February 24, 2003
Jonathan W. Emord
Emord & Associates, P.C.
1050 17th Street, N.W.
Washington, D.C. 20036
Dear Mr. Emord:
Thank you for your February 24, 2003 e-mail stating Dr. Kyl 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:
1) "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 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.
Christine Taylor, Ph.D.
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Original petition at Dockets