FDA allows supplements containing high levels of the amphetamine isomer BMPEA

The idea you can buy an amphetamine-like compound, BMPEA (beta-methylphenylethylamine), in a dietary supplement from a store without a prescription or any safety scrutiny is disturbing. How can this happen? An alarming article in The New York Times highlights the lack of regulatory oversight by the FDA over the dietary supplements market. More specifically, the reporter Anahad O'Connor raises potential conflict of interest issues for a former high-ranking FDA official in charge of the supplements program who previously was a top executive of one of the largest supplements lobbying groups.

Dietary supplements are a big business, but they are not overseen in the same rigorous manner as drugs by the FDA. This raises the possibility that some supplements can be harmful. In a previous post, I mentioned that over 100 million Americans spend $32 billion a year on supplements that promise all sorts of claims about losing weight building muscle and fighting off disease.

In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 which stated that "The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed," and that the "FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market." In other words, the manufacturer of the supplement is responsible for its safety, and the FDA can act only after reports of adverse reactions.

As a result, the FDA defends its non-response to the over-the-counter selling of supplements containing BMPEA by saying that it can act only after there are reports of adverse reactions to BMPEA.

What is BMPEA? It is an amphetamine isomer (i.e. it possesses a similar chemical structure as amphetamine) that was first synthesized in the 1930s, and then more or less forgotten. The problem is that its physiologic effects have not been well-studied and safety data in humans are lacking. A priori, one might expect that BMPEA would act as a stimulant like amphetamine but its potency is unknown. According to The New York Times article:

"Bastiaan Venhuis, a scientist who studies tainted supplements at the National Institute for Public Health and the Environment in the Netherlands, said that the physiological effects of BMPEA are most likely very similar to those of DMAA, an amphetamine-like stimulant that can cause heart attacks and strokes. Supplements containing DMAA were banned from military bases by the Department of Defense in 2011 after they were implicated in the deaths of two soldiers. The F.D.A. issued a health alert warning consumers about DMAA 16 months later — long after Australia, Britain, Canada and Sweden had banned it."

Interestingly BMPEA is marketed as natural extract of the plant Acacia rigidula. This marketing claim is likely to be false because there is no evidence that BMPEA can be made by any natural organism; instead it is highly probable that it is synthesized by chemists.

As a group, amphetamines are a class of molecules that have similar structures, properties, and physiological actions. The most prominent amphetamines are amphetamine itself, dextroamphetamine, and methamphetamine ("Crystal Meth"). Physiologically amphetamines can inhibit the dopamine transporter allowing dopamine to accumulate at neural synapses resulting in its well-known stimulatory properties. They may also increase dopamine release.

Amphetamines possess some medicinal value. They can be used to treat the sleeping disorder narcolepsy, as well as attention deficit disorder (AHDH). They may also be found in prescription diet pills (appetite suppressant). Amphetamines are FDA approved, but require a prescription because of possible abuse.

The DEA (Drug Enforcement Agency) classifies amphetamines as controlled substances. They are categorized as Schedule I and Schedule II for high potential for abuse and addiction. One can overdose on amphetamines, and chronic use can lead to severe withdrawal symptoms.

All of these concerns have led the Canadian equivalent of the FDA to yank BMPEA-containing supplements from store shelves in December calling it a "serious health risk".

It should be noted that we do not know the degree of danger BMPEA poses. As mentioned above, rigorous safety studies have not been performed. However, the chemical structure of BMPEA, an isomer of amphetamine, suggests that there is a good chance it could have amphetamine-like properties. Clearly, it should be a priority to test (and disprove) this hypothesis before BMPEA is allowed to be given to consumers over-the-counter. If it indeed is a potent stimulant then BMPEA should be regulated like other amphetamines.

Finally and most importantly, there is the larger issue of conflict of interest at the FDA. The New York Times article reports that "Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards." His replacement at the FDA, Cara Welch, is a former official from the same trade organization.

“To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,” said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.'

Figure 1. Researchers have shown that at least 9 over-the-counter supplements contain significant quantities of the amphetamine isomer BMPEA (from NYTimes).