Faced with conflicting research, the US Food & Drug Administration (FDA) is proposing to withdraw the authorised health claim of soya protein lowering the risk of developing heart disease.

The proposal was 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 on 30 October.

The FDA said its authorised health claims reflected well-established relationships based on “the most robust level of scientific evidence”.

“While some evidence continues to suggest a relationship between soya protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorised in 1999 – the totality of currently available scientific research calls into question the certainty of this relationship,” said Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition.

Some studies published after the authorisation of the health claim had shown inconsistent findings regarding soya protein’s reducing effects on ‘bad’ low-density lipoprotein (LDL), according to Mayne.

The FDA said that if it ended up revoking the authorised health claim, it would still allow soya producers to make a qualified health claim as long as there was sufficient scientific evidence to support the claims of reduced risk of heart disease.

A qualified health claim requires a lower scientific standard of evidence than an authorised health claim and it requires the industry to use qualifying language that explains the limited evidence between the product and the claimed health benefit, according to FDA guidelines.

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.

“In a time when heart disease is the number one cause of death both in the USA and the world, we can’t afford to discourage people from taking steps to improve their diets with heart-healthy ingredients,” Moore said, adding that ASA was disappointed with the FDA’s proposal.

FDA has opened a 75-day comment period on the proposal and is encouraging producers to share their opinions on the matter.

In the meanwhile, manufacturers will be allowed to keep making the current authorised health claim until FDA makes its final decision.