Came across this the other day......FDA is still hard at work
- 11-11-2011, 10:19 PM
Came across this the other day......FDA is still hard at work
Press Release - United States Attorney's Office, Northern District of California
SAN JOSE, Calif. – Anabolic Resources, Inc., doing business as Anabolic Xtreme, a corporation registered in California and Nevada, pleaded guilty today in federal court in San Jose to the introduction and delivery for introduction of unapproved new drugs into interstate commerce with intent to defraud and mislead, United States Attorney Melinda Haag announced. The guilty plea was entered on behalf of the corporate defendant by Kevin Smith, the president of Anabolic Resources, before US District Judge D. Lowell Jensen.
At the same court appearance, Nutrition Distribution, Inc., which also did business as Anabolic Xtreme, pleaded guilty before US District Judge D. Lowell Jensen in federal court in San Jose to the introduction and delivery for introduction of unapproved new drugs into interstate commerce with intent to defraud and mislead. That guilty plea was also entered on behalf of the corporate defendant by Kevin Smith, who is also the president of Nutrition Distribution.
Although Anabolic Resources and Nutrition Distribution were separate corporations, they were owned and operated by the same principals and each used the dba Anabolic Xtreme at different times.
In pleading guilty, Anabolic resources admitted that, beginning in approximately April 2005 and continuing through January 2006, Anabolic Resources knowingly caused to be manufactured and distributed in interstate commerce, the purported dietary supplement, Anabolic Resources Superdrol, which contained a drug that was not approved by the Food and Drug Administration.
Specifically, Anabolic Resources knowingly caused to be manufactured and distributed in interstate commerce Anabolic Resources Superdrol, a purported dietary supplement whose main active ingredient was the synthetic steroid methasteron, also known by the chemical name 17 β-Hydroxy-2α, 17α-dimethyl-5α-androstane-3-one. Anabolic Resources knowingly labeled Anabolic Resources Superdrol in a manner that was intended to deceive consumers and the Food and Drug Administration, in that it was labeled as a dietary supplement, when in fact Anabolic Resources Superdrol could not be defined as a dietary supplement because the active ingredient in the product was a synthetic steroid. Superdrol was actually a drug not approved by the Food and Drug Administration.
In pleading guilty, Nutrition Distribution admitted that, beginning in approximately February 2007, and continuing through August 2009, Nutrition Distribution knowingly caused two purported dietary supplements to be manufactured and distributed in interstate commerce: Anabolic Xtreme Hyperdrol, and Anabolic Xtreme Slim Xtreme, both of which contained drugs that were not approved by the Food and Drug Administration.
Specifically, Nutrition Distribution knowingly caused Anabolic Xtreme Hyperdrol, a purported dietary supplement whose main active ingredient was the synthetic drug 6-Bromodione to be manufactured and distributed in interstate commerce. Furthermore, multiple lots of Anabolic Xtreme Hyperdrol contained the scheduled anabolic steroid androstenedione. Nutrition Distribution knowingly labeled Anabolic Xtreme Hyperdrol in a manner that was intended to deceive consumers and the Food and Drug Administration, in that it was labeled as a dietary supplement, when in fact Anabolic Xtreme Hyperdrol could not be defined as a dietary supplement, as the active ingredient in the product was a synthetic drug, and in some lots, contained a scheduled anabolic steroid.
In addition, Nutrition Distribution knowingly caused Anabolic Xtreme Slim Xtreme, a purported dietary supplement whose main ingredient was the synthetic designer stimulant, 2-diphenylmethyl pyrrolidine, to be manufactured and distributed in interstate commerce. Anabolic Xtreme Slim Xtreme also could not be defined as a dietary supplement, as the active ingredient in the product was a drug.
The Plea Agreements:
Anabolic Resources pleaded guilty pursuant to a plea agreement with the government to violating 21 U.S.C. §§ 331(d) and 333(a)(2), a felony, and was sentenced immediately after the entry of the guilty plea. Anabolic Resources was sentenced to a fine of $500,000, the maximum fine allowable under the statute.
Nutrition Distribution pleaded guilty pursuant to a plea agreement with the government to violating 21 U.S.C. §§ 331(d) and 333(a)(2), a felony, and was sentenced immediately after the entry of the guilty plea. Nutrition Distribution was sentenced to a forfeiture of $100,000, which the defendant paid immediately.
The plea agreements require that Anabolic Resources, Nutrition Distribution, and any other continuing entities involved in the manufacture and distribution of dietary and nutritional supplements operated or controlled by Anabolic Resources or Nutrition Distribution, monitor and test, at its own expense, all products distributed by those companies for a period of five years. The testing must be done by an independent testing organization agreed upon by the parties.
The plea agreements also require that Anabolic Resources, Nutrition Distribution and any other continuing entities operated or controlled by Anabolic Resources or Nutrition Distribution not introduce into interstate commerce any products unless and until the monitoring and testing results of that specific lot of product has been received by the FDA from the independent third party testing organization. This monitoring and testing is also separate from, and in addition to, any inspections, sampling, testing or other regulatory actions by FDA which are authorized by statute or regulations.
The plea agreement further requires that Anabolic Resources and Nutrition Distribution destroy, at its own expense, any remaining Superdrol, Hyperdrol, and Slim Xtreme product that was not seized by the government previously. The defendant further agreed to provide certification of such destruction to the government within 30 days of said action.
Matt Parrella and Jeff Nedrow are the Assistant U.S. Attorneys who are prosecuting the case with the assistance of Nina Burney Williams. The prosecution is the result of an investigation by the Food and Drug Administration, Office of Criminal Investigations.
Case #: CR-11-00790-DLJ (Nutrition Distribution)
CR-11-00791-DLJ (Anabolic Resources)
A copy of this press release may be found on the U.S. Attorney’s Office’s website at www.usdoj.gov/usao/can.
Electronic court filings and further procedural and docket information are available at https://ecf.cand.uscourts.gov/cgi-bin/login.pl.
Judges’ calendars with schedules for upcoming court hearings can be viewed on the court’s website at www.cand.uscourts.gov.
All press inquiries to the U.S. Attorney’s Office should be directed to Jack Gillund at (415) 436-6599 or by email at Jack.Gillund@usdoj.gov.
This site does not contain all press releases or court filings and is not an official record of proceedings. Please contact the Clerk of Courts for the United States District Court for official copies of documents and public information.iForce Nutrition Online Representative Manager
iTrain. iCompete. iDominate…iForce!
- 11-12-2011, 02:56 AM
iForce always staying classy by going negative.
Here is the press release that was made the day of the court hearing: Anabolic Xtreme Moves Forward with New Testing and Manufacturing Standards
Now that this is over I can finally talk freely about it. This dated back from the Bodybuilding.com raid that happened 2.5 years ago. It has been an ongoing investigation since that date. Several other companies from iForce to AMS (and many more soon) had similar outcomes. I'll turn that into some cliff notes below.
1. Anabolic Resources was fined $500,000 for selling Superdrol. Any other company, brand, or formulator who had anything to do with Superdrol or clones will have their day in court. This is a guarantee. This was 6 years after it was discontinued. They don't move fast but they are thorough.
2. Anabolic Xtreme was fined $100,000 for selling Hyperdrol and Slim Xtreme.
-----a. Hyperdrol contained 6-Bromodione which failed to meet the guidelines of a New Dietary Ingredient as outlined in the Dietary Supplement Health Education Act of 1994 (DSHEA). Any new ingredient that fails to meet the guidelines for DSHEA is categorized as a drug by the FDA. It also had trace amounts of a scheduled anabolic steroid Andro (androsteinedione) that could not be detected by standard Gmp testing procedures during manufacturing.
-----b. Slim Xtreme contained 2-diphenylmethyl pyrrolidine which failed to meet the guidelines of a New Dietary Ingredient as outlined in the Dietary Supplement Health Education Act of 1994 (DSHEA). Any new ingredient that fails to meet the guidelines for DSHEA is categorized as a drug by the FDA.
Slim Xtreme was not found to be spiked as all of the rumors suggested. On the first run we vaguely labeled the ingredient "Proline Analog". It was a proline analog, however this was a very bad decision by the company. By the second run the product was labeled with full name of the ingredient. When the FDA raided AX all of the seized product had the correct nomenclature. Also at that time the majority of product in commerce had the correct nomenclature. There were rumors that this was a switch that was made because it had been "discovered". However anyone who knows anything about production and manufacturing would realize this is an impossibility. It takes months to have packaging created, printed, and product manufactured (typically 2 months). In reality we realized this was a bad decision months before any "drama" hit the boards and started making the appropriate changes. When the drama hit the boards it was the same time as the Bb.com raids and we were advised not to talk about anything due to the investigation. We were advised not to talk about anything Superdrol, Hyperdrol, or Slim Xtreme and get away from the boards. The timing could not have been any worse and it allowed the rumor mill to go crazy. At the same time we could not really be angry as we brought the problem on ourselves.
Facts about Slim Xtreme:
1. It is not related to Adderall and it is not an analog of any prescription drugs. I still see company representatives still spreading this information (iForce). If this were the case it would have been a DEA issue. Part of this investigation included having to have a very expensive third party research firm verify this information for the FDA. The outcome as I stated above was that the proline analog was in fact a proline analog and it was not related to any illegal or prescription drug and was not an analog of any drug. It was a designer stimulant that was not DSHEA complaint. Just like all of the "PH's". They are designer steroids that are not complaint, they are considered illegal drugs by the FDA.
2. To this date there have been no serious adverse events filed for Slim Xtreme. The same cannot be said for many commonly used ingredients like DMAA (1,3 Dymethyl).
3. Not labeling the compound correctly on the first run was a very big mistake and a huge lesson learned. This was in an attempt to protect what was believed to be a competitive advantage of a novel ingredient against other supplement companies, in an industry where it is difficult to protect one’s discoveries and work.
Still to this day many companies small and large are using this same tactic of vaguely labeling novel ingredients. I am not going to name them here but everyone will hear about them soon enough. A classic example is DMAA. When it was first released it was simply called "a constituent of germanium". There was nothing about what the ingredient actually was. Consumers had no idea what they were ingesting. When the hammer does come down on DMAA it will also be considered a "designer stimulant and drug". In all honesty this was the example that led to the "proline analog" name. We were simply trying to protect what we thought was a very novel discovery at the time. In the end that did not matter as it was not DSHEA compliant. Or iForce labeling the active ingredient in Protodrol as "Protodrol". No one that found and purchased the product had a clue what they were ingesting if they were not on the boards. That is just as vague as SX. You can look across some of the more popular brands on the boards today and see XXX Extract for YYYY content. In reality most of these are synthetic substances with the real active not being listed in order to protect their invention. (see post #3 in this thread)
I know during this ordeal that AX lost a lot of trust from consumers. I can only hope that they can regain this trust by the realigned values and principles that have been put in place. As a result of lessons learned through this situation, AX has instituted, and will continue to incorporate the following corrective actions in the future:
1: AX is fully committed to support DSHEA regulations and will subject every novel ingredient to the costly, yet important process, of verification with a reputable regulatory compliance team, even if that ingredient is being used by other supplement companies.
2: AX has been working with the Banned Substance Control Group (BSCG) for over two years. BSCG is commissioned to test every batch of every AX product for banned substances before it ships to retail locations. This is the highest level of testing possible in the industry. It ensures every product in every batch is free of contaminants and banned substances. They test at the nano-gram level.
3: AX is committed to complete labeling transparency for each and every product. Every ingredient will be listed by it's most commonly known name. The company believes that its future competitiveness will be achieved through a combination of introducing new safe, effective, and innovative products that adhere to a new set of principles that will instill trust in AX’s products and brand.
AX regrets and accepts full responsibility for these actions. We hope will instill trust in our customers and create leadership in the industry.
Let me restate one main point. AX made a huge mistake by not using the full nomenclature with SX. They have paid dearly for this strategy that many companies have and still use today. I am confident however that no company has a higher level of quality control procedures or more talented formulation team (PHD+) post 2009. Now it is time for AX to regain the trust of consumers.
- 11-12-2011, 03:20 AM
Here is a fun fact that everyone will be hearing about soon enough. I was the president of AX. As of this Wednesday my ties are completely cut. I had decided to move in a different direction three years ago by selling my shares. However this could not fully happen until the investigation was over. This decision was not because I didn't love AX it was simply because I had a passion for what I have always done (design and programming management). I wanted to get back to what I love doing full time. I found two great partners and started a firm that still does the design work for several companies in the industry including AX.
During the last three years I began writing a book on the supplement industry with the help of several industry folk. Now that the investigation is over I can finish the final chapter with the writer and publish the book. It has gone though various legal vetting processes over the last year. I have worked out a deal with the publisher to offer the book for free (digital format) for the first month.
From 2005 - 2011 I documented everything. The other unnamed participants in the book did as well. It covers my successes, mistakes and fumbles, and lessons learned. More intriguing and eye opening will be the 8 chapters that cover everything else. Detailed third party lab tests that brands had no idea were happening, internal emails they never wanted anyone to see, spiking, mislabeling, fairy dusting, etc. Companies forming together privately to harm and spread information about competitors and using forum members to do the spreading to keep their hands clean. Companies exposed that were using shill accounts online to defame and cause general mistrust in brands. And not just brands but private label co-packers, Chinese suppliers, etc. And much more. All I can say is that this book will change the way people think about many popular brands (especially on the boards) and characters in the industry. Everything in this book is factual and has been vetted by a legal team. Myself and the other individuals that helped have spent several hundred thousand dollars over the course of three years to bring this out (nanogram level testing, PHD's for analytics and reverse engineering, IT specialists for legal and digital media verification and forum shill account discovery, etc). After the book hits there will be shifts in popularity with brands, recalls, regulatory actions, lawsuits, finger pointing, excuses, and a myriad of other domino effects. I've been biting my tongue for several years now. Being pleasant to people I know just days ago were backstabbing me. Finally it is almost time to clear the air in a way that no one has ever done before (in this industry).
There was one person that I became friends with during this process. We would speak weekly on the phone. His name on the forums was Placebro and he was murdered a few weeks ago. He was a great kid that will be missed. He will have a dedication in the book as he was passionate about what it represents.
EDIT: AX nor it's owners (besides me) had any involvement in this book. Until today they had no idea it was written. This was a personal project with the help of financial and intellectual contributors; most of whom are outside the smaller sport nutrition segment of the dietary supplement industry.
11-12-2011, 03:42 AM
that was a good read. thanks. new to the boards, and heard about placebro nice to see he reached many people, from CA to NY. dude seemed amazing.
11-12-2011, 03:43 AM
Old stuff. The wheels of the legal system is turning slow.
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My advice is exclusively my own and may not correspond with the views of SNS
Questions or concerns? → conny[@]seriousnutritionsolutions.com
11-12-2011, 03:51 AM
iForce Nutrition Online Representative Manager
iTrain. iCompete. iDominate…iForce!
11-12-2011, 03:56 AM
If that is not true I will give you the benefit of the doubt and remove that remark and this post. But come on....
The press release was going up Monday on the boards anyways. No one was trying to hide this as you can note the date of the AX press release sent to every media agency was November 9th. http://www.prweb.com/releases/2011/11/prweb8946456.htm
11-12-2011, 04:04 AM
Ω Omega Sports Representative Ω
The Omega Vision Ω Honor. Integrity. Trust.
11-12-2011, 04:04 AM
11-12-2011, 04:20 AM
11-12-2011, 05:30 AM
Yup subbed. Big trees fall hard. U mentioned someone was murdered, I'm deeply sorry.. Any relation to this u think?
"no failure is final, nor is any success"
Follow my 2014 training and supps!
11-12-2011, 05:38 AM
11-12-2011, 05:52 AM
God I hope it wasnt related... That would be one sad world if it came down to that already..
11-12-2011, 06:01 AM
11-12-2011, 06:38 AM
Pretty sure AX isn't the only company that went through legal problems...doesn't seem fair to pick on one single company when there were a bunch of companies with similar problems. One specifically comes to mind thanks to the OP.
DIETARY SUPPLEMENTS MANUFACTURER SENTENCEDFOR IMMEDIATE RELEASE
May 05, 2011
Tribravus Enterprises, LLC, dba IForce Nutrition, was sentenced today in federal court in Boise for causing purported dietary supplements to be unlawfully manufactured and distributed in interstate commerce, U.S. Attorney Wendy J. Olson announced. Chief U.S. District Judge B. Lynn Winmill sentenced Tribravus to three years probation; a $125,000 fine, payable in installments, and a $400 special assessment. As conditions of probation, the court ordered future financial disclosures and a monitoring and testing protocol that includes testing of all products distributed by Tribravus / IForce for banned steroids.
According to the plea agreement, Tribravus / IForce distributed the products “17aPheraFLEX,” “Dymethazine” and “Methadrol” as dietary supplements. The FDA found that these products contained synthetic steroids, known as “DMT” or “Madol” and “Superdrol.” Thus they were not dietary supplements but rather unapproved drugs under the Food, Drug and Cosmetic Act. Tribravus Enterprises agreed to pay the $125,000 fine and implement a testing protocol for its products to ensure future products sold as dietary supplements do not contain synthetic steroids.
Tribravus Enterprises is organized in Arizona and does business as IForce Nutrition in Vista, California. The charges were brought in federal court in Idaho because Tribravus delivered its products to a retail company located in Idaho for further distribution throughout the United States.
The case was investigated by the Food and Drug Administration, Office of Criminal Investigations.
http://steroidreport.com/2011/01/25/...investigation/ (this link actually has three more links related to this at the bottom of the article)
http://www.anthonyroberts.info/2011/...pay-125k-fine/ (even though Anthony Roberts is a DOUCHE)
Many many more articles about this with a simple google search.
My point in this response is not to make a dig at iForce, as I use some of their products and have had great results, but to simply remind some people that when you point a finger at someone else, there are 3 pointing back at you.
Just because you represent a company on here doesn't mean all other companies suck. It seems as if pride blinds some people all too much.
I doubt the OP uses only iForce products just because he is a company rep. I can almost guarantee he's even used an AX supp in the past.
When newly joining a company as a rep I think it is important to do some background research on said company before jumping out with bold posts like this. In doing so, you will have a much better knowledge of the "PAST" of said company as well as the hindsight to know that a post like the OP's can tarnish one's reputation on the boards.
Throwing other companies under the bus (or attempting to) doesn't look good on a resume.
And BigSmith, very sorry to hear about your friend. It is a shame.
11-12-2011, 06:39 AM
Awful..Originally Posted by BigSmith
As an avid supplement n training enthusiast, I am very interested in the book.. I'm 23.. Been "hooked" since 17.. Started slow, n now have tried it all. My family n gf always tell me "you never know what sh!t they put in there"... I want to believe there's no reason for these companies to harm us, but it is all about money, everything.on.earth. Starts n ends w the almighty $ (sad truth) so hopefully I'm not swallowing tons of garbage n "snake oils" ... Hopefully your book addresses this..
"no failure is final, nor is any success"
Follow my 2014 training and supps!
11-12-2011, 07:10 AM
11-12-2011, 07:26 AM
That and the fact that there's always some greedy Bastards out for money and will do anything to get someone sued.Originally Posted by mattrag
11-12-2011, 10:38 AM
Sorry to hear about your dear friend. Very interested in the book info...
11-12-2011, 11:23 AM
A lot of people speak of Placebro...
I heard of him on the bb dot com boards and now here...
Anyhow interesting read on the topics at hand.
11-12-2011, 12:52 PM
One thing I disclose in the book are my personal finances all certified by a well known accounting firm. Hyperdrol Slim Xtreme, any of the products. No owners took a dime out of the company other than a modest salary of about $5,000 a month (besides the company paying the tax abilities). Many of the employees made much more than the owners at AX. Which is a good thing since employees are what can make a company great.
I hear rumors online talking about me buying expensive cars and all kinds of stuff. Never happened and I always laugh when I hear these things. I had done well before AX and it was not about trying to cash out for a quick buck.
11-12-2011, 06:15 PM
11-12-2011, 06:19 PM
11-14-2011, 01:22 AM
BigSmith.. looking forward to your book. I always respected you and am interested in hearing what you have to say. I truly feel for the all the companies and individuals who have and will get caught up in this. I am a bodybuilder, I love supplements in generally, not any specific brand of supplements, all supplements. I respect all companies who provide us with products to better our physiques. You will never see me bad mouthing another company, and will have a very hard time finding a previous post I made talking bad about another company; I say hard time, because I don't remember what I said 6+ years ago when I was a teenager.
Wish the best for everyone here.
11-14-2011, 01:31 AM
11-14-2011, 04:18 AM
Well putOriginally Posted by criticalbench
11-14-2011, 02:26 PM
11-14-2011, 06:21 PM
11-18-2011, 07:49 AM
PS - fwiw, I will be buying your book. Screw the freeness. Better yet, I will be READING it. I have NOT read a single book since 1999... Kudos, Kev.
-RecoverBro Zombie Specialist and Paracord Wrangler
-Independent due to lies that hurt my family. Loyal to myself and my Bro's.
11-18-2011, 08:41 AM
11-18-2011, 08:42 AM
As will I.Originally Posted by FL3X MAGNUM
11-18-2011, 09:43 AM
11-18-2011, 09:49 AM
It is not, so much, underhanded companies, but rather an FDA that seems out of control IMO.
Evolutionary Muse - Inspire to Evolve
05-04-2012, 04:20 PM
Update on the E-book?
Serious Nutrition Solution ~~
mw at seriousnutritionsolutions dot com
Cycle Assist $23.50 shipped http://anabolicminds.com/forum/suppl...edge-labs.html
05-04-2012, 04:27 PM
05-04-2012, 05:15 PM
No offense, but 2-diphenylmethylpyrrolidine is hardly an analogue of proline.
It is, however, very similar to pipradrol:
(bottom left is the stuff in SX.. top right is Schedule IV controlled substance Pipradrol)
If pipradrol was Schedule I/II instead of Schedule IV, you bet your ass the DEA would have come after it. But since it wasn't, the Federal Analogue Act didn't apply. But pipradrol was mostly withdrawn from the market due to its abuse potential, and desoxypipradrol is a known designer stimulant that seems to cause extreme insomnia and eventually psychosis due to his very long half life. Due to the chemical similarity, it was highly irresponsible for AX to bring SX to market knowing what related substances do.
05-04-2012, 06:09 PM
At the exact places that you buy standards for the material it is cataloged as "proline analog" or "analogs of proline", secondly the firm that did the research for analog act concurred and understood why it would be cataloged as a "proline analog". Several catalogs it is referenced this way. This is what led to the extremely bad choice. The choice was made to label it a "proline analog" not to be dubious but to protect the "discovery" for a while. Every time something innovative had been launched another company would clone it, drop the price, and take market share. Again, it was a bad choice that would never be repeated.
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I am not arguing about the choice (3 years old). This was my mistake and choice and the price has been paid. I can say this, to this day there has not been any serious adverse events reported on SX. There are (say pre-workouts) on the market today that are very popular, and are using designer stims that I can show have much more negative toxicology when compared, and they won't talk about it. In fact this is the exact data I am waiting on. But people have no problem with that I guess.
EDIT: for complete disclosure since I can talk about it.
2mg was the dosage and you really did not feel it by itself unless combined with caffeine. For me that was interesting. You could really feel it by itself at a dosage of 7-15mg, but 2mg + 150mg of caff if felt good and was the dosage for those two ingredients in the formula. The 5HTP was also very important.
Labeling aside, I personally feel that methyl designer steroids were probably a more irresponsible choice across the industry as I have personally seen injury result from them.
05-04-2012, 08:01 PM
And yes, what you linked to is the same structure as the bottom left in the picture in my post.
Search for the effects of something like desoxypipradrol (the bottom right substance) on bluelight or some similar site:
Desoxypipradrol is the same thing as the designer stimulant in SX but with a piperidine instead of a pyrrolidine ring and should have similar effects.
Don't underestimate the potency of the stuff that was in SX. I think AX got lucky by being found out before it became a widespread drug of abuse.
05-04-2012, 08:31 PM
It would still be hard to convince me on my opinion. Hundreds of thousands of doses sold and no severe adverse events, but take a product like Superdrol that had significantly less doses sold (probably 1/16th) that had many adverse events reported, some very serious. I do agree that if it were on the market longer there would be some. But dose to dose I think the methyls would heavily win.
If I were entering the industry again with a new company it would be very different.
05-05-2012, 02:19 AM
very interesting and informative read
I'm surprised no research chem places have tried selling the proline analogue