Biotivia launches first UK resveratrol supplement

By Ben Bouckley

- Last updated on GMT

Biotivia is hoping its resveratrol supplements will make a splash in the UK, but admits regulatory challenges remain
Biotivia is hoping its resveratrol supplements will make a splash in the UK, but admits regulatory challenges remain

Related tags Resveratrol

Herbal supplement producer Biotivia has launched a resveratrol supplement onto the UK high street for the first time, but has expressed frustration at the EU regulatory climate.

As an antioxidant, resveratrol occurs naturally fruits such as grapes and pomegranates, as well as foods such as peanuts. Most abundant in red wine, it has been linked to the so-called ‘French Paradox’, where the nation has a lower incidence of heart disease than other western countries despite high red wine consumption.

In 2003, David Sinclair and his Harvard team found that resveratrol​ was able to increase the lifespan of yeast cells, leading to hopes for a miracle anti-ageing pill. Meanwhile, other studies have indicated anti-cancer and anti-inflammatory effects, cardiovascular benefits, anti-diabetes potential, energy endurance enhancement, and protection against Alzheimer’s.

Established in Austria, bioceutical firm Biotivia sources its resveratrol from Japanese knotweed (polygonum cuspidatum​) and its pills go on UK sale in Nutri Centre health stores (complementary medicine stores that belong to retail giant Tesco) from February; recently it also inked a deal with UK distributor Isora Nutraceuticals.

Managing director, Biotivia, Dr James Betz, told NutraIngredients.com why it had taken time to bring the product to market in the UK, despite its sales success in the US for several years.

“Prior to this we sold the product via our website in the UK, but not with retailers. We only signed the Nutri Centre deal very recently, with delays due to finding the right partners and market confidence,”​ he said.

“Previously, when we met with retailers they felt that the launch might be premature, and that consumer demand wasn’t high enough.”

Tricky regulatory environment

Betz also expressed frustration at EFSA’s (the European Food Safety Authority) mass rejection​ of antioxidant foods and constituent health claims under article 13.1 last February, which he said was problematic for resveratrol-based food supplements.

“We’re very aware of EFSA’s restrictions, and they’ve ruled that we can’t characterise resveratrol as an antioxidant, and describe it as such on labelling, despite a massive scientific consensus that it is one.”

The EU’s Traditional Herbal Medicines Directive (THMPD) became law in 2004, and ruled that manufacturers selling herbal products making medicinal claims had seven years to register their products by submitting a supporting dossier.

Nigel Baldwin, senior scientific and regulatory consultant and EU manager, Cantox Health Services, explained this is essentially a licensing application under the auspices of national bodies (such as the UK’s MHRA).

Once products demonstrate ‘safety, quality and efficacy’ upon the basis of accepted scientific monographs, he said, a license is granted that includes the ability to make health claims.

But with the April 30 2011 deadline looming for registrations, concerns are growing that thousands of herbal medicines now legal under national laws could be removed from sale.

Although Biotivia's products are mainly registered as food supplements, Betz said the company was affected by the directive: “One product we might either have to take off the market or reformulate​ [due to the THMPD] is ​[trans-resveratrol product] BioSpan.”

 “That’s one product that we’re working hard to get registered under the directive, our other products are registered under national health ministries.

 “Registration under THMPD is time-consuming and expensive. Most firms don’t bother with registration, but we felt we had no choice.”

 

 

Dosage levels and side effects

Historically, critics suggested that there were insufficient human studies on resveratrol, with one recent media report criticising animal studies using 2,000mg daily doses, and stating that doctors advised human doses of no more than 50mg.

Asked about this issue, Betz said: “That’s completely wrong. Last September I attended the first international conference for scientists researching resveratrol. About 120 scientists were there from the top research institutions in the world.

 

“The consensus amongst researchers there was that the human consumption limit is 1,000mg a day – the limiting factor above that dosage is gastric issues.”​ Betz also rubbished claims that resveratrol side-effects include insomnia, joint pain and acne.

Yesterday we revealed that the Danish government has committed €2.47m​ to a new resveratrol study investigating multiple metabolic syndrome endpoints for resveratrol, including obesity, type-2 diabetes and osteoporosis.

Stimulates cerebral blood flow

Meanwhile, Betz said, human studies continued to show positive results: “We are closely involved in a number of human trials, including the Northumbria University study ​[Kennedy et al. 2010​] on cerebral blood flow, and due to its success we’re talking to Dr.Kennedy there about dramatically expanding the trial,”​ said Betz.

 

He mentioned a study by the New York-based Albert Einstein College of Medicine (announced last December) looking at resveratrol’s effects on pre-diabetes, and others at Ottowa Hospital in Canada and Stoney Brook University Medical Centre, with Biotivia supplying products for the latter "large-scale multi-year human trial"​ examining resveratrol's role in preventing heart disease in susceptible subjects.

 

“We’ve just signed up for a trial conducted by the University of Turin,”​ Betz added. “It’s at their Department of Endochrinology, and although they’re remaining pretty secretive, we think, based upon who appears to be involved, that they might be looking at diabetes or pre-diabetes.”

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