A podcast investigates complaints of liver harm from users of a market-leading nutraceutical created by a New Zealand businessman. Jonathan Milne and Mike Wesley-Smith report.
The US Food and Drug Administration reveals it’s received 118 adverse event reports this year alone from users of a supplement previouslymarketed by big-name influencers as “made in NZ”.
In particular, there are 30-plus reports of elevated hepatic enzymes and related symptoms of liver harm in 2023 and 2024. Scientists and consumers say they are entitled to know what risk there may be with using the supplement.
The company dismisses the liver harm reports as “extremely rare”, saying liver harm can be caused by a range of things – alcoholic liver injury, non-alcoholic fatty liver disease, viral hepatitis and autoimmune disease, among others. The FDA hasn’t investigated the liver harm reports to confirm whether they were indeed caused by AG1, as users and their medical professionals believe.
Here in New Zealand, the Ministry of Primary Industries has confirmed it is investigating AG1 but won’t reveal any details on its probe. The supplement was made entirely in New Zealand until two years ago, when it began shifting much of its production offshore, costing about 140 Nelson workers their jobs. Now its US product is made in Utah.
There are calls from leading scientists for further inquiries by the FDA and other national regulators.
Andy Ricchiuto, a father-of-three from Indiana, tells how he started using AG1 this year after hearing about it on Joe Rogan and Dr Andrew Huberman’s podcasts.
But routine blood tests revealed his liver enzymes spiked, ten-fold. “The only thing that had really changed about my lifestyle, as far as what I was eating or drinking, was AG1.”
He spoke out to the Powder Keg podcast about his experience; fortunately he didn’t get sick. When his doctor saw his blood test results, she warned him to stop using AG1 immediately, and go straight to hospital if he felt any pain.
He says the company has been warned of the risk of “real world” consequences from its product. “I think you owe it to the consumer to … make all of those things clear and upfront,” he says.
AG1 was created by Aucklander Chris Ashenden, the founder of a US$1.2 billion ($2.1b) dollar US-based nutraceutical business. His company commissions big-name influencers like Rogan, Huberman, Gwyneth Paltrow and Formula 1 champion Sir Lewis Hamilton to endorse the product.
Powder Keg, a Newsroom DELVE podcast, has reportedon Ashenden’s criminal past, the supplement industry’s lack of science and regulation, and the millions paid to influencers such as Rogan and Huberman. The podcast hit No 1 on New Zealand’s Apple Podcast charts just a few days after it launched.
AG1 was created by Aucklander Chris Ashenden, the founder of a US$1.2 billion US-based nutraceutical business. Photo / Jonathan Milne
AG1 and its safety consultant haven’t warned consumers about the reports of liver harm; they say the numbers aren’t significant. But toxicology professors Dr Ian Shaw (Canterbury University) and Dr Rob Chilcott (University of Hertfordshire) say the sharp rise in self-reports is a safety signal that warrants investigation by regulators.
Some of the FDA reports say the users’ hepatic enzymes rose after starting AG1, and dropped again when they stopped. Some reported they had made no other changes to their diet and lifestyle.
In nine cases, it was reported the complainant had been hospitalised. Two of those cases were listed as life-threatening. And there are more people who have suffered elevated liver enzymes who didn’t report their experiences to the FDA, but did speak out for the podcast.
The presence of any adverse event report in the FDA register does not mean it’s been proven to have caused the event. But, among the complaints were some made by health professionals, like one by a pharmacist on behalf of a cancer patient under oncological care. That complaint described the patient experiencing significantly impaired liver function.
Ashenden stepped down as chief executive this year, a day after Powder Keg podcast questions about his failure to disclose his New Zealand criminal record to his company and his customers. The company said the handover to company president Kat Cole was planned.
He had wound up his New Zealand companies 10 or 12 years ago, without paying $182,000 of fines and reparations ordered as part of the sentence for an illegal housing scheme he masterminded in South Auckland and Invercargill. Some families lost their money and their homes.
He remains the public face of AG1, a director of Athletic Greens International and its US and UK subsidiaries, and is thought to still hold a large ownership stake.
Ashenden went to the private Kristin School on Auckland’s North Shore, and studied science at Auckland University before dropping out. He joined the police and was stationed for two years as a constable in Wiri, south Auckland, before leaving to set up his property schemes.
Ashenden says he created the AG1 product – “a synergistic blend of 75 high-quality vitamins, minerals, and whole-food sourced ingredients” – in 2010 to treat himself, when he was unwell.
Now, thecompany employs about 300 staff and according to Ashenden has 700,000 customers – but there’s little scientific evidence to support its efficacy, nor to say whether it’s safe. The first clinical “pilot study” was published in October, tracking the biomarkers of 15 AG1 users and a 15-strong control group for just four weeks.
Ashenden’s successor, Kat Cole, declined to say how many reports of harm the company has received, or how many daily doses it distributes, but claims there’s only one report of harm for every 100,000 daily doses sold.
“Reports of any adverse events to AG1 are extremely rare, notably rare for a product that customers consume daily,” she says. “To put it in context, reports year to date of serious adverse events related to liver health accounted for just 0.00001% of AG1 servings sold.”
That’s an unorthodox way of measuring the incidence of harm, experts say. Shaw and Auckland University’s associate professor Dr Andrea Braakhuis say the real measure is what proportion of customers report harm.
“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 says. “I would expect that to be investigated.”
Braakhuis adds: “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.”
Chilcott cautions that it will require an in-depth investigation to establish whether the liver harm is caused by a supplement containing green tea extract. “There does appear to be a risk of hepatotoxicity in some individuals that has been associated with consumption of green tea supplements,” he says. “It is important to emphasise that an ‘association’ is not necessarily ‘causal’.”
Cole says the company is deeply committed to customer safety and transparency, and takes its regulatory obligations seriously, especially in complying with the FDA’s requirements for reporting serious adverse events.
She says the company contracts third-party experts to independently review adverse events reported. AG1 fronted up one, Rick Kingston, for interview.
Kingston, a toxicology professor at the University of Minnesota, is co-founder of a company called SafetyCall International, and of a pet poisoning helpline.
SafetyCall helps AG1 with its FDA reporting obligations, Kingston says. He eventually decided not to be interviewed, but he did reply to some questions by email.
He does not believe an investigation or public warnings about the adverse harm reports are necessary. “Given the fact that there is no safety signal, there are no remedial actions warranted,” Kingston says.
He stands by the company’s technique for counting the incidence rate of liver harm, though he doesn’t reply to requests for published reports supporting this methodology.
How safe is AG1? “What I would say is that I have had no issue recommending it to family and friends that are looking for a broad-spectrum supplement.”
He doesn’t use it. “I have a supplement regimen that I personally use, but would not hesitate to use AG1 myself.”
Like Shaw and other university experts, Andy Ricchiuto wants the FDA to investigate the liver harm reports.
Andy Ricchiuto with wife Dana, daughters Finley and Kayla, and baby son Mikey. The Indiana IT engineer’s liver enzymes skyrocketed when he began using the supplement AG1. Photo / Supplied
And he wants the company to fully disclose the composition of AG1 – not just what’s in it, but in what quantities. “What exactly is in this product that I’m putting into my body?” he asks.
The IT professional has a baby boy who’s just 3-months-old – he says he can’t risk getting seriously ill. He questions how long AG1 has known about the reports of raised liver enzymes, and why they haven’t proactively warned consumers.
“I think that’s at best irresponsible,” he says. “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.”
Approached in the street in the Mexican resort town of Playa del Carmen, outside the Grand Hyatt hotel where he was meeting with AG1’s executive leadership team, Ashenden refused to answer questions about the reports of liver harm.
He insists his AG1 business is different from his previous failed business ventures, thanks in part to the leaders with whom he’s worked. “They have helped transform it from a start-up into a global business that has served millions of customers worldwide. That’s why AG1 is even better today than when we started.”
