CHPA Executive Newsletter

CHPA and CTFA support the direct sale of tooth whitening products in the EU

CHPA and the Cosmetic, Toiletry, and Fragrance Association (CTFA) submitted joint comments January 27 to the Scientific Committee of Consumer Products of the European Commission. The purpose of the task group's submission was to endorse a proposal that would allow cosmetic tooth whitening products containing up to six percent hydrogen peroxide to be marketed directly to European consumers.

In its comments, the task group pointed out that since 1997 more than 42 million units of cosmetic tooth whitening products have been sold directly to consumers in the United States through a variety of retail outlets including supermarkets, drug stores, convenience stores, and bulk purchasing outlets, as well as through dental offices. Further, the associations stated that no serious adverse events, as defined by FDA regulations, have been associated with the use of these products since they were initially marketed. Adverse events that are reported by consumers are due to oral soft tissue irritation and tooth sensitivity, which are mild, self-limiting, and self-resolve shortly after discontinuing product use.

The joint task group comments support the The European Cosmetic Toiletry and Perfumery Association's recommendation for the marketing of cosmetic tooth whitening products containing up to six percent hydrogen peroxide with appropriate labeling in all retail outlets in Europe.

CHPA's 2005 Annual Executive Conference (AEC), scheduled for March 10-12 at The Fairmont Turnberry Isle Resort & Club in Aventura, Florida, will conclude with an exceptional line-up of speakers. The final day of the business program begins with the Reader’s Digest breakfast featuring Arthur Caplan, Ph.D., chair of the department of medical ethics at the University of Pennsylvania. In addition to his academic interests, Caplan writes a regular bioethics column featured on MSNBC.com and also is a widely sought-after television commentator. He will share with AEC attendees his vision on how the future of biotechnology will affect business, institutions, and personal choices. Special thanks to Reader’s Digest for sponsoring this session.

Next up on the March 12 program is the Cargill Health & Food Technologies General Session, which will lead off with “The View from Wall Street.” Industry consolidation has been a theme of both the consumer healthcare products industry and the larger pharmaceutical industry for at least the past two decades, but is there an acceleration of merger, acquisition, buyout, and recapitalization in our area? Straight from the money men’s mouths, Kenneth Berliner of Peter J. Solomon Co., Kevin Lewis of Lehman Brothers, and Ben Thorpe of Goldman Sachs will provide their perspectives on this topic.

Wrapping up the General Session is Robert Reich, a predominant thinker on the workforce and the economy. Reich is a professor of social and economic policy at Brandeis University, and previously served as secretary of labor. How can companies organize their people in the face of shifts in physical, intellectual, and social capital? How can large organizations transform themselves into quick moving teams to both grasp what needs to be done and then do it? These are the themes of Reich’s talk on “The Art and Practice of Change Insurgency,” thanks to Cargill Health & Food Technologies.

Who will be at the AEC?

Interested members may view an AEC attendance list by last name as well as an attendance list by company in the Members Only section of CHPA's web site. Both lists are updated frequently.

As mentioned in previous issues of the Executive Newsletter, one of the networking highlights of the 2005 AEC will be the March 10 Casino Night Dinner, sponsored by ACNielsen. In addition to sampling delicious food, members also will have the chance to win one of several grand prizes. Everyone in attendance will receive one raffle ticket and additional raffle tickets can be won at the various gaming tables.

Many thanks to the CHPA members that have generously contributed the following grand prizes:

Favor bags filled to the brim

The AEC favor tote bags are filled to capacity and the Association can no longer accept contributions. Thanks to the many members that contributed to this effort.

AEC 2005 is just five weeks away. For registration information, members should visit the Members Only section of CHPA's web site. For hotel reservations, visit www.fairmont.com/tir/chpa. Reminder: CHPA's room block at the hotel will be released February 8. Make your reservations now!

Governor Tim Pawlenty announces Minnesota Meth Watch program

This week, the Land of 10,000 Lakes became the twelfth state to adopt a Meth Watch program. Minnesota Governor Tim Pawlenty was joined by a bipartisan group of state political and law enforcement officials February 1 to lend their support for the launch of the Minnesota Meth Watch program.

Pawlenty, who made the announcement at a local St. Paul drug store, expressed his excitement about the public-private partnership. “Having [retailers] aware, equipped, and educated will help a great deal in trying to combat and reduce some of the activities that lead to meth development," he said.

CHPA provided the grant to fund the program in the state, and accolades were made by state officials who place high value on the partnership with the Association. Senator Julie Rosen (R-Fairmont) echoed the governor’s sentiment, “Minnesota should be happy about this partnership.” Rosen, who participated in CHPA’s State Leadership Training Seminar in July 2004, underlined her enthusiasm for the program since learning about its successes in Kansas.

Nancy Christensen, executive director of the Minnesota Grocers Association and grant recipient, expressed her enthusiasm on behalf of the retail community for the state’s support, and indicated that in the coming months, over 7,500 stores throughout the state will be receiving Meth Watch materials. Minnesota is the ninth state to receive funding from CHPA members for the Meth Watch program.

CHPA staff travel inside the Beltway and beyond

CHPA's Vice President-International and Assistant General Counsel David Spangler met with the Director of the U.S. Department of Commerce's Office of Health and Consumer Goods Jeff Gren January 27. The purpose of the meeting was to brief Gren and others on his team on CHPA's international interests, particularly in Japan and the European Union...

CHPA's Vice President-International and Assistant General Counsel David Spangler met with a group of 11 provincial regulators and pharmaceutical manufacturers from China January 25 in CHPA's office. Among the issues discussed were CHPA's services to non-OTC manufacturer Associate members and the basis for marketing both monograph and new drug application OTCs in the United States...

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Industry News

Draft guidance available on nonclinical safety evaluation of drug combos

FDA has developed a new draft guidance for industry entitled Nonclinical Safety Evaluation of Drug Combinations. According to an Agency notice in the January 26 Federal Register, the guidance recommends nonclinical approaches to support the approval of combination products, co-packaged products (i.e., two drugs packaged together with appropriate labeling to support combination use), and adjunctive therapies (i.e., when two drugs are used together but one is secondary to the other and they need not be given or taken simultaneously and may or may not be labeled for concomitant use).

FDA points out that while the guidance discusses all three types of drug combinations, it is only intended to describe general building principles. The Agency therefore recommends that drug sponsors should contact the appropriate review division prior to submitting an Investigational New Drug application.

Comments on the draft guidance are due April 26.

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FDA published a notice in the February 3 Federal Register announcing that the Agency will hold an educational public workshop May 11 in Kansas City, Missouri, to provide information on its premarket approval requirements to the drug industry. According to FDA, the meeting is specifically targeted small businesses, startups, and entrepreneurs. Registration for the meeting begins April 6 and space is limited. For additional information, e-mail David Arvelo or Cassandra Davis at oraswrsbr@ora.fda.gov.

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CDER seeks public input on the use of color in labeling and packaging

FDA's Center for Drug Evaluation and Research (CDER) issued a February 3 Federal Register notice announcing that it will hold a public hearing on the current practice of using color on pharmaceutical product packaging and labeling. The hearing will be held March 7 from 8:00 a.m. to 4:00 p.m. on the campus of the National Institutes of Health in Bethesda, Maryland.

The Agency is interested in hearing public comment on the following issues:

Written or electronic notices of participation and comments for consideration at the hearing are due by February 11. Written or electronic comments will be accepted after the hearing until April 7.

U.S. Surgeon General's 2005 agenda includes a plug for folic acid

U.S. Surgeon General Richard H. Carmona, M.D., M.P.H., F.A.C.S., released his agenda for 2005, declaring it "The Year of the Healthy Child." In a January 24 U.S. Department of Health and Human Services (HHS) news release, Carmona rolled out the agenda with a reminder to all women of child-bearing age to consume the recommended amounts of folic acid each and every day.

"We know that the health needs of children grow into the health problems of adulthood," said Carmona. "So this year I will be taking a hard look at ways to improve the health of children both domestically and internationally."

According to the HHS news release, this plan includes taking folic acid as a vitamin supplement. Because folic acid is necessary to ward off serious birth defects, Carmona recommends that women of child-bearing age supplement their diet with 400 micrograms of folic acid each day. Women with a family history of high risk for neural tube defects should increase that amount to four milligrams. Carmona warned, however, that the increased dosage should come specifically from folic acid supplements and not by increasing the number of multivitamins, because of the risk of vitamin A poisoning.

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In Brief

2005 CHPA member dues reminder

CHPA member dues statements for 2005 were sent out December 1, 2004. Dues for Active members should be calculated on total net sales of OTC and nutritional supplement products. For advertising agency members, dues should be calculated on total billings for these products. All Active and Associate member dues payments were due January 31, 2005. Payments not received by February 28, 2005, are subject to a one percent per month late fee. Please note: 2005 Annual Executive Conference registration confirmations will be provisional until member dues are paid.

If you have not received your statement or have questions, please contact CHPA’s Roman Blazauskas or Hyacinth Fray via e-mail or at (202) 429-9260.

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FDA holds 11th annual science forum in the nation's Capitol

FDA is hosting its 2005 science forum April 27-28 at the Washington Convention Center in Washington, D.C. Under the theme "Advancing Public Health Through Innovative Science," the conference showcases the Agency's scientific achievements, facilitates discussions between FDA and its stakeholders, promotes both internal and external collaborations, and recognizes outstanding research and science-based review performance with scientific achievement awards. For program and registration information, visit www.dcscienceforum.org.