XP2G Legal Ephedra?
September 22, 2008
Since 2004, the FDA has prohibited the sale of supplements containing ephedrine alkaloids - the chemicals derived from the ephedra plant. Supplements containing those ingredients "supposedly" pose a health risk (according to the FDA). But champion bodybuilder Aaron Garza , who runs Pump Nutrition and a gym called Pump 24 Hour Training Mecca gym , said he isn’t breaking any laws by selling his own brand of Ephedra supplements due to its unique formula. The product, called XP2G , lists Ma Huang and Sida Cordifolia as ingredients (both of which normally contain the banned ephedrine alkaloids). Garza said because XP2G contain a special type of Ephedra that does not contain the banned alkaloids and thus it does not present the same risk of side effects as traditional ephedra products. He feels that it does not fall in any violation of the bans.
"What these people have done is realized there’s a few plant species in the ephedra family that don’t contain any of those 6 banned chemicals … Technically, they can still call it ephedra, because they’ve sidestepped that ephedra alkaloid prohibition." - Karen Tannert, Chief Pharmacist with the Texas Department of State Health Services .
It’s still a difficult area for regulators, since the only way to verify claims like Garza’s is through laboratory testing of the supplements in question. However, the newspaper I got this article from talked to a Gynocologist named Dr. Fermin Barrueto who was happy to comment on an area he had little qualifications to comment on.
The Vagina Doctor said that "legal ephedra is only a marketing gimmick " and that "the only way to remove banned chemicals from ephedra is through a complicated extraction process that manufacturers are unlikely to perform. "
I agree that it is a "marketing gimmick" Dr. Barrueto but to say that manufacturers are unlikely to perform the extraction process on Ephedra is complete bullshit. Supplement manufacturers will do almost anything to an herb if you’re willing to pay for it.
Hi-Tech Pharmaceuticals also makes a fat burner called Lipodrene that uses the same form of Ephedra as XP2G and manufacturers the product themselves. I would not be surprised if Hi-Tech was the company that manufactured XP2G for Pump Nutrition.
SOURCE: The Monitor
Hi Tech Pharmaceuticals Employees Admit Importing and Distributing Drugs
August 26, 2008
If you aren’t familiar with the “Hi-Tech Pharmaceuticals” case or haven’t been reading the Supplement Genius blog, click HERE first, then read the following:
Employees once working at Georgia-based supplement company “Hi Tech Pharmaceuticals ” makers of the very popular Fastin , Lipodrene , and Stamina Rx supplements, have now gone to trial and things aren’t looking good for these dudes! The company itself, as well as Jared Wheat, Stephen Smith, Tomasz Holda, and Sergio Oliveira all pleaded guilty to conspire to import and distribute adulterated, mislabeled and unapproved new drugs, and to commit mail and wire fraud. If you’ve been around the bodybuilding industry 
for a while you may recognize Sergio Oliveira as the former owner of BODY International magazine and a guy that’s pushed the supposed “health” benefits GHB, GBL, and other GHB precursors to unsuspecting bodybuilders for years.
United States Attorney David E. Nahmias said of the pleas,
“These defendants set up an offshore manufacturing facility where, in unsanitary conditions, they reproduced leading pharmaceutical products for importation into the United States, all without FDA approval or licensing from the rightful patent holders. Their motive in flouting the law, violating patents and exposing their customers to unknown health risks was greed, pure and simple. I commend the FDA and the DEA for their thorough investigation in this case. The Department of Justice and these agencies will continue to work hard to protect American consumers from such fraudsters.”
FDA Office of Criminal Investigations Special Agent In Charge David Bourne said,
“As in this conviction, the FDA’s Office of Criminal Investigations actively pursues those who deceive the public by manufacturing and selling unapproved and unregulated medications which may pose risks to the health of consumers. We are committed to investigating and preventing those who use trickery and deceit to illegally and unscrupulously sell medications over the internet at the expense of the public health.”
According to Nahmias and the information presented in court: The defendants in this case established a manufacturing facility in a small park in rural Belize. Inside what was essentially a four-room home, the defendants produced unauthorized generic versions of such popular prescription pharmaceuticals as Xanax, Valium , Ambien , Vioxx , Zoloft , Viagra , and Cialis . The manufacturing processes complied with none of the sanitary, hygienic, or quality-control regulations issued by the FDA, nor had the defendants obtained approval from the FDA or licenses from the patent-holders to make such drugs. Nonetheless, the defendants made the drugs and marketed them, primarily via the internet, to customers in the United States and elsewhere. The drugs were made available without prescription and also without disclosure of the unsanitary manufacturing conditions. The defendants realized millions of dollars of sales before the scheme was initially disrupted by Belizean authorities and ultimately ended by U.S. authorities.
United States District Court Judge Jack T. Camp accepted today’s guilty pleas in federal court in Newnan. All defendants pleaded to conspiring to violate federal prohibitions against mail and wire fraud and the importation and distribution of adulterated, unapproved, and mislabeled drugs. This conspiracy offense carries a maximum penalty of five years in prison and a maximum fine of $250,000 . The company itself will face a maximum of five years on probation and a fine of the greater of $500,000 or double the fraud amount. Sentencing for the defendants is now set for October 21, 2008. In determining the actual sentence, the Court will consider the United States Sentencing Guidelines.
SOURCE: NPI Center