Pharmachem's Phase 2 holds new FDA health claim

Pharmachem has announced that the Food and Drug Administration has been notified of structure function claims for weight control and starch reduction for the company's Phase 2 Starch Neutralizer ingredient.

The structure function claims for the proprietary white kidney bean extract is good news for New Jersey-based Pharmachem, as such health claims require extensive clinical data. Notification must be made prior to in advance of making claims on products, and if the FDA does not believe the science holds up it will object.

If used on labelling, the claims have the potential to drive sales for Pharmachem's ingredient in the biggest weight loss and diet market in the world: the United States.

Phase 2 was first introduced in the US in 2001, and has since been made available internationally. Pharmachem has also introduced a food version of Phase 2, StarchLite, for potential applications in a variety of food and beverage products.

"The implications for both our Phase 2 ingredient in weight control supplements and StarchLite for food applications, are tremendous," said Pharmachem CEO David Holmes of the new health claims.

The US accounts for 63 percent of the world slimming products market, according to Euromonitor International, with retail sales amounting to $4.34bn.

With an estimated 65 percent of US adults overweight or obese, demand in the category does not look ready to slow down.

According to Pharmachem, the two health claims for its ingredient read as follows:

-"May assist in weight control when used in conjunction with a sensible diet and exercise program."

-"May reduce the enzymatic digestion of dietary starches."

Phase 2 is marketed for reducing the calories gained from eating starchy food such as potatoes, bread, pasta or rice. The ingredient is said to function by neutralizing the digestive enzyme alpha amylase before it can convert starch into glucose and then into fat. As such, Pharmachem claims consuming Phase 2 permits carbohydrate to pass through the system with potentially less caloric intake.

"To Pharmachem's knowledge, Phase 2 Starch Neutralizer is the first nutritional ingredient to receive structure function claims for both weight control and reduced digestion of dietary starches," said Holmes.

Health claims have the potential to increase sales for functional ingredients, not only thanks to the authoritative aspect they lend to products, but also because market research has shown consumers are increasingly buying dietary supplements or functional foods based on specific ailments.

In its 2005 Health & Wellness Trends Database, the National Marketing Institute tracked a 17 percent compound growth rate for such condition specific supplements over the past five years. In its report, the analyst explained that due to a lack of public knowledge as to what supplements can be used for what condition, consumers look for labels that spell out therapeutic benefits.