FDA’s new Draft Guidance on New Dietary Ingredients continues to be a hot topic for those in the dietary supplement industry.  Rick Collins recently presented his thoughts on the subject at Nutracon 2012, an annual industry conference held in Anaheim, California, in conjunction with Expo West.  Rick was joined by John Zenk and Elan Sudberg for the session entitled “NDI: From a Legal, Medical & Testing Perspective.”  The session description was as follows: Read the rest of this entry »

Honors MMA Superstar for Couture’s Lifetime Achievement and Role in Charitable Endeavors

Rick Collins recently presented MMA superstar and actor Randy Couture with a special award to commemorate Couture’s contributions to the sports/fitness arena and his philanthropic work.  Collins, the founder of the worldwide fundraiser “The Global Leap for Life” (www.leapforlife.org) — a unique skydiving fundraising initiative that to-date has raised nearly $100,000 for charity — presented Couture with a plaque on behalf of Leap for Life at the recent Arnold Sports Festival held earlier this month, in Columbus, Ohio, and attracting more than 175,000 sports and fitness enthusiasts from across the country.   The plaque was presented in honor of Couture’s longtime leadership both as one of the most successful mixed martial arts fighters of all time, as well as the important role he has played through his many charitable endeavors. Read the rest of this entry »

This coming weekend, CMG will once again have a major presence at the Arnold Sports Festival in Columbus, Ohio – as we continue our tradition of sponsorship for this event that has  become the largest multi-sport event in the nation.  For the tenth consecutive year, CMG will proudly be in attendance at “The Arnold”  (which takes place from March 1^st – 4^th ) – where more than  175,000 fitness enthusiasts will gather to experience thrilling moments of sports competition and fitness entertainment.  In addition, attendees at this major event will also have the chance to experience the 700-booth Arnold Fitness EXPO offering the biggest names in health & fitness who present the latest trends in fitness apparel, supplements, and training equipment.

Once again, CMG will be a sponsor of the Arnold Amateur competitions.  CMG partners Rick Collins and Marc Gann will be up on the EXPO stage handing out trophies to the contest winners midday on Saturday.  Also, this year we are particularly excited to announce that Rick Collins is scheduled to present a special award to MMA superstar Randy Couture.  Couture – three-time Heavyweight UFC Champion and two-time Light Heavyweight Champion – remains one of the most successful figures in MMA history.  He is also an actor who can be seen in The Expendables and The Expendables 2 – working alongside major action stars including Sylvester Stallone, Arnold Schwarzenegger, Jet Li, Eric Roberts, Steve Austin and Jason Statham, among others.  Rick, the founder of the Leap for Life fund-raiser (www.leapforlife.org), will be presenting Randy with a Lifetime Achievement Award for his outstanding career achievements and charitable endeavors on Friday at 11:45 AM on the EXPO stage — photos and more information on this will be posted after the presentation! Be sure to stop by to say hello to Rick and Marc, and also to CMG lawyers Alan Feldstein and Mike DiMaggio who, along with Rick and Marc, will be at the EXPO on both Friday and Saturday meeting with the many supplement company principals who are CMG clients. Read the rest of this entry »

Last week, in a move that has shocked many in the supplement industry, the FDA rejected the request of Senators Orrin Hatch and Tom Harkin asking the FDA to immediately withdraw the New Dietary Ingredients (NDI) Draft Guidance.  This move was more than surprising to many in the industry – especially considering that the Senators were the authors of the Dietary Supplement Health and Education Act (DSHEA)!  According to the Senators, the current Draft Guidance “serves to undermine DSHEA in a number of important aspects” and did not meet their intent when they wrote the law. The Senators had requested an in-person meeting with the FDA back in December to discuss the issue in the hopes that FDA would withdraw the controversial Draft Guidance and replace it with a new one that was consistent with the law and their intent.

The meeting between FDA‘s Dr. Daniel Fabricant and Sens. Hatch and Harkin ended with the FDA, as noted by some in the industry, “sticking to its guns on its interpretation of what the NDI section of DSHEA means, regardless of what the senators say they meant when they wrote the law.”  Sens. Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here.  The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA). Read the rest of this entry »

In what may be considered highly encouraging and promising news for the supplement industry, Senators Orrin Hatch (R-UT) and Tom Harkin (D-Iowa) have asked FDA Commissioner Dr. Margaret Hamburg to withdraw the controversial NDI Draft Guidance — and replace it with a new draft that, according to the Senators, “will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”

As reported in yesterday’s American Herbal Products Association Update, Senators Hatch and Harkin — who were the principal authors of the Dietary Supplement Health and Education Act (DSHEA) and are in a unique position to comment on this controversial new draft guidance and whether it is consistent with DSHEA — wrote a letter to the FDA to formally ask them to withdraw the document.  In their letter, the Senators pointed out that the draft guidance “serves to undermine DSHEA in a number of important aspects” — and went on to note their many concerns with the draft guidance (which many experts in the supplement industry have been noting since this controversial draft guidance for NDIs was introduced.) Read the rest of this entry »

FDA issued a News Release yesterday stating that 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – found to contain “ephedrine alkaloids” were seized by U.S. Marshals. The allegation that these alkaloids were found in those raw materials is troubling and manufacturers should be on alert.

Read the full News Release below: Read the rest of this entry »

There have been several occasions when an athlete has tested positive for a substance banned by their governing body.  Sometimes it is because of false positive, a few times it is because of a less than scrupulous manufacturer spiking their product.  Most of the time though it is because the athlete does not take the time to find out whether or not an ingredient is prohibited.  Such was the case of Maryland-based track athelete Phillipe H. DeRosier, Jr.

DeRosier tested positive for a stimulant called DMAA that is contained in a popular nutritional supplement, Jack3d made by USPlabs.  DeRosier was banned from competition and sued USP Labs.  A federal judge dismissed his $1.8 million lawsuit.  The judge ruled that testimony supporting his claim was ”wholly speculative and conclusory.”

One of the main reasons for the dismissal was that the ingredient is listed on the product label.  The product is being sold on the open market.  And while some ingredients are openly being sold, they may be banned by sanctioning bodies.  That is why it is important for any athlete consuming dietary supplement products to read the label and check to be sure that there is nothing in there that would be prohibited by their sanctioning body.

It is also good practice for companies who have ingredients in their product that may be banned by sanctioning bodies or that can result in false positives to put warnings on their labels that though the ingredient is appropriate it may be banned by not only athletic bodies, but by law enforcement agencies and other employers who regularly test their employees.  This can be a further risk management endeavor to eliminate the risk of costly defending oneself from a suit such as this.

Will Congress exempt Pre-Jan. 2007 Dietary Supplements from New Dietary Ingredient (NDI) Regulations?

Rep. Dan Burton

Although we don’t yet know whether this legislation has any legs, on November 4^th Rep. Dan Burton (R-Ind.) proposed the H R 3380 – Burton, a bill that would grandfather tens of thousands of dietary supplement ingredients that have been marketed since the passage of DSHEA (October 15, 1994) up to January 1, 2007, effectively “reclassifying” their NDI status.  Recognizing that industry practices, including the cGMP’s, Adverse Event Reporting, and voluntary product auditing and testing for quality and purity, have improved dietary supplement safety for consumers, the bill highlights that fact that corresponding FDA policy remained unchanged. The bill seeks to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expand the definition of a new dietary ingredient, because the FDC Act “does not recognize the current safe market in supplements, nor how intensively supplements have been regulated over the 17 years since enactment of DSHEA to protect public health and safety, and should be updated to reflect this reality.” We will be following the progress of this legislation in hopes that it will gain momentum and support from industry, and ultimately, from Congress.

On November 2nd, the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi’s National Center for Natural Products Research (NCNPR) announced a collaborative effort to address “adulteration of botanical ingredients” and educate members of the dietary supplement industry on accidental as well as intentional adulteration through the Botanical Adulterants Program (BAP). The program has received support from many industry members, retailers and trade associations. Read the rest of this entry »

Just recently, CMG partner Rick Collins was named to a high profile list of the country’s “Most Controversial Health Figures” – coming in at  #8 (just below  Dr. Oz, but above celebrities like Richard Simmons, Jamie Oliver and Kim Kardashian – see the whole list here: http://www.livestrong.com/slideshow/546327-most-controversial-health-figures/?utm_source=newsletter&utm_medium=email&utm_campaign=111011#slide-18 ).  Rick is one of the country’s leading legal experts when it comes to anabolic steroids and has recommended a more practical and sensible approach to controlling their use – one that balances preserving fairness in sports, protecting adolescents from drug abuse, and enhancing adult liberties regarding personal health.  Given that steroids continue to be one of the most heatedly controversial topics today, his inclusion on this list of controversial health figures is not surprising.

Unlike many of the others who “made the list” due to their involvement in conflicts of interest, questionable promotions/endorsements, and/or unfounded health claims, Rick’s inclusion on this list has nothing to do with any of that.  He made the list by simply “telling the truth” as he sees it and speaking out vocally (and rationally) on a highly controversial subject – proving the notion that “controversy sells” and bringing more attention to this timely topic. Read the rest of this entry »