In 1997 the FDA, responding to concerns about the safety of an over-the-counter (OTC) stimulant, proposed a ban on products containing a high dose of the stimulant drug and warning labels on low doses, informing consumers of a risk of heart attack, stroke, and even death with overuse or in susceptible people. The industry responded by opposing these measures. They formed an "Education Counsel" as a PR group and consulted a private firm to conduct their own research into its safety. Unsurprisingly, they found that the stimulant was safe.
A company manufacturing the drug received 14,000 complaints of adverse side effects, including deaths. They failed to report these to the FDA (resulting in its cofounder spending 6 months in Federal prison). The senator from the company's home state, whose son worked for a lobbying group on behalf of the drug, opposed the FDA regulations, arguing that the reports of adverse effects was not adequate to take such measures. The company spent 4 million dollars opposing the proposed FDA regulations, and in 2000 the FDA removed their proposal, leaving consumers vulnerable to a potentially dangerous product.
At that same time, in 2000, an article in the New England Journal of Medicine documented "Adverse Cardiovascular and Central Nervous System Events" associated with the drug. Still, the mood in Congress did not change until Steve Bechler, a pitcher for the Baltimore Orioles, died from heatstroke during practice, which on autopsy was found to be "significantly related" to use of the drug. This celebrity death suddenly inspired Congress to push the FDA toward regulation, which the above senator now characterized as "long overdue."
In 2004 the FDA finally banned the stimulant from OTC products. Industry responded by legally challenging the ban, with the FDA ban finally being upheld in 2006.
This is a pretty shocking story of industry malfeasance, of putting profits ahead of the public health, and of deep-pocket industry lobbying opposing and successfully delaying effective regulation (and probably preventing it, were it not for a high-profile death).
This is the story of Ephedra, a dietary supplement that was allowed to be sold without evidence of safety or efficacy under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The industry here is the supplement industry, the specific company is Metabolife, and the senator is Orrin Hatch.
Ephedra is a drug, but the scientific delusion embodied in DSHEA is the naturalistic fallacy that because ephedra is naturally occurring in some plants (specifically Ephedra sinica, known in Chinese as ma huang) that it is somehow magically not a drug.
The supplement industry has successfully created a "mom and pop" image for themselves, but in reality they are indistinguishable from the pharmaceutical industry (and in many cases are the pharmaceutical industry), except for the fact that they are not effectively regulated, thanks to DSHEA.
Ephedra was a popular supplement ingredient because it is a stimulant. Stimulants have been a favorite additive for patent medicines and now supplements for centuries - they give the user a little boost of energy, which provides an effective placebo effect. For this reason cocaine was a popular supplement back in the patent medicine era. Weight loss products especially benefit from including a stimulant. For this reason many weight loss supplements still contain stimulants, such as caffeine, or caffeine metabolites (that are not easily recognized by the consumer by their chemical name).
We are now seeing the story of Ephedra repeated again with 1,3-dimethylamylamine, or DMAA. This is another stimulant, and is also linked to adverse events. While the FDA has not yet banned DMAA, because it is a lengthy process requiring the FDA to conduct a great deal of research, the FDA can order dangerous ingredients removed from products while investigation is underway. The FDA has issued a warning letter, stating:
"DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient found illegally in some dietary supplements and often touted as a natural stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack."
One of the companies that market DMAA, USPLabs, responded by sending the FDA published studies they say shows DMAA is safe. The FDA reviewed the evidence and concluded that it does not.
There is another interesting wrinkle to the DMAA story. Industry claims that DMAA is a supplement and not a drug because it can be found naturally occurring in a plant, specifically geranium. This, in my opinion, is an absurd argument, although it is the law under DSHEA. Whether or not this chemical happened to have evolved in one of the many plants on Earth does not affect whether or not the chemical acts like a drug in the human body.
However, recent research had found that DMAA is not present in geranium or pelargonium. This evidence may strip DMAA of its supplement status and force its reclassification as a drug, unless the industry can provide evidence that it is naturally occurring somewhere.
In all of this nonsensical regulation, lost are the more salient facts - what are the effects of DMAA in the human body, what are the benefits if any, and what are the health risks.
Whether or not it exists in a plant is irrelevant, scientifically and logically, but apparently not legally.
Steven Novella, M.D. is the JREF's Senior Fellow and Director of the JREF’s Science-Based Medicine project.