Chromium supplement manufacturer Nutrition 21 has released a statement highlighting the evidence to support the safety of chromium picolinate, following a new report from the UK which may lead to the ban of the supplement in the British market.
The company, which markets Chromax chromium picolinate, one of its core products, claims that decades of scientific research conducted at leading institutions finds the compound to be safe and to have potentially important health benefits for human and animals.
Other members of the US industry have also spoken in support of the supplement, which is Generally Recognized as Safe (GRAS) in the US. However the report by the Expert Group on Vitamins and Minerals (EVM), which makes recommendations on 31 vitamins and minerals, found that chromium should be limited to 10mg in the diet, and that there is not enough evidence to back the safety of chromium picolinate in supplements. The UK's Food Standards Agency has issued a consultation proposal for the ban of the mineral form in the UK.
Other vitamins and minerals have been given new warnings, including B6, which according to the EVM report, should only be taken at 10mg, rather than the 100mg total daily intake advised by the Food and Nutrition Board (FNB). Vitamin C intake should not exceed 1000mg as it can cause diarrhoea, and vitamin A also has a USL lower than advised by the FNB or Europe's Scientific Committee on Food (SCF).
In the US, chromium has been at the centre of much discussion recently, and despite a recent study which reported that the picolinate form could cause genetic damage in flies, a conference last month highlighted the body of research suggesting that chromium picolinate may help lower some risk factors for diseases associated with insulin resistance, such as obesity, cardiovascular disease, type 2 diabetes, Polycystic Ovarian Syndrome (PCOS) and even atypical depression.
Nutrition 21 says that there is no evidence of toxicity in any of the numerous studies in which chromium picolinate was administered orally to humans or animals, and cites numerous studies carried out by centres including the US Department of Agriculture's (USDA) Human Nutrition Research Center, Duke University Medical Center, Harvard University School of Public Health, Johns Hopkins University.
Other researchers back the safety of the supplement. Dr Richard Anderson, a researcher at the USDA Human Nutrition Research Center, said the Food Standards Agency's committee drew inaccurate conclusions based on data using intravenous injection. "The body's response to mineral injection is unique compared with oral administration, and does not translate to human supplementation guidelines."
He added: "I'm disappointed that this UK agency has misrepresented the large body of scientific evidence that supports the safety of chromium picolinate supplementation."
Dr John Hathcock, vice president of scientific and international affairs at CRN, was equally concerned by some of the EVM recommendations. "The report reaches conclusions on chromium picolinate based on animal studies because there is not sufficient human evidence. This is not scientifically defensible. They also did this with vitamin B6, deciding that none of the human data was reliable enough, and so used animal studies. The SCF and FNB both use human data for B6 so why does EVM take a different approach?"
Dr Hathcock also points to the different levels of vitamin A recommended by EVM. "The group uses new evidence suggesting a risk of fracture in bones, but both the SCF and FNB concluded this insufficient to make conclusions. The EVM are the only ones to conclude on this new evidence."
The report met with similar concern from the industry in the UK. The Health Foods Manufacturers Association found the report to be "flawed in a number of aspects of the interpretation of the science of safety to the extent that it could lead to unnecessary bans on some key nutrients and unreasonably restrictive levels being imposed on others".
It also said in a statement: "In the absence of harmonised safe upper limits, there is potential to confuse customers, to hinder free circulation of products within the European Community and from other countries, to create unnecessary barriers to trade and to restrict consumer choice."
Dr Hathcock reiterated the need for global harmonisation of the science. "This is clearly an attempt by the UK to set a precedent for European law on this issue. But it shows that we are in great need of international recognition of the science to prevent future trade disputes. We need to encourage the World Health Organisation and Codex to come up with their own numbers to supersede all the different levels."
If the UK implements the new upper safe levels prior to implementation of the European Food Supplements directive, all US companies trading in the British market will have to comply. The EVM report is available from the FSA website.