Last year an expert group on vitamins and minerals (EVM), set up by the UK's Food Standards Agency to report on safe intake levels, concluded that there was some evidence (from in vitro not in vivo studies) suggesting that chromium picolinate might be genotoxic, or could damage DNA.
The agency advised consumers to use other types of chromium and commissioned a genotoxicity review from the Committee on Mutagenicity (COM). The committee has since received further research that tips the balance in favour of the safety of the supplement, given that it had a number of reservations about the way in which the in-vitro tests that had found some genotoxicity were carried out.
“We are delighted with the result,” said Gail Montgomery, CEO of US-based Nutrition 21, which makes the picolinate form of chromium.
“We expected it because we have been working with the science for a long time and have amassed a significant body of evidence. But these misperceptions on safety have been around since 1997. Now we have a definitive statement from a major scientific body,” she told NutraIngredients.com.
In addition, the FSA has recommended a maximum upper level of 10 mg chromium picolinate per day, well above the level commonly used in studies.
“Typically the dosage is between 200 and 1000mcg,” said Montgomery. “An upper limit of 10mg really speaks to the overall safety of this mineral. It is probably the safest of all minerals available.”
Chomium picolinate has a limited presence on the European market to date, with Nutrition 21 supplying some markets through NBTY's subsidiary in the UK and Ireland, Holland & Barrett. However the company could gain access to the whole region under the food supplements directive, set to enter into force next year.
“We will initiate regulatory filings for both Canada and Europe under our long-term strategy to introduce Diachrome into these markets,” revealed Montgomery.
While chromium features on the European directive's ‘positive list', numerous forms of the trace mineral, including chromium picolinate, do not. Yet supplement makers say these forms make the mineral more bioavailable to the body.
Nutrition 21 is currently preparing a dossier of scientific evidence to support the product's inclusion in the European market. It will include the research now supported by the FSA, and be submitted to the European authorities next spring, according to Montgomery. US rival Interhealth is also preparing a dossier on its chromium form polynicotinate.
The companies could benefit from increasing research into chromium's role in insulin metabolilsm. A number of trials have found that daily supplements of 1,000 mcg of chromium picolinate helped control blood sugar levels in people with insulin resistance and diabetes.
Nutrition 21 has applied to the US Food and Drug Administration to allow the use of health claims supporting the glucose control function of its Chromax brand chromium picolinate. It is also working on novel combinations such as its Diachrome brand chromium picolinate and biotin, recently tested in a 450-patient trial that is currently completing analysis.
“There are an estimated 18.2 million people in the United States with diabetes and globally this number will reach 300 million by 2005. We see our product as applicable to an extremely large market,” added Montgomery.
Sales of chromium picolinate, worth around $106 million in 2003 in retail terms, have grown by around 25 per cent since 2002, according to Montgomery. She expects the new safety data to substantially increase product sales.
