California Supreme Court agrees with CHPA on federal preemption case

Rules FDA warning trumps Proposition 65

In a unanimous opinion, the California Supreme Court declared that the state cannot impose a Proposition 65 warning on OTC nicotine replacement therapy (NRT) drugs where FDA has declared that the warning would misbrand the products and mislead consumers. Dowhal v. SmithKline Beecham et al was decided April 15.

In a victory for FDA and for the industry defendants, the court concluded that when the Proposition 65 warning directly conflicts with one required by FDA, FDA’s decision preempts Proposition 65. The plaintiff had argued that a provision of the 1997 FDA Modernization Act “saving” Proposition 65 from federal preemption was all-encompassing. The California Supreme Court disagreed and ruled that where a direct conflict between Proposition 65 and the FDA requirement exists, FDA has authority to prohibit use of the Proposition 65 warning “if the FDA concludes that it would have the effect of misleading consumers.”

The suit was an attempt by the plaintiff to force manufacturers to label their OTC NRT products with the Proposition 65 warning that “this product contains a chemical known to the state of California to cause birth defects or other reproductive harm”  because the products contain nicotine, a listed Proposition 65 chemical. FDA repeatedly denied the companies' permission to include the warning on their product labels, on the grounds it would misstate the risks. Instead, FDA required a warning that balanced the risks of continued smoking with exposure to nicotine in NRT products. 

The Court observed that FDA’s ruling reflected concern that Proposition 65 warnings on NRT labels might mislead pregnant women to believe NRT products were as dangerous as smoking, or nearly so, and discourage the women from stopping smoking. FDA’s authority, said the court, “extends to barring [Proposition 65] warnings that are misleading.”  

CHPA and a coalition including Grocery Manufacturers of America, Pharmaceutical Research and Manufacturers of America, and the Cosmetic, Toiletry and Fragrance Association filed a friend of the court brief with the state Supreme Court supporting the FDA and company defendants.

Contact: Eve Bachrach

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FDA reopens comment period on limited set of issues surrounding Bioterrorism Act

FDA announced April 16 that it will reopen the comment period for registration and prior notice regulations under the Public Health Security and Bioterrorism Preparedness Response Act of 2002. FDA is seeking comments on the costs associated with the U.S. agent hiring requirement as well as timeframe requirements for food products including dietary supplements subject to FDA’s prior notice. Additionally, FDA and the U.S. Customs and Border Protection (CBP) announced the availability of a plan entitled "Joint FDA-CBP Plan of Increasing Integration and Assessing the Coordination of Prior Notice Timeframes." Comments on these issues must be submitted to FDA by May 14.

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Nutrition science expert to lead CFSAN

Barbara O. Schneeman, Ph.D., former chairwoman of the National Academies Committee on the Framework for Evaluating the Safety of Dietary Supplements, was recently named to lead FDA's Center for Food Safety and Applied Nutrition’s (CFSAN's) Office of Nutritional Products, Labeling, and Dietary Supplements. Since 1976, Schneeman has been on the faculty at the University of California-Davis and has been recognized as an authority on issues relating to the safety of dietary supplements. Schneeman will join FDA May 3, where her primary responsibilities will include overseeing the development of policy and regulations for dietary supplements, nutrition labeling, food standards, infant formula, and medical foods.

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FDA issues proposed rule on toll-free number for reporting adverse events on labeling

FDA published a proposed rule in today's Federal Register on the toll-free FDA MedWatch number to appear on drug labeling, required under the Best Pharmaceuticals for Children Act of 2002. The proposed rule would require the toll-free FDA MedWatch number to appear on the labeling of NDA'd and ANDA'd products, including OTC drugs. CHPA plans to submit comments, which are due by July 21. The final rule would be effective 30 days after it is published in the Federal Register, however, manufacturers would have one year from the effective date to comply.

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CHPA staff travel inside the Beltway and beyond

CHPA President Linda A. Suydam, D.P.A., CHPA Vice President of Corporate Development Ted Peterson, and Vice President for Communications and Strategic Initiatives Virginia A. Cox joined over 2000 business leaders from the chain drug, mass merchandiser, and food industries and their suppliers at the National Association of Chain Drug Stores’ (NACDS's) 2004 annual meeting, April 17-21, in Scottsdale, Arizona. The 2004 NACDS annual meeting proved to be a successful event, where many CHPA members gained unprecedented visibility and identified enhanced business opportunities. Suydam, Peterson and Cox met with several existing CHPA members, prospective members, allied associations, trade press, and retailers in their efforts to progress CHPA's many activities and initiatives...

CHPA Vice President and Assistant General Counsel David Spangler and CHPA Director of Communications and Media Relations Elizabeth Assey were in Boca Raton, Florida, April 13-15 for the Consumer 360 conference, a comprehensive educational conference for the consumer packaged goods industry. Sponsored by ACNielsen, Spectra, and other companies of the VNU Marketing Group, conference attendees heard from a range of speakers who delivered their own insights on today’s marketplace...

Washington, D.C., hosted the Food and Drug Law Institute’s 47^th Annual Conference April 14-16. CHPA President Linda A. Suydam, D.P.A., CHPA Senior Vice President, General Counsel, and Secretary Eve E. Bachrach, CHPA Assistant General Counsel Paul Larsen and CHPA Vice President-International and General Counsel David Spangler attended the event, billed as the premier opportunity for professionals from the drug, biologics, veterinary medicine, medical device, and food industries. The theme for this year’s conference was “Transforming Challenges into Opportunities,” and featured speakers who discussed future challenges in food and drug policy, law, and regulation, including Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D, and Centers for Medicaid and Medicare Services Director and former FDA Commissioner Mark B. McClellan, M.D., Ph.D.... 

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Famulare to keynote upcoming FDAnews conference

Joseph Famulare, director, Division of Manufacturing and Product Quality, FDA Center for Drug Evaluation and Research, will present those attending the May 5 FDAnews conference with the keynote address: FDA – the new era of quality systems. The event, “Quality Systems – Bottom Line Benefits,” is sponsored by FDAnews, an organization that provides regulatory, legislative and business news and information for the pharmaceutical and medical device industry.   

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FDA/CHPA Summer Workshop
July 12, 2004
Parsippany Hilton
Parsippany, NJ

FDA/CHPA Summer Workshop
August 9, 2004
Hyatt Regency Chicago
Chicago, IL

CHPA Market Exchange
September 23, 2004
Hilton East Brunswick
East Brunswick, NJ

Manufacturing Controls Seminar
October 7-8, 2004
Parsippany Hilton
Parsippany, NJ

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

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