CSPI Expects Pfizer’s Centrum Claim Changes To Resonate Across Industry
This article was originally published in The Tan Sheet
Executive Summary
Pfizer will discontinue advertising claims for Centrum Ultra Women’s and Silver Women’s multivitamin supplements for “breast health” and Centrum Ultra Men’s and Silver Ultra Men’s for “colon health.”
Pfizer Inc.’s agreement with the Center for Science in the Public Interest to discontinue cancer-related claims for its Centrum line of multivitamins signals to firms that the advocacy group will contest similar claims for vitamins and dietary supplements.
Pfizer and CSPI July 5 released an agreement reached after the advocacy group threatened litigation. The firm will discontinue advertising claims for Centrum Ultra Women’s and Centrum Silver Women’s multivitamin supplements for “breast health” and Centrum Ultra Men’s and Centrum Silver Ultra Men’s for “colon health.”
CSPI says though “cancer” or “disease” is not explicitly stated in marketing for the products, the language skirts FDA’s regulation that claims to cure, mitigate, treat or prevent disease are not allowed for nutritional products.
“Breast health is some term that some lawyer made up in an effort to get around the law that says that supplements can’t make disease claims. I don’t care if my colon is healthy as long as it’s non-cancerous. It’s just a code word and consumers read it to mean breast cancer or colon cancer,” said Stephen Gardner, CSPI’s director of litigation.
Pfizer will remove the claims on product advertising and its websites for the products within 30 days. The firm also will add the statement “Not a replacement for cholesterol-lowering drugs” to advertising and the websites where “heart health” appears.
CSPI says Pfizer partially relied on the presence of vitamin D in the Centrum products to make the claims. But while a qualified health claim for calcium to make reference to colon cancer is allowed, a similar claim is not approved for vitamin D.
Pfizer also will add language to the label and advertising to clarify that the product does not directly provide energy or an energy “boost,” but rather helps energy.
Although it is making the changes, the firm does not agree with CSPI’s concerns. A Pfizer spokesman said the firm “agreed to make these changes in order to fully resolve the issues raised by the organization” and avoid further litigation.
Some Brands “Set The Standards”
Gardner acknowledged that other nutritional products likely make cancer-related claims, but CPSI realizes few have brand recognition as wide as Pfizer’s Centrum, a line the firm acquired in its 2009 merger with Wyeth.
“We look at the people who set the standards,” Gardner said in an interview. “Don’t look at the small fry, look at the big companies who are doing the right thing and hope that other companies know that they could be next,” he added.
In a similar case, the Federal Trade Commission in 2009 asked [Pharmavite LLC] to revise marketing language for the Nature Made brand CholestOff supplement. The product claimed plant sterols and stanols lowered low-density lipoprotein cholesterol up to 24%, but the percentage reduction claim troubled FTC, which pointed out clinical studies of the ingredients' heart health benefits largely used esterified plant sterols/stanols, not the free form of the substances contained in CholestOff (Also see "Pharmavite Amends CholestOff Claims After FTC Joins Heart Health Hunt" - Pink Sheet, 8 Jun, 2009.).
And in litigation that resulted in a $3.3 million settlement in 2010, CSPI sued Bayer Inc. over prostate health claims linked to the selenium in the firm’s Men’s One A Day multivitamins (Also see "Regulatory News In Brief" - Pink Sheet, 1 Nov, 2010.).