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USPlabs has agreed to stop manufacturing dietary supplements containing DMAA

USPLabs Jack3d and Oxy Elite Pro
USPLabs Jack3d and Oxy Elite Pro


USPlabs has agreed to stop manufacturing dietary supplements containing DMAA

DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient found illegally in some dietary supplements and often touted as a “natural” stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. 

Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. In 2012, FDA issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance. Most companies warned are no longer distributing products with DMAA. While FDA is working to get these products off the market, consumers should not buy or use any dietary supplement product containing DMAA.

On July 2, 2013, as a result of follow-up legal action by FDA, the dietary supplement firm USPlabs voluntarily destroyed its DMAA-containing products located at its facility in Dallas, Texas. The products - USPlab's OxyElite Pro and Jack3d - are estimated to have been worth more than $8 million at the retail level. USPlabs has agreed to stop manufacturing dietary supplements containing DMAA.

USPlabs agreed to destroy the products after FDA administratively detained them under the Federal Food, Drug and Cosmetic Act, recently amended by the Food Safety Modernization Act (FSMA). Under its administrative detention authority, FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure. Under FDA regulations, detained articles can be voluntarily destroyed by their owner.

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

Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner. Consumers can also report such incidents directly to FDA, see Dietary Supplements - Adverse Event Reporting. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label.

article source: FDA

What is Dimethylamylamine (DMAA)?


Dimethylamylamine powder
Dimethylamylamine powder

What is Dimethylamylamine - (DMAA)?


Dimethylamylamine is a drug made synthetically in a laboratory. It was originally used as a nasal decongestant. Today, dimethylamylamine is sold as a dietary supplement used for attention deficit-hyperactive disorder (ADHD), weight loss, improving athletic performance, and body building.

Some products claim that dimethylamylamine naturally comes from rose geranium oil. Supplements that contain this ingredient sometimes list rose geranium, geranium oil, or geranium stems on the label. However, laboratory analysis shows that this drug probably does not come from this natural source. It is thought that these manufacturers have artificially added this drug to the supplement rather than obtaining it from a natural source. Dimethylamylamine is considered a drug in Canada is not permitted in dietary supplements or natural health products.

Many athletes take dimethylamylamine to improve performance. However, dimethylamylamine was added to the World Anti-Doping Agency’s prohibited substances list for 2010. Therefore, competitive athletes should avoid taking it.

Due to safety concerns, dimethylamylamine has been temporarily removed from military stores in the US. It has also been banned in New Zealand. Its use has been linked to several reports of serious, life-threatening side effects.

How does it work?


Dimethylamylamine is thought to have stimulant effects similar to decongestants such as pseudoephedrine, ephedrine, and others. Some promoters say that it is a safer alternative to ephedrine. However, there is no scientific information to back up this claim.

Dimethylamylamine - Uses


    Weight loss.
    Athletic performance.
    Body building.
    Other conditions.

Dimethylamylamine is likely unsafe when taken by mouth. Since it is thought to work like a stimulant, there is concern that it might increase the chance of serious side effects such as rapid heartbeat, increase in blood pressure, and increase the chance of having a heart attack or stroke.

In clinical research, taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure.

There have been several reports of dangerous side effects including stroke, a condition called lactic acidosis, heart attack, and death in people who have taken dimethylamylamine.


Special Precautions & Warnings


Pregnancy and breast-feeding: Not enough is known about the use of dimethylamylamine during pregnancy and breast-feeding. Stay on the safe side and avoid use.

High blood pressure: Dimethylamylamine might have stimulant effects and can increase blood pressure. If you have high blood pressure, avoid taking dimethylamylamine.

Glaucoma: Dimethylamylamine might have stimulant effects and cause blood vessels to constrict. This could worsen some types of glaucoma. If you have glaucoma, avoid taking dimethylamylamine.

Irregular heartbeat (heart arrhythmia): Dimethylamylamine might have stimulant effects and can cause a rapid heartbeat. This could worsen heart arrhythmias.

Surgery: Dimethylamylamine might have stimulant effects, so it might interfere with surgery by increasing heart rate and blood pressure. Stop taking dimethylamylamine at least 2 weeks before a scheduled surgery.

Dimethylamylamine (DMAA) Dosing


The appropriate dose of dimethylamylamine depends on several factors such as the user's age, health, and several other conditions. At this time there is not enough scientific information to determine an appropriate range of doses for dimethylamylamine. 

Keep in mind that natural products are not always necessarily safe and dosages can be important. Be sure to follow relevant directions on product labels and consult your pharmacist or physician or other healthcare professional before using. 

article source: Webmd

The lure of Jack3d


Jack3d
Jack3d

The lure of Jack3d


Jack3d (sometimes known as “Jacked”) is, according to the bottle, a “powerful pre-workout supplement that increases your capacity to perform.” HPRC did an extensive search for evidence-based information on Jack3d and found that all the apparently scientific literature on the product led to its promotional website, where they offer their own reviews. Anyone taking supplements should know that there have been reports about “tainted” dietary supplements containing active ingredients of FDA-approved drugs or other compounds that are not classified as dietary supplements. But there are still testimonials, blog entries, and bodybuilding forums touting the effects of Jack3d. It’s important to know exactly what is in Jack3d and that there isn’t any information on how much of each individual ingredient is in a serving.

The label of Jack3d says that it contains 4145 mg of a “Proprietary Blend” in one scoop, with 45 servings per container. 

In that blend are the ingredients:

- arginine alpha-ketoglutarate,
- creatine monohydrate,
- beta alanine,
- caffeine,
- 1,3-dimethylamylamine (geranium [stem]), and
- schizandrol A, as well as some flavoring and color additives.

So, what does this all mean to a consumer? There have been individual studies conducted on each of the ingredients in Jack3d. Some are more effective than others for potentially enhancing athletic performance and building muscle mass. For example, creatine may increase muscle mass and enhance exercise performance during short, high-intensity repeated exercise bouts. 

We know that 1,3-dimethylamylamine (DMAA), a chemical from the geranium plant and also synthetically made, is used in supplements promoted for weight loss, bodybuilding, and enhanced athletic performance. According to the Natural Medicines Comprehensive Database, it’s thought to have stimulant effects. Its chemical structure is similar to that of amphetamine, and it is on the World Anti-Doping Agency’s banned substance list. No scientific literature exists on the effectiveness of DMAA for weight loss, bodybuilding, or enhanced athletic performance. 



Caution is advised on the use of DMAA with caffeine, since both have stimulant effects and could increase the chance of increased heart rate and blood pressure.

The amount of caffeine per scoop of Jack3d has not been released, although it has been estimated that there is less than 150 mg of caffeine/scoop. Caffeine is included on the FDA’s list as a substance “generally recognized as safe.” However, the FDA has established a maximum concentration for caffeine in cola beverages: 32.4 mg per 6 oz or 71 mg per 12 oz. Other than colas, the caffeine content of food and beverages is not regulated. 

The label of Jack3d states: “Do not use in combination with caffeine or any stimulants from other sources whatsoever, including but not limited to, coffee, tea, soda and other dietary supplements or medications.” Caffeine seems to increase physical endurance, but it does not seem to affect activities that require high exertion over a short period of time, such as lifting.

The main issue with Jack3d is the same one that exists with many bodybuilding products on the market. There is no way to judge the interaction between the ingredients, especially when the consumer is unable to determine how much of each ingredient is in the product. This product contains multiple ingredients and, potentially, additional and potent ingredients not listed. It also could be contaminated, as has been seen with many other supplements. The FDA has put together information on tainted products promoted for bodybuilding.

It is important to mention that Jack3d comes with serious warnings on its label. As with any supplement, be educated, be advised, and consider all the unknowns before you decide whether the possible benefits are worth risking your health.

article source: HPRC-Online

Can Jack3d cause death?

UPSLabs Jack3d
UPSLabs Jack3d

Behind The DMAA Supplement Marathoner Claire Squires Used Before She Died


The DMAA-containing performance-enhancing supplement Jack3d has come under the microscope after it was revealed Wednesday that marathoner Claire Squires died last year after using it.

Squires' death at age 30 shocked the global running community last April when she collapsed a mile from the finish line of the 2012 London Marathon. Her death remained unexplained until Wednesday, when coroner Philip Barlow told a court that she had ingested Jack3d before competing in the race, and that the supplement was the most likely cause of her death, according to the Guardian newspaper.

Jack3d, which is made and sold online by the Texas-based company USPLabs (Ultra-Premium Supplements Labs), was legal in England when the coroner says Squires consumed a scoop of it mixed into her water bottle, but it was banned four months later by the country's Medicines and Healthcare Products Regulatory Agency amid growing controversy, the Guardian reported.

The supplement contains DMAA (1.3-dimethylamylamine), which produces amphetamine-like effects in users, many of whom are not aware of the harmful - even deadly - effects such drugs can have on athletes.

One of those unaware users was Squires' partner, Simon Van Herrewege, who told the Guardian that she had bought the Jack3d powder found in her water bottle online, and that it was advertised on the Web as a workout and weight-loss aid that could provide boosts to energy, concentration, metabolism and athletic performance.

"Claire was always in the gym, where this stuff was being widely talked about," Van Herrewege told the British paper. "She took it a couple of times [while training for the marathon] but didn't really get on with it. She never particularly liked it but wanted to beat her previous marathon time [of just over four hours]. She said she was going to take one scoop, as recommended. In her own words, 'if I hit a bit of a wall, I might take this drink and see if it pushes me through the end of the marathon'."

Little did the couple know that Jack3d contained DMAA, which has been linked to a range of side effects, some of which are life-threatening, according to WebMD:

"Dimethylamylamine is LIKELY UNSAFE when taken by mouth," WebMD says. "Since it is thought to work like a stimulant, there is concern that it might increase the chance of serious side effects such as rapid heartbeat, increase in blood pressure, and increase the chance of having a heart attack or stroke. In clinical research, taking a product containing dimethylamylamine plus other ingredients seems to increase heart rate and blood pressure. There have been several reports of dangerous side effects including stroke, a condition called lactic acidosis, heart attack, and death in people who have taken dimethylamylamine."

Australian officials banned DMAA-containing products after a man died from taking a supplement he purchased online, and in early 2012 the U.S. Defense Department banned it from its stores after two soldiers bought the drug at a military base shop, took it, then died while exercising, according to the Army Times. And DMAA is on the list of supplements currently banned by the World Anti-Doping Agency.

The USPLabs website claims that Jack3d, which it sells online in 8.8-ounce containers for $44.99, is the "subject of 2 peer-reviewed published clinical research studies" and "voted #1 pre-workout," but it is currently out of stock. The unidentified studies are not sourced on the section of the USPLabs site that sells Jack3d.

And a number of "amazing testimonials" are listed on the site, including this one from Zack V. of Rochester, N.Y.:



“USPlabs Jack3d is easily the most intense pre-workout product I have ever used. The amount of energy and focus are perfect, my pumps and vascularity were out of control, but most importantly; I feel great all workout. No crash, no bloat, no headaches, no blow workouts.”

Jack3d - pronounced “jacked” - powder, which is designed to be mixed with water to create a fruity drink, comes in tropical fruit punch, lemon-lime and grape bubblegum flavors.

In a section of the Jack3d page of the USPLabs website called "Directions for Use & Warnings," there is zero mention of any harmful side effects, but the company does provide this disclaimer in an addendum at the very end of its description of the supplement:

"It's mandatory that athletes or anyone subject to testing check with their governing body before using this product. Read the entire label, including directions, precautions & warnings. Tested athletes make up the extreme minority of the American public and have to follow strict rules on what they can and cannot use in competition."

According to the Telegraph newspaper, Jack3d was initially marketed "as a 'natural' stimulant, apparently derived from geranium, that could increase performance."

But last spring the U.S. Food and Drug Administration wrote a letter to retailers selling DMAA-containing products warning them of potential complications.

The letter cautioned that DMAA is "known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack," according to the Telegraph. “The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.”

DMAA-containing products including Jack3d are still available for purchase via online retailers based in countries that have not banned the sale of the drug, which is legal to possess in both the U.K. and U.S.

Time will tell if the associated death toll will lead to any further restrictions on DMAA-containing supplements as Squires’ use of Jack3d becomes known.

 
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