Hot Topic: New Dietary Ingredients
FDA’s new Draft Guidance on New Dietary Ingredients continues to be a hot topic for those in the dietary supplement industry. Rick Collins recently presented his thoughts on the subject at Nutracon 2012, an annual industry conference held in Anaheim, California, in conjunction with Expo West. Rick was joined by John Zenk and Elan Sudberg for the session entitled “NDI: From a Legal, Medical & Testing Perspective.” The session description was as follows:
In this comprehensive session on NDI, our experts will cover Medical, Legal and Identification issues. Dr. Zenk, the Chief Medical Officer of Humanetics Corporation, will speak on his company’s experience in filing six premarket notifications for new dietary ingredients. His discussion will include a description of the ingredients, the filing content, the filing process and the outcomes of the filings. Understanding this process and identifying the importance of obtaining the NDI designation offers long-term opportunities for companies eventually marketing these ingredients. In the second segment Mr. Elan Sudberg, Chief Executive Officer of Alkemists Laboratories, will discuss his company’s expertise in analytical development/validation work and related challenges supporting proficient fit-for-purpose testing of New Dietary Ingredients and related finished products. His presentation will include critical decision making steps considering costs and timing for new dietary ingredients/products with respect to development and validation strategies, routine vs. non-routine quality control testing, outsourcing best practices and investigative approaches to solving labels claim discrepancies throughout the supply chain. In the third segment Mr. Collins, a lawyer with extensive experience in the field of nutritional supplements, will speak on the changing legal landscape of new dietary ingredients (NDI’s). The controversial highlights of the FDA’s new Draft Guidance on NDI’s will be explored, including an evaluation of the burdens placed upon industry in the Notification process. Also discussed will be the FDA’s recent enforcement efforts involving supplement products which contain substances that fail to meet the criteria for a dietary ingredient, ranging from warning letters to criminal prosecutions against companies and/or their principals. Finally there will be a panel discussion and questions from the audience will be encouraged. https://www.nutraconference.com/nutracon12/public/SessionDetails.aspx?SessionID=1006100
The session was well-attended and was followed by question-and-answer interactions with the audience.
New Dietary Ingredients were also a hot topic in Washington this month. Members of the House of Representatives submitted a letter to FDA threatening Congressional action if the agency fails to withdraw or substantially revise its Draft Guidance on NDI’s. Rep. Dan Burton and 16 other House members contacted FDA after efforts by Senators Orrin Hatch and Tom Harkin were unsuccessful in getting FDA to reevaluate or withdraw those provisions of the guidance deemed inconsistent with the intent of the Dietary Supplement Health and Education Act (DSHEA). The House letter increases the pressure on FDA to rein back the more objectionable provisions by warning that in the “unfortunate event that FDA does not withdraw or reconsider this guidance as requested, legislation to clarify (DSHEA) will be considered.”
Collins, McDonald & Gann will keep a close eye on developments as they unfold in Washington. Those in industry who have questions about the Draft Guidance should feel free to call us at 516-294-0300.