FDA: DMAA off the market ASAP.

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DMAA Dietary Supplement Legal Information Center

The U.S. Food and Drug Administration (FDA) has ordered the manufacturers of the dietary supplement 1,3-dimethylamylamine, also known as DMAA and methylhexanamine, to remove it from the market because the agency believes it to be ineffective, and it might cause life-threatening heart-related side effects.

What Are DMAA Dietary Supplements and What Is It Used For?

DMAA was sold by at least 11 companies until 2012. It purportedly promoted weight loss, muscle-building, and performance enhancement in users. DMAA was first discovered by Eli Lilly and Company in 1944, which sold it as a nasal decongestant called “Forthane” until 1983. It reappeared as a dietary supplement in 2006. Here is a list of companies that sold DMAA as a dietary supplement before the FDA ordered the drug removed from the market:

  • Exclusive Supplements – Biorhythm SSIN Juice
  • Fahrenheit Nutrition – Lean Efx
  • Gaspari Nutrition – Spirodex
  • iSatori Global Technologies, LLC – PWR
  • Muscle Warfare, Inc. – Napalm
  • MuscleMeds Performance Technologies – Code Red
  • Nutrex Research – Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers
  • Regeneca, Inc. – RegeneSlim
  • SEI Pharmaceuticals – MethylHex 4,2
  • SNI LLC – Nitric Blast
  • USP Labs, LLC – Oxy Elite Pro, Jack3D

DMAA Dietary Supplements Might Cause Life-Threatening Side Effects

In April 2012, the FDA issued a press release stating that it had mailed warning letters to 10 manufacturers of DMAA dietary supplements, warning them that because they had not submitted scientific evidence showing that DMAA was safe, they were required to take their DMAA-containing products off the market. The agency added that synthetic DMAA was not a “dietary ingredient” under the Dietary Supplement Health and Education Act of 1994, and therefore it could not legally be used as an ingredient in dietary supplements. An eleventh manufacturer received the warning letter in August of 2012.

One manufacturer, USP Labs, LLC, maker of Oxy Elite Pro and Jack3D, disputed the FDA’s decision and supplied the agency with scientific studies purporting to show that DMAA was safe. In April 2013, the FDA reviewed USP Labs’ submissions and concluded that they were insufficient to overturn the agency’s decision. In July 2013, USP Labs destroyed $8 million worth of supplements containing DMAA.

According to scientific research, DMAA might cause the following heart-related side effects:

  • Elevated blood pressure
  • Shortness of breath
  • Tightening of the chest
  • Heart attack
  • Death

Use of DMAA with caffeine can increase the likelihood of these side effects.

The FDA reports that by April 2013, it had received 86 adverse event reports from people who were injured or died after using DMAA. However, at this time the FDA has not officially banned DMAA because the legal process to do so is lengthy and ongoing. In the meantime it is using its regulatory power to order manufacturers to take the supplement off the market.

RLG’s DMAA Dietary Supplement Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a DMAA dietary supplement lawsuit on your behalf if necessary. RLG will also keep you up to date on any DMAA dietary supplement class action lawsuits, additional FDA DMAA dietary supplement warnings, and DMAA dietary supplement FDA recall announcements. If you or a loved one has used DMAA dietary supplement, and you believe it caused an injury, contact RLG today.

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