The Alliance for Natural Health International (ANH-I) raised a red flag this week about the implications of changes in German food supplement laws enacted in 2005, that look set to increase the kind of data required to back products.
The ANH-I said the law changes would in essence introduce a pre-market approval system that would be biased toward bigger firms with greater research budgets.
“Initially it would apply just to new products being put on the market, but after two years, it would retrospectively act on all existing products,” said Robert Verkerk PhD, ANH-Intl executive and scientific director.
“If a manufacturer found itself unable to meet the data requirements, a product would have to be withdrawn, regardless of it having had an impeccable safety record.”
“For German consumers and practitioners (‘heilpraktiker’), this could be a disaster.”
Foods or drugs?
Dr Verkerk continued: “This shift to a pre-market authorisation system is yet another indication that European regulators, often led by the views of the Germans, are desperate to treat food supplements not like foods, but like drugs — at least when it comes to regulating them.”
In an interview published on the ANH-I website, Dr Verkerk canvassed the concerns of Markus Junge, managing director of German natural products association (Tisso Naturprodukte GmbH ).
Junge said his group and others had been lobbying hard to ensure the mooted revisions don’t make it into law.
“Throughout my contacts with Members of the German Bundestag [Parliament] we heard that a lot of feedback has been received from many quarters,” he said.
“That is very positive. My last received information is that the BMELV is working on a revised ministerial draft bill.”
“These topics are only discussed among key government organisations and stakeholders — and the media have not helped in any way to make it an issue of national significance.”
“German citizens are presently just not aware of what’s happening and that has to change soon.”