No particular dose of phosphatidylserine works better at reducing the severity of cognitive dysfunction and the risk of dementia, according to a health claim petition filed with FDA April 19.

"Studies have shown phosphatidylserine supplementation to have nutritive value from 75 mg to 500 mg a day," the petition notes.

Moreover, the document states a "safe upper limit for [the ingredient] has not been established, but it has been shown to be safe at intake levels up to 500 mg per day." As a result, the health claim petition for phosphatidylserine does not reference a particular dose.

Filed by the law firm Emord & Associates (Washington, D.C.) on behalf of Kyl Smith, the petition requests FDA allow two health claims for phosphatidylserine to appear on dietary supplement labeling.

The health claims read: "The consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly"; and "The consumption of phosphatidylserine may reduce the risk of dementia in the elderly."

Phosphatidylserine is found in soy products and eggs, and while there is no recommended daily intake, the petition maintains "the nutritive contribution of phosphatidylserine is widely recognized."

The need for supplementation stems from the fact "it is virtually impossible for any one person to consume daily those foods in conventional form that contain enough [of the ingredient] (50-500 mg/day) to affect" a possible reduction in cognitive dysfunction or dementia.

The petition adds that the proposed claims would address an important health need, as "an estimated four to five million Americans...have some form and degree of cognitive dysfunction."

To support the claims, Smith cites various studies illustrating the ingredient's safety and efficacy. The majority of the research is described as showing phosphatidylserine alleviates cognitive dysfunction and dementia by disrupting the rate of cognitive decline.

However, Smith notes he is willing to accept inclusion of a "reasonable, short, succinct and accurate disclaimer" if FDA determines the body of evidence does not amount to "significant scientific agreement."

A guidance issued by FDA in December 1999 states that significant scientific agreement is met "when the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be redefined over time" (¹ Also see "SSA Guidance Provides Review Methods, Not Definition" - Pink Sheet, 3 January, 2000., p. 4).

The petition explains that phosphatidylserine works by becoming "incorporated into neuronal cell membranes, influencing the metabolism of neurotransmitters acetyl-choline, norepinephrine, serotonin and dopamine."

Numerous open-label and randomized, placebo-controlled trials, as well as animal studies, are referenced as evidence of the product's efficacy in arresting the development of dementia in elderly subjects.

Animal studies cited show phosphatidylserine boosts neuronal communication by increasing the synthesis of neurotransmitters in the cerebral cortex, improving neurotransmission and preventing the loss of nerve growth factor receptors, Smith says.

Open-label studies lasting either 60 days or 90 days show that elderly patients with mild cognitive decline who took 100 mg phosphatidylserine three times daily had significant improvement in "verbal learning, verbal recall, verbal fluency, visual learning, attention, communication skill, initiative, socialization and self-sufficiency," the petition continues.

Moreover, "in a study of subjects with more severe memory loss and cognitive decline, six weeks of daily supplementation with phosphatidylserine stabilized cognitive function, improving recall, long-term memory, pattern recognition and performance of daily life activities," Smith notes.

A longer, six-month trial of oral phosphatidylserine similarly showed the ingredient reduced symptoms of withdrawal and apathy while improving overall cognitive functioning, the petition points out.

With regard to phosphatidylserine's safety, Smith notes the 2001 Physicians' Desk Reference for Nutritional Supplements "indicates no significant contraindications, only a general statement that it is contraindicated for persons that are hypersensitive, i.e. allergic, to any component of the preparation." In addition, Smith says no proof exists to indicate cumulative consumption leads to adverse effects.

However, the petition recommends that pregnant women, nursing mothers and children, as well as individuals who have antiphospholipid-antibody syndrome, should avoid consuming the ingredient. It also points out that phosphatidylserine may occasionally cause indigestion and nausea.

FDA has 540 days to make a decision on the health claim. While the agency considers the Smith petition, two other health claim petitions still are in litigation. A claim linking antioxidants with a reduced risk of certain cancers, as well as a claim for saw palmetto and benign prostatic hyperplasia, were rejected by FDA.

After FDA rejected the antioxidant claim, Emord & Associates filed suit against the agency on behalf of the petitioners, alleging FDA inappropriately concentrated on scientific evidence for cancer prevention and cancer treatment, rather than cancer risk reduction, which was the subject of the claim (² Also see "FDA Antioxidants Claim Review Improperly Focused On Prevention - Lawsuit" - Pink Sheet, 23 July, 2001., p. 5).

Additional dietary supplement health claims are on the horizon. Emord & Associates said a health claim petition regarding selenium's benefits for certain types of cancers likely will be filed in the next few weeks. The law firm noted a scientist has been evaluating the evidence for three months and will be reporting his findings soon.

Roughly five or six more petitions should be filed by the end of the year, according to the law firm.

The health claim petition for phosphatidylserine marks Kyl Smith's latest activity concerning dietary supple-ments for cognitive function. Smith developed Focus Factor , a supplement recently cited by the National Advertising Division of the Council of Better Business Bureaus for lacking sufficient evidence to substantiate claims the product improves attention and memory.

Claims mentioned by NAD included, "children and teens feel a boost in their focus and concentration" (³ Also see "Focus Factor Trial Underway To Substantiate Improved Memory Claims" - Pink Sheet, 25 March, 2002., p. 7). Marketing firm Vital Basics is looking to support the claims by funding an independent trial, which is slated for completion by the end of May.

Phosphatidylserine, Dementia, Cognitive Decline Health Claim Sought

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