Supplement Associations Ask FDA to Issue Revised Draft Guidance on NDI Ingredient Identity

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Press Releases and Statements | May 6, 2013

(SILVER SPRING, MD.) — The five associations representing the dietary supplement industry have requested that the 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 new dietary ingredient.

The request, made by the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), the 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 groups 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Earlier comments submitted by each of the trade associations to FDA’s June 2011 draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, were generally critical.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 the agency 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.”

“Reviewing the NDI notifications submitted to date indicates that FDA often cites absence of clear information on ingredient identity,” noted Loren Israelsen, UNPA’s executive director. “Guidance from FDA should therefore more closely focus on information that is needed to provide an accurate description of an ingredient that is the subject of an NDI notification. In fact, this is what the associations had anticipated the June 2011 draft guidance would comprise.”

“These new comments offer FDA a blueprint of what the associations and our members think should be included in NDI notifications to clearly establish the identity of these ingredients,” added John Shaw, NPA’s executive director and CEO.

“We urge FDA to consider these additional comments and release a new draft guidance on the notification issue,” commented 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.”

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.

The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal and botanical products industry. AHPA is comprised of more than 300 domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn

The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents approximately 1,000 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements and health/beauty aids. Visit www.npanational.org.

The United Natural Products Alliance (UNPA) is an international trade association representing more than 100 leading natural products, dietary supplements, functional food, scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in legislative and regulatory issues and industry best practices. Visit www.unpa.com.