WASHINGTON — Sen. Chuck Schumer (D-N.Y.), the most powerful person in the U.S. Senate, wants the Food and Drug Administration to investigate the increasingly popular energy drink brand Prime.
But it’s unclear what grounds the FDA would have to single out the company in the near future, or what the agency could really do on its own if it wanted to take serious actions against its co-founder, social media star and professional wrestler Logan Paul.
While energy drinks in general are risky for kids, the FDA hasn’t yet received a single so-called adverse event report through its main reporting portal about injuries from Prime, an agency spokesperson confirmed to STAT. The caffeine level in Paul’s beverage isn’t even close to the strongest energy drink on the shelves of convenience stores. And while Schumer is right that the product is being pushed on young people through social media advertising, Prime isn’t the only energy drink company doing this type of marketing — and marketing is typically regulated by another federal agency altogether, the Federal Trade Commission.
All of those facts put the FDA, and its commissioner, Robert Califf, in an awkward position. While Schumer might want the agency to single out Prime, there’s little legal justification for the agency to do so in the near term. The FDA typically only cracks down on a specific food product when people are clearly being harmed, or that product is widely out of step with other similar legal products on the market.
That means Schumer’s anti-Prime crusade likely won’t be realized unless there’s a clear trend of kids getting sick from the product.
“This isn’t like the tobacco laws and regulations where the FDA can very specifically go after some of the vaping products that are marketed to kids; this is a completely different circumstance,” said Stephen Ostroff, a former head acting FDA commissioner and deputy commissioner for foods. “The regulatory and statutory requirements [for the FDA going after a product] are that the product has to be shown to be unsafe.”
The company defended its product in a statement to the BBC, arguing it “contains a comparable amount of caffeine to other top selling energy drinks, all falling within the legal limit of the countries it’s sold in.” The company did not respond to a request for comment from STAT.
Here are three key reasons why Schumer’s current focus on Prime Energy doesn’t make much sense, and what’s likely to come next.
There’s hardly any evidence of harm caused by Prime
The FDA typically doesn’t go after food products unless people are being hurt, and there’s no evidence yet that Prime is hurting anyone in the U.S.
In fact, the agency confirmed to STAT that it hasn’t received any so-called adverse event reports for the drink through its reporting system known as CAERS. The FDA’s reporting system isn’t perfect — the reporting from health care providers and food companies is voluntary, and doesn’t establish a causal link between products and health outcomes.
Ostroff, who previously worked on regulation of energy drinks during his tenure at the FDA, cautioned that a lack of reported adverse events from Prime doesn’t prove that no one is being hurt. But adverse events are typically the first sign that a product is making people sick.
So far, it seems that much of the concern about the potential risks of Prime stems from a U.K. report that an elementary school student suffered a “cardiac episode” as a result of the drink and had to have their stomach pumped. (It’s unclear what type of event the student suffered, or their current state.)
That isn’t to say energy drinks are harmless. The American Academy of Pediatrics has recommended since 2011 that children avoid consuming energy drinks because of potential heart issues and other health problems. And calls to poison control centers concerning kids’ consumption of energy drinks does appear to be on the upswing. There have been 287 calls so far this year concerning children ages 6-12 consuming energy drinks, more than in 2020, 2021, or 2022, according to data from America’s Poison Centers, which compiles poison control call data from all 55 poison centers across the country.
But it’s impossible to say whether those calls are tied to Prime. A spokesperson for America’s Poison Centers said it could not provide data on Prime specifically because it was “just added to our system.”
Based on the product’s ingredients, it doesn’t appear to present risks above and beyond other drinks.
Physician Marcie Schneider, who served on the AAP panel that reviewed energy drink safety, agreed that Prime appears to present many of the same potential risks of all energy drinks. She added that she suspects Prime was singled out because of its popularity.
“I’m not sure why this one in particular got picked on,” Schneider said. “My bet is how it was marketed.”
Prime isn’t stronger than other energy drinks
Prime contains 200 milligrams of caffeine per can. It’s a lot of caffeine, but it’s pretty standard for current energy drinks on the market.
Gatorade’s new energy drink, Fast Twitch, has 200 milligrams of caffeine, too. So do Ghost, Celsius, and Alani Nu, which sell products in kid-friendly flavors like Bubblicious Strawberry Splash, Oasis Vibe, and Cherry Slush.
There are stronger drinks out there, too. Rockstar Punched, C4 Ultimate, and Bang all have more caffeine than Prime — and they’re just as available to kids.
Paul’s drinks also appear to follow industry best practices of clearly marking how much caffeine they contain. The fact that Prime contains 200 milligrams of caffeine is clearly listed on the side of the can and on the back near the nutrition facts label. So too is a warning that the product is “not recommended for children under 18 years of age.”
It’s possible that the FDA could determine that 200 or more milligrams of caffeine in a single drink is unsafe, and thus take more sweeping action against the industry. But it’s hard to imagine regulators doing so, given the agency has said that adults can safely consume upwards of 400 milligrams per day.
Prime isn’t the only energy drink marketed on social media
Part of Schumer’s dislike for Prime seems to stem from his claims that the products are being heavily marketed to kids. “A simple search on social media for Prime will generate an eye-popping amount of sponsored content, which is advertising,” Schumer wrote in his recent letter to the FDA.
Prime and its co-founder, Logan Paul, are also highly popular with young people — as is Prime. Prime has more than 3 million followers on TikTok, for example; Paul himself has 23.6 million subscribers on YouTube and 17.8 million followers on TikTok.
But there are plenty of other energy drinks following a similar playbook.
Gatorade promotes Fast Twitch on TikTok too, and has partnered with influencers like Ryan Garcia — a telegenic 24-year-old professional boxer with 10 million followers on Instagram.
Celsius, one of Prime’s competitors, even penned a sponsorship deal with Paul’s younger brother, Jake Paul, also a popular influencer.
And even if the FDA did decide it took issue with Prime’s marketing, it wouldn’t have much it could do about it on its own. Marketing, with the exception of things like policing proper labeling and unsubstantiated medical claims, typically falls to the Federal Trade Commission.
What the FDA could do about Prime
It doesn’t seem likely that the FDA will put Prime out of business anytime soon, unless kids start showing up to the ER in droves.
But legal experts STAT spoke to said the agency could, hypothetically, take some steps to show Schumer it is taking the issue seriously.
First, it could request that Prime provide a dossier that most food companies are already required to compile establishing their product is “Generally Recognized as Safe.” Those dossiers don’t typically need to be submitted to the FDA, but the agency can call for them in certain circumstances.
It would be hard for the FDA to challenge the company’s status as safe, however, unless Prime failed to compile the dossier, or if the FDA was able to establish that its product was actually “intended” for kids. This also seems unlikely, given the warnings about underage use emblazoned on Prime’s label. But if it wanted to pursue that path, the agency would likely need to use the company’s marketing to argue the product was still intended for kids, despite the label.
The FDA could also, hypothetically, work alongside the FTC to look into the company’s marketing. The two agencies have done so recently, for example, for cannabis products marketed to look like kids’ candies. The FTC said the products violated their rules because the marketing “present[ed] unwarranted health or safety risks.”
The simplest step, according to Ostroff, might be for the FDA to just use its bully pulpit.
The former FDA regulator suggested the FDA could meet with Prime leadership and urge them to revamp their marketing.
It seems unlikely Logan Paul, who has done everything from jumping into traffic to tazing dead rats for clicks, will abandon the marketing playbook that has amassed him millions of followers. But some changes may be possible.
Prime said in a statement to Reuters that “we welcome discussions with the FDA or any other organization regarding suggested industry changes they feel are necessary in order to protect consumers.”
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.