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Webinar: FDA’s NDI guidance overreaches

BY Michael Johnsen

WASHINGTON — The New Dietary Ingredient draft guidance, which recently was issued by the Food and Drug Administration, is causing a stir within the dietary supplement industry as experts continue to evaluate what kind of impact the guidance will have on their businesses.

An attorney panelist at a recent industry-sponsored webinar suggested the draft guidance may not stand up in a court of law if finalized and enforced as is.

CRN’s Duffy MacKay, VP scientific and regulatory affairs, moderated the webinar, which included four speakers: FDA’s Daniel Fabricant, director of the Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition; FDA’s Dan Levy, supervisor for the New Dietary Ingredient Review Team, Division of Dietary Supplement Programs, CFSAN; James E. Hoadley, senior consultant at EAS Consulting Group; and Ashish Talati, partner at Amin Talati.

The two FDA officials provided an overview of the draft guidance, discussed FDA’s reasoning and rationale for the draft guidance, and explained the process the agency goes through during New Dietary Ingredient Notification reviews. Hoadley offered his best practices for submitting NDI notifications, and Talati shared his legal perspective of the draft guidance, including his opinion that the draft guidance may not withstand judicial review; specifically referencing an established legal test for review of agency actions that he believes undercuts FDA’s position.

"Our industry requested an NDI draft guidance from FDA to help clarify the law and level the playing field; however, this draft guidance overreaches and attempts to perform an end run around the original intent of the Dietary Supplement Health and Education Act," MacKay said. "We hope that FDA is serious about listening to industry concerns about the document and will moderate its interpretation to incorporate many of our concerns about the legal requirements for NDIs.”

The Sept. 14 webinar was co-hosted by the Council for Responsible Nutrition and VIRGO, and is available through Dec. 21 for purchase on-demand, CRN stated.

In addition to the webinar, VIRGO will hold a town hall discussion on the topic at its annual trade show Supply Side West, which will be held October 10-14 in Las Vegas. CRN will hold a wrap-up session at The Conference, “NDIs—What’s Our Next Move?” to explore next steps.  The Conference will be held in Rancho Palos Verdes, Calif., October 19-22 at the Terranea Resort. 


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Following 2010 pilot success, Carmex launches two new flavors

BY Michael Johnsen

MILWAUKEE — Carma Labs on Thursday announced the permanent addition of two new lip balm flavors: Carmex Lime Twist and Carmex Vanilla Click Sticks.

“We had an overwhelming response to the limited release [in late 2010] of Vanilla and Lime Twist,” Carma Labs president Paul Woelbing said. “Customers told us how much they liked the new flavors and would like them to be available year-round. We are happy to oblige and have added them to our family of flavored lip balms.”

Formulated with vitamin E and aloe, Lime Twist and Vanilla Click Sticks provide moisturization and improved glide, the company stated. Vitamin E acts as an antioxidant and helps prevent premature aging by preventing the forming of free radicals. Aloe helps heal and soothe sensitive lips. The 0.15-oz. solid sticks also include SPF 15 to provide additional protection.

The suggested retail price for the new flavored Carmex lip balms is $1.99.


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Report: Fifth dietary supplement trade association in the works

BY Michael Johnsen

BOULDER, Colo. — A fifth dietary supplement trade association may be in the early formulation stages, specifically designed to address the Food and Drug Administration’s recent issues of New Dietary Ingredient guidance, according to a Nutrition Business Journal report published Wednesday.

According to the report, Jarrow Rogovin, Jarrow Formulas president, announced his plan to found the Dietary Supplements Manufacturers and Marketers Association during a meeting at the Natural Products Expo East last week in Baltimore.  Rogorvin has hired attorneys to set up a Delaware-based non-profit and made an appeal to meeting attendees for at least 10 companies to sign up at a cost of $20,000.

Rogovin’s first order of business would be to call for the resignation of Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs, suggesting a conflict of interest exists out of his prior tenure as VP scientific and regulatory affairs for the Natural Products Association.

For NBJ‘s take on the proposed association, click here.


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