Executive Newsletter is published every other week by:

Consumer Healthcare Products Association
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www.chpa-info.org

Copyright ©2009 by the Consumer Healthcare Products Association (CHPA)

CHPA's Executive Newsletter is for general information purposes only. Information reported in this newsletter is compiled from various sources. All efforts are made to assure the accuracy of the content, but CHPA cannot guarantee the information.




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Top Stories

PATS survey shows more parents are talking with their teens about cough medicine abuse

CHPA issued a press release May 4 applauding nationwide survey results that show that more parents than ever before are discussing OTC cough medicine abuse with their teenaged children. The 2008 Partnership/Metlife Parents Attitude Tracking Survey (PATS) indicates that 65 percent of parents are talking to their teens about the dangers of abusing OTC cough and cold medicine to get high, up from 55 percent in 2007. PATS-Parents is a nationally projectable survey of 1,004 parents of children in grades 4-12 and was conducted by the Partnership for a Drug-Free America with major funding from MetLife Foundation.

"We know that parents play a critical role in keeping their kids drug-free," said CHPA's Linda Suydam. "It is great news that more and more parents are exercising that power and talking to their kids about cough medicine abuse just as they would about any substance abuse behavior."

The latest PATS-Parents results show an 18 percent increase in parent-teen conversations about cough medicine abuse. This was the single highest increase in all categories examined in the survey.

"The data are encouraging, since we know that kids who learn a lot from their parents about the risks of drugs are up to 50 percent less likely to ever use drugs," remarked the Partnership's Steve Pasierb.

Suydam says that its members are committed to preventing teen medicine abuse. "With the help of such partners as the Partnership for a Drug-Free America, the Community Anti-Drug Coalitions of America, and D.A.R.E. America, we will continue our efforts to make sure all parents are aware of this substance abuse behavior and most importantly, are talking with their children about it," she stated.

All of CHPA's efforts on teen cough medicine abuse awareness and prevention are available at StopMedicineAbuse.org.

CHPA contact: Virginia Cox and Mimi Pappas | Back to the top

Industry coalition advises against the use of dietary supplements as swine flu remedy, cure

CHPA, together with the American Herbals Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance, issued a joint press release May 1 warning consumers to avoid any dietary supplements that are presented as treating or curing the H1N1 flu virus ("swine flu").

The coalition says that while it is aware of public concern regarding swine flu and of the desire of the public to protect itself, it is unaware of any scientific data supporting the use of dietary supplements to treat the virus. The organizations also point out that federal law does not allow dietary supplements to treat any diseases, including swine flu.

Because the industry coalition supports the responsible sale and use of dietary supplements, it endorsed the following unified advisory for marketers, retailers, and consumers:

• Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing swine flu.

• Marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for swine flu.

• Anyone who believes they may have swine flu or may have come in contact with the virus should contact a health professional. More information on swine flu and the proper actions to take is you suspect you are ill is available on the Centers for Disease Control's web site.

CHPA contact: Mimi Pappas | Back to the top

Dextromethorphan educational icon introduced

In a continuing effort to empower parents with the tools to stop medicine abuse among teens, the leading makers of OTC cough medicines are adding a new educational icon on the packaging of products containing dextromethorphan. The icon has begun rolling out in stores and will be on the majority of cough medicines containing dextromethorphan, including brand name and private label products, by the end of 2009.

OTC cough medicines containing dextromethorphan are safe and effective when used as directed; however, they can be very dangerous when intentionally abused in extreme amounts to get high. While educational efforts have seemed to curb the rise in dextromethorphan abuse rates among teens, the intentional abuse of cough medicines remains an issue. Data from the Partnership for a Drug-Free America indicate that one in 10 teens reports having abused OTC cough medicines to get high, and 28 percent know someone who has tried it.

The educational icon is the latest parental awareness-raising tool introduced by the leading makers of OTC cough medicines. It serves as a mini public service announcement, alerting parents to the potential for abuse among teens and to prevention resources on StopMedicineAbuse.org. It is part of the industry’s ongoing effort and commitment to partner with parents, retailers, healthcare professionals, law enforcement, and communities to help stop cough medicine abuse.

CHPA contacts: Virginia Cox and Mimi Pappas | Back to the top

Federal Agency News

FDA provides tips on avoiding health fraud

FDA recently posted a consumer update to the agency's web site warning about health scams that waste billions of consumer's dollars each year and can potentially lead to delay in proper treatment and cause serious injuries. Health fraud is the deceptive advertising or sale of products that claim to be effective against medical conditions or to promote wellness, but have not been deemed safe and effective.

According to FDA, common types of health scams include fraudulent products or treatments for cancer, HIV/AIDS, arthritis, weight loss, sexual enhancement, diabetes, and influenza.

To help prevent health fraud, FDA says consumers should be wary of the following red flags:

• Claims that a product is a quick, effective cure-all or a diagnostic tool for a wide variety of ailments;

• Promotions using words such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy;"

• Text with impressive-sounding terms such as: "hunger stimulation point" and "thermogenesis" for a weight loss product;

• Undocumented case histories by consumers or doctors claiming amazing results;

• Limited availability and advance payment requirements;

• Promises of an "easy" fix; and

• Claims that the product is "natural" or "non-toxic" (which doesn't necessarily mean safe).

FDA encourages consumers to make a report to the agency if they suspect a person or company is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics.

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Federal Register Update

FDA publishes guidance for small businesses on OTC labeling

FDA issued a notice in the May 13 Federal Register concerning a new guidance entitled Labeling OTC Human Drug Products; Small Entity Compliance Guide. The guidance, which finalized the December 2004 draft version, is intended to help small businesses comply with FDA's OTC labeling requirements and to prepare new labeling. FDA notes that since the agency did not receive any comments on the draft, the final guidance includes only editorial revisions.

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Government agencies project future regulatory actions

The Unified Agenda of Federal Regulatory and Deregulatory Actions was published in the May 11 Federal Register and posted to www.reginfo.gov. The items listed are rough projections of what certain government agencies, including FDA, hope to publish in the Federal Register over the next 12 months. Please note that the Federal Register notice includes the following disclaimer: “The regulatory actions capsulized do not necessarily reflect the policy perspectives of the Obama Administration. The statutorily dictated timing of the agenda caused initiation before a full review. By contrast, the timing of the October 2009 agenda will, obviously, provide the department with an opportunity to set out a regulatory agenda that does reflect current policy directions of the Obama Administration.”

The following are some issues of interest: 

U.S. Food and Drug Administration 

For a copy of the U.S. Department of Health and Human Services' agenda, click here and select the appropriate agency. 

—Proposed rule on electronic submission of data from drug studies: 9/09
—Proposed rule on Rx and OTC combination policy : 12/09
—Final action on changes to drug establishment listing and registration,
    including NDC changes and electronic submission: 12/09
—Final action on safety reporting requirements and revisions: to be
    determined
—Final action on dietary supplement Good Manufacturing Practices and 100
    percent identity testing: to be determined (an interim final rule was issued
    6/07, subject to comment)
—Final action on Good Manufacturing Practices cut label controls,
    amendment: to be determined
—Proposed rule on Good Manufacturing Practices, incremental modifications
    within “GMPs for the 21st Century” initiative: 2/10 

OTC Review-related:

Laxatives
—Proposed rule on professional labeling, sodium phosphate:
    09/09 
—Proposed rule on professional labeling: to be determined 
—Final action on laxative drug products: to be determined

Sunscreens 
—Proposed rule on time and extent applications: 09/09
—Final action on Ultraviolet A and Ultraviolet B: 09/09
—Proposed rule on sunscreen and insect repellent: to be
    determined

Internal analgesics
—Proposed rule on combinations with sodium bicarbonate,
    amendment: 05/10
—Proposed rule on miscellaneous Issues, amendment: 05/10
—Proposed rule on overindulgence/hangover, amendment:
    05/10
—Proposed rule on pediatric, amendment: to be determined
—Final action on internal analgesics: to be determined

Stimulants
—Proposed rule on hangover claims, amendment: 5/10

Cough/cold products
—Proposed rule on antihistamine claims: 4/10
—Proposed rule on changes to the final monograph to address
    safety and efficacy issues associated with pediatric products,
    amendment: 9/09
—Final action on bronchodilator/expectorant combinations,
    amendment: 9/09
—Final action on decongestants, phenylpropanolamine,
    amendment: 5/10

Bronchodilators
—Final action on ephedrine single ingredient, amendment:
    9/09

Topical antimicrobials
—Three proposed rules on food handlers, testing, and consumers,
    (healthcare already proposed): to be determined

Certain Category II and Category III ingredients 
—Proposed rule on making ingredients not GRAS/GRAE:
    to be determined

Skin protectants
—Final action on diaper rash: 12/09
—Final action on fever blisters and cold sores: to be
    determined

External analgesics
—Final action on GRAS/E dosage forms for patches: 12/09

Convenience size products
—Final action on labeling: 5/10

Antacids
—Final action on bismuth subsalicylate and overindulgence
    labeling: 5/10

Ophthalmic products
—Final action on emergency first aid eyewashes, amendment:
    to be determined

Oral healthcare products
—Proposed rule on plaque and gingivitis: to be determined

Vaginal contraceptives
—Proposed rule: 5/10

Weight control products
—Final action on phenylpropanolamine: 5/10
—Proposed rule on benzocaine: 9/09

Skin bleaching products
—Final action on hydroquinone: to be determined

Antidiarrheals
—Proposed rule: to be determined

Poison treatments
—Proposed rule on ipecac: 6/10

Urinary analgesics
—Proposed rule: to be determined

Acne products
—Final action on benzyol peroxide: 10/09

U.S. Drug Enforcement Administration

For a copy of the U.S. Department of Justice' s agenda, click here and select the appropriate agency.

—Final action on ephedrine, pseudoephedrine, phenylpropanolamine chain
    of distribution, importer information: 8/09
—Final action on Combat Meth Act self-certification by regulated sellers of
    listed chemicals: 10/09
—Final action on Combat Meth Act transfers following import/export: 9/09
—Final action on Combat Meth Act List I location registration: 8/09
—Final action on Combat Meth Act threshold removal: 12/09
—Final action on Combat Meth Act certification record-keeping requirements:
    1/10
—Final action on precursor chemical security requirements: to be determined

U.S. Federal Trade Commission  

For a copy of the U.S. Federal Trade Commission's agenda, click here and select the appropriate agency.

—Notice of guides to review in 2010: 1/10

CHPA contact: David Spangler | Back to the top

FDA opens docket on Sentinel Initiative

FDA published a notice in the May 7 Federal Register announcing the agency has opened a docket to receive input and provide information on its Sentinel Initiative. Launched by FDA in May 2008, the purpose of the Sentinel Initiative to develop a national electronic system that will complement existing agency systems to track reports of adverse events linked to the use of FDA-regulated products. FDA also announced the availability of a Sentinel Initiative report on the evaluation of signal detection methods for use in prospective post-licensure medical product safety surveillance.

Comments may be made to the docket at any time. Additional information on the Sentinel Initiative is available on FDA's web site.

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Meetings

The 2009 RSC focuses on global growth and innovation

The new Gaylord National Resort & Convention Center in National Harbor, Maryland, proved to be an ideal location to host the 2009 CHPA Regulatory & Scientific Conference (RSC). Over 150 representatives from the OTC industry and FDA were in attendance May 7-8 to learn about global factors impacting their responsibilities as manufacturers, researchers, and regulators of nonprescription drug products. 

Thinking outside of the box is key to growth

The RSC opened with high energy as Gene Slowinski of Rutgers University delivered his presentation on “Implementing Open Innovation: Lessons from the Leaders.” Slowinski encouraged attendees to think beyond the traditional method of R&D noting, “the consumer does not care about the source of innovation,” but is concerned with product novelty and function. He recommended companies explore how new ideas, technologies, processes, and products outside their institutional walls can be incorporated into product development programs. Regarding growth opportunities, Slowinski gave the following pointer: growth in the OTC industry will be through innovation.

Gene Slowinski, Rutgers University, delivered a spot-on keynote address that capitalized on the RSC theme of growth and innovation.

Exploring the international regulatory landscape

Following the keynote address, an RSC panel provided a virtual tour of the regulatory environment around the globe. The nuances to OTC product regulation in Russia, China, India, the Middle East, and Latin America were highlighted in remarks delivered by Tatiana Alifan and Amra Pasovic of Johnson & Johnson Consumer Companies – Russia, Mark Bowden of Johnson & Johnson Consumer Companies – Asia Pacific, Lauren Quinn of Wyeth Consumer Healthcare, and Héctor Bolaños of the Industria Latinoamericana de Automedicación (ILAR). 

Pasovic noted that OTC switches in Russia are based on safety data and OTC drug status in other countries. Bowden explained that China is projected to be the fifth largest Rx and OTC market by 2010. Based on available data through 2008, 391 OTC products were introduced to the Chinese marketplace via the switch process, which was initiated in 2004. Attendees learned that in India, all drugs not specifically listed in the Drug and Cosmetics Act  of 1940 as prescription drugs are considered OTC. Quinn advised that the regulatory environment in the Middle East is dynamic and challenging because individual companies are in different stages of development with regulatory markets ranging from established to emerging. Finally, Bolaños informed RSC attendees that Mexico has the largest number of product categories and ingredients in the Latin American region approaching that of Canada.

Examining the switch process at home and abroad

Day one of the conference also featured discussions concerning the switch environment in the United States and Europe. Marcia Crosse of the U.S. Government Accountability Office (GAO) offered an overview of the GAO’s recently-released report on drug classification. She described both the benefits and disadvantages of adopting a behind-the-counter (BTC) class of medicines in the United States, such as possible increases and decreases in cost to consumers, depending on insurance co-pays and potential pharmacist consultation fees. Moving the discussion overseas, physician, pharmacist, and author John Blenkinsopp from Keele University, talked about the United Kingdom’s success in leading the world in Rx-to-OTC switch. He also described the current facilities and services available in the UK to aid consumers with their BTC purchases. Blenkinsopp noted that pharmacists were becoming more hands-on with consumers and predicted that future training for pharmacists will include procedures to make proper prescribing decisions once patients have been diagnosed by a physician.

Covington & Burling’s Scott Danzis challenged audience members to think broadly about how OTC and medical devices might intersect to allow future switches in the United States within the current framework of laws and regulations. He also suggested that it may be appropriate to re-think OTC “labeling.” Audience members were asked to consider whether a kiosk could be classified as a medical device, and if after consumers completed a questionnaire, it could dispense “labeling” based on the responses. Finally, George Quesnelle of GlaxoSmithKline Consumer HealthCare (retired) offered a commercial perspective for growth of OTCs. He expressed the challenges related to switches and the regulatory, scientific, and political issues behind the process, pointing out that there really have not been any “easy” switches. 

From left: Mark Bowden, J&J; Charles Ganley, FDA; and David Hilfiker, J&J ; converse during a break between conference sessions.

Reviewing current and future FDA activities

Rounding out the first day of the RSC were a number of presentations by FDA officials, including Lonnie Smith of the FDA Data Standards Council, who provided an update on the agency’s Structured Product Labeling (SPL) program. He reminded industry personnel that beginning June 1, all drug establishment registrations, NDC labeler code requests, and drug listing for OTC products must be completed electronically. (See related story). Joel Schiffenbauer and Matthew Holman from the agency’s Center for Drug Evaluation and Research's Division of Nonprescription Clinical Evaluation and Division of Nonprescription Regulation Development, respectively, highlighted division staff changes, FDA accomplishments, and project initiatives. Schiffenbauer gave an overview of FDA’s Safety First Initiative, outlining the current goals of the program. Holman indicated that FDA's Office of Nonprescription Products believes “change is opportunity” and hopes to continue striving for increased autonomy, productivity, and transparency while improving global perspective through harmonization.  

The final FDA presenter was Vasilios Frankos, from the Center for Food Safety and Applied Nutrition (CFSAN), who described scientific issues impacting safety and regulation of dietary supplements. Those issues include economic adulteration, Good Manufacturing Practices (GMP) issues, contaminants, adverse event report (AER) monitoring, drug and dietary supplement interactions, evidence needed to ensure the safety of new dietary ingredients, and safety evidence for non-traditional users of dietary supplement products.

Integrating sustainability and innovation

The second day of the RSC began with a discussion about incorporating principles of sustainability into innovation programs. In addition to sustainability, supply chain integrity and environmental awareness were the common themes of panelists Annie Weisbrod of The Procter & Gamble Company, Kevin Smith of Sustainability Supply Chain Consulting (retired CVS), and Jim Chrzan of Healthcare Packaging Magazine. Weisbrod stated that due to a global increase in the population, more than 60 percent of the world’s ecosystem’s goods and services are highly degraded. She then stressed industry's responsibility in considering environmental, social, and cost sustainability of its consumer products. Smith introduced the concept of industry collaboration to address cost optimization, profit increase, and environmental benefit. He said that the declining global economy appears to have caused a decrease in consumer concern for the environment, but this trend is expected to reverse when the economy improves. In his remarks, Chrzan emphasized that although he does not believe totally “green” packaging exists, the industry and regulators should think about innovating “greener” packaging.

Looking toward the future of OTCs

Nearing the end of the RSC, audience members heard reflections from Ed Hemwall of Johnson & Johnson•Merck Consumer Pharmaceuticals Co., about the history of Rx-to-OTC switches and the opportunities and challenges for the future. Following Hemwall was a panel discussion on “OTC Healthcare: Policy, Politics, and the Issue.” Among the panelists was Peter Barton Hutt of Covington & Burling, who described switches as “the life blood of the OTC industry.” He also commented that globalization efforts for drug and food safety should be focused on risk-based approaches and GMPs. Stuart Pape of Patton Boggs LLP, praised FDA’s new leadership and predicted that we will see a more action-oriented approach to protect public health. Representing FDA's Office of the Commissioner, Murray Lumpkin outlined the issues and challenges facing the agency in today’s global economy. Lumpkin commented on the realities of the 21st century and advised that borders are now boundaries, but not barriers. He also pointed to a common goal of both FDA and industry: building consumer trust. Finally, CHPA’s Allen Segal presented an overview of congressional activities. Although stressing the important of CHPA member interaction with FDA, he reminded attendees that congressional action on such issues as OTC reform, import safety, and health reform have the potential to change the regulatory environment.

Sponsors made the 2009 RSC possible

CHPA thanks the many generous sponsors of the 2009 RSC. Your support is greatly appreciated.

See you next year

CHPA's next RSC is scheduled for May 13-14, 2010, at the Bethesda Hyatt Regency, in Bethesda, Maryland. We hope to see you there.

CHPA contact: Dr. Marcia Howard | Back to the top

Join fellow consumer packaged goods executives at the 2009 unsaleables conference

Make plans today to attend the 2009 Joint Industry Unsaleables Management Conference, set for July 28-30 at the J.W. Marriott Las Vegas Resort & Spa in Las Vegas, Nevada. Produced by the Grocery Manufacturers Association, the Consumer Healthcare Products Association, the Food Marketing Institute, the National Association of Chain Drug Stores, the National Grocers Association, and the Package Machinery Manufacturers Institute, this event includes representation from all key unsaleables constituencies.

Join professionals from across the industry involved in all aspects of reclamation, operations, logistics, sales, merchandising, marketing, and product development to chart a new course for unsaleables management that will address modern marketplace pressures.The first-rate agenda, expert speakers, and unmatched networking opportunities make the conference an exceptional value. Attendees also can maximize the return on their investment by participating in pre-conference retailer-manufacturer business meetings.

Now more than ever, consumer packaged goods professionals need to find innovative ways to grow and strengthen their operations. Learn how at the 2009 Joint Industry Unsaleables Management Conference. Additional details, including registration information and a conference attendance list are available online.

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CHPA's Market Exchange is where the industry comes to grow

CHPA contact: Phyllis Taylor |  Back to the top

Industry News

FDA to require electronic registrations and drug listings

Starting June 1, agency will no longer accept paper forms

FDA notified companies in July 2008 in the draft guidance, Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing, of its intentions to expand requirements for submissions in the Structured Product Labeling (SPL) format. Starting June 1, all companies that manufacture, prepare, propagate, compound, or process Rx products, including human pharmaceuticals, biologics, or vaccines; OTC drugs; and veterinary medicine products are asked to provide FDA with establishment registration and drug listing information in SPL.

Before the introduction of the SPL electronic format, companies were required to submit several paper forms to FDA to register manufacturing and packaging establishments. Companies also were required to provide a product’s listing, including ingredient composition, dosage form, and packaging information.

Effective June 1, FDA will no longer accept drug registration and listing paper forms. Instead, companies will submit NDC labeler code requests, registration establishment requests, and drug listing data in a fully electronic format via SPL submissions. Companies must submit an SPL file to register establishments that manufacture, package, analyze, import, or serve as a U.S. agent for the company’s products or product components. Companies must submit another electronic SPL file for each product, listing its composition and packaging information, and providing its usage information.

More information on the SPL program, including links to FDA resources and details on joining the SPL Working Group is available at chpa-info.org.

CHPA contact: Dr. Marcia Howard | Back to the top

In Brief

Thompson's offers food labeling reference manual

Thompson Publishing has released a new publication entitled Food Labeling: Q&A Reference Manual. The manual includes questions posed by professionals involved in the food and dietary supplement industry, which are answered by FDA officials and food and drug law attorneys and consultants. Specific topics covered in the manual include general labeling requirements, qualified health claims, and country of origin labeling. Additional information on the reference manual is available online.

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