The FDA Phosphatidylserine Claim and Its Warning

The asterisk points to a statement that FDA has not evaluated the claim.

Structure and function claims, such as "Supports Focus*", are not pre-approved. The maker must have evidence that the claim is truthful, notify FDA of the wording within 30 days of marketing, and print the disclaimer that the product is not meant to diagnose, treat, cure or prevent any disease (FDA, Structure/Function Claims).

That is how the MemoPryl bottle works. Its claims are label wording, quoted here as label wording only.

1. Label A“Optimized Memory*”MemoPryl itself has not been tested in a trial. Ginkgo did not lower dementia rates against placebo in the 3,069-person GEM trial, and NCCIH calls the evidence for most supplements inconclusive. (DeKosky 2008, GEM trial, JAMA) (NCCIH, Supplements and Cognition)
2. Label A“Improves Mental Clarity*”'Improves' is a strong verb to use in a structure/function claim. A meta-analysis of bacopa trials lasting 12 weeks or more found faster attention at 300 mg or more of extract, an amount none of the bottle images prints. (Kongkeaw 2014, Bacopa meta-analys.) (LiverTox, Bacopa monnieri)
3. Label A“Supports Focus*”St. John's wort was studied for mood rather than focus, and glutamine has no memory trial. None of the bottle images prints an amount for any ingredient. (NCCIH, St. John's Wort in depth) (MSK, Glutamine)
4. Label B“Supports Concentration*”The evidence is for single ingredients, at doses this site cannot see. A health claim generally needs randomized human tests of the product itself. (FTC, Health Products Guidance)
5. Label B“Supports Brain Energy*”'Brain energy' is not something medicine measures. In dementia, a Cochrane review found acetyl-L-carnitine had no effect on severity. (NIH ODS, Carnitine) (Pennisi 2020, ALC in dementia)
6. Label B“Supports Productivity*”Supplement trials do not measure productivity. In the FTC's view, personal stories are never enough to back a health claim. (FTC, Health Products Guidance)
7. Both labelsThe FDA asteriskStructure/function wording is permitted when the FDA disclaimer goes with it. It is neither FDA approval nor a disease claim. (FDA, Structure/Function Claims)
8. Badges“Doctor formulated”, “GMP certified”, “FDA registered”None of them names a doctor, certifier or audit. FDA registers facilities but approves neither them nor the supplement. (FDA, Hidden Ingredients) (FDA, Using Dietary Supplements)
9. Bottle30 capsules and Cognitive Support, or 60 capsules and Advanced FormulaThe brand set's two bottle images do not agree. Only the bottle you receive settles it.

The claims exactly as the two bottle images print them. A health claim needs competent and reliable scientific evidence, usually human trials of the same product (FTC, Health Products Guidance).