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Healthy INSIDER Podcast 47: Probiotic NDI Challenges

As living organisms, probiotics are different from other types of ingredients used in supplements, such as botanicals and vitamins; yet, probiotics are subject to the same regulatory requirements. In this episode, Ivan Wasserman, partner, Amin Talati Upadhye, and outside general counsel to the International Probiotics Association (IPA), and Sandy Almendarez, editor in chief, INSIDER, discuss how FDA's thinking on new dietary ingredient (NDI) regulations apply to probiotics.

As living organisms, probiotics are different from other types of ingredients used in supplements, such as botanicals and vitamins; yet, probiotics are subject to the same regulatory requirements. In this episode, Ivan Wasserman, partner, Amin Talati Upadhye, and outside general counsel to the International Probiotics Association (IPA), and Sandy Almendarez, editor in chief, INSIDER, discuss how FDA’s thinking on new dietary ingredient (NDI) regulations apply to probiotics, including:

  • Why IPA believes a change in probiotic fermentation medium isn’t a chemical alteration that would require a new NDI notification (NDIN).

  • Why each strain of probiotics should not require a new NDIN, even though they are separate ingredients, according to IPA

  • Tips for probiotic brands to submit an NDIN to FDA that won’t be rejected

Wasserman also quizzes the INSIDER lead editor about probiotics. Listen in to see if he can stump her!

Hear more from Wasserman about probiotic regulations and science at Probiotics Marketplace, a day-and-a-half event that provides insights on probiotic science and formulation considerations, as well as issues to consider for an effective go-to-market strategy on April 18 and 19 as part of Ingredient Marketplace in Orlando. Probiotics Marketplace is produced with the International Probiotics Association (IPA), the premier underwriter is Nutraceutix, and additional support is provided by BIO-CAT, Sabinsa, Unique Biotech and Viva5.

Learn more about how from Feldman and other probiotic experts in INSIDER’s Probiotic Science Digital Magazine, and in the Healthy INSIDER Podcast 40: Probiotic for Oral Health, Foods & Beverages, Healthy INSIDER Podcast 41: Probiotics’ ‘Fantastic’ Sales Growth and Healthy INSIDER Podcast 44: Bacillus Probiotics for Digestive Health.

About the Author(s)

Sandy Almendarez

editor in chief, Informa

Sandy Almendarez entered the natural products industry in 2009 when she joined Virgo Publishing (now Informa Exhibitions) as an assistant editor. Since then, she's worked her way up to editor in chief where she writes, edits and manages content for INSIDER. Under Sandy’s direction, INSIDER has won editorial awards from Folio: every year since 2014, including B2B Editorial Team of the Year in 2015.

Ivan Wasserman

Partner, Amin Talati Upadhye

Ivan Wasserman is one of the nation’s premier attorneys for health, wellness, beauty and other consumer products. Companies of all sizes making, marketing and selling food, dietary supplements, cosmetics, over-the-counter drugs and medical devices praise the depth of his knowledge and experience, his humor and his ability to maintain the human perspective while leading them through this heavily regulated landscape. Frequently cited by the media as a legal authority, Ivan helps his clients launch products and create and execute advertising campaigns that match the clinical evidence they have for their products, paying close attention to the changing rules governing internet marketing, consumer testimonials and social media.

Ivan advocates for clients subject to the often overlapping jurisdictions of the U.S. Food and Drug Administration, the Federal Trade Commission,  and the U.S. Consumer Product Safety Commission.   When advertising disputes arise, he regularly represents companies before the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). He has been included in Best Lawyers in America from 2007 – 2017.

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