DMAA in Products Marketed as Dietary Supplements (2024)

August 2018

DMAA in Products Marketed as Dietary Supplements (1)

What is DMAA?

DMAA (1,3-dimethylamylamine) is an amphetamine derivative that has been marketed in sports performance and weight loss products, many of which are sold as dietary supplements. DMAA is not a dietary ingredient, and DMAA-containing products marketed as dietary supplements are illegal and their marketing violates the law.

Also known as methylhexanamine or geranium extract, DMAA is often touted as a “natural” stimulant; however, the FDA is not aware of any reliable science indicating that DMAA exists naturally in plants. Although DMAA at one time was approved as a drug for nasal decongestion, it is no longer approved for this use and no medical use of DMAA is recognized today. DMAA, especially in combination with other stimulant ingredients such as caffeine, can be a health risk to consumers. Taking DMAA can raise blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack.

The FDA continues to advise consumers not to buy or use products marketed as dietary supplements that contain DMAA due to the health risks they present.

Is it safe to consume DMAA?

The FDA does not have any information to demonstrate that consuming DMAA is safe. When DMAA is added to a product marketed as a dietary supplement, the FDA considers it to be an unsafe food additive. The FDA is very concerned about DMAA, and we advise consumers not to purchase or use any product containing DMAA. This substance narrows blood vessels and arteries, which can raise blood pressure, and may lead to cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack, as well as seizures and other neurological and psychological conditions.

What is FDA doing to remove DMAA-containing products marketed as dietary supplements from the market?

Over the past several years, the FDA has used different methods to ensure DMAA-containing products are taken off the market. These actions are being taken to protect consumers and get these products off the shelves as quickly as possible.

Starting in 2012, the FDA has issued warning letters to companies notifying them that marketing DMAA-containing products violates the law. When we find products containing DMAA during facility inspections, we discuss our concerns with firms and give them an opportunity to voluntarily recall and destroy these violative products. Most companies warned are no longer distributing products with DMAA.

When firms have chosen not to comply voluntarily, the FDA has taken other actions. In 2013, the FDA administratively detained two DMAA-containing products, OxyElite Pro and Jack3d, after USPLabs initially refused the FDA’s efforts to achieve voluntary compliance. USPLabs ultimately destroyed the detained products – which were estimated to have been worth more than $8 million at the retail level, and agreed to stop manufacturing with DMAA. Also in 2013, the FDA seized DMAA-containing products from Hi-Tech Pharmaceuticals; a federal district court ruled in April 2017 that the products were adulterated and ordered them condemned and forfeited to the United States for destruction.In 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed the lower court ruling, finding that DMAA is not a dietary ingredient and is not generally recognized as safe, and condemning and forfeiting the seized articles containing DMAA. The Supreme Court denied a request from Hi-Tech Pharmaceuticals to review the case in 2020. The products were destroyed on November 12, 2020.

The FDA continues working to get DMAA products off the market when it identifies them. Consumers should not buy or use any product containing DMAA.

How do consumers know if a product marketed as a dietary supplement contains DMAA?

Consumers should look for DMAA listed on the product label. It may also be listed as:

  • 1,3-DMAA
  • 1,3-Dimethylamylamine
  • 1,3-Dimethylpentylamine
  • 2-Amino-4-methylhexane
  • 2-Hexanamine, 4-methyl- (9CI)
  • 4-Methyl-2-hexanamine
  • 4-Methyl-2-hexylamine
  • Dimethylamylamine
  • Geranamine
  • Methylhexanamine
  • Methylhexanenamine

Some products will also list Pelargonium graveolens extract or Geranium extract, which may indicate that the product contains DMAA.

What should consumers do if they believe they’ve been harmed by consuming DMAA- containing products marketed as dietary supplements?

Consumers who believe they have been harmed by using a DMAA-containing product should contact their health care practitioner. Consumers can also report such incidents directly to the FDA through the Safety Reporting Portal. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label.

Warning Letters Issued by FDA

  • Exclusive Supplements, Inc 4/24/12
  • Fahrenheit Nutrition 4/24/12
  • Gaspari Nutrition 4/24/12
  • iSatori Global Technologies, LLC 4/24/12
  • Muscle Warfare, Inc 4/24/12
  • MuscleMeds Performance Technologies 4/24/12
  • Nutrex Research, Inc 4/24/12
  • SEI Pharmaceuticals, Inc 4/24/12
  • SNI LLC 4/24/12
  • USP Labs, LLC 4/24/12
  • Regeneca, Inc 8/28/12
  • Formulife, Inc 6/17/13
  • Pure Energy Products, Inc 9/6/13
  • YoungYou International, Inc 10/7/14
  • Line One Nutrition, Inc 3/31/16
  • Naturecom Inc 4/20/17
  • Total Body Nutrition 9/28/17 (Includes reference to a voluntary destruction)
  • Nexagen, LLC 10/6/17 (Includes reference to a voluntary destruction)

    This webpage describes FDA’s views and recent actions with regard to an ingredient used in products marketed as dietary supplements. If you have evidence that calls FDA’s views into question, we invite you to submit it, along with your reasoning, to FDA at ODSP@fda.hhs.gov.

    This page is not intended to provide a complete list of all FDA actions and communications with regard to this ingredient and its use in products marketed as dietary supplements.

    DMAA in Products Marketed as Dietary Supplements (2024)

    FAQs

    What products contain DMAA? ›

    Two of the most prominent supplements containing DMAA are “Jack3d” and “OxyELITE Pro” (USP Labs) However, there are over 250 commercial dietary supplements containing DMAA on the market. As has been reported elsewhere,1 DMAA supplements are immensely popular among consumers.

    What does DMAA do to the body? ›

    Taking DMAA can raise blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. The FDA continues to advise consumers not to buy or use products marketed as dietary supplements that contain DMAA due to the health risks they present.

    When was DMAA banned in the US? ›

    DoD follows federal guidelines with regard to dietary supplements, and in April 2013, FDA declared DMAA illegal for use as a dietary supplement ingredient.

    Does GNC still sell DMAA? ›

    Acting very much like the publicly-traded company it had become in 2011, GNC decided to play it both ways: They agreed not to restock any of the products containing DMAA, but didn't yank any of the products that already inhabited their warehouses either.

    What energy drinks have DMAA? ›

    The drink linked to Squires' death, Jack3D, was found to contain DMAA, an amphetamine derivative posing as a natural supplement.

    What is the closest thing to DMAA? ›

    Dimethylhexylamine (DMHA) is a stimulant similar to dimethylamylamine (DMAA), which is banned by many sports and governments due to safety concerns. DMHA is structurally similar to DMAA.

    How long does it take for DMAA to leave your body? ›

    The results from the Saudan laboratory found that 1,3-DMAA could be detected in urine samples up to 105 hours after administration of a 40 mg dose.

    Does DMAA affect testosterone? ›

    The inhibition by DMAA of the conversion of testosterone to 5 alpha-dihydrotestosterone by rat prostate 5 alpha-reductase is competitive with testosterone, the apparent Ki being 5 nM, and uncompetitive with NADPH, DMAA inhibited both membrane-bound and solubilized 5 alpha-reductase.

    How does DMAA affect the brain? ›

    DMAA is a neurological stimulant which causes a quick spike of energy similar to caffeine and other classical stimulants, but does so by different mechanisms in the brain. It was first introduced as a nasal decongestant as 'Germanium Oil Extract' but more recently is used as a neurological stimulant and party pill.

    Does the C4 have DMAA? ›

    C4 pre-workout does not contain DMAA. According to Cellucor's website, its C4 Sport Series is NSF® Certified for Sport, ensuring it meets strict standards and has no contaminated substances or hidden ingredients.

    What is the most potent pre-workout? ›

    Our picks for the strongest pre-workouts
    • Strongest overall: Transparent Labs Bulk Black.
    • Strongest natural: Legion Pulse.
    • Strongest high stim: Nutricost Pre-X Xtreme.
    • Strongest for a pump: C4 Ultimate Pre Workout Powder.
    • Strongest with creatine: Gainful Pre-Workout Caffeinated High Intensity + Creatine.
    Sep 4, 2024

    Is DMAA illegal in the military? ›

    Service members are prohibited from using dietary supplement products containing DMAA but may not be aware of its presence in a product, especially if it is listed by one of its other ingredient names.

    What is the generic name for DMAA? ›

    Methylhexanamine (also known as methylhexamine, 1,3-dimethylamylamine, 1,3-DMAA, dimethylamylamine, and DMAA; trade names Forthane and Geranamine) is an indirect sympathomimetic drug invented and developed by Eli Lilly and Company and marketed as an inhaled nasal decongestant from 1948 until it was voluntarily ...

    Does Vitamin Shoppe sell DMAA? ›

    Despite warnings from the FDA, Vitamin Shoppe continued to sell the product containing DMAA in Oregon. The State also alleged that Vitamin Shoppe sold products in Oregon containing picamilon, an unlawful dietary ingredient sold in other countries as a drug to treat psychiatric disorders.

    What preworkouts contain DMAA? ›

    ProductManufacturerBanned or Unapproved Compounds
    Simply Skinny PollenBee Fit with Trish1,3-DMAA* and 1,4-DMAA
    Cannibal Ferox AMPEDChaos and Pain1,3-DMBA*
    Triple XGold Star1,4-DMAA
    *Previously found to be unlawful dietary ingredients by the U.S. FDA
    3 more rows

    Does C4 contain DMAA? ›

    C4 pre-workout does not contain DMAA. According to Cellucor's website, its C4 Sport Series is NSF® Certified for Sport, ensuring it meets strict standards and has no contaminated substances or hidden ingredients.

    Why was Jack3d banned? ›

    Jack3d (pronounced 'jacked') is a caffeinated pre-workout supplement that was banned in the U.S. in 2013 because of the illegal substance, dimethylamylamine (DMAA), though its updated formula sits on store shelves to this day. Three flavor selections for Charged Lemonade with caffeine warning labels.

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