WASHINGTON – Senator Chuck Schumer (DN.Y.), the most powerful person in the United States Senate, wants the Food and Drug Administration to investigate the increasingly popular energy drink brand Prime.
But it’s unclear what reasons the FDA would have for singled out the company in the near future, or what the agency could really do on its own if it wanted to take serious action against its co-founder, social media star and professional wrestler Logan. Paul .
Although energy drinks are generally risky for children, the FDA has not yet received any report on side effects Through are main reporting portal of Prime’s injuries, an agency spokesperson confirmed to STAT. The caffeine content in Paul’s drink isn’t even close to the strongest energy drink on convenience store shelves. And while Schumer is right about pushing the product to young people through social media ads, Prime isn’t the only energy drink company doing this kind of marketing — and marketing is usually regulated by another federal agency, the Federal Trade Commission.
All of those facts put the FDA and its commissioner, Robert Califf, in an awkward position. While Schumer may want the agency to pick Prime, there’s little legal justification for the agency to do so any time soon. The FDA typically only intervenes on a specific food product if people are clearly being harmed, or if that product is out of step with other similar legal products on the market.
That means Schumer’s anti-Prime campaign probably won’t materialize unless there’s a clear trend of kids getting sick from the product.
“This is not like the tobacco laws and regulations where the FDA can go very specific on some vaping products marketed to children; this is a very different circumstance,” said Stephen Ostroff, a former chief Acting FDA Commissioner and Deputy Food Commissioner. “The laws and regulations [for the FDA going after a product] that the product must be unsafe.”
The company defended its product in a rack to the BBC, arguing that it “contains a similar amount of caffeine to other top-selling energy drinks, all of which are within the legal limit of the countries in which it is sold.” The company did not respond to a request for comment from STAT.
Here are three main reasons why Schumer’s current focus on Prime Energy doesn’t make much sense, and what’s likely to come.
There is hardly any evidence of damage caused by Prime
The FDA typically doesn’t go after food products unless people get hurt, and there’s no evidence yet that Prime hurt anyone in the US
The agency even confirmed to STAT that it has not received any so-called side-effect reports for the drink Through are reporting system known as CAERS. The FDA’s reporting system isn’t perfect – reporting from healthcare providers and food companies is voluntary and does not establish a causal relationship between products and health outcomes.
Ostroff, who previously worked to regulate energy drinks during his tenure at the FDA, cautioned that a lack of reported side effects from Prime does not prove that no one is getting hurt. But side effects are usually the first sign that a product is making people sick.
So far, it seems that much of the concern about Prime’s potential risks stems from the UK report that an elementary school student had a “heart attack” as a result of the booze and had to have his stomach pumped out. (It’s unclear what kind of event the student went through, or their current condition.)
That is not to say that energy drinks are harmless. Since 2011, the American Academy of Pediatrics has recommended that children not consume energy drinks because of possible heart problems and other health problems. And calls to poison control centers about children’s consumption of energy drinks appear to be on the rise. There have been 287 calls so far this year about children ages 6 to 12 consuming energy drinks, more than in 2020, 2021 or 2022, according to data from America’s Poison Centers, which collects data from all 55 poison centers nationwide. country.
But it’s impossible to tell if 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 seem to pose any risks beyond other drinks.
Physician Marcie Schneider, who served on the AAP panel that reviewed the safety of energy drinks, agreed that Prime appears to present many of the same potential risks of all energy drinks. She added that she suspects Prime was chosen because of his popularity.
“I’m not sure why this one in particular was teased,” Schneider said. “My bet is how it was marketed.”
Prime is no 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 today’s energy drinks on the market.
Gatorade’s new energy drink, Fast Twitch, also contains 200 milligrams of caffeine. So does Ghost, Celsius, and Alani Nu, which sell products in kid-friendly flavors like Bubbles Strawberry Splash, Oasis Vibe and Cherry Slush.
There are also stronger drinks. Rockstar Punched, C4 Ultimate, and Bang all contain more caffeine than Prime – and they’re just as available for kids.
Paul’s drinks also seem to follow industry best practices of clearly labeling how much caffeine they contain. The fact that Prime contains 200 milligrams of caffeine is clearly stated on the side of the can and on the back near the nutrition facts label. So does a warning that the product is “not recommended for children under 18”.
It’s possible that the FDA could determine that 200 or more milligrams of caffeine in a single drink is unsafe, and thus take further action against the industry. But it’s hard to imagine regulators doing so, as the agency has said adults can safely consume more than 400 milligrams per day.
Prime isn’t the only energy drink marketed on social media
Part of Schumer’s distaste for Prime seems to stem from his claims that the products are heavily promoted to children. “A simple social media search for Prime will generate an eye-watering 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 very popular with young people, just like Prime. For example, Prime has over 3 million followers on TikTok; Paul himself has 23.6 million subscribers on YouTube and 17.8 million followers on TikTok.
But there are plenty of other energy drinks that follow a similar playbook.
Gatorade also promotes Fast Twitch on TikTok and collaborates with influencers such as Ryan Garcia – a telegenic 24-year-old professional boxer with 10 million followers on Instagram.
Celsius, one of Prime’s competitors, even signed a sponsorship deal with Paul’s younger brother, Jake Paul, also a popular influencer.
And even if the FDA decided it was challenging Prime’s marketing, it wouldn’t be able to do much about it itself. Marketing, with the exception of matters such as verifying proper labeling and unsubstantiated medical claims, is generally subject to the Federal Trade Commission.
What the FDA could do about Prime
It doesn’t seem likely that the FDA will bankrupt Prime anytime soon unless kids flock to the emergency room.
But legal experts STAT spoke to said the agency could, hypothetically, take some steps to show Schumer it’s taking the issue seriously.
First, it could ask Prime to provide a dossier that most food companies already have to create to determine that their product is “Generally Recognized as Safe.” Those files are not usually required to be submitted to the FDA, but the agency may request them in certain circumstances.
However, it would be difficult for the FDA to challenge the company’s safe status unless Prime failed to put together the dossier or the FDA was able to determine that the product was actually “intended” for children. This also seems unlikely given the warnings about underage use on Prime’s label. But if it wanted to follow that road, the agency should probably use it the companies marketing to claim that the product was still intended for children despite the label.
The FDA could also hypothetically work with the FTC to investigate the company’s marketing. The two agencies have done this recently, for example for cannabis products that are marketed to look like children’s candy. The FTC said the products violated their rules because of the marketing “gift[ed] unjustified health or safety risk.”
The easiest step, according to Ostroff, might be for the FDA to just use its bully pulpit.
The former FDA regulator suggested that the FDA could meet with Prime’s leadership and urge them to revamp their marketing.
It seems unlikely that Logan Paul, who has done everything from jumping in traffic to scavenging dead rats for clicks, will abandon the marketing playbook that has earned him millions of followers. But some changes are possible.
Scoop said in a statement told Reuters that “we welcome discussions with the FDA or other organization regarding proposed industry changes that they believe are necessary to protect consumers.”
STAT’s coverage of chronic health conditions is supported by a grant from Bloomberg philanthropies. Us financial supporters are not involved in decisions about our journalism.