CHPA contact: Ted Peterson

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CHPA, dietary supplement trades praise passage of Anabolic Steroid Control Act

CHPA recently united with the other leading dietary supplement trade associations in an October 12 news release which applauded the U.S. Congress for passing S. 2195, the Anabolic Steroid Control Act of 2004. The bill, introduced by Senators Orrin Hatch (R-Utah), and Joseph Biden (D-Del.), provides for the listing of steroid hormone precursors such as androstenedione under the Controlled Substances Act. The legislation effectively prohibits manufacturers from marketing these substances as dietary supplements.

Since the bill was first introduced one year ago, it has received strong support from CHPA, the American Herbal Products Association, the Council for Responsible Nutrition, the National Nutritional Foods Association, and the Utah Natural Products Alliance (See October 30, 2003, XNL), as well as the U.S. Anti-Doping Agency, the American Medical Association, and the National Football League.

The dietary supplement industry believes the Anabolic Steroid Control Act is a positive step toward resolving issues affecting consumer confidence in dietary supplement products.

CHPA contact: Elizabeth Assey

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CHPA briefs National Sheriffs' Association

CHPA's Kevin Kraushaar, vice president, government relations, participated in an October 8 meeting of the National Sheriffs' Association State Executive Directors and Committee Chairmen to provide information on the national Meth Watch program. The meeting, held in Key West, Florida, was attended by sheriff association executives from over 35 states.

Kraushaar briefed attendees on implementation of Meth Watch around the country and explained how the program has been successful in reducing the diversion of precursor chemicals to illegal methamphetamine labs. Since state and local law enforcement budgets have suffered cutbacks in recent years, local sheriffs have been looking for cost-effective ways to address the diversion of meth precursors. Sheriff executives were informed on how their members could get technical assistance and support from CHPA on the development of Meth Watch in their communities.

CHPA is planning on making a similar presentation at the National Sheriffs' Association annual meeting in February 2005.

CHPA contact: Kevin Kraushaar

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Association explains how to implement Meth Watch in the Lone Star State

CHPA staff traveled to San Antonio, Texas, October 7-8 to speak at the Texas Federation of Drug Stores Annual Convention. The theme for this year's convention was "30 Years of Change and Competition," and provided attendees with insight into some the complex health problems the state of Texas is currently facing. CHPA's Elizabeth Assey, director of communications and media relations, represented the Association at the meeting. She took the group through a step-by-step approach on how to implement the Meth Watch program in stores. Also among the participants at the conference was Eric Douglas, manager, state legislative relations, Walgreen Co., who shared his perspective on Walgreen's experience with the Meth Watch program.

CHPA contact: Elizabeth Assey

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Partial stay granted for OTC antiperspirant drug monograph

FDA announced in the October 15 Federal Register that it is reopening the administrative record for the rulemaking on OTC antiperspirant drug products to allow for additional comments. The partial stay applies only to labeling claims for enhanced duration. According to the Agency, this action is being taken in response to a Citizens Petition containing data that showed FDA's testing guidelines for OTC antiperspirants may support an enhanced duration claim greater than 24 hours.

While the rule is effective December 9, the limitation of the enhanced duration claim to 24 hours is delayed until further notice. Comments on the duration claim are due to the Agency by April 13, 2005.

CHPA contact: Dr. Lorna Totman

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FDA schedules public meeting on NDI premarket notification program

A public meeting on FDA's premarket notification program for new dietary ingredients (NDIs) is now on the Agency's calendar. The meeting will be held November 15 from 9:00 a.m. to 5:00 p.m. at FDA's Center for Food Safety and Applied Nutrition in College Park, Maryland.

According to an October 20 Federal Register notice, FDA is seeking comments from interested parties concerning the content and format requirements for NDI notifications under the Federal Food, Drug, and Cosmetic Act. The Agency says that it has identified a number of problems with previously submitted notifications and wishes to rectify the situation by supplying notifiers with better information on the type, quantity, and quality of information that FDA requires.

To help with the scope of the meeting, FDA posted a list of questions concerning:

1. The status of a substance as an NDI,
2. Chemical identification of the NDI,
3. Information about the dietary supplement,
4. Establishing a reasonable expectation of safety,
5. The role of definitions in evaluating NDIs, and
6. Whether a guidance or amendment of current requirements is needed.

Space at the meeting is limited, so persons interested in attending are strongly encouraged to send registration information to FDA's Kelly Williams-Randolph by November 10. Registrations also will be accepted on-site on a space-available basis. Individuals wishing to make oral presentations at the meeting should notify Williams-Randolph at least three days prior to the event. Written or electronic comments are due by December 3.

CHPA contact: Dr. Marcia Howard

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NIH releases 2003 bibliography of dietary supplement research

The Office of Dietary Supplements at the National Institutes of Health (NIH) released the fifth issue of the Annual Bibliography of Significant Advances in Dietary Supplement Research. According to an October 8 NIH news release, a team of 45 expert reviewers in the fields of nutrition and botanical sciences and public health reviewed over 300 original research articles nominated from 34 peer-reviewed journals to determine which studies to include in the bibliography. The top 25 articles selected by the experts for publication in the 2003 bibliography include research in the areas of bone health, cancer, cardiovascular health, inflammation, and early development.

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CHPA staff travel inside the Beltway and beyond

CHPA's Director of Communications and Media Relations Elizabeth Assey, attended the Texas Federation of Drug Stores Annual Convention October 7-8 in San Antonio, Texas, to discuss the implementation of the national Meth Watch program (See related story)...

Kevin Kraushaar, vice president, government relations, was in Key West October 8 to participate in a meeting of the National Sheriffs' Association to explain how members could get technical assistance and support from CHPA on the development of Meth Watch in their communities (See related story)...

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DIA presents drug development forum

The Drug Information Association (DIA) is holding a conference entitled "West Coast Drug Development Forum: Challenging Issues in the Development of Therapeutic Products" October 25-27 in San Francisco, California. The conference will focus on strategic and tactical challenges in developing therapeutic products through interactive case studies and presentations of real-life applications. Topics to be discussed include the importance of early interaction with FDA, the management and monitoring of clinical safety data, and designing a corporate compliance program. In addition, FDA's Acting Commissioner Lester M. Crawford, D.V.M., Ph.D., will present a special keynote address. For more information on this event, visit DIA's web site. 

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Harvard annual conference addresses the future of America's healthcare

The Harvard School of Public Health is convening its 10th annual healthcare conference October 28-29 in Boston, Massachusetts. The conference program features speakers from government, academia, and the medical community who will lead sessions on a number of issues concerning shaping the future of America's healthcare. Some of the topics to be covered include disease management, racial and ethnic disparities in treatment, and strengthening brands with trust. For more information on the program, visit www.hsph.harvard.edu/ccpe/programs/AHC.shtml.

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FDA summit teaches the art of electronic communication

FDA is hosting an information management summit November 30 - December 1 in Bethesda, Maryland. The conference is for industry representatives who wish to learn how to effectively communicate with the Agency using evolving electronic initiatives such as the new gateway program, a portal through which industry may interact with all FDA centers. Industry professionals and top FDA officials will provide expert instruction at 12 interactive conference sessions on such subjects as new drug application submissions, electronic records and signatures, risk-based computer validation, and adverse event reporting. For additional details on the summit, visit FDANews.com.

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Business Development Conference November 3-4, 2004 The Westin Providence, RI

2005 CHPA Annual Executive Conference
March 10-12, 2005
Fairmont Turnberry Isle Resort & Club
Aventura, FL

2005 Regulatory & Scientific Conference
May 5-6, 2005
Mandarin Oriental
Washington, DC

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