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DMAA Lawsuit Overview
Drugmakers and retailers that deal in dietary supplements containing the controversial stimulant dimethylamylamine (DMAA) are coming under increased scrutiny as questions of source and safety mount. Many of the safety issues surrounding DMAA arise from misuse and inadvertent overdosing of the stimulant. In recent months, dietary supplements containing DMAA have been linked to a number of serious side effects including hyperthermia, irregular heartbeats, seizures, heart attacks and strokes. The FDA has issued warning letters to manufacturers for marketing products whose safety has not been proven.
Latest DMAA Lawsuit Updates
May 4, 2012 – Seven DMAA supplement manufacturers who received warning letters from the FDA late last month have been slapped with class action lawsuits alleging their products are ‘illegal and dangerous.’ The litigation process will be watched closely, as the cases center around a hotly-debated point of contention regarding new dietary ingredients (NDIs): that synthetic versions of botanical derivatives are not classified as dietary ingredients, and are therefore not permitted for use in supplement products [1].
April 27, 2012 – The U.S. Food & Drug Administration (FDA) sent warning letters to 10 manufacturers and distributors of DMAA-containing dietary supplements for marketing products whose safety has not been proven. Specifically, the FDA’s letters accuse the companies of marketing products for which a notification has not been submitted for the use of DMAA as a New Dietary Supplement (NDI) [2].
March 9, 2012 – DMAA is to be banned in New Zealand after numerous reports of serious side effects and at least one stroke. It is the first substance other than a synthetic cannabinoid to be banned in New Zealand using the Temporary Class Drug Notices, and is scheduled to be completely off the country’s store shelves by early next month [3].
DMAA Injuries & Side Effects
In recent months, dietary supplements containing DMAA have been linked to a number of serious side effects. The serious side effects reported include:
- Hyperthermia: Dangerous increases in body temperature
- Cardiovascular Issues: Irregular heartbeats and heart attacks
- Neurological Effects: Seizures and strokes
- Fatal Reactions: Death in severe cases
DMAA Source Controversy
The central issue currently causing the most debate about DMAA is the question of whether the stimulant is – as many supplement companies contend – derived from the geranium plant, or whether it is a synthetically manufactured compound. Is it authorized for use in dietary supplements or not?
The sourcing issue is of particular relevance to DMAA manufacturers, because if the stimulant does indeed come from the geranium plant, then botanical grandfathering may be key to the ingredient’s legitimacy. USP Labs, which manufactures DMAA-containing dietary supplements such as Jack3d and OxyElite Pro, claims to have scientific evidence that the substance does indeed come from special geraniums from the Rongjiang region of the Guizhou province, but it has yet to come forward with the documents.
Instead of clearing the air and setting things straight, USP Labs put up a website called DMAAresearch.com that defends the antiquated and highly questionable 1996 Ping study which supposedly found DMAA in geranium oil.
As one quoted study notes (Jain, 2001):
“Significant work on geranium essential oil has been carried out in different parts of India and it was found that chemical composition is influenced by location, drying of biomass prior to distillation, age of the leaves, method of distillation, application of growth regulators, storage of oil, presence of weed, wilt disease, and the effect of the semi-arid tropical climate.”
Which only makes matters pertaining to the actual source of DMAA more unclear. If USP Labs has actual scientific evidence as to the sourcing issue, why is it holding it back, instead choosing to rely on information that could only be considered highly questionable? Many familiar with these issues feel that USP Labs needs to come clean, sooner rather than later.
FAQs
1. How has the FDA responded to the marketing of DMAA as a dietary supplement ingredient?
The FDA issued warning letters to DMAA supplement manufacturers, citing unproven safety and lack of proper notification for its use as a New Dietary Ingredient (NDI).
2. What Is the controversy surrounding the source of DMAA in dietary supplements?
The controversy centers on whether DMAA is naturally derived from geranium plants or synthetically manufactured, impacting its classification and legality as a dietary supplement ingredient.
3. Why is the classification of DMAA as a botanical derivative significant for supplement manufacturers?
Classifying DMAA as a botanical derivative could allow manufacturers to claim it as a legitimate dietary ingredient, potentially bypassing stricter regulatory scrutiny and maintaining product legality.
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See the other related dietary supplements litigations we’ve taken on.
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The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DMAA lawsuits. We are handling individual litigation nationwide and currently accepting new hyperthermia, seizure, heart attack, stroke and death cases in all 50 states.
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References:
- https://topclassactions.com/lawsuit-settlements/lawsuit-news/fda-warning-sparks-new-dmaa-supplement-class-action-lawsuits/
- https://www.nytimes.com/2012/04/28/health/fda-sends-warning-letters-to-10-marketers-of-workout-boosters.html
- https://www.beehive.govt.nz/release/dunne-announces-temporary-class-drug-notice