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request of Senators Orrin Hatch and Tom Harkin asking the FDA to immediately withdraw the New Dietary Ingredients (NDI) Draft Guidance.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  According to the Senators, the current Draft Guidance “serves to undermine DSHEA in a number of important aspects” and did not meet their intent when they wrote the law.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meeting with the FDA back in December to discuss the issue in the hopes that FDA would withdraw the controversial Draft Guidance and replace it with a new one that was consistent with the law and their intent.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 Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here.  The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA).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 Margaret Hamburg to withdraw the controversial NDI Draft Guidance — and replace it with a new draft that, according to the Senators, “will provide needed clarification on what constitutes an NDI, but does not undermine the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Dietary Supplement Health and Education Act (DSHEA) and are in a unique position to comment on this controversial new draft guidance and whether it is consistent with DSHEA — wrote a letter to the FDA to formally ask them to withdraw the document.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 »

Collins Recognized for His Leadership as Attorney, Author and Fitness Authority, and for his Philanthropic Efforts in Creating Worldwide Skydiving Fundraiser

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.
Read the rest of this entry »

On September 8th, the American Herbal Products Association (AHPA) held a one-day intensive event to help herbal and dietary supplement companies “sift through the clutter, the hype and unanswered questions” when it comes to NDI notifications. The event, the AHPA NDI Congress: Crafting an Industry Response and Filing Successful Notifications, took place in downtown Chicago, with CMG’s Alan Feldstein serving as a speaker at this high-profile, interactive industry gathering.

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.” Read the rest of this entry »

This Saturday, September 17^th, 2011, at the Las Vegas Convention Center Expo, Room S219, the attorneys of CMG will be speaking as part of the International Society of Sports Nutrition’s (ISSN) Europa University.

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.