The FDA has warned consumers not to take any dietary supplement containing the ingredient DMAA (dimethylamylamine, which goes by other names as well, listed below), which has been associated with numerous risks, including seizures, heart attack, and death. When asked by the FDA to stop using the ingredient, most companies complied. USPLabs initially disputed the danger of the ingredients, but eventually consented to reformulate its supplements.
The Potential Dangers of DMAA
The FDA is aware of 86 reports of serious adverse side effects associated with DMAA. All reports of injuries associated with DMAA come from voluntary reports from patients and their doctors, and include:
- Lactic acidosis
- Loss of consciousness
- Elevated blood pressure
- Elevated or irregular heart rate
- Heart attack
- Liver and kidney damage
In response to these adverse event reports, especially after the deaths of two US army soldiers associated with the drug in 2011, the FDA moved to get DMAA off the market, but because the DMAA-containing products are dietary supplements, not drugs, the FDA’s ability to act was limited.
In disputing the removal of DMAA, one company argued that the ingredient is both natural and safe, findings the FDA says are not well-founded.
Other Names of DMAA
Consumers need to be able to identify DMAA, which is often listed under many different names, including:
- 4-methyl- (9CI)
- Geranium extract or Pelargonium gravolens extract
The “extract” notation points to the contention that DMAA is a natural ingredient.
Is DMAA Natural?
In order to be legally permitted in a dietary supplement, an ingredient must be both a naturally-occurring ingredient and have been in commercial use before 1994 or be approved as a New Dietary Ingredient (NDI). DMAA was patented by Eli Lily in the 1940s. It was initially approved as a nasal decongestant in 1948, but that approval was withdrawn in 1983 due to the drug’s dangers.
However, dietary supplement makers contend that DMAA is a naturally-occurring ingredient. According to one study, the extract of a Chinese geranium contains 0.7% DMAA. Subsequent studies failed to confirm the presence of the ingredient, until a study published in November 2012 confirmed the existence of DMAA in one sample of geranium plants.
However, most researchers agree that the DMAA found in dietary supplements is unlikely to come from a natural source.
Is DMAA Safe?
In trying to dispute the removal of DMAA from its dietary supplements, USPLabs called attention to six peer-reviewed studies that it claimed showed DMAA was safe. In all, 102 subjects took part in the studies. Not all of the participants in the studies consumed DMAA, since some of the studies were blinded and some participants were given placebos. The data only includes evidence from 74 people who took DMAA. This is approximately the population of a single Phase 1 study in the new drug approval process. Before a drug is approved, the FDA requires 3 phases of study, with populations of up to several thousand in each study, but DMAA can be exempted from this requirement if it is a natural ingredient in a dietary supplement.
The length of the studies in question ranged from a single dose to 10 weeks, with only 25 people (12 of whom took DMAA) participating in the long-term study. Most of the studies reported no adverse events, though some reported elevated heart rate and blood pressure.
When the FDA reviewed the evidence, it concluded the studies were “insufficient to defend the use of DMAA.”
Does the FDA Need More Power in Regulating Dietary Supplements?
The controversy over DMAA shows how difficult it is for the FDA to regulate dietary supplements. Because the FDA cannot require supplement makers to get their ingredients approved before they market their supplements, it must act after the fact to demonstrate that an ingredient is dangerous. Its primary course of action is to issue warning letters and request voluntary compliance.
Because FDA warning letters are announced publicly, this can work as a significant enforcement action to compel supplement makers to remove dangerous ingredients from their products, as well as encouraging retailers to remove products from their shelves.
However, if manufacturers do not voluntarily remove the ingredients in question, the FDA must begin legal proceedings which it describes as “lengthy.” In some cases, the FDA can get products containing dangerous ingredients seized, but in other cases the FDA cannot do anything about products containing dangerous ingredients.
The FDA also faces a major obstacle in just identifying products that contain dangerous ingredients. Although the FDA sent letters to 11 manufacturers known to use DMAA in their supplements, it is unsure whether the ingredient is used in other dietary supplements, either as an ingredient listed on the label or as an “adulterant,” a covert ingredient that some supplement makers include but don’t list.
Every consumer plays an important role in the FDA’s mission. People should report supplements containing dangerous ingredients as well as any adverse events experienced after taking a supplement.