Apr 132013
 

The FDA has issued a warning for US consumers that “dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.”

Here is the warning in full:

“The Food and Drug Administration (FDA) is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.

The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.

As of April 11, 2013, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.

FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. Such warnings offer the quickest way at FDA’s disposal to halt the further distribution of dietary supplements containing DMAA in the marketplace. In fact, all but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, has responded to FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.

However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements. FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Program.

FDA’s authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don’t voluntarily comply.

As FDA continues the process needed to get DMAA off the market, the agency is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The alternatives are listed at FDA’s DMAA web page.”

Additional FDA information on DMAA:

“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. Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. FDA has issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance. Most companies warned are no longer distributing products with DMAA. While FDA is working to get these products off the market, consumers should not buy or use any dietary supplement product containing DMAA.”

Questions & Answers

What is DMAA?

DMAA (1,3-dimethylamylamine) is an amphetamine derivative that has been widely used in sports supplements sold in the United States. Also known as methylhexanamine or geranium extract, DMAA is often touted as a “natural” stimulant, with many claimed functional uses including a body-building aid, an athletic performance enhancer, and a weight-loss aid. Although DMAA at one time was approved as a drug for nasal decongestion, no medical use of DMAA is recognized today. FDA is not aware of any reliable science indicating that DMAA exists naturally in plants.

DMAA-containing dietary supplements are illegal and their marketing violates the law. Based on the scientific information reviewed by FDA, DMAA is not a dietary ingredient.

Is it safe to consume DMAA?

No, FDA does not have any information to demonstrate that consuming DMAA is safe. FDA is very concerned about DMAA and we advise consumers not to purchase or use any dietary supplement containing DMAA. This substance narrows blood vessels and arteries, which can elevate blood pressure, and may lead to cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack, as well as seizures and other neurological and psychological conditions. FDA has received 86 reports of adverse events involving products containing DMAA. These events include psychiatric disorders, heart problems, nervous system disorders, and death.

How does FDA regulate ingredients in dietary supplements like DMAA?

The law requires companies to notify FDA when they intend to market a dietary supplement containing a New Dietary Ingredient (NDI) in the United States, if the NDI has not been used in the food supply in the same chemical form.  An NDI is a dietary ingredient that was not marketed in a dietary supplement prior to October 15, 1994. Unlike drugs, dietary supplements do not have pre-market approval for safety or effectiveness. If a safety issue arises post-market, FDA can investigate and take steps to remove products that may be unsafe from the market. However, in order for FDA to ban a compound in a dietary supplement, FDA is required under the statute to undertake a series of lengthy scientific and legal steps. In the interim, FDA can take direct action by issuing warning letters to industry to obtain removal of ingredients in dietary supplements and protect the public from potentially harmful products. FDA can also take a seizure action to remove products from the market or obtain an injunction against a company to prevent it from manufacturing and distributing illegal products.

What is FDA doing to remove DMAA-containing dietary supplements from the market?

FDA sent warning letters to a total of 11 companies advising them that DMAA-containing products marketed as dietary supplements are illegal and must be taken off the market or reformulated to remove DMAA. These 11 companies account for most of the DMAA products sold in the United States. This action was taken to protect consumers and get these products off the shelves as quickly as possible. To date, all but one of the companies warned by FDA have agreed to stop marketing products with DMAA. FDA is in communication with the one remaining company to bring the issue to closure. FDA is also sending its investigators to the companies that agreed to reformulate or remove DMAA to verify that they have taken the appropriate action. Six companies have been visited so far. Five of the companies were in compliance and the sixth company, which was not in compliance, agreed to recall their product after discussions with FDA.

Why hasn’t the FDA banned this ingredient, especially after the U.S. military took it off their shelves?

The U.S. military initiated a temporary hold on the sale of DMAA-containing products in military exchanges. The law requires FDA to follow certain lengthy steps before the agency can ban dietary supplements containing DMAA. FDA has been working to remove dietary supplements containing DMAA from the marketplace and we will continue to look at all regulatory and legal options to bring companies into compliance and protect consumers.

How do consumers know if a dietary supplement contains DMAA?
Consumers should look for DMAA listed on the product label. It may also be listed as:

  • 1,3-DMAA
  • 1,3-Dimethylamylamine
  • 1,3-Dimethylpentylamine
  • 2-Amino-4-methylhexane
  • 2-Hexanamine
  • 4-Methyl-2-hexanamine
  • 4-Methyl-2-hexylamine
  • 4-methyl- (9CI)
  • Dimethylamylamine
  • Geranamine
  • Methylhexanamine
  • Methylhexanenamine

Some products also will list Pelargonium graveolens extract or Geranium extract, which may indicate that the product contains DMAA.

What should consumers do if they believe they’ve been harmed by consuming DMAA?

Consumers can report incidents directly to FDA. See Dietary Supplements – Report an Adverse Event2.

Consumers can also report these adverse events to the company whose name and contact information is on the product label.

In addition, consumers should contact their health care practitioner if they have suffered or are still being affected by an adverse event.”