Referring to an editorial article written in Scientific American – claiming the FDA is too lenient regarding health claims and should follow EFSA’s lead and hold foods “to the same scientific standards as those for drugs”– Andrew Shao, senior vice president, scientific and regulatory affairs, at the Council for Responsible Nutrition (CRN), said that there were far more similarities than differences between the European and U.S regulatory authorities.
“I think the article in Scientific American actually missed the point, in that they are quite similar in their scientific approach to reviewing claims. The primary difference between the agencies is the regulatory framework that they have to operate under. The FDA does not review all claims whereas EFSA does,” he added.
Shao said that the key difference is that the FDA does not review structure and function claims, whereas EFSA does review and approve all claims (article 13 and 14). However he added that recently the FDA has stepped up its level of enforcement on certain structure function claims, in order to ensure that claims do not cross the line into disease or drug claims.
“I think perhaps they [the FDA] are trying to make their enforcement actions more visible to the industry than they have before,” said Shao.