FDA Stings ‘Bee Pollen’ Dietary Supplement

A dietary supplement being marketed by a New Jersey company online as “all-natural” and “safe” for weight loss is packing some potentially dangerous ingredients, according to the FDA. And what’s more, those ingredients are not labeled on the bottle, the FDA said in its June 5 warning letter to the distributors of Zi Xiu Tang Bee Pollen.

One of the “undeclared” ingredients at issue is sibutramine, which clinical data has linked to an increased rate of heart attack and stroke, the FDA said. In fact, because the product contains sibutramine, it’s “excluded from the definition of a supplement,” the FDA said.

The FDA said the other troublesome ingredient is phenolphthalein, a chemical that carries “a cancer-causing risk” and is not active in any approved drug in the U.S.

This is not the product’s first go-around with the FDA. According to the letter, addressed to Joseph D’Arpa, owner of Nutrishop of Brick, Inc:

In the past year, you have received six import refusal letters from FDA stating that your products appear to be unapproved new drugs and that they contain undeclared sibutramine.

The FDA has received dozens of adverse event reports and is warning consumers not to use Zi Xiu Tang Bee Pollen.