FDA APPROVED CLAIM STATEMENT

In May, 2003, the Food and Drug Administration (FDA) announced it will allow the following claims to accompany products that contain Phosphatidyl Serine:

"PHOSPHATIDYL SERINE MAY REDUCE THE RISK OF DEMENTIA IN THE ELDERLY" AND "PHOSPHATIDYL SERINE MAY REDUCE THE RISK OF COGNITIVE DYSFUNCTION IN THE ELDERLY."

Although the FDA requires the presence of an accompanying statement reading "Very limited and preliminary scientific research suggests that PS may reduce the risk of dementia [cognitive dysfunction] in the elderly," the claim nonetheless is a landmark first for any food or supplement and a positive association with mental illness

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Here is an interesting email from the FDA to the offices of Dr Parris Kidd advising health care professionals on how to share the agreed upon success of Phosphatidyl Serine(PS), the active ingredient found in Prememlo™ with customers written prior to May, 2003:

Dear ____,

Thank you for your February 24, 2003 e-mail stating Dr. Kyle Smith's acceptance of FDA's proposal regarding Dr. Smith's health claim petition for phosphatidylserine (Docket 02P-0413). This letter finalizes our agreement that FDA will consider exercising enforcement discretion with respect to Dr. Smith's two proposed claims - (1) phosphatidylserine may reduce the risk of dementia in the elderly and (2) phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly - if they are accompanied by the following disclaimer:

"Very limited and preliminary scientific research suggests that PS may reduce the risk of dementia [cognitive dysfunction] in the elderly. FDA concludes that there is little scientific evidence supporting this claim."

The brackets around "cognitive dysfunction" indicate that this term should be substituted for "dementia" when the claim is about cognitive dysfunction.

As we have agreed, FDA will consider exercising enforcement discretion with respect to phosphatidylserine supplements that bear your health claim(s) when the applicable disclaimer is placed immediately adjacent to and directly beneath your claim(s), with no intervening material, in the same size, typeface, and contrast as the claim itself.

Phosphatidylserine (PS) supplements bearing the claim(s) and disclaimer(s) are still required to meet all applicable statutory and regulatory requirements under the Federal Food, Drug, and Cosmetic Act, including the applicable requirements for health claims.

Pursuant to this letter, we will immediately begin considering the exercise of our enforcement discretion for supplements that are marketed with the above-referenced health claim(s) and disclaimer(s). We will be posting this letter on our website or otherwise providing guidance to the public regarding our advice in this letter.

As previously discussed, within 60 days of the date of this letter, we plan to issue the formal decision on the phosphatidylserine health claim petition.

Sincerely Yours,

Christine Taylor, Ph.D. Director

Office of Nutritional Products, Labeling and Dietary Supplements

Center for Food Safety and Applied Nutrition

Food and Drug Administration (FDA)

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From the Director of the Alzheimer's Prevention Foundation

"Emerging science has shown that it may be possible to prevent Alzheimer's disease. There is no magic bullet,

but PhosphatidylSerine (PS) is very effective at reversing signs of memory loss. In my clinical experience, it's actually quite remarkable."                    

Dharma Singh Khalsa, MD                 

Medical Director, Alzheimer’s Prevention Foundation, USA.

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1) MY MOM'S TESTIMONIAL:

2) MY BROTHER'S TESTIMONIAL AT AGE 60 WAS THAT HE REMEMBERS THINGS BETTER WHEN HE TAKES PREMEMLO

3) MY SON'S TESTIMONIAL SINCE HE HAS TAKEN IT IS THAT MORE IDEAS ARE COMING TO HIM THAN BEFORE. THINGS HE WOULD NOT HAVE PUT TOGETHER ARE CONNECTING AND THAT HIS MOOD IMPROVES WHEN HE TAKES IT.

4) MY OWN TESTIMONY IS THAT WHEN I HIT MENOPAUSE, THE HORMONES SENT MY MEMORY WALKING. I ALWAYS HAD A WONDERFUL MEMORY. IT CAME BACK WITHIN DAYS OF STARTING PREMEMLO.

5) MY SISTER-IN-LAW RECENTLY TOLD ME SHE FEELS CLEAR HEADED FOR THE FIRST TIME IN YEARS SINCE TAKING IT

6) MY FRIENDS HAVE STARTED TAKING IT AND REORDER REGULARLY BECAUSE THEY SAY THEY ARE APPRECIATING BEING ABLE TO THINK BETTER.

7) AUNT BERNICE RECENTLY RAN OUT OF HER COMPLEMENTARY BOTTLES OF PREMEMLO. AS SOON AS THEY WERE GONE, SHE CALLED ASKING "PLEASE SEND MORE RIGHT AWAY, I CAN'T REMEMBER LIKE I WAS BEFORE I RAN OUT--THAT STUFF REALLY WORKS."

8) DELICA H. FROM CALIFORNIA SAYS: "I DON'T AWAKEN ANYMORE FEELING LIKE MY HEAD IS IN A FOG. MORE ALERT UPON WAKENING AND THROUGHOUT THE DAY. INCREASED RECALL OF FACTS. INCREASED RETENTION OF INFORMATION. NOT NEARLY AS SCATTERBRAINED AS DESCRIBED SO ACCURATELY IN THE HUMOROUS ARTICLE ENTITLED "A-A-A-D-D." THANK YOU SO VERY MUCH FOR YOUR GOD GIVEN PRODUCT."

9) Among the many people who take PREMEMLO ingredients now, let's not forget all the huge amounts of people around the world, who have been researched taking Phosphatidyl Serine (PS), (one of the two main ingredients in PREMEMLO, which is also blended with Phosphatidyl Choline (PC) to make it even more effective):

Please add your testimony after trying PREMEMLO! One free bonus bottle will be sent to you in appreciation!

Thank you!

Dr. Jill 

For Personal Emails click on: drjjoyce@att.net  

Emails in this box will be posted!