USPlabs has agreed to stop manufacturing dietary supplements containing DMAA

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

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F.D.A. Issues Warning on Workout Supplement with DMAA

USPLabs Jack3d

Certain workout-booster and fat-burning products, sold in recent years by retailers like GNC and Vitamin Shoppe, are illegal and may present serious health hazards to consumers, federal health regulators have determined. 

With names like Jack3d and OxyElite Pro, the popular products contain a stimulant known as dimethylamylamine, or DMAA for short. In a public warning late Thursday, the Food and Drug Administration said that the stimulant did not qualify as a legal dietary supplement ingredient and that it could raise blood pressure, potentially causing heart attacks and other health problems. 

Since early 2008, the agency has received reports of 86 health problems, including at least five deaths, in consumers who used DMAA products. Although such reports do not prove that the stimulant directly caused the health problems, agency officials warned people not to consume the ingredient.

“We are very concerned,” Daniel Fabricant, the director of F.D.A.’s division of dietary supplements programs, said in a phone interview Friday. “We think consumers should stay away from products containing DMAA.”

Steve Mister, president of the Council for Responsible Nutrition, a trade group, said on Friday that the dietary supplement industry should honor the agency’s warning.

“The F.D.A. has spoken,” Mr. Mister said. “We are urging the industry not to manufacture products with DMAA. Retailers should heed the advisory as well.”

A lawyer for USPlabs, the Dallas company that markets Jack3d and OxyElite Pro, said his client disagreed with the F.D.A.’s position.

“USPlabs continues to believe that DMAA is legal, or otherwise they would not be selling it,” said the lawyer, Peter B. Hutt of Covington & Burling in Washington.

As of Friday afternoon, GNC was still selling Jack3d (pronounced “Jacked”) on its Web site as a “hot buy.” A company spokesman did not return requests for comment.

Vitamin Shoppe appears no longer to be stocking Jack3d, and now offers only Jack3d Micro, a newly formulated product that does not contain DMAA.

The F.D.A. warning comes as the agency faces mounting pressure from medical researchers, sports organizations and investigations in the news media to take action on the stimulant.

In late 2011, the Defense Department pulled products containing DMAA from stores on military bases, pending an investigation into the deaths of two soldiers who died after they used the stimulant. Last month, an article in The New York Times described the death of one of those soldiers, Michael Sparling, who collapsed during a training run with his unit in 2011 after taking Jack3d and died soon after. The Sparling family has filed a lawsuit against GNC, where he bought the product, and USPlabs.

On Friday night, the NBC News program “Rock Center With Brian Williams” was scheduled to broadcast a segment on Mr. Sparling and DMAA products.

Mr. Hutt, the USPlabs lawyer, said the F.D.A. made its announcement to get out in front of the NBC report and shield itself from being criticized for lax enforcement.

“This is the agency’s customary attempt to protect itself,” Mr. Hutt said. “These reports rely on a plaintiff’s unsubstantiated allegations. There is no evidence that the soldier’s death was caused by DMAA.”

Although health regulators in at least seven countries, including Canada, have effectively banned supplements containing DMAA, the products have remained widely available at supplement stores in the United States. Some medical researchers say federal health regulators should have warned American consumers much earlier.

We’ve had hundreds of millions of dollars spent on products that should have never been on the marketplace to begin with,” says Dr. Pieter Cohen, an assistant professor at Harvard Medical School who studies dietary supplements. “There’s no reason the F.D.A. should have waited to warn the public of the dangers of consuming the ingredient.”

A year ago, the F.D.A. issued letters to 10 companies that marketed DMAA products, saying the stimulant did not fit the legal definition of a supplement as a vitamin, mineral, herbal or botanical ingredient used to supplement the diet. The stimulant was originally developed in the 1940s by Eli Lilly, the pharmaceutical company, as a nasal decongestant called Forthane, but the drug maker officially withdrew the medicine from the market in the 1980s.

Among the companies that received the federal warning letters last year, all but USPlabs agreed to stop marketing DMAA products, according to the F.D.A. advisory. USPlabs submitted published studies on the ingredient in an effort to challenge the F.D.A.’s position, the advisory said, but the agency found the information “insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

Mr. Fabricant said the F.D.A. intended to take further steps to remove the stimulant from the market. Although he declined to comment specifically on USPlabs, the agency’s options in such cases generally include asking a supplement maker for a voluntary recall of potentially hazardous products, seizing such products or instituting a mandatory recall.

“We are going to use all of the tools available to us to get this out of distribution,” Mr. Fabricant said.

article source: NY Times

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New Jack3d Advanced DMAA Free Formula

New Jack3d Advanced Formula without DMAA

Jack3d Advanced from USP Labs

- Advanced Taste. Advanced Feel. Advanced Performance

- High Energy Pre-Exercise Augmentation System

- Exclusive “Nitrate Blast” Formula

Jack3d Advanced formula Supplement Facts

Jack3D Advanced - Product Description

Tireless research and development has lead to the discovery of a precise blend of advanced ingredients worthy of the name jack3d. USP labs' team of scientists have toiled both in the lab and in the gym to bring you exactly what you need to dominate every bar you approach. Blast, smash and unleash your true unhindered potential. Are you ready to get jack3d? Nothing will ever be the same. Bursting pumps, ridiculous energy and massive gains. 

Suggested Use

Mix 1 Ultra-Concentrated Scoop (5.1 grams) with 4 ounces of cold water and consume 30-45 minutes prior to resistance training. Do this the first 3 times using the product. Beginning with the 4th use, if needed, you may gradually increase serving by a half scoop (2.55 grams), up to a total of 2 full scoops. DO NOT UNDER ANY CIRCUMSTANCES EXCEED 2 SCOOPS IN ANY 24 HOUR PERIOD OR USE MORE THAN 5 DAYS IN ANY 7 DAY PERIOD. Consume at least 125 fl. oz. of liquid per day for men and 91 fl. oz. of liquid per day for women.

Warning!!!

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. Do not use under extreme conditions of heat, CARDIOVASCULAR EXERTION, sleep deprivation, or dehydration. Do not combine with alcohol. Pregnant or nursing women should not use this product. 

This product is only intended to be consumed by healthy adults 18 years of age or older. Consult with your Physician before using this product, especially if you are using any prescription or over the counter medication or if you have any pre-existing medical condition including but not limited to high or low blood pressure, cardiac arrhythmia, stroke, heart, liver, kidney or thyroid disease, seizure disorder, psychiatric disease, diabetes, difficulty urinating due to prostate enlargement or if you are taking a MAOI (Monoamine Oxidase Inhibitor) or any other medication. 

Do not use if you are taking erectile dysfunction medication. Do not take additional nitrates in the form of medication or dietary supplements along with this product. This product contains caffeine and should not be taken by individuals wishing to eliminate this ingredient from their diet. Discontinue use 2 weeks prior to surgery. Discontinue use and consult with your health care professional if you experience any adverse reaction to this product. Do not exceed recommended serving. 

Do not use if safety seal is broken or missing. KEEP OUT OF REACH OF CHILDREN. Contents may settle. SHAKE CONTAINER PRIOR TO EACH USE. Store in a cool dry place to prevent clumping and discoloration.

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How to buy Jack3d?

Jack3d and Jack3d micro

How to buy Jack3d?

There are many questions about how to buy Jack3d. Since when information surfaced that Jack3d is harmful to health because of DMAA, Jack3d is much harder to buy than a few months ago. The market appeared a new formula that does't contain DMAA, but many people say that this formula is much weaker than the original Jack3d formula. While in the UK original formula Jack3d became illegal, in most of the rest of the world original Jack3d can buy in the supplements shop. If you can't find a shop which sells original Jack3d, here is some tips to buy Jack3d .

One of the easiest ways to purchase original Jack3d supplement, is through the internet. Two of the biggest online sales (eBay and Amazon) don't offer the sale of original Jack3d formula, so you have a little more to look for if you want to purchase this product online.

Our first choice for shopping is fitrx.com. In preparing this article, on this page can still found old Jack3d formula. Her Cost is $ 30 for 250 grams of this supplement. If you wanna visit this site you can click HERE

On page nutraplanet.com, during the writing this article, are still a few original packaging Jack3d formula. But the price of one product on this site is about $ 75. If you wanna visit this site you can click HERE

Original Jack 3d formula can still buy on the site a1supplements.com, a price for a pack costs about $ 45 and is currently on sale prices of 33%, so one box Jack3d formula costs $ 26. If you wanna visit a1supplements page, you can click HERE

How to buy Jack3d Micro and Jack3d Advanced Formula

However, it should be noted that the UPS Labs Jack3d made two new formula, and both is DMAA free. It's Jack 3d Micro and Jack3d Advanced formula. Both of these formula you can buy in any supplement shop, and the easiest way is to purchase through e-Bay or Amazon. If you want to buy one of these formulas, you can simply click on the image below.

Buy Jack3d Advanced Formula

Buy Jack3d Advanced Formula

Buy Jack3d Micro

Buy Jack3d Micro

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