By Robert Verkerk PhD, ANH-Intl executive and scientific director
It’s no secret that the German government dislikes food supplements. It is currently in the process of revising its own national laws affecting natural health products— apparently not satisfied with the adequacy of the tortuous regulatory system being implemented incrementally by the European Commission since 2002. For German consumers and practitioners (‘heilpraktiker’), this could be a disaster.
For over two years, we’ve been in close discussions with the rapidly growing German natural health trade group, the NEM e.V. The NEM was founded in 2006 in part to help counter German and EU overregulation.
We now feel it essential to sound a warning call to those both within and outside Germany who are not fully aware of what’s going on. In short, the German national law on food and food supplement enacted in 2005, Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch Lebensmittel- und Futtermittelgesetzbuch (LFGB), is in the process of being revised. The law will require pre-approval by the German authorities of all natural health products. Initially it would apply just to new products being put on the market, but after 2 years, it would retrospectively act on all existing products. If a manufacturer found itself unable to meet the data requirements, a product would have to be withdrawn, regardless of it having had an impeccable safety record.
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.
There is great concern by those engaged in discussions with the German authorities that the data requirements for product approvals are likely to make it very difficult for all but the largest German companies to sell natural health products within the country’s borders. This process of regulatory gradualism and overregulation, that seems intended to strangle the supply of natural products to a citizen base that has demonstrated an ever-increasing desire to use such products to help maintain health, is by now a familiar story.
Following are Markus’ answers (denoted as MJ) to my questions (RV).
Markus Junge, Chief Financial Officer at NEM e.V.
and Managing Director, Tisso Naturprodukte
RV: What are the likely consequences of full implementation of the LFGB German national law for food supplement manufacturers in Germany?
MJ: New products could be, and in my opinion will be, easily rejected by the German competent authority (BVL - Bundesamt für Verbraucherschutz und Lebensmittelsicherheit).
A company that has been unsuccessful in its bid to get a product approved may be forced to challenge the authorities in court, to get to their goal of launching a new product. Ridiculously, it may end up being easier for foreign companies to have their products notified in Germany, allowing them to legally deliver their products to every German citizen who wants a comparable product — while German companies get locked out!
Two years after implementation of this third revision of the LFGB, existing products on the German market would have to face the same procedure. While some might not be too worried because the existing text in the proposed revision says that only available data need to be submitted, there’s every likelihood that the BVL will not register your product without you being required to submit a whole lot of additional information, much of this being too costly to produce for many small companies. If you don’t give them the documentation they demand, you will have to withdraw your product from the market once the 2 year grace period built into the LFGB has elapsed.
RV: The German food supplement market has long been the biggest in Europe. How do you think LFGB might affect consumer and practitioner (heilpraktiker) choice when it comes to natural health products?
MJ: The German government doesn’t care how the LFGB regulations will affect companies. But consumers and practitioners who are reliant on good quality, effective products will simply look to being supplied from outside of Germany as they will not quit taking, selling or recommending products that they believe are good for them or their patients.
RV: Is it too late to have an effect on reducing the negative impact of the LFGB on the German food supplement industry and consumer choice?
MJ: No – it’s not too late! In March 2012 the ministerial draft bill was created by the BMELV (Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz) and sent to different organisations and stakeholders. The BMELV received a very long and detailed response from NEM e.V. Throughout my contacts with Members of the German Bundestag [Parliament] we heard that a lot of feedback has been received from many quarters. That is very positive. My last received information is that the BMELV is working on a revised ministerial draft bill. We are following this up all the time and will be ready to critique the latest proposal when it comes out.
RV: Are German consumers and practitioners suitably aware of the problems with the LFGB?
MJ: Unfortunately, not at all! 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. The members of the NEM e.V. are acutely aware of the need to get these issues out to a wide audience. We hope the publishing of an article on the ANH Europe website can help us get the information out further. German citizens are presently just not aware of what’s happening and that has to change soon!
Updated: 24 Oct 2012
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