Looks like a DMAA ban will be coming sooner rather than later.
FDA challenges marketing of DMAA products for lack of safety evidence
Agency cites ten companies in warning letters
The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a "natural" stimulant.
The companies receiving warning letters and their product names are:
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,
Lipo-6 Black Ultra Concentrate,
Lipo-6 Black,
Lipo-6 Black Hers Ultra Concentrate,
Lipo-6 Black Hers
SEI Pharmaceuticals MethylHex 4,2
SNI LLC Nitric Blast
USP Labs, LLC Oxy Elite 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.
Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.
The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. 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 companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues in the warning letters.
Two new products just came out from the hottest brand today. Hypercuts is their new fat burner/energy product while Adralin is said to mimic effects similar to the popular ADD (Attention Deficit Disorder) prescription drugs Adderall and Ritalin.
December 12, 2008
Our website has a brand new look! We hope you like it. You may also notice we have some videos on the site now including a few about Axis Labs products and another about Superpump 250. When new videos become available, they will be added to the site periodically.
If you have any problems with the new site or have any suggestions, please let us know and send us an email at info@advantagesupplements.com.
Although some areas of the city still do not have power, all of our operations are now running back to normal after Hurricane Ike. We would like to thank all of our customers who experienced delays with their orders for their patience and understanding.
September 14, 2008
NOTE:
Due to the recent landfall of Hurricane Ike in southeast Texas, all orders placed from Thursday, September 11th, through Tuesday, September 16th, will experience delays in shipping. Power is still in the process of being restored throughout the Houston area, and UPS and US Postal Service routes have not been completely re-established yet. However, all our customers can be assured their orders will be shipped as soon as possible. We appreciate your patience.
August 6, 2008
MARK YOUR CALENDARS AND GET YOUR CHECK BOOKS READY … BSN CHARITY CHOPPER AUCTION SET FOR SEPTEMBER 1st, 2008 ON EBay®!
Bio-Engineered Supplements and Nutrition Inc. (BSN), the world leaders in cutting-edge physique and performance supplements, and the official nutritional supplement provider of the UFC®, is proud to announce that on September 1st, 2008 bidding will commence on eBay® for BSN’s custom OCC replica <> chopper, the proceeds of which will be donated in whole to the Warrior Transition Unit.
If you recall, this chopper was featured on the hit cable TV show American Chopper back on April 24th during the BSN bike build episode. The highly anticipated episode, which brought in almost 2.5 million viewers, featured the OCC crew custom-fabricating the BSN chopper from conceptualization to completion, along with a slew of BSN celebrities participating in various athletic competitions. In addition to hand-crafting the custom BSN chopper, BSN also commissioned the OCC crew to manufacture an additional, authentic replica BSN chopper. It’s this very replica chopper, featured in the closing segment of the episode at the Warrior Transition Unit in a touching and emotional unveil scene, that BSN is putting up for auction come September 1st on eBay®. BSN is pledging to donate 100% of the proceeds from the sale of this replica chopper to the Warrior Transition Unit, is a special division within the Keller Army Community Hospital that provides command and control, primary care, and case management for our nation’s wounded soldiers. BSN co-owner and Vice President Scott James, a key figure in bringing this project to light commented, “Military hospitals have always been a cause near and dear to our heart here at BSN. We really wanted 20080801_bike2to do something special to give back to the soldiers who put their lives on the line every day protecting our country. I’m happy to announce that bidding for our BSN replica chopper will open on eBay® September 1st. Once the chopper is sold, we are donating 100% of the proceeds to the Warrior Transition Unit as a show of support for their tireless efforts helping our nation’s wounded soldiers. I want to thank everyone at OCC, American Chopper, the Warrior Transition Unit, the Keller Army Community hospital and all of our brave military personnel for going above and beyond the call of duty every day.”
Built for performance and eye-catching appeal, this BSN custom replica chopper is a sight to behold … and hear! Decked out in polished chrome with a red, black and gray amazing custom camo paint job, this beautiful 100cc, 6-speed, soft-tail chopper is adorned with OCC custom insignias and proudly displays the Warrior Transition Unit logo on the back fender. This is your chance to own a piece of television history with 100% of the proceeds going to a good cause! Mark your calendars for September 1st, 2008, get your check books ready and look for the BSN replica chopper on eBay®!
BSN TO BE FEATURED ON AMERICAN CHOPPER APRIL 24TH!
We are very happy to report that BSN will be exclusively featured on the popular TV show American Chopper April 24, 2008 at 9:00 P.M. eastern standard time on TLC. American Chopper stars Paul Teutul Sr., his sons Paul Teutul Jr., Mikey Teutul and the rest of the Orange County Choppers (OCC) crew. Filming for this episode was completed during the months of January and February over the course of three days on location in Montgomery, New York at OCC’s headquarters. This episode of American Chopper will document the building of the sickest-ever, custom fabrication, one-of-kind BSN-themed chopper bike, and will have cameo appearances by the Girls Of BSN, and Team BSN athletes Anthony Presciano and 8-Time Mr. Olympia Ronnie Coleman. In addition to having the OCC crew build this incredible custom chopper, BSN also commissioned them to build a replica BSN bike, which will be auctioned off for charity, with 100% of the proceeds to be donated on behalf of BSN to the Warrior Transition Unit of the Keller Army Community Hospital in West Point, New York. One of the most eagerly anticipated episodes of the new American Chopper season, be sure to tune into to see the BSN chopper build on American Chopper April 24th at 9:00 p.m. eastern standard time on TLC!
Yet another new release from CTD Labs. Noxavol is their new nitric oxide product. It looks to be a great formula with the addition of beta alanine and cissus quadrangularis. Feedback so far has been excellent with all of our employees giving it a resounding two thumbs up.
We've waited a long time for this product, and it's hard to believe it's finally out! Judging from the last few products this company has released (i.e. Decabolen and Supervol), Trenbolen should produce some outstanding gains.
November 13, 2007
New Packaging for CTD Labs Products
CTD Labs has a new look. It is still the exact same great product, but with new exterior packaging. Frankly, we think it looks better than the old one.
November 2, 2007
New Products
Some new flavors of your favorite products are in stock now.
For those of you that have purchased whey protein products recently, I’m sure you noticed the price was very expensive. As an example, Optimum Nutrition’s 100% Whey Protein (Gold Standard) went from $25 six months ago to its current price of $38. Dymatize’s Elite Whey went from $25 to $43. Now, these aren’t your minor price increases. These are huge, with anywhere from 50-75% increases depending on the product.
So what’s causing all this? The supplement industry is facing big increases to the price of milk protein, which includes whey protein, milk protein isolates and concentrates, and anything else derived from cow’s milk. This is the result of unprecedented high demand for milk products in China as well as other developing countries. For all you economics majors we all know what happens when demand outstrips supply. The price must go up to compensate. Just like the price of oil (gasoline, fuel) is controlled by supply and demand, so too are milk (whey protein) products.
But prices couldn’t have increased by that much, could it? Unfortunately, yes. If you bought a gallon of milk recently, you might have paid $4.50 or more for it. Starbucks recently raised the price on a cup of coffee by 9 cents. You may think 9 cents is nothing compared to $15 or $20, but Starbucks sells millions of cups of coffee every day. This translates into billions of dollars in additional revenue. A supplement company may only sell hundreds or even thousands of units per day. As a result, their prices must increase more. If they don’t, they lose money instead of profit. There is no incentive for a company to produce a product that loses money. When supplement companies raise their wholesale prices (the price we pay), retailers like ourselves must do the same.
I don’t care if prices are higher or not, I’m still not paying that much for my protein powder. Well, it looks like you’re gonna have to. From what it looks like, prices are going to continue to increase for the foreseeable future. You’re only alternative would be to find other sources of protein such as egg or casein. You can also look for whey proteins that haven’t yet gone up in price yet like DNA Mighty Whey Protein which currently sells for $24.99 for 6.3lbs and 80 servings.
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