As momentum behind the removal of DMAA from the supplement market snowballs, many preworkout manufacturers are in search of new natural stimulants to replace the contentious ingredient.
ErgoGenix CEO James Klein, for example, told Fox News in February that his company had stopped using DMAA in its ErgoPump and ErgoBurn products to ahead of the curve, and instead uses N-Methyltyramine, a stimulant alkaloid found in bitter orange. Bitter orange has its own demons—a source close to Nutrition Business Journal has quipped that the extract has more science proving what it isn’t than what it is. Venable LLP partner Todd Harrison told me last week that synthetic forms of synephrine—a bitter orange extract—are likely to come under similar scrutiny as DMAA.
But another extract has emerged as a new contender in preworkout stimulant—Dendrobium nobile (or Dendrobium officinale), a type of orchid. One of the 50 fundamental herbs used in traditional Chinese medicine, Dendrobium stem extract appears in the popular preworkout Craze from Driven Sports. It appears on Craze’s ingredient list under the trademark Dendrobex. Interestingly, Craze also uses N-Methyltyramine—under the trademark Citramine—though it lists the source as Citrus reticulate, or mandarin orange.
According to Loren Israelsen of the United Natural Products Alliance (UNPA), Dendrobium extract appears on UNPA’s list of Old Dietary Ingredients (ODIs)—those ingredients on the market prior to the 1994 passage of the Dietary Supplement Health & Education Act. It also appears in the book Herbs of Commerce from the American Herbal Products Association.
The question, of course, is whether Dendrobex has been altered in any way to change its status as an ODI. (Geranimine, for example, was the trademark that chemist Patrick Arnold used to try to qualify synthetic DMAA as a geranium extract.) If Dendrobex is at all altered, it would theoretically require a New Dietary Ingredient (NDI) notification.
More on this as it develops. Stay sharp out there, manufacturers.
Questions & Answers
UPDATED April 30, 2013
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 letter3 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:
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 Reporting4. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label.