New York, New York – July 6, 2011– The National Advertising Division of the Council of Better Business Bureaus has determined that Bayer Healthcare, LLC, provided reasonable evidence to support the claim that its Citracal calcium supplement now includes a bone density builder, Genistein.

NAD recommended, however, that the advertiser modify or discontinue broad claims that Genistein has been clinically proven to “significantly increase bone density up to 5%,” because, NAD found, there was no clinical evidence that Genistein offered benefits to users other than postmenopausal women with lower-than-normal bone density.

The claims at issue were challenged by Pfizer, Inc., a competing manufacturer of calcium supplements. 

NAD, the advertising industry’s self-regulatory forum, requested substantiation for claims made in product packaging and in broadcast, print and Internet advertising, including: 

• “PLUS Bone Density Builder”
• “with Genistein – which is Clinically Proven to Significantly Increase Bone Density Up to 5%”  
• “How is this different from regular calcium supplements? As you age, it gets harder to build bone density with calcium and vitamin D alone.  Citracal Plus Bone Density Builder is the only leading calcium supplement to contain Genistein, an ingredient found in nature in soy that has been clinically proven to significantly increase bone density by up to 5%.”

Both parties manufacture calcium supplements with added vitamin D. The advertiser’s Citracal PLUS Bone Density Builder contains genistein, a soy isoflavone which the advertiser claims is clinically proven build bone mass tissue by up to five percent.  

Following its review of the advertising at issue, NAD determined that the “clinically proven” claim related to the ingredient Genistein, not to the product as a whole. NAD noted in its decision that the advertiser relied on two studies to support its bone density efficacy claims. Both studies were conducted on the ingredient Genistein and not on the product itself.

NAD then considered whether the advertiser’s evidence supported the claim that Genistein is clinically proven to increase bone density by up to five percent and determined that the evidence did not support the broad and unqualified claim that all consumers who used the product would experience a five percent increase in bone density. NAD recommended the advertiser discontinue the claim. However, NAD found that – absent evidence of consumer confusion – the product name was not misleading.

Neither party submitted consumer-perception evidence and NAD relied on its expertise to determined the messages conveyed by the claim: “How is this different from regular calcium supplements?  As you age, it gets harder to build bone density with calcium and vitamin D alone.  Citracal Plus Bone Density Builder is the only leading calcium supplement to contain Genistein, an ingredient found in nature in soy that has been clinically proven to significantly increase bone density by up to 5%.”

The question, NAD determined, “is clearly an invitation to the consumer to make a comparison between the advertiser’s product and other supplements on the market.  As such it is a comparative superiority claim for which the advertiser would require head-to-head testing, evidence that is not in this record.”

 Consequently, NAD recommended that the advertiser discontinue the claim.

The company, in its advertiser’s statement, said it agreed with NAD that “our label and advertising should more explicitly identify the population for whom we have designed the product.” The company also said it would “modify the question and answer currently comparing our product and other calcium supplements to take into account NAD’s recommendation.”