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The event was designed to help herbal and dietary supplement companies take the next step in responding to the FDA’s draft guidance on NDIs and to develop and submit NDI notifications for numerous product categories.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.

The industry breathed a temporary sigh of relief when they learned that FDA had extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA extend the comment period by 45 days. Jarrow Formulas, a dietary supplement manufacturer, had also sent a request to FDA for a 1 year extension of the comment period, so the 60 day extension is an apparent compromise by FDA. Dietary supplement manufacturers and distributors are encouraged to confer with their legal counsel and/or trade association to continue to develop and prepare comments for FDA.

While so many in the industry seem to be talking about NDI notifications as the biggest issue facing supplement companies, a recent poll of approximately 100 attendees at the recent United Natural Products Alliance (UNPA) seminar indicates that there’s another issue of more concern in the supplement industry today: GMP compliance. According to the survey results, reported in the August 15^th “Tan Sheet” (see thumbnail image), 60% of the attendees polled said that GMP compliance is currently the most important issue facing the industry – compared to only 31% of attendees who believe that NDI notification tops the list of current concerns.

Those polled aren’t the only ones noting the importance of GMP compliance on the industry; according to Daniel Fabricant, director of FDA’s Division of Dietary Supplements, “GMPS are probably the most substantial thing industry has to work on” – noting that the FDA “is seeing a pretty high rate of noncompliance.” Fabricant went on to note that “the industry should expect more GMP enforcement” – but also disconnected the two issues by saying that the agency would “likely not” enforce NDI notification through GMP inspections.

So, for now, NDI notifications and GMPs remain two separate issues – with, it appears, more in the industry possibly less concerned about NDIs than they are about GMP compliance in today’s complex supplement industry. Therefore, as GMP compliance continues to be a growing issue, ensure that your company is following all proper practices and adhering to all current and future regulatory guidelines – and, to best meet any potential expanded GMP enforcement, consider seeking professional legal counsel to help you navigate through this important time.

When clients ask me about insurance, my response is that they should not look at insurance as a separate issue but rather as part of an overall risk management program for their company.  A risk management program encompasses several things.  The idea is to minimize your company’s exposure to lawsuits, regulatory investigations and other distractions that can not only cost you time and money but, if serious enough, sink your company and everything you have worked for.

In addition to insurance, one needs to look at several factors to manage risk.  Included among those factors:

• Do your independent reps have auto insurance on their vehicles?
• Have your claims on your labels and advertising gone through legal review?
• Do you have a written AER policy and are you following it?
• Are you managing and adhering to good manufacturing practices and are you checking to make sure your manufacturers and raw material suppliers or doing so as well?
• Have you trained your customer service representatives on how to properly respond to inquiries and do you have a written policy on how to handle emergency types of calls?
• Do you know what to do when FDA shows up for an inspection at your offices?

All of these are part of your risk management program.  And questions like these are asked by insurance underwriters … how you answer them may affect your rates.
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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.

Some insight and clarification offered from FDA but many questions left unanswered

The Natural Products Association hosted a Webinar featuring both an audio and video conference in the form of a slide show presentation. The Webinar featured two speakers, Dr. Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP, followed by a Question and Answer segment. Dr. Fabricant began by providing an overview of the document as well as FDA’s position and thought process in preparing the draft guidance. Scott Bass then briefly presented his initial impressions based on his experience with the drafting and implementation of DSHEA. He also offered his interpretation of how this document will affect industry and some feedback that he has gathered from industry.

While Dr. Fabricant did not offer much clarification with respect to many of the questions posed by Bass and the teleconference participants during the Q & A segment, he should be commended for his efforts to address the barrage the of questions he received as the representative of FDA.
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Just before the start of July 4th holiday the U.S. Food and Drug Administration released a Draft Guidance for Industry, which is entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. While it does not carry the authority or the enforceability of a law or regulation, it does when finalized, represent the Food and Drug Administration’s (FDA’s) current thinking on this topic of NDIs.

The FDA has asked for comments to be provided within the 90 day period that follows its issuance. We will be contacting our clients to discuss this matter with them, to assess how this Guidance will affect the products they manufacture and sell and to get their input to be included as part of a response which we will be filing. We will also assist them to prepare their own comments, which we encourage every manufacturer, distributor, retailer or supplier of dietary ingredients to submit.

There are some highlights to what FDA has put forth that you should be aware of:
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The 8th Annual International Society of Sports Nutrition (ISSN) Conference and Expo was held this past weekend in Las Vegas. Once again, the successful program included presentations from many of the brightest minds in the fields of nutrition, exercise and human performance. The Keynote Lecture was presented by one of the key historic figures in the world of sports nutrition science, Dr. Roger Harris. Both Rick Collins and Alan Feldstein attended the conference as ISSN Legal Advisors.
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