July 16, 2013
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. In 2012, FDA 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.
On July 2, 2013, as a result of follow-up legal action by FDA, the dietary supplement firm USPlabs voluntarily destroyed its DMAA-containing products located at its facility in Dallas, Texas. The products - USPlab's OxyElite Pro and Jack3d - are estimated to have been worth more than $8 million at the retail level. USPlabs has agreed to stop manufacturing dietary supplements containing DMAA.
USPlabs agreed to destroy the products after FDA administratively detained them under the Federal Food, Drug and Cosmetic Act, recently amended by the Food Safety Modernization Act (FSMA). Under its administrative detention authority, FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure. Under FDA regulations, detained articles can be voluntarily destroyed by their owner.
FDA continues to advise consumers not to buy or use dietary supplement products that contain DMAA due to the health risks they present.
Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner. Consumers can also report such incidents directly to FDA, see Dietary Supplements - Adverse Event Reporting. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label.
- Consumer Update: Stimulant Potentially Dangerous to Health, FDA Warns
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 bring 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?
As of April 30, 2013, FDA has 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. 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. Ten companies agreed to stop marketing products with DMAA. One company, USPlabs, responded to FDA's warning by submitting published studies that purport to challenge FDA's conclusions. After reviewing the studies provided by USPlabs, FDA found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements. On April 10, 2013, FDA notified the company it still needed to take corrective action to remove its products containing DMAA from the market, and that a formal letter would be issued shortly. On April 16, 2013, USPlabs announced its plans to phase out its products containing DMAA. FDA issued its formal response letter on April 18, 2013. In addition, FDA is sending its investigators to the companies that agreed to reformulate or remove DMAA to verify that they have taken the appropriate action. Seven companies have been visited so far and all had either stopped producing products containing DMAA or 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 believe this goal will be achieved soon, as the agency has contacted all DMAA supplement manufacturers and distributors of which we are aware, and all of them have taken their DMAA products off the market or have agreed to do so.
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:
- 2-Hexanamine, 4-methyl- (9CI)
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 should contact their health care practitioner if they have suffered or are still being affected by an adverse event. Consumers can report incidents directly to FDA, see Dietary Supplements - Adverse Event Reporting. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label.
Warning Letters Issued by FDA
Warning letters to 11 manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
- Press Release: FDA challenges marketing of DMAA products for lack of safety evidence [ARCHIVED]
April 27, 2012
iSatori Global Technologies, LLC 4/24/12 Exclusive Supplements, Inc. 4/24/12 USP Labs, LLC 4/24/12 Response Letter to USP Labs LLC Concerning DMAA Fahrenheit Nutrition 4/24/12 Nutrex Research, Inc. 4/24/12 Gaspari Nutrition, Inc. 4/24/12 SNI LLC 4/24/12 SEI Pharmaceuticals, Inc 4/24/12 Muscle Warfare Inc 4/24/12 MuscleMeds Performance Technologies 4/24/12 Regeneca, Inc 8/28/12