Is the FDA Allowing Dangerous Ingredients?


A dangerous chemical present in several weight loss and workout supplement is among the ingredients that the U.S. Food andDrug Administration (FDA) is accused of allowing that have many health officials questioning whether the FDA is capable of doing enough for consumer safety. Harvard University scientists alerted the public last week about the situation, via the New York Times, and since them some stores have stopped selling the questionable items.

The Harvard researchers conducting lab tests found beta-methylphenylethylamine (called BMPEA for short), which is an ingredient similar to speed, in 11 common over-the-counter supplements. The supplements, with the chemical related amphetamines, are readily available in stores carrying dietary pills

Once the news hit papers and television, some chains, such as Vitamin Shoppe, broadcast that they were pulling the supplements involved from stores. Vitamin Shoppe executives, when announcing that the company was pulling pills containing BMPEA from their shelves, acknowledged that “the safety of these products is now in question.”

The situation has led many consumers and reporters to wonder how the FDA is allowing potentially dangerous ingredients in over-the-counter pills. They are also wondering if the reaction is overkill. However, there is also a question of whether the FDA even has the authority to do anything about the supplements.

BMPEA is a phenethylamine, the family of chemicals that includes amphetamines as well as hallucinogens like mescaline. Phenethylamines target brain receptors like the ones controlling energy, but they have also been known to produce LSD-like effects. The chemical, which is classied as a doping agent by the World Anti-Doping Agency, has been shown to raise heart rates and blood pressure in cats and dogs. However, the substance has reportedly not been thoroughly tested for safety or effectiveness on humans.

The problem is that BMPEA is a dietary supplement component that is not found naturally in the Acacia rigidula plant so testing it is difficult. The FDA has tested varies parts of the Acacia rigidula, including leaves, twigs and bark. They consistently found phenethylamines, but not BMPEA. However, the FDA scientists found BMPEA in almost half of the 21 products they tested that contain phenethylamine. But the supplements contained more types of phenethylamine than in the actual plant.

One of the manufacturers, Hi-Tech Pharmaceuticals, produces Fastin-XR. The company reports that Fastin-XR includes Thermo-Rx, which they say is a phenylethylamine alkaloid blend from the Acacia rigidula plant, as well as other potent stimulants to enable extreme energy, a great mood, and optimal weight control.” While they do not specifically mention BMPEA, the firm paid for its own study on the substance. In their clinical trial, the supplement was tested on 10 men. The subjects’ heart rates reportedly increased by 11 beats per minute and their systolic blood pressure rose 22 points.

The supplement industry has been producing supplements with newer stimulants since some, suh as ephedra, were banned by the FDA. In the FDA’s defense, the substances technically do not have to be tested prior to being sold so the agency is not allowing dangerous ingredients as much as prohibiting from stopping their inclusion. The 1994 Dietary Supplement Health and Education Act (DSHEA) permits supplements to be sold without safety testing. Further, they can only be removed from the market if there are enough reports of adverse reactions. That means that enough people have to get sick from a supplement before the FDA can even step in and do anything. For example, it took more than 900 reports of adverse effects (including strokes and heart attacks) from ephedra in the 1990s before they took action.

By Dyanne Weiss

NBC News
PBS News Hour

Your Thoughts?