Since the new health claims regulations went into effect in Europe in 2007, manufacturers have been watching the European Food Safety Authority (EFSA) give its opinion on hundreds of submitted claims. Several opinions on article 13.1 (well-established claims) and 14 (risk-reduction claims) applications have been published. The overwhelming majority of the issued opinions were, however, negative, ultimately leading to these claims being rejected by the European Commission. EFSA bases its rejections on the assertion that the studies submitted to support the claims are insufficient.
This, of course, is a major problem for manufacturers who will either have to take their products off the market, or at least take the respective claims off the labels.
Glucosamine was one of the ingredients impacted by claim rejections. The claims in question were related to glucosamine’s beneficial effect for joint health. For example: “glucosamine contributes to maintenance of joint function,” “glucosamine helps maintain joint cartilage” and “glucosamine helps maintain joint mobility.”
Glucosamine studies are generally conducted with WOMAC scores. EFSA opines that an extrapolation from data derived from WOMAC scores onto the target population of osteoarthritis patients is not possible, since healthy cells differ genetically and functionally from inflamed, osteoarthritic tissue.
This argument, coincidentally, is similar to the U.S. FDA’s argument on glucosamine claims.
The problem here is that there are no validated biomarkers or risk factors for arthritic or pre-arthritic conditions. For that reason, a program was initiated in 2004, tasked with finding new ones. The first potential biomarkers have been tentatively identified as COMP and CTX1, which are markers for cartilage growth and cartilage degradation. With these markers, it may now be possible to design clinical studies on patients or volunteers instead of assays. This will hopefully addess EFSA’s main criticism.
Unfortunately this does nothing for the claims that have already been submitted, or for those claims that have already been rejected. They are still faced with the threat of being taken off the market.
The Glucosamine Action Alliance
To respond to these recent challenges, a group of companies formed the Glucosamine Action Alliance, an organization made up of manufacturers and stakeholders in glucosamine marketing. The goal of the alliance is to get EFSA to change its mind on glucosamine. To that end, an expert board was tasked with compiling a report on glucosamine and its benefits for joint health—called the Glucosamine Report.
According to the report, EFSA’s rationale for its negative opinion on glucosamine should be revised. Specifically, EFSA’s assertion that cartilage effects on healthy cells cannot be transferred to patients with osteoarthritis.
Another strategy the alliance promotes is re-submission of claims, if possible with product-specific substantiation using the new markers.
In July 2010, the EU Commission was scheduled to make a decision on the rejected substances in the first batch of 13.1 article claims—specifically whether or not these substances should be relegated to a register of negative or undesirable substances in food and food supplements. Due to the Glucosamine Alliance’s efforts, the decision on glucosamine has been postponed until October 2010.
In the meantime, manufacturers are still free to use their claims until a final decision has been made. It remains to be seen what that final decision will be, and how, if and when it is made, it will affect other rejected claims.
In any case, the glucosamine issue should send a signal to manufacturers of other rejected substances that they may have a chance to save them. No matter what the outcome, the Glucosamine Action Alliance has already proven that EU Commission decisions can be delayed.