When Natalie Penney, a 25-year-old from Manchester, UK, ordered weight loss pills online, she had no concerns about potential adverse health effects. "You assume you're going to be safe because you're buying this prepared, packaged product that someone somewhere must have regulated," she says, "but you're not."
The pills Penney bought were T5's, a thermogenic fat burner currently available for purchase in a variety of forms on Amazon. Within the first two weeks of taking the pills, Penney dropped ten pounds. "I started to look better, even though I didn't feel better," Penney tells Broadly. "But I did notice that I was sweating more. I felt like everything was going 100 miles an hour. I couldn't settle; I couldn't sleep properly—I was literally living off two hours sleep. I wasn't eating, which obviously isn't good for you either."
Convinced that the unpleasant side effects would go away if she just pushed through, Penney says that she kept taking her T5's until she eventually collapsed and was rushed to the emergency room. According to her, the experience left her with permanent heart damage: "Now I have a condition called atrial tachycardia, which causes your heart rate to always be a little bit higher than what a regular person's heart rate would be," she explains.
Upon analysis, she says, doctors found the supplements contained high levels of ephedrine, a drug used to prevent low blood pressure during spinal anesthesia. Ephedrine is illegal when sold as a dietary supplement in the US and UK, but the ingredient was not listed on the supplement's packaging.
Dietary supplements are a massive industry in the US. A whopping 150 million Americans use them every year, turning alternative medicine into a $34 billion industry. However, critics note that supplements are largely unregulated, leading to potentially dangerous health risks to unknowing consumers: Indeed, according to a 2015 study published in the New England Journal of Medicine, injuries caused by dietary supplements lead to over 20,000 emergency room visits in the US per year—many of them related to cardiovascular issues, as was the case with Penney.
Dietary supplements do not require FDA approval before they're sold to consumers; as a report from Consumer Reports found earlier this year, this means that basically anyone can create and market herbal diet pills—regardless of whether or not those pills contain harmful ingredients.
Of course, it's not a total free-for-all. According to Lyndsay Meyer, a spokesperson for the FDA, manufacturers are required to submit a text detailing what their product claims to do for FDA review and approval. Supplements that have not been reviewed must state in a "disclaimer" on a product's packaging that the FDA has not evaluated the claim, and that the dietary supplement product is not intended to "diagnose, treat, cure, or prevent any disease." However, submissions for approval can be sent up to 30 days after a company has started selling a product, meaning that a product could be—and usually is—already in the hands of consumers once the FDA decides it is unsafe. If a claim is rejected after a product is already on the market, the FDA sends out warning letters and injunctions to the manufacturer demanding the product be removed.
I was literally living off two hours sleep. I wasn't eating, which obviously isn't good for you either.
According to a 2014 article published in the New England Journal of Medicine, over 500 non-prescription supplements "have been found to be adulterated with pharmaceuticals or pharmaceutical analogues" due to this lack of oversight. In the media, horrifying stories abound regarding such products' adverse side effects: In 2015, 21-year-old student Eloise Aimee Parry died after taking diet pills she'd bought online. The pills contained a lethal chemical called dinitrophenol; Parry took eight pills at once, according to reports, and "burned up from the inside" as a result. In 2011, Philadelphia nurse Karen Jacobs-Poles was diagnosed with jaundice, acute hepatitis, and an enlarged liver after taking Slimquick, which she had considered safe after seeing ads that stated it was made with green tea extract. In 2013, the weight loss supplement OxyElite Pro was linked to an outbreak of liver disease, which sickened 97 people. Of those 97, 47 were hospitalized; three required liver transplants; and one, a woman named Sonnette Marras, eventually died of liver failure.
In a 2013 lawsuit, Jacobs-Poles alleged that the makers of Slimquick "knew, or should have known, that Slimquick contained ingredients that cause injury to humans and, in particular, liver injury." Of the two ingredients singled out as hepatotoxins—meaning a toxic chemical substance that damages the liver—one was camellia sinensis, the green tea extract touted in Slimquick ads.
Similarly, the FDA found that OxyElite contained aegeline, a synthetic form of a substance naturally found in bael trees, which is classified as a "new dietary ingredient"—meaning that it lacks "a history of use or other evidence of safety." Under federal law, the company that manufactures OxyElite should have informed the FDA of its use of aegeline; it had failed to do so.
As Dr. Pieter A. Cohen, an assistant professor at Harvard Medical School, explained to the New York Times, it's a common practice for supplement companies to use synthetic chemicals in their products, "then hide them on their labels under the names of obscure plants to give the impression they are natural botanical extracts."
Worsening matters, industry loopholes allow manufacturers to continue selling potentially dangerous products even after the FDA has intervened. "Dietary supplements have a complex and fractured supply chain," says Meyer. "Any one product can be sold under multiple brand names, and there are more and more sellers of supplements online. So even if we become aware of a problem with a supplement, that company can stop selling, switch their product name, and we're back at square one."
Because federal law allows supplement companies to enter the marketplace unchecked, policing these products to ensure each one holds up to their claims remains virtually impossible. Working within the jurisdiction, if the FDA finds a product to be harmful once it's already on the market, they are forced to issue consumer alerts and press releases warning the public about a tainted product. But it can be easy to miss these notices: Most people aren't likely to find themselves casually spending time on the FDA's website, which feels a bit like a doctor's waiting room reincarnated into code.
The FDA attributes its shortcomings in maintaining the industry's integrity to a lack of resources. "We're talking about regulating a $40 billion a year industry with a budget of less than $5 million annually," Meyer says. Due to these constraints, the FDA is unlikely to examine a product unless it's causing people to get seriously ill. Priority is assigned by level of urgency, she says: "We leverage resources across the agency, but still have to prioritize our efforts to maximize impact, focusing first on the level of safety concern."
This means that as consumers started falling ill from over-the-counter OxyElite Pro in May of 2013, it took the agency until October to issue an injunction letter to the manufacturer to cease operations. In that time three people required liver transplants and one died from taking the drug. Meanwhile, when Kim Kardashian decided to endorse Diclegis—an FDA-approved morning sickness drug only available by prescription—without properly disclosing its associated risks and side effects, the agency was able to issue a warning to Kardashian within three weeks. Kardashian corrected her mistake shortly after and no noted injuries were sustained.