HEALTH

Rothenberg to speak at CRN annual meeting

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition on Wednesday announced the addition of Stuart Rothenberg to the association’s speaker docket for its annual meeting, to be held in just outside Albuquerque, N.M. Oct. 2-5.

“As the editor and publisher of a biweekly political newsletter, The Rothenberg Political Report, Rothenberg is widely regarded as one of the nation’s keenest minds when it comes to analyzing U.S. elections and political trends,” the association stated.

During his keynote speech, Rothenberg will address the likely results of the presidential elections as well as focus on key congressional races, and discuss how the balance of power in Washington could change—or not—based on the 2008 national and state election results.

In addition to his own political newsletter, Rothenberg writes a twice weekly column in Roll Call and has contributed pieces to The Wall Street Journal, The Washington Post, and The New York Times. His political expertise has been on display on NBC’s Meet the Press and ABC’s Nightline, and in the past, Mr. Rothenberg has served as a political analyst for both CBS and CNN.

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FDA identifies ingredients to be considered non-GRASE

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration last week identified a host of ingredients and indications that will be considered not generally recognizable as safe and effective as part of a proposed rule.

Industry will have 60 days to comment on the proposed rule. According to the agency, FDA first requested data on these ingredients/indications in December 2003 as part of its ongoing review of OTC drug products.

The following ingredients and indications will be identified as non-GRASE if the rule is ratified:

  • Any external analgesic drug products containing aloe vera or urea
  • Any topical antimicrobial drug products containing aloe vera
  • Any drug products containing urea for any labeled claims
  • Ammonia as a reflex stimulant
  • All skin protectant blister guard drug products
  • Any skin protectant drug products labeled with claims or directions for use as a nipple protectant (previously referred to as breast creams for use when nursing), except lanolin
  • Any drug products formulated as a wet dressing other than skin protectant and astringent drug products formulated and labeled in accordance with 21 CFR part 347
  • Any drug products labeled with claims or directions for the following uses—bed-wetting deterrent; blemish remedy (other than topical acne drug products); bunion remedy; drawing salve (for drawing or removing splinters, slivers or similar items), except ichthammol; foot balm, bath, or other topical dosage forms for any ‘‘foot’’ claims (including relieving foot muscle strains and soreness from working out), other than topical antifungal drug products; impotency cure; medicated bath preparation; nonantimicrobial skin wound cleanse; topical products for treatment or prevention of male urethral problems; treatment or prevention of prickly heat; urinary acidifier or urinary alkalinizer; weight control drug products with ingredients formulated as an impregnated body wrap; and wound wash saline.

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DSEA, NPF announce merger

BY Michael Johnsen

WASHINGTON The Dietary Supplement Education Alliance on Wednesday merged with the Natural Products Foundation, the companies announced during a noon press conference.

“DSEA’s Dietary Supplement Information Bureau and consumer and media outreach programs are highly regarded and will fit perfectly with the mission of the foundation, which is to enhance and promote the integrity of natural products through quality, science and education,” stated Randy Dennin, chairman of the Natural Products Foundation. “This merger allows us to not only strengthen and expand the foundation’s educational scope, it provides an established infrastructure that can be used to grow initiatives begun and planned by DSEA.”

As part of the affiliation and in order to take advantage of the Natural Products Foundation’s tax-exempt status, DSEA was dissolved as a corporate entity. Elliott Balbert, DSEA’s founder and past president and chief executive officer of Natrol, and fellow DSEA past-president Jon Benninger have joined the foundation’s board of directors. DSEA staffer Deb Knowles has also joined the foundation team.

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