Author Archive

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request of Senators Orrin Hatch and Tom Harkin asking the FDA to immediately withdraw the New Dietary Ingredients (NDI) Draft Guidance.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  According to the Senators, the current Draft Guidance “serves to undermine DSHEA in a number of important aspects” and did not meet their intent when they wrote the law.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meeting with the FDA back in December to discuss the issue in the hopes that FDA would withdraw the controversial Draft Guidance and replace it with a new one that was consistent with the law and their intent.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 Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here.  The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA).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 »

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.
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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.

Alan Feldstein

Dietary supplement law expert Alan Feldstein presented at the American Herbal Products Association webinar last week to address issues surrounding the FDA’s controversial new draft guidance on NDIs (new dietary ingredients).  In his presentation, Feldstein noted that not only is there  “no logic” to FDA’s guidance regarding some of these notifications, but cautioned that this insistence would place “an impossible burden on the industry.”  Read the news story published by Nutraingredients USA on this timely and critical topic, click HERE.

To see Alan’s complete presentation, click here: Webinar Presentation 7-19-11.