The five associations representing the dietary supplement industry have requested that the U.S. Food and Drug Administration (FDA) issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify the NDI.
The request, made by the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), Natural Products Association (NPA) and the United Natural Products Alliance (UNPA), was made in the form of comments submitted by AHPA to FDA on April 27 and joined by CRN, CHPA, NPA and UNPA in separate submissions.
The associations note that FDA’s rule on NDI notifications, as codified in 21 CFR 190.6, does not specifically state what information should be provided to the agency on the identity of the ingredient that is the subject of an NDI notification. Yet the most common objection communicated by FDA in its responses to NDI notifications is that the agency “is unable to establish the identity” of the dietary ingredient that is the subject of the notification.
“This is clearly an area in which guidance is needed by the regulated supplement industry,” said Michael McGuffin, AHPA president. “We are therefore requesting that FDA prioritize its attention to this specific issue and provide the industry with clarity on this matter.”
Earlier comments submitted by each of the trade associations to FDA’s June 2011 draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, were generally critical. In June 2012, FDA informed the associations that it was planning to promulgate revised draft NDI guidance and would permit additional input from the industry on these topics.
“Other issues raised by FDA’s 2011 draft NDI guidance are still concerning to the supplement industry,” said Steve Mister, president and CEO of CRN. “We will continue our active dialogue with FDA until each of these is resolved. But in the meantime, it benefits both the industry and FDA to move forward on the topics where there is agreement. What constitutes an adequate description of the ingredient in an NDI notification is one of those issues where the trade associations and FDA are likely to agree.”
“We urge FDA to consider these additional comments and release a new draft guidance on the notification issue,” added Scott Melville, president and CEO of CHPA. “We must continue our discussions about what demonstrates whether an ingredient is grandfathered under the law, what constitutes chemical alteration of an old ingredient, and other matters. However, there’s no need to hold up guidance on this issue while we continue discussions on the meaning of the statute in other areas.”
For more information, visit www.ahpa.org, www.crnusa.org, www.npainfo.org, www.chpa-info.org or www.unpa.com.
The United Natural Products Alliance (UNPA) has announced a one-day seminar to educate food and dietary supplement companies about the changing landscape regarding the labeling and sales of products containing genetically modified organisms (GMOs) as well as the future for products sourced without GMO ingredients.
The seminar, titled “The Non-GMO Future: How to Source, Test, Label and Market Food & Dietary Supplement Ingredients,” is designed for all manufacturers, ingredients suppliers, retailers and anybody that sells foods, dietary supplements and other consumer goods.
Slated for May 23, at the Salt Lake Marriott—City Center in Salt Lake City, UT and will address the overwhelming consumer demand for GMO labeling and the growing demand for non-GMO foods and dietary supplements. Additionally, companies face a fast-changing landscape that includes both state and federal regulatory initiatives and major retailer transparency initiatives, such as those recently announced by Whole Foods Market and New Leaf Markets.
Attendees will learn how they can address new market realities and emerging consumer demands, including:
• Becoming a non-GMO company (for big or small players)
• How to develop your supply chain partners’ testing and branding issues
• Regulatory and legislative initiatives
“The move away from GMO-based products is a watershed event for all food and supplement companies,” said Loren Israelsen, executive director of UNPA. “But moving in this direction presents a number of strategic and logistical challenges, especially for companies that sell dietary supplements. Forward-thinking companies that choose to get in front of this historic market trend will likely enjoy a distinct market advantage over their competitors.”
For more information, visit www.unpa.com/events.
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