While chitosan, a fibre derived from shellfish, has become a popular weight loss supplement, numerous Asian suppliers of the ingredient have flooded the market in recent years, offering cheap material that is not always effective, claims Iceland-based Primex.
What's more, after buying the LipoSan brand chitosan early last year, Primex (http://www.primex.is/) has seen rapidly growing demand for the fibre in the cosmetics market but sales to supplement makers have declined as European markets shifted the regulatory status of the product to a drug.
"We have seen years where there was a decline of 10 per cent," Thore Ivar Thorsen, sales and marketing director at the firm, told NutraIngredients.com.
But after a couple of years investing in new science to differentiate the LipoSan brand from others on the market, Primex could be about to make a mark on the weight loss category, and create new demand for its product.
"We are completing a turnaround from a generic product, [into a quality brand] and using new clinicals, to make this year into a strong growth year," said Thorsen.
He added: "We are getting chitosan repositioned as an effective ingredient again."
A recently published meta-analysis showed that there was not enough evidence to prove the fibre's efficacy for weight loss, despite annual consumption of around 2,000 metric tons of supplements mostly for this application.
It follows similar findings from other skeptical researchers. However Primex claims that there is a major variation in efficacy owing to the different levels of product quality, which clouds the positive results for some products.
"If you actually looked at what type of chitosan was being used [in study reviews] and disregarded the poor quality products, the results would be different," commented Bjarte Langhelle, marketing director at Primex.
Langhelle believes that numerous chitosans on the market are totally insoluble, making them ineffective.
"Chitosan needs to solubilise in the stomach. Otherwise it cannot precipitate to form a gel in the intestine that binds to the fat," he explained.
LipoSan has been developed to dissolve within 3-5 minutes in stomach acid.There is also a double blind, placebo-controlled study involving 59 women showing significant weight loss after use of LipoSan Ultra supplements, without the benefit of a reduced calorie diet or exercise.
However despite such trials, the pressure on weight loss ingredients is such that Primex is currently funding a study to demonstrate the mechanism by which the product works.
The scientific commitment has helped the firm in its discussions with a multinational partner that is planning to add the ingredient to a daily consumed food.
A study supporting the benefit of this food product is due to be published in the autumn, backing the product's launch, which could take place by the end of the year.
"That's a new growth area for us," noted Thorsen.
While chitosan has had GRAS status in the US for some time, it is mainly used in foods as a preservative. But the next six months could see a number of new foods marketed for weight loss containing the ingredient, predicts Thorsen.
The US is the world's biggest weight management foods market, seeing rapid growth as a result of the obesity problem. Functional foods will also present a much larger sales opportunity than supplements on the European market.
In Europe, the firm has begun the process of registering LipoSan as a dietary fibre, which would allow foods to make claims referring to its binding properties in the intestine.
"After this we have to team the products up with our new clinicals to make further claims outside of those allowed on dietary fibre," Thorsen said.
New foods will help compensate for the loss of supplement markets in European countries like Germany, Italy and Denmark, which all changed the regulatory status of chitosan last year to a drug.
Primex is however now registering the supplement under medical device registration this year, which has the added advantage of giving it EU-wide approval and removing national restrictions.