AX - Official SX / Hyperdrol Statement
- 08-30-2010, 03:38 PM
AX - Official SX / Hyperdrol Statement
We know this has been a long time coming and will continually update this with more information as we progress in the closure of the Hyperdrol issue with the FDA. AX had stopped all marketing (to include online forums, print media, etc) for the entire time of the investigation. Dropping offline was not something that AX wanted and we knew it would allow the rumors to continue to spread, however this was a demand by our legal counsel during the time of the investigation for Hypedrol.
Last spring the rumors were flying about two of the products in our then-existing line of nine Anabolic Xtreme products. Both products were voluntarily discontinued over a year ago, but we never made an official statement on the circumstances due to the Hyperdrol investigation that was taking place. Instead, we fully cooperated with federal authorities and regulatory agencies to ensure our compliance with the law. We even launched our own investigation, retaining independent scientific consultants to evaluate our existing product line. It’s time to set the record straight.
One of the products was Slim Xtreme. There were claims that SX was intentionally spiked with a controlled substance or prescription drug. Those rumors were absolutely false. No AX product was ever intentionally spiked with any ingredient not on the label, and AX would never distribute a product knowing it contained any controlled substance or prescription drug whatsoever. There were also claims that the active ingredient in SX was so similar to a controlled substance as to make it an “analogue” of that substance. Scientists can argue over what degrees of similarity render chemical compounds “analogous” to each other (reliable independent experts often offer conflicting opinions); however, despite extensive expert review, the analysis conducted by the third-party scientific consulting firm we retained could not conclude that SX contained an analogue of any controlled substance within the meaning of the law. We nevertheless took the step of recalling the product and issuing refunds and credits to our customers. Why? Well although we originally believed that the active ingredient in Slim Xtreme was a derivative of the amino acid proline and could therefore be legally marketed, the attention that Slim Xtreme received by online message boards prompted us to revisit the formula. Upon further review in conjunction with our regulatory legal counsel, we no longer felt comfortable that the dietary supplement ingredient satisfied the criteria for a “dietary ingredient” under existing regulations. Since the law is notoriously lacking in industry guidance with respect to new dietary ingredients, evaluating the viability of new dietary ingredients often boils down to interpretation.. We were no longer comfortable with the product being on the market, so we voluntarily discontinued it and recalled all lots and batches. It was the right choice, and the most responsible choice, even though it meant incurring substantial costs and more grist for the rumor mill. To this day there has been no serious adverse events reported with SX which cannot be said for many of the stimulant products on the market.
The other product was Hyperdrol, our testosterone support product. The active ingredient in Hyperdrol – 6-bromo (6-Bromo androstane-3,17-dione) was used in dozens of dietary supplement products marketed by a variety of companies and was widely sold in vitamin stores across America. The ingredient had been on the market long before Hyperdrol was produced. While 6-bromo was itself neither a controlled substance nor an analogue of a controlled substance under the law, reports began to circulate that products containing the ingredient were being found to contain small amounts of androstenedione or “andro.” Andro was once sold as a dietary supplement but had been reclassified by Congress as a controlled substance in 2004. While some lots of Hyperdrol were tested and found to contain very small concentrations of andro, it is critical to note that the presence of andro in supplement products containing the 6-bromo ingredient products was not exclusive to our particular product. In fact, the 6-bromo products of other supplement manufacturers were also found to contain varying amounts of andro as a contaminant. As best we can determine, the explanation for the andro contamination in so many 6-bromo products is most likely either cross-contamination at the raw material supplier’s facility or the chemical conversion of the 6-bromo ingredient by environmental degradation (or a combination of both). Neither our consultants nor Government experts are absolutely sure which explanation is primarily responsible for the contamination. However, what all parties do agree is that the presence of andro in Hyperdrol was not attributable to spiking and the contamination was unintentional and undiscoverable under existing quality control testing requirements. In any event, to our best understanding the concentration of andro in Hyperdrol was too small to present any significant health risks to consumers at daily serving recommendations and was even too small to have any physiological effect whatsoever. Nonetheless, the presence of even harmless amounts of andro in our 6-bromo product obligated us to take action. We recalled the product, issued consumer credits and refunds, and discontinued its manufacture.
The rumors and allegations that Hyperdrol was also found to contain “Tren,” is completely false. “Tren,” as it has been referred to by the government, was the prohormone substance marked by some sports nutrition companies and became a controlled substance in January of this year. In the well publicized Bodybuilding.com search warrant affidavit, it was incorrectly noted that Hyperdrol was found to contain Tren. Our attorneys have confirmed with the FDA that Hyperdrol was not found to contain Tren and that this was an error in the affidavit.
We regret the distribution of these products and accept full responsibility for them. We hope our earnest efforts to make things right will not impair the loyalty of our valued customers. Our tribulations have helped us grow as a company, and have spurred us on in a new direction. Our goal is to set new standards of quality control and trustworthiness. Athletic Xtreme is dedicated to this end. The first step was commissioning BSCG to test every AX product before it ships to retail locations.
BSCG is headed by Dr. Don Catlin the banned substance guru and world renowned scientist who has been at the forefront of athletic drug testing and banned substance detection since its inception. BSCG was established by professionals and scientists with decades of experience in anti-doping analysis and the detection of banned substances. These are the very substances you will find banned by organizations such as the IOC, NFL, NCAA, and MLB. Since the term "Athletes" includes recreational fitness and physique enthusiasts, not all athletes are subject to rules that prohibit the use of certain dietary supplement ingredients. Therefore, some AX products may contain ingredients that are prohibited by some sports organizations although they are safe, legal dietary ingredients. Rest assured that while not every product will be certified by BSCG as free from substances prohibited by sports, ALL the products in the AX line will be tested to contain safe, legal dietary ingredients and have been tested and approved by BSCG as free from banned substances or contaminates not indicated on the label.
More to come....
- 08-30-2010, 04:08 PM
08-30-2010, 04:47 PM
That is good you posted that and cleared the air. I still am curious why I had the reaction I did to Slim Xtreme and no other stim based fat burner but that is neither here not there. If you have independent third party anaylsis of both products, post them so that eliminates any further ambiguity.
If my direct and cynical approach bothers you, just ignore it. I'm just saying what you need to hear ;).
08-30-2010, 05:11 PM
@oufinny. I'm not sure what third party tests you would want to see or what they would prove. Hyperdrol was found to have andro as stated above like all other 6-br products. SX, two third-party scientific consulting firms reviewing the proline analog on an ingredient level found it was not an analogue of any controlled substance however DSHEA compliance was questionable at best. Dispelling the rumor that it is a "illegal drug" or is "like meth", etc. So again there really are no third party tests to show other than a test that shows yes, hyperdrol contained an amount of andro that would have no physiological effect whatsoever.
The SX issue boils down to DSHEA law (the law stating an ingredient is found in nature and consumed by humans) and labeling and should have gone into more detail than "proline analog", much like the original ErgoPharm AMP was originally listed as "geranium oil extract" and then changed to the proper 1 3-dimethylamylamine nomenclature after the Washington Post article on the ingredient. A mistake that will never be made again and would never pass our new BSCG certification program. Many companies have and still use obfuscated labeling practices and it is something we should have have followed suit in to protect getting an ingredient copied out of the gate.
08-30-2010, 05:14 PM
Fair enough and appreciate the further explanation. Hopefully now that this is behind you guys you can get back to your existing product line, it does look to have some quality choices in there.
If my direct and cynical approach bothers you, just ignore it. I'm just saying what you need to hear ;).
08-30-2010, 05:55 PM
Nice to finally see an official statement
08-30-2010, 06:03 PM
A lot of time and money was spent with independent firms reviewing the claims that people had said online about it being illegal, a controlled substance, etc. So this is us finally being able to talk about it. The exact ingredient was in the public domain and I did not realize that was still a question. In fact it was on the box of the last run of product prior to it being brought up online.
Phenyl-pyrrolidinyltoluene aka (R)-2-DIPHENYLMETHYLPYRROLIDINE a proline analog.
Originally it was said to be (S)-diphenyl-2-pyrrolidinyl-methane which it is not. We apologize as we thought this was common knowledge now as to what was in SX. We had no idea that was a question still at this point as a company owner had confirmed this online at bb.com quite a while ago as well as Phenyl-pyrrolidinyltoluene being listed on the label at the end of the product life cycle.
ww w.sigmaaldrich.com/etc/medialib/docs/Aldrich/Brochure/al_chemfile_v7_n9.Par.0001.Fil e.tmp/al_chemfile_v7_n9.pdf
08-30-2010, 06:14 PM
First supplement that I had ever tried from AX was stimulantx, which I received a sample of at a fitness show only a few short months ago, so I'm fairly new to your company as a customer. I enjoyed the product and have subsequently ordered more. I can only hope that my trust as a consumer is not misplaced, and as such is rewarded with quality products that produce measurable results. The point of supplementation is to help enhance health, not just to enhance personal performance with the highest cost beings one's health. Good luck and make the best of it this time around.
08-30-2010, 06:17 PM
08-30-2010, 06:32 PM
08-30-2010, 06:37 PM
The new stimulant product will be out in just a few weeks. It is completely novel and has safety data behind the new ingredient (although never used in a supplement product before). It will contain no 1,3Dymethl (Geranium) and lasts a good 10-12 hours. We imagine this ingredient will be the new "Geranium" of the mood enhancing and appetite reduction products.
08-30-2010, 06:45 PM
08-30-2010, 06:51 PM
I find it funny that many people gripe about various adverse reactions that they had received but not one person went to the doctors or reported it to the FDA.
The system is in place for these type of things people. AX did nothing wrong...simply a case of Internet voice at its finest bringing fear from simple heresay.
08-30-2010, 06:58 PM
08-30-2010, 07:03 PM
08-30-2010, 07:05 PM
08-30-2010, 07:19 PM
08-30-2010, 07:21 PM
08-30-2010, 07:27 PM
08-30-2010, 07:28 PM
08-30-2010, 07:41 PM
Slim Xtreme never gave me enough result to use as a recreational supplement, I believe that people do this for reasons only they know. People are dumb.
08-30-2010, 07:43 PM
Thanks for your interest, "Hank". We all hope that the resurgence/rebirth of AX will not only provide everyone with the confidence in the products prior to their use via the testing and QC procedures, but will be exceedingly happy with the results that they see after using them. And of course, as always, the online team is ever-present to aid in anything you need.
-RecoverBro Zombie Specialist and Paracord Wrangler
-Independent due to lies that hurt my family. Loyal to myself and my Bro's.
08-30-2010, 09:55 PM
08-30-2010, 10:33 PM
As someone who purchased, consumed, and stll possesses hundreds of doses of SX, I have been thoroughly disappointed with how this has been handled. I felt uneasy when the first doubts were raised, I felt some nasty effects when I discontinued use, and I really felt uncomfortable when the product was pulled without much of an explanation.
For a long time no further information came but promises and the only words we had were words of ridicule from reps who promised we'd be sorry once the truth was revealed. When this statement was released today I felt that it wasn't anything more than what was said a year ago and was again disappointed that this was the big "setting straight of the record" that had been promised.
All of that said, perhaps I got too caught up in all of it and flew off the handle in this thread. While I still feel that today's statement is an unsatisfactory resolution to an unfortunate fiasco, that doesn't justify the colorful language I used to express that point.
As a result, I have deleted all of my posts from this thread. Most of them still show up in quotes so I'm not trying to hide anything so much as I'd like to clean up some of my contribution to something that is already a big enough mess without me adding to it.
08-31-2010, 02:45 PM
No reason to delete your posts, that just shows cowardice. As far as everything is concerned AX isn't wrong in the slightest. Just look at the facts.
Are you familiar with Medwatch? Here give this a read: www . fda . go v
/ Safety/ MedWatch/ default. htm
Next time use it when you receive an adverse reaction. Actions speak louder than words.
08-31-2010, 02:51 PM
08-31-2010, 09:11 PM
08-31-2010, 09:26 PM
08-31-2010, 11:08 PM
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