Joerg Gruenwald01.01.09
Harsh Health Claim Standards?
What does your company need to know in order to get a health claim through the approval process?
By Joerg Gruenwald
The European Food Safety Authority (EFSA) is currently in the process of evaluating some 240 health claims submitted for approval. So far it has adopted a harsh line in its opinions, a fact that, while bewildering some and frustrating others, is mostly having a rallying effect on the industry. EFSA is setting pretty high standards, so manufacturers are actually gearing up to comply.
EFSA has published opinions on 25 claims to date (as of December 4th), and only six have been accepted. While this sounds devastating, taking a closer look at the rejected health claims reveals another side to the story. For the most part, EFSA has blamed health claim failures on methodological problems with the submitted studies (i.e., statistical weaknesses, study groups not corresponding to the target group, etc.). In those cases, EFSA’s opinion was that no cause-effect relationship could be established based on the studies provided for the ingredient in question and the submitted claim. So what lessons can manufacturers take away from these rejections?
First, the food or constituent in question must be sufficiently characterized. At least four claims were rejected because this was not the case. If an applicant wishes to make a claim for “dairy foods,” then data on the nutritional composition and variability of the dairy foods in question must be provided.
Second, the claimed effect must be defined. One submission was worded, “Clinically tested as of 14 days. Your silhouette is apparently and globally redrawn, resculpted and refined at 28 days.” EFSA’s opinion was that the proposed effect is not measurable.
In another case, an applicant claiming reduced risk for osteoporosis used bone mineral density as a biological marker; it was rejected by EFSA as being only an indirect marker. The lesson here is that both the claimed effect and the relevance of the claim must be sufficiently characterized.
The third point—one that was criticized most often by EFSA—relates to sufficient substantiation of a claim. From our experience of conducting more than 175 clinical trials, and after more than two dozen rejected health claims, we were able to identify some recurring weaknesses.
One is that cross-sectional studies do not provide sufficient evidence for a cause-effect relationship. From the claims that have been approved by EFSA, it seems that, to be on the safe side, manufacturers should generally go for intervention studies using the product in question when possible.
The product in question should show beneficial effects in the studies—deficiency symptoms alone might not be enough for EFSA. Also, the effect shown must be clinically significant. For example, if a study shows a reduction of waist circumference by 1 centimeter, EFSA may not consider that clinically significant.
One point of contention with combination products is that, in the eyes of EFSA, it is not sufficient to substantiate the efficacy for the individual components. In other words, at least one clinical trial for the combination in question must be submitted as part of the substantiation.
As stated previously, the subjects in the submitted studies must be equal to the target group. For instance, if a product is intended for children ages six months and older, then studies conducted on children ages one and older will not be considered relevant to the claim.
If the submitted claim is a risk reduction claim, then the effects observed in the studies must be accepted risk indicators. While this sounds obvious, at least one case so far has been rejected on these grounds.
There can also be problems with the formulation itself. For example, one submission discussed freeze-dried probiotic bacteria in a cap, released into the bottle on opening. EFSA criticized the applicant for not submitting any proof that the bacteria were still alive after freeze-drying. They also forgot to mention whether they were stable and active in the food matrix. In that particular case, there was also an issue with the submitted studies—they weren’t conducted on the same strains of bacteria in the same combination or in a similar food matrix, which meant that EFSA, based on the submitted studies, could not establish a cause-effect relationship for the submitted product.
So far, it seems, EFSA’s rejections have mostly been based on issues, which were avoidable by the company submitting the claim. If companies pay more attention to detail, EFSA just might start approving more health claims in the future.