Industry Addresses FDA on New Dietary Ingredients

　　
　　Alan Feldstein, Esq., Of Counsel to the New York law firm of Collins, McDonald & Gann, P.C. (CMG) [http://www.cmgesq.com], and Richard D. Collins, Esq., a principal in the firm, were among those who presented formal comments at a public meeting on pre-market notification of new dietary ingredients (NDI) held on Monday by the Food and Drug Administration (FDA). The comments were from the lawyers' perspective as counsel to numerous companies in the sports and fitness nutrition industry. While citing specific issues which require clarification about the NDI notification process, the comments more broadly addressed the "the perception that both the FDA and the sports and fitness supplement industry have of each other, and how that perception impacts the actions, philosophies and attitudes of both sides, " stated the attorneys.

The comments were intended to bring out into the open a long-standing atmosphere of distrust which appears to be held on both sides, and, the lawyer's comments cited historical examples of failed communication and lack of cooperation. "We believe that many of the issues raised by the FDA for this meeting ... can be resolved with improved cooperation and communication," Feldstein testified.

The lawyers strongly urged the appointment of an ombudsman within the FDA's branch dealing with dietary supplements known as the Center for Food Safety and Applied Nutrition (CFSAN), as is done with respect to many other industries regulated by the FDA. "Having someone who can help with communication between industry and the CFSAN will go a long way toward achieving a balance between the need to keep Americans safe and the right of Americans to make their own health decisions about dietary supplements," concluded Collins and Feldstein's statement.

Collins, McDonald & Gann, P.C., represents not only individual supplement companies but also a non-profit sports nutritional supplement coalition, the United Supplement Freedom Association. Contact: info@cmgesq.com

From prnewswire.com

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