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NDI Guidance and Sports Nutrition

Article-NDI Guidance and Sports Nutrition

FTC Official Responds to Criticism on Dietary Supplement Advertising Substantiation
<p>FDA&#8217;s new dietary ingredient (NDI) draft guidance further defines the need for sports nutrition companies to know the legal status of all the ingredients in their products.</p>

The sports nutrition segment of the marketplace is filled with consumers and companies that have researched and identified specific ingredients, whether synthesized or extracted from natural sources, that provide specific benefits. While this makes this segment of the industry incredibly subject-matter knowledgeable, it does not automatically render these dietary ingredients “legal."

The requirements for new dietary ingredients (NDIs) apply to the ingredients in sports nutrition products. This challenge is further exacerbated by the most recent NDI notification draft guidance. The ultimate resolution and implementation of this draft guidance will have an enormous effect on the sports nutrition world. This draft guidance contains information concerning what constitutes an NDI and a requirement that every use of these new ingredients be notified each time it is used in a dietary supplement. It is the determination of an NDI that renders it “legal" or not. Inclusion of an unnotified new ingredient in a dietary supplement renders that product adulterated (equivalent to being illegal).

An additional challenge within this draft guidance concerns the manufacture of an ingredient that is chemically identical to that found in nature. Implementation of this draft guidance would render a wide range of ingredients suddenly illegal. To make matters worse, alteration of the manufacturing process used to produce these dietary ingredients also requires a new notification, without which any product using it is considered illegal (adulterated).

The problem then is what to do. There are three actions that should be taken particularly by this segment of the industry.

Learn what those three actions are, and learn more about the sports nutrition category in INSIDER’s Sports Ingredient Science Digital Magazine.

Attend the Sports Nutrition Marketplace to get insights on the ingredients, formulation, demographic and regulatory considerations that can drive a go-to-market strategy. The day-and-a-half event is held on April 18 and 19 in conjunction with Ingredient Marketplace in Orlando. Produced with the International Society of Sports Nutrition (ISSN), Sports Nutrition Marketplace is underwritten by IDF.

As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.

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