The latest batch of European Food Safety Authority (EFSA) opinions on health claims confirms the disturbing trend seen in earlier batches, namely negative opinions on claims that do not carry truly exhaustive levels of proof. In the interest of protecting consumers from being misled, EFSA is throwing the baby out with the bathwater, in the opinion of many in the industry and in the scientific community.
EFSA seems to be aiming at the level of proof of action yielded by pharmaceutical-style clinical trials. This is one of the key complaints that industry has with the way the agency is going about rending its opinions on the health claims dossiers, according to Peter van Doorn. Van Doorn is the Chairman of the European Federation of Associations of Health Product Manufacturers (EHPM) and Vice-chairman of International Alliance of Dietary Supplement Associations (IADSA).
"Nutrition can't be investigated the way you investigate a pharmaceutical because it has a completely different way of working," van Doorn said. "Nutrition works over longer periods of time and it works on different organs in the body. It has a completely different modus operandi. So if you would want to (conduct a pharmaceutical-style trial) it makes it too expensive. And lesser levels of proof can be used to make statements."
"We as industry know that certain claims are not completely, convincingly demonstrated, but there is a high chance that a certain effect occurs. And that is what we are pleading for, that a qualified expression of the health effect should be made and then it's up to the consumer that whether we do this or not."
"There is a good case to disseminate to the consumer what is known, whether it’s 100 percent (proven) or 75 percent or 50 percent and then leave the choice up to the consumer," he said.
As in previous rulings, claims associated with letter vitamins and trace minerals fared reasonably well, while almost all others were rejected. Claims associated with dietary fiber (for weight management blood glucose control and bowel function), DHA (for eye health) and live yogurt cultures (for lactose intolerance) were the lone exceptions.
In a letter to its non-EU members, IADSA summed up the rulings this way:
1. Claims that received a favorable opinion:
Covers 88 claims for 30 substances. But note that 28 of these have already been assessed in previous batches. EFSA just stated that the claim already received a favorable opinion.
2. Claims that received an unfavorable opinion:
- Vitamins and minerals: Vitamin E (except for the anti-oxidant effect)
- Amino acids and proteins: Branched-Chain Amino Acids, Methionine, Cysteine, Phenylalanine, Whey protein, Bonito protein peptide, Soy protein
- Carbohydrates and dietary fibers: Carbohydrates in dairy products, Isomalto oligosaccharides, Dietary fiber as such, Whole grain, Wheat Dextrins
- Herbs/Plants, other substances and foods: Camellia sinensis (including catechins from green tea), Wheat Germ Oil, Pomgranate, Prune Juice, Propolis, CoEnzyme Q10, Zeaxanthin, Conjugated Linoleic acid (CLA), Methylsulphonylmethane (MSM), Rutin, Beta-alanine, Superoxide dismutase (SOD), Flavan-3-ols, Lecithin, Phosphatidyl serine
- A number of specific probiotic bacteria: Lactobacillus fermentum, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillys gasseri
3. Claims that received a negative but insufficient opinion:
- Cocoa flavanols: Maintenance of normal blood pressure
- Chromium: Maintenance or achievement of a normal body weight
4. Group rejections:
- Effect insufficiently defined (considered as generic and non-specific claims): Antioxidants, Energy and vitality claims, Biotransformation of xenobiotics, Digestive system claims and Immune claims
- Effect not considered to be beneficial: Increase of micro-organisms in the gut and Renal water elimination
- Claim considered to fall out of the scope of Article 13.1 of the claims Regulation: Claim relating to children’s development and health and Claims relating to bioavailability
- Substances that are not or insufficiently characterised: Dietary fiber.
So where does the industry go from here? Van Doorn's outlook is determined, yet cautious.
"This is so complex that hardly anybody can follow it," van Doorn said.
"We will put our efforts into demonstrating that the way the situation is going is not appropriate. And how far we will be getting with that, well, we can do predictions on that but I’d rather just do the work as see what is the outcome."