In this comprehensive session on NDI, our experts will cover Medical, Legal and Identification issues. Dr. Zenk, the Chief Medical Officer of Humanetics Corporation, will speak on his company’s experience in filing six premarket notifications for new dietary ingredients.  His discussion will include a description of the ingredients, the filing content, the filing process and the outcomes of the filings.  Understanding this process and identifying the importance of obtaining the NDI designation offers long-term opportunities for companies eventually marketing these ingredients.  In the second segment Mr. Elan Sudberg, Chief Executive Officer of Alkemists Laboratories, will discuss his company’s expertise in analytical development/validation work and related challenges supporting proficient fit-for-purpose testing of New Dietary Ingredients and related finished products. His presentation will include critical decision making steps considering costs and timing for new dietary ingredients/products with respect to development and validation strategies, routine vs. non-routine quality control testing, outsourcing best practices and investigative approaches to solving labels claim discrepancies throughout the supply chain. In the third segment Mr. Collins, a lawyer with extensive experience in the field of nutritional supplements, will speak on the changing legal landscape of new dietary ingredients (NDI’s).  The controversial highlights of the FDA’s new Draft Guidance on NDI’s will be explored, including an evaluation of the burdens placed upon industry in the Notification process.  Also discussed will be the FDA’s recent enforcement efforts involving supplement products which contain substances that fail to meet the criteria for a dietary ingredient, ranging from warning letters to criminal prosecutions against companies and/or their principals. Finally there will be a panel discussion and questions from the audience will be encouraged.  http://www.nutraconference.com/nutracon12/public/SessionDetails.aspx?SessionID=1006100

The session was well-attended and was followed by question-and-answer interactions with the audience.

New Dietary Ingredients were also a hot topic in Washington this month.  Members of the House of Representatives submitted a letter to FDA threatening Congressional action if the agency fails to withdraw or substantially revise its Draft Guidance on NDI’s.  Rep. Dan Burton and 16 other House members contacted FDA after efforts by Senators Orrin Hatch and Tom Harkin were unsuccessful in getting FDA to reevaluate or withdraw those provisions of the guidance deemed inconsistent with the intent of the Dietary Supplement Health and Education Act (DSHEA).  The House letter increases the pressure on FDA to rein back the more objectionable provisions by warning that in the “unfortunate event that FDA does not withdraw or reconsider this guidance as requested, legislation to clarify (DSHEA) will be considered.”

Collins, McDonald & Gann will keep a close eye on developments as they unfold in Washington.  Those in industry who have questions about the Draft Guidance should feel free to call us at 516-294-0300.

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.

Presenting Couture with the award on the EXPO stage at the 2012 Arnold Sports Festival, Collins noted Couture’s many contributions not only to MMA history but his groundbreaking work in founding and growing his charity –The Xtreme Couture GI Foundation (www.xcgif.org.)  The Xtreme Couture GI Foundation is a 501 (c) 3 non-profit corporation founded by Couture to honor the veterans of America’s armed forces, with the goal of raising money and awareness for those wounded in action and their families.

“On behalf of Leap for Life, we wanted to recognize Randy for his continuing contributions not only to the sports and fitness arena, but to honor him for the tremendous work he is doing with the Xtreme Couture GI Foundation,” said Collins, a partner at Collins, McDonald & Gann which celebrated its tenth year of sponsorship of the Arnold Amateur competitions this year.  “In fact, we are so moved by the work being done by Randy and his charity in helping our country’s veterans that we are now in discussions to raise money for the Xtreme Couture GI Foundation through the 2012 Global Leap for Life, scheduled to take place in August.”

Further details about the 2012 Global Leap for Life will be forthcoming, and Collins remains excited about moving forward to raise awareness, and funds, to help the Xtreme Couture GI Foundation’s mission.  Previously, Collins had encouraged hundreds of people across the globe to “skydive for a cause” to raise money for cancer research, and is looking forward to now also raising a significant amount of money for this important cause, as well.

For more information about Rick Collins, including information about the Global Leap for Life and links to last year’s event, visit www.rickcollins.com.

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.

We are thrilled to be a part of this year’s Arnold Classic – and are looking forward to talking to those in the industry about the latest news, trends and innovations in the health and fitness arena.  As we gather with nearly 200,000 fitness enthusiasts and industry professionals, we remain pleased to not only have a role in bringing this event to the public, but to have continued to offer our legal services and counsel to those in the industry throughout the years.  A lot of exciting developments in the health/sports/fitness arena have occurred over the past decade since we became involved annually with The Arnold … and we remain proud to not only be affiliated with this prestigious event, but to continue our role as a leader this industry.

Be sure to check back on our website and Facebook page for our updates (and photos) from the 2012 Arnold Classic.  In addition, as always, we’ll continue to bring you the latest information about issues that affect you – both from this coming weekend at The Arnold, as well as through our work as attorneys in the sports/health and fitness/nutritional supplement practice areas.

For more information about the 2012 Arnold Sports Festival, visit: www.arnoldsportsfestival.com/home/sports-and-events/amateur-bodybuilding.html

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).

What can we do now, as members of industry who are upset by the FDA’s lack of consideration of the many problems with the current NDI Draft Guidance and the agency’s refusal to listen to the advice of the two leading authors of the law that literally governs the supplement industry?  Many are hoping that writing a new amendment to DSHEA on the topic of NDI’s might be possible – although, considering FDA’s strong position, this looks like it may be something either not in the foreseeable future or a “last ditch effort.”

For now, we can – and should – continue to voice our opposition to this controversial NDI Draft Guidance.  Write a letter to your local congressional representatives noting your strong concerns as a member of the industry. Conveying a stand on this issue to your elected officials, rather than to agency bureaucrats, may eventually bring pressure for the withdrawal of the current Draft Guidance.

There may still be hope, as noted by Loren Israelsen of the United Natural Products Alliance in this week’s New Hope 360° – who has said that he believes that “the issue will rise to a level of significance that both senior FDA and likely HHS officials will take a view on this.”

Let’s hope so – and let’s hope that they’ll listen to the facts, and the voices of reason, when it comes to considering withdrawing this draft guidance … before damage is done to the entire industry. In the meantime, many of our clients have begun re-evaluating their products and ingredients, turning to us for advice as to whether they are in line with FDA’s Draft Guidance. If FDA maintains their interpretation of DSHEA, the next step will be enforcement of that interpretation, which may or may not begin before a final Guidance Document is issued. Responsible dietary supplement companies should be prepared to face future FDA enforcement of their interpretation of DSHEA or the result could be costly.

For more coverage of last week’s meeting and a discussion of the issue as reported in New Hope 360°, click here.

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.)

With the support of these two powerful Senators, who are both long-time supporters of the natural health industry, there may be a glimmer of hope that this highly contested NDI draft guidance document may not be finalized in its current state, if at all.  According to reports, a meeting will take place in early January to discuss the issue — and the many concerns with this draft guidance — in more detail.

Although nothing is set in stone yet and it’s not clear what the final draft guidance will look like, this recent development is certainly welcome news for the supplement industry — and is an important step in helping to illustrate to the FDA that there is a tremendous opposition to this draft guidance.  We’ll keep you posted as to further developments after the parties convene sometime over the next few weeks — and hopefully will bring you word of a new, “improved”  policy concerning NDIs that is far more acceptable to everyone involved in the supplement industry.

To read the AHPA Update report, click here.

Read the full News Release below:

FDA NEWS RELEASE

Consumer Inquiries: 888-INFO-FDA

FDA: U.S. Marshals seize products containing banned ephedrine for dietary supplements
Potentially dangerous products banned for use in supplements in 2004

For Immediate Release: December 6, 2011
Media Inquiries: Pat El-Hinnawy 301-796-4763, patricia.el-hinnawy@fda.hhs.gov

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements.

The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of these potentially dangerous dietary supplement ingredients from the market.

Judge Gary A. Feess of the Central District of California issued a warrant for the seizure of more than 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – containing the ephedrine alkaloids.

“Working in close coordination with our federal colleagues in U.S. Customs and Border Protection, Immigration and Customs Enforcement and the Drug Enforcement Administration, the FDA helped identify and remove these potentially dangerous products from the marketplace,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “We will continue to take enforcement action that prevents potentially harmful products from reaching consumers and endangering their health.”

Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Prior to 2004, dietary supplements containing ephedrine alkaloids had been extensively promoted for aiding weight control and boosting sports performance and energy. But available data showed little evidence of the compound’s effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raised blood pressure and otherwise stressed the circulatory system. These effects were linked to significant adverse health outcomes, including heart attack, stroke and death.

FDA’s chemical analysis confirmed the presence of these alkaloids in the shipment, but the shipping drums carried no labels indicating that the material contained the banned ephedrine alkaloids.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm282537.htm

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.

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.

According to their press release, “The ABC-AHP-NCNPR Botanical Adulterants Program aims to help protect consumers and responsible members of the herb and dietary supplement industry, as well as other manufacturers, by producing a series of detailed white papers, which will serve as an authoritative source of information on botanical adulterants with references to published official and unofficial analytical methods for companies and/or third-party laboratories to utilize to help detect the presence (or absence) of known adulterants.”

“In addition to the series of white papers, The Adulterants Program will include contributions and consultations from some of the leading independent third-party laboratories with experience in quality control and botanical identification issues. The editorial committee, which will advise on all technical publications, includes expert scientists from various universities, government agencies, and third-party analytical laboratories with extensive knowledge of herbal quality control. The Program is also being supported by several leading trade associations in the dietary supplement industry: the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance.”

While efforts toward industry “self-regulation” as opposed to “federal regulation” should be looked upon favorably by industry, the question that may be raised by Congress and FDA is why the quality control measures and identity testing required by the cGMP’s does not prevent this kind of adulteration of botanical ingredients. If accidental adulteration cannot be prevented by these mechanisms, it will be interesting to see what measures the BAP will suggest for manufacturers and retailers of products that contain botanical ingredients.

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.

In his definitive book on the topic and in numerous articles, Rick has cited medical and scientific experts who believe that the body of evidence condemning anabolic steroids as too dangerous to be administered to healthy adults is lacking and note that these drugs have been utilized in the medical context for many decades (key points made in the documentary film “Bigger, Stronger, Faster*”, in which Rick appeared, and in a ground-breaking exposé on HBO’s “Real Sports”).  However, as is all too common in media reports, the “Most Controversial Health Figures” list write-up oversimplifies Rick’s position on this complex subject. He doesn’t advocate “legalizing” these drugs by removing them from the supervision of physicians.  On the contrary, he advocates a more practical control of them, through physicians and within the doctor-patient relationship, to reduce the black market and keep steroids out of the hands of cheating athletes or misguided teenagers. In today’s society – where government seems to be trying to play a greater role in health care by calling for such measures as a government-mandated smoking ban in public parks and other food and beverage regulations/mandates (including the much debated “sin tax” on sodas and other similarly unhealthy beverages), there’s a fine line that exists between having our health “protected” by the government and protecting our mature adult freedoms.  Mature adults are legally permitted to make their own health decisions (even including poor ones) on smoking, drinking, diet choices, risky cosmetic surgery options, and high-risk sports activities, so why is physician-supervised administration of anabolic steroids a crime?  When it comes to adult personal health choices, whose decision is it really?

The controversy over anabolic steroids won’t settle down soon, but where there’s controversy, there’s conversation. It’s vital to keep the conversation going when it comes to how we can find the proper balance between protecting our health and protecting our freedoms.

The debate continues … and, at CMG, so does our overriding commitment to helping people protect their rights in the criminal defense context generally, and regarding anabolic steroid crimes in particular.  For more information about our groundbreaking work in this area, and to see just why Rick Collins was named to this high profile list of some of the most recognizable names in health care today, visit www.steroidlaw.com and www.supplementcounsel.com.