Photo Source: AG1 Official Website
The U.S. Food and Drug Administration (FDA) is looking into AG1 after receiving 118 adverse event reports in 2023 and 2024, including more than 30 cases of elevated liver enzymes. Nine hospitalisations and two life-threatening situations have been linked to the supplement, sparking growing concerns among users and healthcare professionals. Although the FDA has not yet drawn any conclusions, the alarming trend is drawing widespread attention.
A Rise in Reports Raises Concern
The increasing number of adverse event reports surrounding AG1 has led to calls for a deeper investigation. Dr. Ian Shaw of Canterbury University highlighted the serious nature of the concerns, saying, “In my opinion, if you get a number of adverse events like that, they have the propensity to be quite serious because of their liver damage, although it looks to be reversible.”
Shaw added that such trends warrant regulatory attention. Originally made in New Zealand, AG1 shifted its manufacturing base to Utah two years ago, a decision that resulted in significant job losses. The supplement has gained momentum, aided by endorsements from high-profile figures like Joe Rogan, Gwyneth Paltrow, and Sir Lewis Hamilton.
Consumer Testimonies Highlight Potential Risks
Andy Ricchiuto, a father from Indiana, is one of the people who has reported harm after using AG1. Following a change in his routine, blood tests showed a startling tenfold increase in liver enzyme levels.
“The only thing that had really changed about my lifestyle, as far as what I was eating or drinking, was AG1,” Ricchiuto explained. His doctor promptly advised him to stop the supplement and seek medical help if any symptoms arose. Ricchiuto criticised the company’s lack of clarity on the product’s potential risks, stating, “I think you owe it to the consumer to … make all of those things clear and upfront.”
Experts are also voicing concerns, including Professor Rob Chilcott from the University of Hertfordshire, who pointed to ingredients like green tea extract as a potential risk factor, having been linked to liver damage in other supplements. Chilcott warned, “It is important to emphasise that an ‘association’ is not necessarily ‘causal.’”
Company Defends Its Product
AG1’s leadership has countered concerns, with Kat Cole, the newly appointed president, defending the supplement’s safety. She noted that liver-related adverse events are incredibly rare, accounting for just 0.00001% of AG1 servings sold. However, experts have criticised this statistic, describing it as unscientific. AG1’s safety consultant, Rick Kingston, has dismissed calls for public warnings, saying,
“Given the fact that there is no safety signal, there are no remedial actions warranted.” Kingston also revealed that, despite recommending AG1 to friends and family, he does not use the product himself. The company’s lack of transparency regarding the full composition and dosages of AG1 has drawn criticism from both consumers and scientists. “What exactly is in this product that I’m putting into my body?” Ricchiuto asked, echoing calls for more disclosure.
Broader Questions About the Supplement Industry
AG1’s ongoing controversy has renewed debate over the lack of oversight in the supplement industry. Unlike pharmaceuticals, supplements are not subject to pre-market FDA approval, placing the burden on consumers to rely on post-market reporting and companies’ voluntary transparency. Professor Shaw pointed out the need for reform, stating, “What I am concerned about is that a lot of the case outcomes are pretty serious. A lot of these people have been hospitalised. So even though it might not be related to AG1, it needs to be looked at. A regulator would need to look at this.”
Founder’s History Adds to Scrutiny
The controversy surrounding AG1 has drawn renewed attention to its founder, Chris Ashenden, who has a controversial legal past in New Zealand. He was convicted for his role in an illegal housing scheme and was required to pay considerable fines and reparations. Ashenden remains a high-profile representative of AG1, despite stepping down as CEO this year, . When approached by journalists in Mexico, he declined to comment on the adverse event reports, instead claiming that AG1 remains a superior product, shaped by expert contributions.
Next Steps and Industry Implications
The ongoing investigation has sparked calls from consumer health advocates for stronger regulations and clearer transparency from AG1 and similar companies.
The FDA and other regulatory agencies are under growing pressure to review the safety of the supplement and determine if further action is necessary. For consumers like Ricchiuto, the concern is personal. With a young child at home, he insists that companies have a responsibility to disclose potential risks, stating,
“If you’re putting out a product and you think there even could be a chance of harm, I feel like it’s your responsibility to communicate that transparently and honestly.”