Help - Search - Members - Calendar
Full Version: Feds Raid LG Sciences
Mind and Muscle Forums > Supplements > Supplements 101
rpen22
FDA News
FOR IMMEDIATE RELEASE
April 4, 2007

Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
Products alleged to be adulterated under the Federal Food, Drug, and Cosmetic Act


At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.

The dietary supplements seized were marketed and distributed on-line and in retail stores under the names "Methyl 1-D," "Methyl 1-D XL," and "Formadrol Extreme XL."

The seized products previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury.

"The FDA takes seriously its responsibility to protect Americans from unsafe dietary supplements," said Margaret Glavin, FDA's Associate Commissioner of the Office of Regulatory Affairs. "Wednesday's action shows FDA's commitment to protecting consumers from potentially harmful products."

"Working with the FDA, we are taking prompt civil action to protect the public health by seizing these illegal products and forestalling their shipment into the stream of commerce in any manner that could create harm to the public," said U.S. Attorney Stephen J. Murphy. "I commend the professionalism and swift action of the FDA investigators who discovered and investigated this serious problem, and I am glad our lawyers could provide the legal muscle needed to support the seizure."

FDA has not received scientific information on the safety of the seized products and cannot determine, at this time, whether they represent a hazard to consumers. Therefore, consumers who still have the products should strongly consider discussing the use of these products with their health care professionals. FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products' use. Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.FDA.gov/medwatch/report.htm.

On March 2006, the FDA warned Legal Gear (the predecessor of LG Sciences) to cease distribution of a different product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01815.html
rpen22
And no, I don't know why it says 2007 on the FDA site; this is on their home page at the top of News & Events, though.
rpen22
QUOTE (legalgear)
Oddly enough the ingredients they had issue with were 6OXO-androdione and ATD. We have an official response and will submit our DSHEA compliance information on Monday to the FDA. They try their best to be on top of everything but DSHEA is a tough law to understand and is very subjective. I am confident we will have this matter cleared up quickly.


QUOTE (legalgear)
You guys need to dispense with all of the conspiracy theories. This is just a misunderstanding and should be cleared up soon. We have complete DSHEA compliance information and it will get handled on monday. The FDA have always been pleasant and professional with us. The complaint sites 6OXO and ATD specifically and both of those are DSHEA compliant.


http://forum.bodybuilding.com/showthread.p...8251&page=2
eclypz
so what happens when the fed's realize they made a mistake? Do they just hand over the million dollars worth of product and say "my bad"?

I just don't understand how the FDA would mobilize a team of people and spend an entire afternoon hauling away a bunch of stuff and making a real scene simply because someone forgot to tell them that 6oxo and atd are perfectly fine.

Benson
QUOTE (eclypz @ Apr 5 2008, 10:18 AM) *
I just don't understand how the FDA would mobilize a team of people and spend an entire afternoon hauling away a bunch of stuff and making a real scene simply because someone forgot to tell them that 6oxo and atd are perfectly fine.


Because the MO for federal enforcement agencies like the FDA is to swoop in, seize stuff, make a big splash and the issue a press release. After the dust settles, you end up with some small fines and big legal bills but this never makes the paper. Keeps people thinking they are doing their job.
eclypz
QUOTE (Benson @ Apr 5 2008, 07:32 AM) *
Because the MO for federal enforcement agencies like the FDA is to swoop in, seize stuff, make a big splash and the issue a press release. After the dust settles, you end up with some small fines and big legal bills but this never makes the paper. Keeps people thinking they are doing their job.


gotcha...
xGringox
QUOTE (Benson @ Apr 5 2008, 10:32 AM) *
Because the MO for federal enforcement agencies like the FDA is to swoop in, seize stuff, make a big splash and the issue a press release. After the dust settles, you end up with some small fines and big legal bills but this never makes the paper. Keeps people thinking they are doing their job.


This holds true for almost all federal employment, regardless of the agency/department.
eclypz
QUOTE (xGringox @ Apr 5 2008, 08:17 AM) *
This holds true for almost all federal employment, regardless of the agency/department.


Except that when the FBI busts down your door and takes everything into evidence, even if they figure out you've done nothing wrong your life will never be the same. With the bigger companies it seems like the FDA makes this big scene and then the next day it's business as usual.
CustomNW
And people ask why we dont carry much grey area shit
rpen22
LG Sciences Public Response
QUOTE
In response to recent action taken by the FDA, LG Sciences wishes to clarify that we believe that all of its products are completely legal and safe. The FDA's detainment is merely a preliminary step in determining compliance with food regulations. LG Sciences wishes to specifically note that no court has made any determination as to the correctness of FDA's allegations. Although LG Sciences feels that the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public. Although we disagree with the situation, LG Sciences will cooperate with the FDA in resolving this matter.

Unfortunately, the Dietary Supplement Health Education Act (DSHEA) of 1994 is ambiguous and unclear in determining what substances are considered new dietary ingredients (NDI). An NDI requires data be submitted to the FDA regarding safety for human consumption prior to its introduction into the market. Due to a lack of a definitive list of approved dietary ingredients, the FDA mistakenly asserts that the products seized contain substances that are either not dietary ingredients, as defined in the Federal Food, Drug, and Cosmetic Act or that the substances are NDI. However, the substances are not NDI because these ingredients are naturally occurring, with confirmed studies over 25 years ago, and have been on the market in competitors products for several years. Thus, the ingredients have empirically been shown to be safe to consumers.

Items deemed unapproved food additives by the FDA 1,4,6 etiocholan-dione or commonly known as ATD or 1,4,6 Androstatriene3,17-dione. Additionally items alleged to require a new dietary ingredient status 4-etioallocholen-3,6,17-trione or better known by the trade name 6-OXO-4-androstenedione. LG Sciences looks forward to assisting the FDA in clarifying this matter and the prompt return of its inventory.

http://anabolicminds.com/forum/supplements...tml#post1290168
ScottL
QUOTE (eclypz @ Apr 5 2008, 12:21 PM) *
Except that when the FBI busts down your door and takes everything into evidence, even if they figure out you've done nothing wrong your life will never be the same. With the bigger companies it seems like the FDA makes this big scene and then the next day it's business as usual.



Don't know it if was FDA or who, but they did this to a well known alternative doc Jonathan V. Wright, M.D. who practices in the seattle area. Apparently it was carried out swat style and they confiscated $$$ supps (his has a large practice).
xGringox
QUOTE (eclypz @ Apr 5 2008, 12:21 PM) *
Except that when the FBI busts down your door and takes everything into evidence, even if they figure out you've done nothing wrong your life will never be the same. With the bigger companies it seems like the FDA makes this big scene and then the next day it's business as usual.


My post was in reference to federal employees choosing to appear like they are performing their jobs, rather than actually doing them. Not the consequences of their tactics.
Tkarrde
Any updates here?
rpen22
Not really.
-People started calling each other snitches in the BB.com version of this thread
-LG wanted PA/Rich Gaspari to share their facts on 6-OXO and ATD's DSHEA compliance
-PA refused because LG doesn't purchase theirs from him so it's not his problem(and LG didn't contribute anything to the USFA back in the day)
-Lots of insults, most of which were quite comical
-PA, Deserusan, and a few others ended up banned
-Thread got deleted
-Not much from LG has been said since the initial public response.

Various Quotes(not in order or from same thread):
QUOTE (carcinogen)
I have a lot to say - but, yet, nothing to say.


Well, ok, just this one thing...

The common denominator with all three of these products is ATD. That is how I see it. They didnt license 6-oxo from us; so, this doesnt directly involve us. Plain and simple.

QUOTE (legalgear)
That post on bb.com was horrific. Pat Arnold is such a foul horrible human being. It's sad to see someone with so much potential be so bitter and petty.

Anyway, we are working feverishly to get things resolved.

Oh, and for all you conspiracy theorists. M1T and the rest had ZERO to do with this. Our M1P fiasco was spawned out of Balco. Balco is why the Anabolic Control Act of 2004 was passed and Balco is why Amy Shippley wrote that completely false article about us trying to cheat the Olympics. Look at my email and phone records...I don't even know ONE person in the Olympics. We were young and inexperienced at the time though... This whole thing is because we got an investigator that wanted to make a name for herself...nothing more. She didn't even ask us for compliance information which we could have provided. If you want to help, let me know! We need to keep our supplements free. However, if we want to use a new ingredient that is in question, I am forced to now go to the FDA for clearance to avoid these issues going forward.

QUOTE (3clipseGT(LG rep))
We are taking the atd out of M1D and you will still be able to get it. This also goes for the formadrol.
Mr.Kite
QUOTE (rpen22 @ Apr 8 2008, 05:58 PM) *
Not really.
-People started calling each other snitches in the BB.com version of this thread
-LG wanted PA/Rich Gaspari to share their facts on 6-OXO and ATD's DSHEA compliance
-PA refused because LG doesn't purchase theirs from him so it's not his problem(and LG didn't contribute anything to the USFA back in the day)
-Lots of insults, most of which were quite comical
-PA, Deserusan, and a few others ended up banned
-Thread got deleted
-Not much from LG has been said since the initial public response.

Various Quotes(not in order or from same thread):

Wow. BB.com is hella ban happy. That place is continually going down hill with all their bans (among other things).
rpen22
QUOTE (legalgear)
The FDA has a tough job, for sure but mishandling sports supplements because of some stupid baseball players is the problem. We have complete DSHEA compliance information for ATD and 6-OXO™ yet no one ever asked us for that information from the FDA. Holding supplements from one company when the products have been on the market for over 6 years is another problem.

We cooperate with the FDA in every case. Has anyone ever read DSHEA? You couldn't get a more vague and hard to inforce/follow law. Makes me wonder who drafted it anyway? We are decent, honest business people and we will move forward. We can replace ATD with Androsterone and it will be fine. Androsterone would be better in some cases, but ATD is a good, strong, safe and DSHEA legal AI and will be missed if they don't return our goods.
And FYI...I love the US, but I may leave it. Things are just going to get worse here until we go to complete socialism.


http://anabolicminds.com/forum/supplements...tml#post1296893
Dopamine
A lot of supplements being sold are not DSHEA compliant, but the law is broad and gives the FDA discretion as to who to prosecute and when.

If a product had not been marketed and sold as a dietary supplement prior to 1994, it is considered a "new ingredient" and requires submission of New Dietary Safety Information to the FDA for review at least 75 days prior to be introduced into the market (21 U.S.C 321). You can view most of the safety information submitted on the FDA website, though most detailed content is omitted due to copyright/trade secret concerns. The onus is on the seller of a potential "new ingredient" to show under the statutory requirements that 1. the product is in fact a "dietary supplement" and 2. that the product is safe for human consumption. When new ingredients are discovered and sold, the legal requirements of DSHEA compliance are often overlooked due to lack of enforcement.
Proton Soup
i find it amusing that this came out on the same day as the greek doping scandal
This is a "lo-fi" version of our main content. To view the full version with more information, formatting and images, please click here.
Invision Power Board © 2001-2008 Invision Power Services, Inc.