US FDA MULLS REVOKING SOYA-PROTEIN’S HEART HEALTH CLAIM

The U.S.Food & Drug Administration(FDA) is proposing to withdraw the authorized health claim of soya protein lowering the risk of developing heart disease.  This is the first time the agency had deemed it necessary to consider revoking an existing health claim due to inconsistent results from latest scientific studies, the FDA said last month.  The FDA said its authorised health claims reflected well-established relationship based on “the most robust level of scientific evidence”.   

The FDA said that if it ended up revoking the authorized health claim, it would still allow soya producers to make a qualified health claim as long as there was sufficient evidence to support the claims of reduced risk of heart disease.  According to FDA guidelines, a qualified health claim requires a lower scientific standard of evidence than an authorized health claim and it requires the industry to use qualifying language that explains limited evidence between the product and the claimed health benefit.   

Ron Moore, president of the American Soybean Association (ASA), said there was still evidence linking soya protein to reduced heart disease risk and that it was important to remind consumers that soya could be a part of a heart-healthy diet.  FDA has opened a 75-day comment period on the proposal, but in the meanwhile manufacturers will be allowed to keep making the current authorized health claim until a decision has been made by the agency.