FDA Authorizes Lipogen to be Used as Food Additive

17 Apr 2007

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The research showed significant memory and mental improvements in comparison to the placebo groups. The results also showed that dietary supplementation with PS can play a vital role in supporting human cognitive functions as we age.

17/04/07 Americans looking for a natural way to improve memory and mood now have a powerful tool at their disposal. The FDA has authorized an Israeli-made product called Lipogen to be used as a food additive.

A natural functional food ingredient that improves brain functions in both children and adults, Lipogen contains phosphatidylserine (PS), a nutrient found in fish, green leafy vegetables, soybeans and rice, which goes to the brain and regulates metabolic processes such as neuronal signaling. Studies have associated the nutrient to improvements in memory and mood, and specifically linked it to delaying symptoms of early-onset Alzheimer's.

"PS is a naturally occurring material within the membranes of the cells in the brain. Generally the brain produces the required amount of the material, but age as well as the stress of modern life slows down its production," explained David Rutenberg, the founder and CEO of the Galilee-based company Lipogen which developed and produces the product.

"When it's lacking, the neurochemistry of the cells in the brain malfunction, leading to potential memory loss," he told ISRAEL21c.

According to a report issued last week, more than five million Americans are living with Alzheimer's disease, a 10 percent increase since the last Alzheimer's Association estimate five years ago - and a count that supports the long-forecast dementia epidemic as the population grays. Unless scientists discover a way to delay Alzheimer's brain attack, some 7.7 million people are expected to have the disease by 2030, the report says. By 2050, that toll could reach 16 million.

"Lipogen PS simply recuperated the loss of the material in the brain. It's effective for memory functions. Memory degradation with age isn't considered a disease but a natural process of getting older. Therefore, it's not regarded as medicine. We regard Lipogen PS as the brain vitamin," said Rutenberg.

Lipogen began developing its vegetarian and kosher PS products in 1992, focusing on natural mental health solutions for dietary supplements or for enhancing foods and beverages. Rutenberg explained that prior to the company's start; the difficulty that has existed in bringing PS substance to the market has primarily been due to supply source. The only commercially available PS was derived from cow's brain (BCPS - Bovine Corte Phosphatidylserine). However, Lipogen introduced soy lecithin PS, whose enzymatic reaction process utilizes cabbage enzyme.

"We were the first to produce Lipogen PS from soya lecithin in substantial amounts at competitive prices. It's administered orally, in tablet or capsule," he said.

Lipogen PS has been clinically tested in double-blind, placebo-controlled studies. The research showed significant memory and mental improvements in comparison to the placebo groups. The results also showed that dietary supplementation with PS can play a vital role in supporting human cognitive functions as we age. Among the numerous studies conducted with PS, most were concerned with subjects already experiencing noticeable declines in judgment, abstract thought, memory, behavior, and personality.

In Israel, where Lipogen PS is marketed under the brand name L-Telect, no side effects or any adverse events were reported. "Israelis have been using Lipogen for several years - we're popular in health food stores and pharmacies," said Rutenberg. "But the market is not in Israel, it's in America."

In 2003, the FDA recognized the validity of Lipogen and allowed it to have a certified health claim that it 'may reduce the risk of cognitive dysfunction in the elderly', said Rutenberg. "It was sold over the counter as a dietary supplement."

Now, the FDA has issued a 'no questions' approval following Lipogen's self-affirmed generally recognized as safe (GRAS) status notification for PS.

"With this new ruling by the FDA, Lipogen can now be introduced into food as a functional ingredient. It's a major breakthrough," said Rutenberg.

As a result, Lipogen has announced it is increasing production of its Lipogen PS patented product line for the food and beverage fortification, and dietary supplement markets in the US.

"We're looking forward to cooperating with food companies to introduce Lipogen as a functional ingredient in order to make the food more beneficial for children and adults alike," said Rutenberg who's been traveling back and forth to the US meeting with major food companies. "We have a lot of interest."