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Regulatory Agencies Meet To Discuss the Status of DMAA Products

Speculation into the questionable nature of DMAA and subsequent links to adverse health events has raised concern for several regulatory agencies around the globe. As a result, recent weeks have witnessed DMAA products become a topic of urgency as food and medicine regulators in the United Kingdom are trying to establish the status of the highly controversial dietary supplement. Regulators are currently in the process of determining the origins of DMAA, as an attempt to further clarify the already ambiguous situation.

DMAA has been marketed as a dietary supplement ingredient in combination with caffeine and other ingredients to be used as an over-the-counter thermogenic or general purpose stimulant intended to increase workout energy and efficiency. However, misconceptions regarding the origins of DMAA have caused a great deal of controversy in the pharmaceutical industry.

Misconceptions suggesting that DMAA is a constituent of the geranium species have their origins in a single, non reputable, peer-reviewed journal of chemistry. According to a report in the journal, researchers identified the presence of 1,3-dimethylamylamine (DMAA) in geraniums. However, officials at the AHPA believe that the results of this study are far from conclusive. A review of the chromatogram from the original data revealed an inadequate separation of compounds. Other issues with the data include significant concerns over the experimental conditions, the interpretation of data, the quality of data reporting, and the validation of findings.

In a statement recently issued by Health Canada, officials acknowledged that DMAA is synthetically manufactured and not a derivative of geranium plants. John Travis, manager of clinical operations for NSF International and the AHPA analytical laboratories committee, in association with existing scientific literature, concurred with the findings made by Health Canada.

Steven Dentali, AHPA’s chief science officer stated that “there are no known-published reports indicating that this is a natural product. Any labeling stating that it is naturally occurring in geranium, or any other natural source, would need appropriate scientific evidence to support it. None has yet been found in the public domain.”

The ambiguous nature of DMAA calls into question its status as a dietary supplement. As a result, the United Kingdom’s Food Standards Agency (FSA) and Medicines and Healthcare Products Regulatory Agency (MHPRA) have convened a meeting to discuss the future classification of DMAA.

“It is turning out that this is not a straight forward situation and so we are having a conversation with the MHRA and trying to get to the bottom of it,” the FSA spokesperson acknowledged. The FSA and MHRA are the most recent to join the growing list of regulatory agencies trying to classify DMAA. The U.S. Food and Drug Administration (FDA), Health Canada, along with authorities in France Italy and Ireland, have already begun conducting an investigation into the effects, usage, and legality of DMAA. Their findings may have resounding implications on the future of DMAA products. If they deem DMAA as a synthetically derived ingredient with medicinal purposes, products containing it would be considered unapproved drugs.

Do I Have a DMAA Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in DMAA lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by DMAA, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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