HFMA, in conjunction with supplement and healthy food groups in the Netherlands (Gezondheidsproducten Nederland (NPN)) and Italy (Federsalus), argued for the annulment of the 13.1 general function claim list that contains more than 230 mostly vitamin and mineral-based health claim approvals under the NHCR but has rejected 1500+.
The hearing (Case T-296/12) took place yesterday, and the groups, along with the rest of the European food and supplements industry now awaits the judgement, which may not arrive until summer 2015.
“We are obviously very pleased to have finally got to have our day in Court, and a chance to help defend our industry, members and consumers against this hugely flawed and badly implemented Regulation,” said Graham Keen, executive director of the HFMA.
"We initiated this legal action back in July of 2012 as a ‘last resort’ when our serious concerns about many aspects of the implementation of the NHCR were falling on deaf ears."
“We now await the judgment of the Court, and hope that they will come to the right decision. We obviously hope that the Court will find in our favour, but whatever the outcome it will be important to have clarity from the Court on this vital issue for industry.”
Regulatory maelstrom
At the time the action was mounted, Sebastián Romero Melchor, partner in the Brussels office of K&L Gates LLP, observed the success of the NPN-HFMA-Federsalus challenge may lie in the way the ECJ views the regulation itself, rather than its application.
“Some aspects of its application by the Commission can be subject to criticism, but, in my view, it is the NHCR itself that is the origin of the maelstrom,” Melchor said.
“For example, the ban on factual information relating to health in commercial communications unless supported by an authorised claim is disproportionate, but it results from the text of the regulation.”