DMAA – One of the Most Heavily Clinically Studied


(CNN) — Dietary supplements are commonly used to lose weight and build muscle, but the Food and Drug Administration has issued a warning regarding exposure to a potentially harmful ingredient.

The FDA said in the advisory last week that it is using “all available tools at its disposal” to eliminate supplements containing the stimulant dimethylamylamine, or DMAA, from the market. The agency says DMAA, found in supplements including OxyElite Pro and Jack3d, can cause increased blood pressure, shortness of breath, chest tightening, cardiovascular problems and even heart attacks.

It may be difficult for consumers to tell whether DMAA is an ingredient in their supplement. Different names such as methylhexanamine, 1,3 DMAA or geranium extract could be used.

The FDA says it has received reports of 86 illnesses and deaths associated with supplements containing DMAA as of last week. Illnesses also included nervous system and psychiatric disorders, the agency said, and DMAA could be especially dangerous taken with caffeine.

Dietary supplements with DMAA have been promoted as a natural way to enhance athletic performance and speed up weight loss. According to its website, the FDA does not currently recognize any medical use of DMAA, but it was approved for nasal decongestion in the past.

Unlike with a drug ban, the FDA must go through a series of lengthy scientific and legal steps to ban compounds in dietary supplements, according to its website.

In the meantime, FDA spokeswoman Tamara Ward said that 11 companies have received warning letters from the FDA over the past year asking them to stop marketing products that contain DMAA. All but one — USPlabs in Dallas, which manufactures OxyElite Pro and Jack3d — agreed to stop using DMAA in supplements.

The FDA has visited six of the companies that received warning letters. Five had ended production of supplements with DMAA. “The sixth company, which was not in compliance, agreed to recall its product after discussions with FDA,” Ward said. Company names were not provided.

In a statement, USPlabs said it “stands behind the safety and quality of its products,” citing “eight peer-reviewed published clinical studies detailing the safety of (DMAA) and products containing it, making it one of the most heavily clinically studied dietary ingredients ever.”

However, details provided by the company showed that the studies were each conducted with 50 or fewer participants. The FDA said it “has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements,” and it is finalizing a formal response to USPLabs to reflect the findings.

Consumers can report DMAA-related incidents directly to the FDA or the supplement manufacturer. The FDA said consumers should also contact a health care provider if they become ill.

Source: CNN – Fox 6 News

“NY” to Ban DMAA

Dimethylamylamine (DMAA) (Methylhexamine, Geranamine, Forthane)

Promote weight loss by suppressing appetite and Nasal decongestant.

By Stephen Daniells Nutra Ingredients USA

New York State Senate Majority Coalition Leader Jeff Klein is seeking to ban the sale of products containing the controversial ingredient DMAA (dimethylamylamine) in the Empire State.

Klein introduced legislation yesterday, and the announcement was met with opposition by Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN).

“It’s not unusual to see a state legislator target an ‘ingredient du jour’, and try to create a cause for themselves,” Mister told NutraIngredients-USA.

“Our position is that it is inappropriate for a state to introduce legislation for an ingredient that is already on the FDA radar and is an open case for the Agency.

FDA issued warning letters to manufacturers and distributors of supplements containing DMAA last year and again earlier this year. The companies have responded to these warning letters. “The ball is back with FDA,” said Mister.

“FDA is in the best position on this,” he added. “They have all the data and they are charged with protecting public health. It’s therefore inappropriate for a state legislator to introduce something like this, however well meaning. For that reason we oppose it.”

DMAA

DMAA (1,3-Dimethylamylamine, also known as methyl hexaneamine (MHA), and several other names) has been a subject of intense debate about whether it is in fact a constituent of geranium. The ingredient was first manufactured synthetically by drug giant Eli Lily in the 1940s.

The ingredient has come under scrutiny across the globe and is currently banned in six countries, as well as by the U.S. military .

The deaths of two soldiers that were linked to DMAA are cited by Klein as a reason behind his legislation. Senator Klein was joined by Leanne and Michael Sparling, the parents of Private Michael Sparling, a soldier at Fort Bliss military base who died shortly after ingesting DMAA-containing Jack3d, on June 1st 2011. The Sparling family has filed a suit for wrongful death against the product’s manufacturer, USPLabs, and against *** Stores.

“If it’s not safe for soldiers, it’s not safe for our kids,” said Senator Klein. “These manufacturers are exploiting shortcomings in FDA oversight to profit off of unsuspecting student athletes.

“Our kids are being told that DMAA will give them an edge over their competition. But that’s dead wrong. Not only are these products dangerous, but they jeopardize the athletic eligibility of anyone who uses them. We’re here to put an end to that.

“The outright refusal by drug makers and retailers to place a meaningful warning label on these products is shameful. We will not allow their recklessness to endanger any more student athletes. I hope that the FDA eventually acts—but until then, it’s up to the states to take action.

“That’s why I’m introducing legislation today to eliminate the DMAA threat in New York once and for all.”

“Attacking the problem in exactly the right way”

Senator Klein’s actions were supported by former MLB All-Star Jose Canseco.

“Senator Klein is attacking this problem in exactly the right way,” he said.

“I know how dangerous these products can be and I’ve seen how easy they are for kids to buy. I’m proud to be here today to support Senator Klein, because instead of sitting on his hands like most politicians, Senator Klein is actually out there leading on this issue.

“It’s clear that Senator Klein means business—I’m just glad that I could be here to help him make his case.”

Step in the right direction

The medical discussion at Monday’s roundtable was led by Dr Pieter Cohen, an assistant professor at Harvard Medical School and a general internist at Cambridge Health Alliance who has personal experience caring for patients harmed by DMAA.

“It’s unacceptable that an experimental drug is sold is in the guise of a natural supplement. Senator Klein’s legislation is an important step in the right direction toward ensuring the safety of supplements sold in New York,” said Dr. Cohen.

Source: NY to Ban DMAA