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FDA Issues Safety Warning on DMAA Dietary Supplements

April 27, 2012 – The U.S. Food & Drug Administration (FDA) today 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). 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.

Free DMAA Lawsuit Evaluation: If you or a loved one has suffered a serious injury after consuming a dietary supplement containing DMAA, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the dietary supplement and we can help.

Update: Feds ask Judge to Reject Hi-Tech’s Motion in DMAA Lawsuit

May 3, 2017 – The U.S. Justice Department has asked a federal judge to deny a request by Hi-Tech Pharmaceuticals Inc. to vacate an order stating that the manufacturer’s DMAA supplements are adulterated. In a summary order issued last month, U.S. District Judge Willis B. Hunt, Jr., ruled in favor of the FDA and against Hi-Tech and its CEO and principal owner Jared Wheat when he declared that DMAA is not a dietary ingredient, and that Hi-Tech’s DMAA-containing supplements are adulterated and subject to seizure.

What’s the problem?

The FDA sent warning letters to these companies regarding the following DMAA-containing dietary supplements:

CompanyProduct(s)
Exclusive SupplementsBiorhythm SSIN Juice
Fahrenheit NutritionLean Efx
Gaspari NutritionSpirodex
iSatori Global Technologies, LLCPWR
Muscle Warfare, Inc.Napalm
MuscleMeds Performance TechnologiesCode Red
Nutrex ResearchHemo Rage Black
Lipo-6 Black Ultra Concentrate
Lipo-6 Black
Lipo-6 Black Hers Ultra Concentrate
Lipo-6 Black Hers
SEI PharmaceuticalsMethylHex 4,2
SNI LLCNitric Blast
USP Labs, LLCOxyElite Pro
Jack3d

“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.

Under U.S. law, companies who use certain ingredients not marketed in a dietary supplement before Oct. 15, 1994, must submit evidence to the FDA that their products are safe. These companies must provide such notification no fewer than 75 days before marketing their supplements. The establishments listed above have been warned that this requirement has not been met.

The FDA’s warning letters went on to state that DMAA has been found to narrow blood vessels and arteries, which can raise the blood pressure and lead to side effects ranging from shortness of breath and tightening in the chest to heart attacks. To date, the FDA has received at least 42 adverse event reports involving DMAA-containing supplements, some of which included cardiac disorders, nervous system disorders, psychiatric complications, and even death.

Additionally, the administration warned the companies that DMAA is not a ‘dietary ingredient,’ and therefore is not eligible to be used as an active ingredient in dietary supplement products. The Dietary Supplement Health and Education Act (DSHEA) defines a dietary ingredient as a “vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.”

The warning letters concluded by saying that the companies have 15 days to respond to the FDA with specific information as to how they will address the problems with their DMAA-containing products.
Dietary Supplement Lawsuit Update 6/7/12: In a recent landmark lawsuit, a leading online dietary supplement retailer pled guilty to selling products laced with steroids and agreed to pay a hefty $7 million fine. Many legal experts believe the case will set a new precedent for cracking down on vendors of adultered products. Click here for more information.

DMAA Lawsuit Update 5/4/12: Four 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. Click here to learn more.

Do You Have a DMAA Lawsuit?

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 DMAA side effects cases in all 50 states.

Free DMAA Lawsuit Evaluation: If you or a loved one has suffered a serious injury after consuming a DMAA-containing dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a DMAA injury suit and we can help.

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