Methylsynephrine (Oxilofrine) Supplements

FDA warning letters take aim at banned stimulant.

Apr 08, 2016

Methylsynephrine (Oxilofrine) Supplements

The FDA has issued warning letters to seven companies regarding a total of eight weight-loss and bodybuilding products whose labeling listed the banned stimulant methylsynephrine, which is also known as oxilofrine and p-hydroxyephedrine.

“(M)ethylsynephrine is not approved as a food additive or prior sanctioned for use in dietary supplements. Further, FDA’s review of this substance does not identify a basis to conclude that the substance is GRAS (Generally Recognized as Safe) for use in food,” the FDA said.

The recipients and their problematic supplement(s) are:

A TINA.org review found that, as of April 7, at least four of the seven companies were still taking online orders for the supplements, including New York-based Total Body Nutrition for Ephedra Free Tummy Tuck, whose product label appears at the top of this ad alert. Many of the labels TINA.org found online that the FDA deemed problematic (including Tummy Tuck’s) split methylsynephrine into two words: methyl and synephrine (though Tummy Tuck’s had a typo). Synephrine, on its own, is a legal supplement ingredient. Splitting methylsynephrine into two words is just “one of the techniques companies use to deceive consumers,” says Harvard doctor Pieter Cohen, who co-authored a recent study on supplements with methylsynephrine that he said prompted the FDA action.

The study found methylsynephrine in 14 out of 27 supplements labeled as containing the banned ingredient, which has been linked to cases of nausea, chest pain, vomiting, and cardiac arrest. The doses ranged from “absolute zero to much higher than pharmaceutical levels,” said Cohen. The World Anti-Doping Agency also prohibits the substance and several professional athletes who have tested positive have claimed that they inadvertently consumed it in sports supplements, the study said.

The supplements that the FDA took issue with that TINA.org found still available for sale online cost between $33.99 (56 pills) and $99.99 (90 pills). Some of the products also claim to increase mental focus, in addition to burning body fat.

This latest batch of FDA warning letters marks the fourth time since December that the agency has taken action against supplements containing illicit substances. Previous rounds of warning letters cited supplements containing picamilon, cannabidiol, and acacia rigidula. (In fact, Texas-based M4 Nutritional Companies, which was warned about methylsynephrine, was also flagged by the FDA in the same letter for putting picamilon in its iBurn 2 supplement.)

Find more of our coverage on supplements here.