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 Authors

Sandy Almendarez

VP of Content, Informa

Summary

• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands SupplySide Supplement Journal and SupplySide Food & Beverage Journal, the education programming for the health and nutrition trade shows SupplySide Connect New Jersey and SupplySide West, the education program SupplySide Fresh for industry newcomers and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

Contact:

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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