Around 8 p.m. one evening this past January, a 51-year-old Texas man named Arthur took a sexual enhancement supplement he’d purchased earlier that day at a gas station in a town outside San Antonio. Several hours later, he lost consciousness, according to a statement his wife later gave to regulators, and a “foam-like liquid” trickled out of the right side of his mouth, which drooped in a frown. At one point, he came to and began complaining of stomach pain, before blacking out again.
Arthur, who reportedly had no known medical problems, was taken to the emergency room of a local hospital. His hands were trembling, and the admitting doctor asked about a history of seizures.
“Then he noticed Arthur wasn’t breathing and had no pulse,” according to his wife’s statement. “They started resuscitation efforts for about 15 minutes, and Arthur never came back.”
A couple of days after Arthur’s death, his wife brought the episode to the attention of the Food and Drug Administration, which regulates dietary supplements in the U.S. She believed the supplement she says her husband took—called Magic Stick Crazy 60000—contributed to his death. (Consumer Reports is not providing Arthur’s last name.)
The agency filed a report on the incident in a database, known as CAERS (for the Center for Food Safety and Applied Nutrition Adverse Event Reporting System), which tracks cases of harm linked to supplements, cosmetics, and food. The FDA analyzes the reports—which are submitted by consumers, healthcare providers, and manufacturers—for signs that products are potentially dangerous and that action, like a recall, may be needed. Though a report, on its own, doesn’t prove that a product caused an incident, the FDA publishes the data so that consumers and researchers can access it.
But when the FDA published the summary of Arthur’s case in CAERS, the agency redacted the product name. Indeed, CR could find no case in CAERS mentioning Magic Stick Crazy 60000. (No useful information on the product’s manufacturer was provided in the report, and CR was unable to locate the relevant firm for comment.)
Instead, in a column where the supplement’s name would normally go, appeared the term “Exemption 4,” a reference to an obscure regulation that requires the FDA to shield a product’s name from public view when a report of harm has been submitted voluntarily by manufacturers.
It shouldn’t have been. In the case of supplements, when the report of harm is “serious”—resulting in hospitalization or death, for example—a manufacturer is required to notify the FDA and the cited product’s name is supposed to remain public. And no reports submitted by consumers or doctors are supposed to have product names redacted.
The FDA enacted the exemption in the 1970s as part of an effort to increase voluntary reporting of adverse events to the agency. As designed, the measure could prevent abuse of CAERS by potential litigants or competing companies.
But the regulation keeps critical information on thousands of reports of harm shielded from the public light, effectively creating a black hole in the CAERS data, according to an investigation by CR. Indeed, more than 19,700 products in the database—15 percent of the total number—are labeled as “Exemption 4.”
And its use has rapidly grown in recent years: In 2019 alone, the agency filed twice as many redacted reports as it had in the first decade of operating CAERS, which was launched in 2003.
CR also found that the FDA appears to be applying the exemption inconsistently, removing from public view product names cited in reports that come from consumers or doctors, or that describe events that are serious in nature. For example, among more than 1,300 supplements labeled Exemption 4 in CAERS, more than a third involved deaths or hospitalizations.
Moreover, using the Freedom of Information Act, CR obtained the underlying paperwork behind more than 175 reports labeled Exemption 4, covering a period of more than 15 years. Because the FDA labeled the products as Exemption 4 in the public-facing CAERS database, we initially expected that product names would still be redacted.
But in 47 percent of those reports, the products were named. That includes the one regarding Arthur, whose wife had contacted the FDA, not the manufacturer.
An officer with the FDA’s FOIA division acknowledged to CR that some reports were incorrectly labeled Exemption 4 as a result of “technical issues.” Nathan Arnold, an FDA spokesperson, had no immediate explanation for why, or for how long, the CAERS database had been experiencing the problem, nor could he say how many reports had been mislabeled. An update of the database was expected in the next two months, he says, but industry groups are concerned, and the issue has now attracted the attention of Congress.
Rep. Rosa DeLauro (D-CT), a senior member of the House Appropriations subcommittee responsible for FDA spending and oversight, tells CR that it’s “troubling” to learn the FDA has withheld critical information in adverse event reports.
“Because the FDA does not review dietary supplements for safety and effectiveness before they go on the market, any information on serious adverse events must be available so that consumers can protect themselves and their families from potentially harmful products,” DeLauro says. “The FDA must resolve this immediately and remove barriers to this information.”
A Sudden Death
That serious adverse event reports citing dietary supplements have been granted Exemption 4 puzzles researchers and industry groups. It goes against the spirit and intent of the law requiring manufacturers to submit reports of serious injuries associated with their products, they say.
“The FDA should explain what they’re up to,” says Pieter Cohen, an associate professor of medicine at Harvard Medical School who studies supplements.
The underlying reports CR obtained detail some potentially alarming episodes involving supplements whose names had been blacked out in the public-facing database.
In California, a 19-year-old home from college went to work out at a local gym with a friend on Aug. 18, 2010. Just before, he took two workout supplements acquired at a nearby Vitamin Shoppe, according to a report filed with the FDA. That included Xpand, a supplement manufactured by Texas-based Dymatize Nutrition.
The following morning, the man’s brother discovered him in the “same position as [the] previous evening,” and rigor mortis had set in, according to the report. The responding coroner declared his death was due to possible cardiac arrhythmia.
“The post-mortem examination indicated the death occurred a few hours after the use of the supplements,” the report says. The coroner, Craig Nelson, declined to comment in an email to CR. Vitamin Shoppe didn’t comment directly on the incident but said in a statement that it “rigorously” adheres to all FDA regulations and fully cooperates with disclosure requirements.
Casey Carty, a spokesperson for Dymatize parent company Bellring Brands, says it takes all consumer complaints seriously and that “we pride ourselves on using safe, best-in-class ingredients.” The incident predates Bellring’s acquisition of Dymatize in 2014, Carty says, and as a result, she had no further details to provide.
Hindrance to Research
Consumers aren’t the only ones kept in the dark about serious adverse events because of Exemption 4. Public health experts who use the CAERS database in their research say it’s a roadblock for them, too.
That’s particularly true when it comes to cosmetics and beauty products. Of the 27,758 cosmetic products cited in CAERS, more than 61 percent are labeled Exemption 4, according to CR’s review. A 2018 study in the Journal of the National Cancer Institute looked at cancer-related adverse event reports submitted in CAERS for cosmetic products. But the researchers found that the FDA “redacted the specific product names in 95 percent of cancer-related reports.”
“The exemption is a challenge,” said Steve Xu, assistant professor of dermatology at Northwestern University, who co-authored the study. “Manufacturers can be making hundreds or even thousands of different personal-care products. There may be different formulations for different countries. Identifying the exact product would help isolate problems.”
‘The presence of the exemption certainly presents some challenges from a research and public health perspective, as we may not be getting the entirety of the dataset or certain products that happen to be problematic.’
ANDREW JAGIM, SPORTS MEDICINE RESEARCHER AT THE MAYO CLINIC HEALTH SYSTEM
An August study in Mayo Clinic Proceedings that looked at adverse event reports citing caffeine-containing products similarly illustrated limitations as a result of the law. The researchers looked at CAERS reports filed between 2014 and 2018, but noted that almost a third had to be excluded because product names were not provided.
CR obtained the underlying documents behind one report in that timeframe, in August 2016, that redacts the name of a beverage allegedly consumed by a 35-year-old male before he suddenly died. The man “was big on drinking [redacted],” and he’d consumed it before passing away, according to a family member’s statement in the report, which was submitted by an unnamed manufacturer. The product can’s label was similarly blacked out in the report.
“The presence of the exemption certainly presents some challenges from a research and public health perspective, as we may not be getting the entirety of the dataset or certain products that happen to be problematic,” says Andrew Jagim, a sports medicine researcher at the Mayo Clinic Health System, who co-authored the study.
Confusion All Around
The FDA’s admission that some reports were incorrectly labeled Exemption 4 may renew concerns about the limited utility for consumers of the CAERS database. Compared with FAERS, the database’s counterpart for drug-related adverse event reports that provides a searchable online portal for consumers, the FDA publishes CAERS in multiple, large, and unwieldy spreadsheets.
Consumers who downloaded and examined the datasets would have to mine tens of thousands of rows in CAERS for any reports pertaining to the product being researched. A consumer could miss a report because it’s been misspelled in the database—a common problem—or because it’s masked by Exemption 4. Making sense of risks is even more complicated, especially for reports labeled, in some cases improperly, as Exemption 4, unless consumers decided to file a FOIA request of their own.
‘I am at a loss to understand why the agency is not providing the name of the product when they list these CAERS citations in the database.’
STEVE MISTER, PRESIDENT & CEO, COUNCIL FOR RESPONSIBLE NUTRITION
Industry groups and experts were surprised to learn from CR that the product names on many serious adverse event reports had been redacted. One such organization, the Council for Responsible Nutrition, based in Washington, D.C., was surprised to learn from CR that many serious adverse event reports had, in effect, been deep-sixed.
“I am at a loss to understand why the agency is not providing the name of the product when they list these CAERS citations in the database,” says Steve Mister, CRN’s president and CEO.
An incident involving the sudden death of a previously healthy and active 55-year-old man after taking a popular workout supplement in May 2018 is a case in point.
In the underlying report, obtained through FOIA, CR learned that he reportedly took Hydroxycut, a popular supplement available in numerous formulations. (The report notes that it was not clear which version he’d allegedly consumed.) But while the case involving the Atlanta man appears to have been submitted by a member of the public and meets the definition of a “serious” report, it was filed by the FDA as an Exemption 4, with the product name blacked out.
Amanda Lamers, Iovate’s senior legal counsel, says that the company learned about the case from the FDA, and that there is no evidence Hydroxycut contributed to the man’s death. Iovate files reports to the FDA as required under federal law, she says, and the company has never requested that a product name be redacted in the database.
“There is no reason to doubt that Hydroxycut products are safe for consumption when taken by healthy adults in accordance with label instructions,” Lamers says.
How to Fix CAERS
Even after the FDA performs the promised fixes to the database, researchers say more work needs to be done to make CAERS better and more useful.
Harvard’s Cohen understands the motivation to prevent meritless submissions, especially because the existence of a report doesn’t necessarily mean a named product caused harm. Active participation from manufacturers, doctors, and consumers to voluntarily submit reports helps provide the FDA information it needs to detect potentially problematic products.
“But you’ve got a choice,” he says, “and if you’re going to be transparent and allow other independent experts to evaluate the data, it’s essential that all the data is presented. If you’re hiding the names of the products and things can’t be matched, no one can figure out what the data really means.”
Xu, the Northwestern professor, agrees that voluntary reporting needs to be promoted. He suggests limiting the time a company could have a product name redacted: The FDA could withhold a product’s name for a set period of time, he says, until a more robust analysis of the underlying concerns can be conducted.
“If a company and the FDA reach some kind of conclusion around safety, then the product name can remain redacted” or be released, he says.
Brian Ronholm, director of food policy for Consumer Reports, agrees that changes are necessary.
“There needs to be an active reporting system and complete transparency of data in a form that is easy to understand if consumers are to feel confident about the safety of dietary supplements,” Ronholm says.