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CRN: FDA plans to reissue revised New Dietary Ingredient Notification draft guidance

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition on Wednesday commended the Food and Drug Administration for its plans to reissue a revised New Dietary Ingredient Notification Draft Guidance. The FDA’s announcement to revisit the draft guidance came following a meeting with agency officials including FDA commissioner Margaret Hamburg and deputy commissioner Mike Taylor and Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa.

“We are grateful to FDA for its willingness to have an open and ongoing dialogue with our industry," CRN president and CEO Steve Mister said. "We understand the complexities involved for FDA in developing practical and workable regulation, and we remain willing to work cooperatively to help ensure the guidance will be manageable for industry and enforceable for FDA, and will ultimately benefit consumers.”

CRN credits the industry’s perseverance in communicating to the agency its legitimate concerns about the original draft guidance, issued last July, combined with misgivings voiced from numerous members of Congress. According to CRN, the agency will revisit the five specific areas of concern that CRN and other industry trade associations highlighted as particularly problematic for the industry, including:

  • Industry responsibility for proving grandfathered status of particular ingredients;

  • The permissibility of using synthetic versions of botanical components in supplements;

  • The definition of the term “chemically altered”;

  • NDI submissions for an ingredient versus finished products; and

  • The level of data necessary to demonstrate the safety of NDIs.

“We pledge to continue to help educate the industry about the statutory requirements for NDI notifications, even as we engage in dialogue with the agency about specifics of FDA’s interpretation of the law," Mister said.


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Lisa Boylan appointed NACDS communications director

BY Allison Cerra

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has hired a new communications director.

Lisa Boylan, former senior editor and director of print and online publishing for the Epilepsy Foundation, joins NACDS’ marketing, communications and media relations team and will play a key role in external- and member-communications initiatives including NACDS websites, newsletters, media relations, social media and marketing communications related to NACDS events. Boylan will report to Chrissy Kopple, NACDS VP media relations.

"Lisa brings to NACDS 14 years of communications experience, nearly half of which she earned in the field of patient advocacy," NACDS president and CEO Steve Anderson said. "It is said that content is king in today’s fast-moving, multi-media communications environment. Lisa will play a key role in creating compelling content for NACDS communications vehicles on the topics of public policy, the value of pharmacy, and NACDS’ meetings and member programs. We are excited for her contributions to NACDS’ success in advancing a pro-patient and pro-pharmacy public policy agenda, and in reporting to the NACDS membership on pivotal issues."


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Zinn Beauty hits Duane Reade, introduces reformulated products, redesigned packaging

BY Antoinette Alexander

NEW YORK — Zinn Beauty Collection, a brand of organic argan oil-based skin care products, now is available at Duane Reade and features reformulated formulas and new packaging.

Zinn Beauty is one of the first affordably priced beauty lines that feature argan oil, sourced and imported in its purest form from Morocco. The skin care line has been reformulated recently to yield even better skin care benefits. The latest formula of these products include such known ingredients as jojoba seed oil, orange peel oil, evening primrose oil, shea butter and tea tree oil, in addition to the 100% organic argan oil.

The Zinn collection includes the Zinn 100% Moroccan argan oil to hydrate and repair dry skin, hair and nails; the Zinn Facial Velvet Cleansing milk to hydrate, clean and illuminate skin; the Zinn Revitalizing anti-aging cream to reverse and protect against skin-aging; and Zinn Smooth Body milk for total body hydration. The products retail for $29.99 each.

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