FDA Adds Two More Qualified Claims

United States

Two more dietary supplements have won FDA approval for a qualified health claim, in a move some marketers are calling significant while others are complaining they don't go far enough.

The two supplements are the phospholipid phosphatidylserine (PS) related to cognitive dysfunction and dementia in the elderly, and the mineral selenium to reduce the risk of certain cancers.

The qualifying language authorised by FDA for both nutrients, some say, diminishes the impact of the claims. For instance, the claim for PS reads: "Phosphatidylserine (PS) may reduce the risk of dementia in the elderly. Very limited and preliminary scientific research suggests that PS may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim."

"These claims allowed by FDA are unnecessarily modest compared with the extent of the clinical research that supports PS," says phospholipid researcher Dr Parris Kidd. "However, they are a concession by the agency that a nutrient can make a real difference for people struggling to overcome memory breakdown."

Depite the agency's tepid support, it nonetheless gives marketers an opportunity to develop and sell more products.

"The establishment of health claims for PS is significant," said Scott Hagerman, president of Chemi Nutraceuticals. "It underscores the health benefits of PS, and now allows the addition of PS to many more products."

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