FDA gives GRAS go-ahead to Lipogen PS
status for its patented product line, suggesting increasing US
market interest in this mental health ingredient.
The US Food & Drug Administration issued a "no questions" approval following Lipogen's self-affirmed generally recognised as safe (GRAS) status notification for phosphatidylserine (PS). This means the ingredient can now be used in food.
This is the second FDA GRAS affirmation granted to a PS ingredient in the past month and points to the growing importance of plant-sourced phospholipids in a market where aging consumers look for natural ingredients to support cognitive function.
In August, US-based GCI Nutrients announced it obtained GRAS affirmation for use of its phosphatidylserine ingredient, Liposerine, in foods.
The FDA approved a qualified health claim for PS dietary supplements in 2003 - that "phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly."
Found in fish, green leafy vegetables, soybeans and rice, PS regulates metabolic processes such as neuronal signalling. Studies have associated the nutrient to improvements in memory and mood, and specifically linked it to delaying symptoms of early-onset Alzheimer's.
"Awareness and demand for this product is constantly growing," Lipogen CEO David Rutenberg told NutraIngredients-USA.com. "We hope this will continue into the functional food category, especially because of the health claim."
PS for dietary supplements was once derived from cow's brain, but since 1992 Lipogen has produced the ingredient from soy lecithin.
Rutenberg attributes Lipogen's FDA GRAS affirmation to the company's use of cabbage enzyme, instead of bacterial enzyme, for the enzymatic reaction process utilized in production. "Other PS ingredients available on the market are produced with bacterial enzymes while Lipogen PS production complies with non-bacterial enzymatic process."
GCI Nutrients also claims to use a non-bacterial cabbage enzyme method.
As baby boomers enter their seventh decade, the demand for supplement ingredients that support cognitive function - such as omega-3 fatty acids - rises.
"Baby boomers are seeking natural brain solutions that will prevent cognitive dysfunction," said Rutenberg.
With higher standards of living and more income than generations before them, this age group is a driving force in the market for all things age-related.
At the same time chronic degenerative diseases such as Alzheimer's and dementia are not going away despite medical advances.
The number of Americans with Alzheimer's disease has more than doubled since 1980, according to the Alzheimer's Association, with an estimated 4.5 million suffering from the disease. Increasing age is the greatest risk factor for Alzheimer's.
Lipogen says that in a two-month study conducted on 54 Alzheimer patients "clear mental and physical improvement of daily functions" were noted for the Alzheimer's treatment group, compared to the placebo group which deteriorated as anticipated. The difference between the two groups was more pronounced in patients at the early stage of the disease.
Lipogen is marketing its PS product, in both powder and liquid versions, worldwide. It can be applied to various key-category applications, such as milk, yogurt products, breakfast cereals, biscuits and meal replacements.
