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 Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here.  The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA).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now, as members of industry who are upset by the FDA’s lack of consideration of the many problems with the current NDI Draft Guidance and the agency’s refusal to listen to the advice of the two leading authors of the law that literally governs the supplement industry?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For now, we can – and should – continue to voice our opposition to this controversial NDI Draft Guidance.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elected officials, rather than to agency bureaucrats, may eventually bring pressure for the withdrawal of the current Draft Guidance.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let’s hope that they’ll listen to the facts, and the voices of reason, when it comes to considering withdrawing this draft guidance … before damage is done to the entire industry.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begun re-evaluating their products and ingredients, turning to us for advice as to whether they are in line with FDA’s Draft Guidance.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.

Rick Collins, a partner at Collins, McDonald & Gann, P.C. (www.cmgesq.com) and a leader in the health/fitness community, has been named by the Long Island Business News as one of Long Island’s Fifty Around 50 – Class of 2011. He was honored on Thursday, October 20 at an awards ceremony celebrating the Class of 2011 inductees, which was attended by hundreds of leading business professionals throughout the region.

Collins was selected as one of this year’s “Fifty Around 50” based on his leadership in business, mentoring, support for Long Island’s not-for-profit organizations and commitment to the community. The award was designed to recognize “the intelligent, hard-working and dynamic men and women dedicated to Long Island’s strong, successful companies and organizations.” Business leaders named to the list were chosen both for their outstanding professional achievements and leadership, as well as for their philanthropic efforts and community involvement.

“I am honored to be included as one of this year’s Fifty around 50,” said Collins, a former Nassau County Assistant District Attorney who co-founded Collins, McDonald & Gann more than 20 years ago. “Along with my fellow awardees, I’m happy to be able to contribute not only to Long Island’s business community, but to continue to dedicate myself to helping so many of the important causes and philanthropies both here on Long Island and nationally, as well.”

Over the past few years, Collins (who, in addition to his work as an attorney is also a health and fitness expert and author of the men’s health/fitness book Alpha Male Challenge) has been instrumental in spearheading many local and national philanthropic efforts and fundraising initiatives. He has been the force behind one of Long Island’s most successful personal fundraising initiatives – the Global Leap for Life (www.leapforlife.org) charity skydiving event to raise money in the fight against cancer. After creating and launching the event as a one-person skydiving fundraiser in 2009 to help raise money for the American Cancer Society, Collins has continued to grow the annual event into a nationwide cause – and in the past three years has raised a total of nearly $80,000 for a number of cancer charities. This year, Collins’ Leap for Life raised money for two organizations: Alex’s Lemonade Stand Foundation (www.AlexsLemonade.org), the national non-profit dedicated to finding a cure for all kids with cancer; and Strength for Life (www.strengthforlifeny.org) – a Long Island-based non-profit dedicated to empowering people with cancer and cancer survivors through exercise.

Collins, who is one of the country’s top legal experts in the area of nutritional supplements and anabolic steroids law, currently serves as a Director of the Nassau County Bar Association. In addition, he also serves on the Advisory Board of the WE CARE Fund, the nationally-recognized charitable arm of the Nassau County Bar Association which helps raise funds to improve the quality of life for children, the elderly and others in need throughout Nassau County. In his role on the WE CARE Fund Advisory Board, he helps to set the policy and direction for WE CARE Fund fundraising activities and grant distributions to charitable causes.

During his law career, Collins has been honored with numerous awards, including the 2001 President’s Award of the Nassau County Bar Association. He works on the Executive Committee of the Criminal Justice Section of the New York State Bar Association, and has testified regarding criminal justice issues before the Council of the City of New York on behalf of the 60,000 members of the association. He is a past president of the Criminal Courts Bar Association of Nassau County and an officer or member of numerous other state and national professional organizations including the National Association of Criminal Defense Lawyers (Life Member), the New York State Association of Criminal Defense Lawyers and the New York State Defenders Association. He is an annual faculty member for the National Institute of Trial Advocacy, and is on the Adjunct Faculty of Hofstra University Law School. In addition, he has appeared as a legal commentator on the nationally televised NewsTalk Television Network, and frequently lectures on trial practice and criminal law issues.

For more information about Rick Collins, visit www.cmgesq.com; in addition, to contribute to this year’s Leap for Life fundraising initiative for cancer research, visit www.leapforlife.org.

The event was designed to help herbal and dietary supplement companies take the next step in responding to the FDA’s draft guidance on NDIs and to develop and submit NDI notifications for numerous product categories.  According to the Tan Sheet’s coverage of the event, AHPA President Michael McGuffin stated that he is confident FDA will ultimately require notifications strictly for new dietary ingredients, and not all supplements containing those ingredients. McGuffin went on to state that “There is no way that enforceable, final guidance requires every downstream finished product to file an NDI notification or be subject to enforcement action” — adding that “We will build not only opinions but also a strong legal argument as to why that’s inaccurate.”

Speaking at the event, Alan Feldstein addressed the issue that more input is needed from ingredient suppliers, and not just from finished product manufacturers. Feldstein stressed that “a more efficient approach to this whole situation” is that “ingredient firms should file NDI notifications and then spread their costs across finished product manufacturers that purchase the ingredients.” He went on to note that this approach “gives FDA what they want as far as safety issues, and it gives the industry what it needs, which is the ability to conduct its business with the ingredients that have a reasonable expectation of safety.”

The deadline for comments is December 2.

From 2:00pm-3:00pm PST – Rick Collins, Esq., FISSN, joined by Alan Feldstein, Esq. and Michael DiMaggio, Esq. will be conducting a presentation entitled: FDA Draft Guidance on New Dietary Ingredient Notifications: Is it a “Game Changer” for the Sports Nutrition Industry?

The presentation will include issues such as:

• How FDA’s most recent guidance will affect innovation in the sports nutrition industry.

• The Nuts and Bolts of NDI Notifications: requirements, process and exemptions.

• What industry and consumers should know about supplement Safety Data and studies?

Please join ISSN and the attorneys of CMG this Saturday for this important presentation.