U.S. Marshalls acting upon authority of the Food and Drug Administration (FDA) seized the following supplements from the LG Sciences warehouse in Brighton, Michigan: Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL The FDA alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act with “one or more unapproved food additives and/or dietary ingredients.” (”FDA seizes $1.3 million in supplements marketed for bodybuilders from Brighton warehouse,” March 4)
The U.S. Attorney’s office released the following statement:
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.
LG Sciences (formerly Legal Gear) is trying to minimize the FDA seizure.
Ronald Berry, an attorney for LG Sciences, said Friday evening that all the company’s products are legal, and the ingredients are safe for consumers. He called the FDA seizure “merely a preliminary step in determining compliance with food regulations.”
“Although LG Sciences feels the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public,” Berry said in a statement.
LG Sciences released the following public statement:
In response to recent action taken by the FDA, LG Sciences wishes to clarify that we contend 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 and will cooperate in every possible way.
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.
Former NFL running back Femi Ayanbadejo has filed a lawsuit against Author L. Rea of ALR Industries. He claims an undisclosed ingredient in ALRI Max LMG caused him to fail an NFL doping test leading to his release by the Arizona Cardinals and Chicago Bears. Ayanbadejo tested positive for a “form of nandrolone.” Ayanbadejo’s attorney is blaming the positive steroid test on the manufacturer for possibly intentionally “spiking” the supplement with banned substances or contamination from the manufacturing facility (”Ex-Aztec sues supplement maker, shop over failed NFL steroid test,” March 11).
“We’re still not sure whether we have a pure cross-contamination matter (from the mixing facility), or we have a company that actually spiked the supplement (intentionally),” said Ayanbadejo’s attorney, Jim Miller.
However, he ignores a third possibility that doesn’t work in his client’s favor - that the ingredient that caused the positive drug test was plainly listed on the label and his client was unaware that the metabolites would result in a positive steroid test. Then this is no longer a case of “undisclosed ingredients” or “contaminated supplements.”
The marketing materials for ALRI Max LMG clearly list the ingredients and similarity to other progestin-based steroids like trenbolone and nandrolone.
The active compound in Max LMG is 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one… It is legal because it is a progestin, and before anyone thinks “birth-control”, remember that trenbolone, nandrolone, methyltrienolone and Methyl-Dien all are also progestins. I doubt anyone will disagree with the effects of these compounds upon favorable body composition.
In addition, the label warned consumers about androgenic side effects.
Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen.
Are supplement companies responsible for ensuring that their supplements are “IOC-friendly”? Or are supplement companies only responsible for complying with legal requirements of DSHEA (which permit certain progestin-based steroidal compounds)?
IFBB Pro Bodybuilder and reigning two-time Mr. Olympia Jay Cutler settled his lawsuit with NDS Nutritional Products. Cutler filed the lawsuit in Los Angeles Superior Court in July 2007 “claiming misappropriation of image and likeness, invasion of privacy and unjust enrichment. ” Basically, NDS took a picture of Jay Cutler competing at a bodybuilding contest and placed it on their products without obtaining permission or paying Cutler for the commercial use of his image (”Bodybuilder Settles LA Lawsuit Against Nutrition Firm,” March 10).
Jay Cutler is sponsored by Muscletech, who pays Jay well for the use of his image in the promotion of Muscletech supplements.
“Customers in the northeast can place orders at 7:00 pm EST and still have their orders processed, out the door, and possibly delivered the next day, depending on their location. We are increasing the amount of people we can reach in one day by more than 60 million, and we’ll have an average transit time throughout northeast of 1-2 days,” explains Bodybuilding.com’s General Operations Manager Josh Brouse.
Liberty Media recently acquired a controlling share of Bodybuilding.com making the Idaho-based company one of the most formiddable supplement retailers on the Internet. Ryan DeLuca, CEO of Bodybuilding.com, plans to continuing increasing the company’s support for the sport of bodybuilding in the future.
Former IFBB Pro bodybuilder Milos Sarcev and Rick Robinette founded Koloseum Nutritional Science (KNS) in 2006. Redux Holdingspurchased 100% of remaining shares in KNS. The acquisition by Redux Holdings has been in the works for some time. The Los Angeles Business Journal explains the role of Redux Holdings and how its holding of Naturade resulted in the acquisition of Koloseum:
Thus was born Redux Holdings Inc., which uses its penny stock to acquire assets of underperforming and distressed companies on a non-cash basis. He then leverages debt financing from investment banks and other sources to pay off creditors and rebuild the company, often employing bits and pieces of other acquisitions.
“Usually what you see in the turnaround market is people with a lot of money who would hire someone else to do the turnaround; it’s a pure financial play for them,” said Michelin, most recently a partner at Santa Monica-based restructuring firm Kibel Green Inc.
“What I wanted to do is combine the capital with the operational expertise of people who know how to turn it around, so in the end we’d have the equity.”
Michelin’s current focus is re-establishing Anaheim-based Naturade Inc., a venerable Orange County nutritional supplement maker that fell on hard times, according to regulatory filings, following mismanagement by a new owner earlier in the decade.
In January 2007, Rick Robinette came aboard Naturade (a subsidiary of Redux Holdings) while it was recovering from Chapter 11 bankruptcy. When Naturade emerged from bankruptcy in November 2007, it quickly raised $1.2 million in funding, gave significant equity stakes to Rick Robinette (who was promoted to Chief Operation Officer (COO)) and Milos Sarcev (who was retained as Chief Science Officer). Redux Holdings also acquired a 30% stake in Koloseum Nutritional Sciences.
The recent purchase completes the acquisition of KNS by Redux Holdings. What does this mean? Trey Meehan, private equity manager and venture capitalist involved with Redux Holdings offered the following analysis:
Well, here is what I think it does for the Company. First, it provides a new product line to market alongside the Naturade brand to a large network that is already in place. Naturade is in stores all across the United States (as well as some international locations) like grocery stores, natural food stores, Sam’s Clubs, vitamin stores and many more. The Naturade brand typically targets the mass audience (moms and pops of the world).
The KNS line targets athletes.
Why does it matter? Well, is there a more efficient way to introduce leading edge, proprietary, nutritional formulas into your “everyday” product line than to take it from a sister product line that already produces supplements for world class athletes.
Congratulations to Milos Sarcev, who in recent years has successfully fought an indictment on steroid charges and deflected controversy from his association with the BALCO scandal.
