BB.com Is Conducting a Voluntary Nationwide Recall of 65 Dietary Supplements

FYI for those who take PH/DS products; specifically those who may participate in sports where drug testing is performed.

The article states that there is not conclusive proof that these products actually contain any type of steroids, but that there is just concern that their labels may not match the contents.

Most of them are smaller companies who only produce PH/DS products.



Bodybuilding.com Is Conducting a Voluntary Nationwide and International Recall of 65 Dietary Supplements That May Contain Steroids

http://www.fda.gov/Safety/Recalls/ucm188929.htm

Company Contact:
1-866-236-8417
service@bodybuilding.com

FOR IMMEDIATE RELEASE - Boise, ID - November 3, 2009 – As part of its ongoing cooperation with the Food and Drug Administration ("FDA"), Bodybuilding.com, LLC (the “Company") announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products (the "Recalled Products") described on the attached list, that were sold through the Company's website.

The FDA has informed the Company that it believes that the Recalled Products contain ingredients that are steroids. Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." While the Company has not had an opportunity to independently confirm the FDA's concerns that the Recalled Products in fact contain these ingredients, the Company is undertaking this voluntary recall in an abundance of caution.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

The Company has not received to date any reports of adverse events in connection with the Recalled Products. Because of the possible harmful effects of using products containing steroids, the Company is cooperating with the FDA to conduct a recall of the products the FDA has identified as containing steroids. Prior to agreeing to carry the Recalled Products, the Company received assurances from all of the manufacturers of the Recalled Products that these products were properly classified as dietary supplements in compliance with federal law, meaning that these products did not contain any unlawful ingredient. Customers who have any of the Recalled Products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.

Any adverse events that may be related to the use of the Recalled Products should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postagepaid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA- 0178].

The Company is committed to providing accurate information about its products. The Company is working voluntarily with the FDA in this recall process.

Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-866-236-8417) or e-mail (service@bodybuilding.com) the Company.

RECALLED PRODUCT LIST

• 4Ever Fit D-Drol
• Advanced Muscle Science Dienedrone
• Advanced Muscle Science Liquidrone UTT
• Anabolic Xtreme Hyperdrol X2
• APS (aka Advanced Muscle Science) Mastavol
• APS (aka Advanced Muscle Science) Revamp
• APS (aka Advanced Muscle Science) Ultra Mass Stack
• APS (aka Advanced Muscle Science) Ripped Stack
• Better Body Sports Finadex
• Black China Labs Straight Drol
• Black China Labs Straight Phlexed
• Body Conditioning Solutions TestraFLEX
• Bjorklund Methyldrostanolone
• BOSC Enterprises Epi-Tren
• BOSC Enterprises Magna Drol
• Chaparral Labs Epivol
• Chaparral Labs Pheravol-V
• Competitive Edge Labs M-Drol
• Competitive Edge Labs P-Plex
• Competitive Edge Labs X-tren
• Diabolic Labs Epio-Plex
• Diabolic Labs Finabolic 50
• Diabolic Labs Revenge
• Ergopharm 6-OXO
• Ergopharm 6-OXO Extreme
• EST (aka Engineered Sports Technology) MethAnstance
• Extreme Labs Susto-Test Depot
• Fizogen ON Cycle II Hardcore
• G.E.T/ (Genetic Edge Technologies) SUS-500
• G.E.T/ (Genetic Edge Technologies) Tren-250
• Hardcore Formulations T-Roid
• I Force Nutrition 1,4 AD Bold 200
• I Force Dymethazine/Reversitol Combo Pack
• I Force Reversitol
• I Force Nutrition 17a PheraFLEX
• I Force Nutrition Dymethazine
• I Force Nutrition Methadrol
• IDS (aka Innovative Delivery Systems) Bromodrol
• IDS (aka Innovative Delivery Systems) Grow Tabs TR
• IDS (aka Innovative Delivery Systems) Mass Tabs
• IDS (aka Innovative Delivery Systems) Oxodrol Pro
• IDS (aka Innovative Delivery Systems) Ripped Tabs TR
• IDS (aka Innovative Delivery Systems) Rapid Release
• Ripped Tabs
• Kilo Sports Massdrol
• Kilo Sports Phera-Mass
• Kilo Sports Trenadrol
• Monster Caps Monster Caps
• Myogenix Spawn
• Nutra Coastal D-Stianozol
• Nutra Coastal H-Drol
• Nutra Coastal MDIT
• Nutra Coastal S-Drol
• Nutra Coastal Trena
• Performance Anabolics Methastadrol
• Performance Anabolics Tri-Methyl X
• Purus Labs E-pol Inslinsified
• Purus Labs Nasty Mass
• Rage RV2
• Rage RV3
• Rage RV4
• Rage RV5
• Redefine Nutrition Finaflex 550-XD
• Redefine Nutrition Finaflex Ripped
• Transform Supplements Forged Extreme Mass
• Transform Supplements Forged Lean Mass

Wow, the APS products have even been taken off their own website at apsnutrition.

For those that don't know this has been in the works for a while, here is an article that gives some insight.

Tren Xtreme Steroid Investigation Leads to Raids of American Cellular Labs and Max Muscle

July 25, 2009 by Millard Baker

FDA Special Agent Jeff Novitzky, the agent who has become the face of the federal government witch-hunt against steroid users in professional sports during the BALCO scandal, has move his attention to investigating dietary supplement companies suspected of selling designer anabolic steroids.

Novitzky’s latest steroid investigation targeted two popular products sold and marketed as dietary supplements, “Tren Xtreme” and “Mass Xtreme”. These products were manufactured by American Cellular Labs Inc. (ACL) and sold exclusively through Max Muscle Sports Nutrition (MMSN) stores and via the ACL website (”Two Dietary Supplements Said to Contain Steroids,” July 23).

The exact nature of the business relationship between ACL and MMSN is unclear. Maurice Sandoval, the owner of the Max Muscle San Francisco franchise and the Regional Marketing Director for Max Muscle, was identified as the chief executive of ACL in a government affidavit. Sandoval told the New York Times that he sold ACL in 2008. ACL, Max Muscle San Francisco, and Sandoval’s residence were targets of search warrants executed on July 23, 2009.

The FDA investigation did not involve any steroid contaminants or undisclosed anabolic steroids. Federal investigators specifically targeted the openly listed ingredients in Tren Xtreme and Mass Xtreme commonly referred to as “Tren” and “Madol”, respectively.

“Tren” in “Tren Xtreme” is also known by the following synonyms: “4-estra”, 19-Norandrosta-4,9-diene-3,17-dione and Estra-4,9-diene-3,17-dione.

“Madol” in “Mass Xtreme” is also known by the following synonyms: desoxymethyltestosterone, “DMT” and 17a-Methyl-etioallocholan-2-ene-17b-ol.

The following information from the “Affidavit of Special Agent Jeff Novitzky in Support of Application for Search Warrant” may be of special interest to certain manufacturers, distributors and retailers of similar products in the sports nutrition segment of the dietary supplement industry.

1. FDA Special Agent Jeff Novitzky is fully aware of the existence of MANY similar products and clones produced by SEVERAL additional supplement companies. He has also been involved in other (apparently non-publicized) raids of supplement companies producing similar products.

I am aware that over the last several years, several products labeled as “dietary supplements” containing the substance “Madol” have become available on the market. [...]

There are numerous purported dietary supplements containing “Tren” that are currently available on the market. I have participated in search warrants of companies that have sold purported dietary supplements containing “Tren” and I am familiar with common avenues ofsupply and distribution.

2. Owners of supplement companies producing similar products are cooperating with Special Agent Jeff Novitzky in his steroid investigation targeting the supplement industry.

As stated earlier in the experience section of this affidavit, I have personally been involved in several investigations concerning “dietary supplements” that are actually drugs, including steroids. Specifically, I have participated in the execution of search warrants on companies selling products similar to those offered by ACL. I have reviewed a portion of the evidence collected during these searches, and I have interviewed and developed contacts and informants within the industry, including owners of purported “dietary supplement” companies that have distributed products containing unapproved drugs and “anabolic steroids” identical to those sold by ACL.

3. Jeff Novitzky asserts that “Tren” and “Madol” are legally classified as “anabolic steroids” under his interpretation of federal law.

[b]ased upon the FDA’s FCC findings that ACL’s “Tren Xtreme” and “Mass Xtreme” contained “Tren” and “Madol,” respectively, and upon the DEA analyses that show that these drugs meet the current definition of an “anabolic steroid” under federal law, I believe that there is .probable cause to believe that the distribution of ACL’s “Tren Xtreme” and “Mass Xtreme” violates the Controlled Substance Act as defined in paragraphs 17 and 18 of this affidavit.

4. The government may be likely to crack down harshly on supplement companies that ignored the DEA’s proposed rule regarding “Madol” and “Tren” over 15 months ago.

I am aware that on April 28, 2008, the Drug Enforcement Adminstration (DEA) listed a proposed rule in the publicly-filed Federal Register entitled “Classification of Three Steroids as Schedule III Anabolic Steroids Under the Controlled Substances Act.” I am also aware that this proposed rule listing is still in a proposed status and has not yet been made final. The proposed rule includes both “Tren” and “Madol” as steroids to be classified as Schedule III Anabolic steroids. The proposed rule summarizes DEA studies that both “Madol” and “Tren” are chemically and pharmacologically related to testosterone and are not estrogens, progestins, corticosteroids, or dehydroepiandrosterone.

5. Jeff Novitzky’s assertion that “Madol” and “Tren” are legally classified as Schedule III Controlled Substances (anabolic steroids) is based upon (a) the testimony of FDA pharmacologist James Tolliver and (b) the April 28, 2009 DEA proposed rule published in the Federal Register.

In particular, I have communicated with Dr. James Tolliver, a chemistry expert presently with the FDA but previously employed by the DEA, who perfonned a scientific analysis on these substances while he was with the DEA and found that both “Madol” and “Tren” are chemically and pharmacologically related to testosterone (and also are not estrogens, progestins, corticosteroids, or dehydroepiandrosterone). Based upon Dr. Tolliver’s infonnation and 21 U.S.C. S02(41)(A), there is probable cause that “Madol” and “Tren” are anabolic steroids and are presently illegal.

[...]

I have been informed by an FDA chemistry expert, Dr. James Tolliver, that “Tren” is a synthetic compound as well, due to its double bond between the carbon atoms 9 and 1 0, something that is not found in nature.

[...]

I am aware that over the last several years, several products labeled as “dietary supplements” containing the substance “Madol” have become available on the market. I have been informed by an FDA expert, Dr. James Tolliver, that “Madol” is a synthetic compound not found in nature.

[...]

While the proposed rule proposes to specifically classify and list these chemicals as steroids under Schedule III ofthe CSA based upon the DEA studies that show they meet the criteria for definition of an “anabolic steroid” under the Steroid Control Act of2004, as outlined in paragraph 17 of this affidavit, the proposed rule also indicates that the steroids meet the defmition of “anabolic steroids” under current federal law.

It is important to note that “DMT” and “tren” were NOT legally defined as an “anabolic steroid” under the Anabolic Steroid Control Act of 1990 and 2004. Most supplement industry experts disagree with Jeff Novitzky’s assertion that “tren” or “Madol” can currently be legally classified as a controlled substance (anabolic steroid).

William Llewellyn, author of the authoritative anabolic steroid reference manual “Anabolics“, reported that there is no known source for “tren” in nature but considers is a misbranded drug and not an anabolic steroids.

“Since the designer steroid “tren” is not natural, it is considered a misbranded drug under federal law.”

Patrick Arnold, most recently the chemist at Ergopharm and Proviant Technologies, is critical of Novitzky’s assertion that the products are legally defined as “anabolic steroids.

“Novitzky claim is that “tren” and “madol” should be considered classified as controlled right now, TODAY… That is never gonna stand up.”

Special Agent Jeff Novitzky has a history of asserting that misbranded and unapproved new drugs are “anabolic steroids” when that may not be legally accurate. Novitzky repeatedly referred to tetrahydrogestrinone (THG) as an “anabolic steroid” in interviews and testimony related to the BALCO case. The Controlled Substances Act was amended to included THG much later with the passage of the Anabolic Steroid Control Act of 2004.

I guess some of the tricky marketing schemes have backfired.

It is unlikely that these products contain trenbolone (in any form), but naming them after the popular anabolic created quite a storm.