gottlieb said.

Current FDA chief Robert Califf added, “What you call a political cycle could end up with people who actually don’t believe in public health in charge of public health.”

Mistrust in public health agencies has surged since the beginning of the COVID-19 pandemic. An Ipsos poll published in April reports that 39% of Americans say they don’t trust the FDA, and among Republicans that number is even higher at 58%.

During the pandemic, the FDA was responsible for authorizing medications, treatments and vaccines against the deadly virus.

“Most of the people I know who work for the FDA still scratch their head wondering how in the heck you can ever get a fully validated vaccine within nine months,” Hough said, adding that he believes vaccines shouldn’t be mandated, nor should employment be terminated for a vaccination refusal. “I mean, we all thought that was a miracle. Well, it may not have been even a miracle, it may just not have even been possible.”

An article from Yale Medicine reports the COVID-19 vaccines authorized in the U.S. range between 90% and 95% effective, although efficacy varies as different strains of the virus emerge.

When a reporter with KSL News Radio asked Hough about his preferred committee assignments, he answered, “... Obviously, it would be awesome to be involved in appropriations … through the (agriculture) department that helps regulate the FDA, and provides funding for the FDA, and agencies like that. That’s a huge part of what the state is involved with both in the biotech industry and the nutritional supplement industry.”

In his congressional campaign, Hough has so far received thousands of dollars in support from wellness industry leaders and lobbyists.

Hough told The Tribune the FDA has a role in regulating “bad actors,” but he doesn’t feel the agency should make new rules. Instead, he’d like to see it better enforce the rules it has now. He said if elected he would support the REINS — Regulations from the Executive in Need of Scrutiny — Act, which would require congressional approval for some executive branch agency regulations before they are implemented.

Nutraceutical’s lawsuit against the FDA, he said, is “a really good example of where the federal government had overreached and where we can push back in those circumstances.”