Europe has rejected 95% of the health and nutrition claims under review. What does this mean for us?
The European Food Safety Authority (EFSA) evaluated 2,037 health claims—that is, statements that a nutrient or food contributes to or has a positive impact on a particular health condition—and authorized the use of only 241 of them. Most of the ones accepted were related to structure or function claims, such as “calcium contributes to normal muscle function.”
As we’ve reported previously, structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans. In the US, structure/function claims like “calcium builds strong bones” or “vitamin D boosts immune system function” are allowed, but one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. With the EU’s list, we see the same censorship at work, only more so.
Claims that were rejected as being unacceptable included “(Cow’s) Milk products help support dental health. (Cow’s) Milk helps support the normal and healthy development of teeth. (Cow’s) Milk contributes to dental health” and “Vitamin D is needed for the normal/proper function of the thyroid. Vitamin D is needed for the proper regulation of blood calcium levels.”
Food and supplement products in the European Union must comply with this permitted list of health claims for use on food packaging, or else face prosecution for misleading marketing.
The EU created its Nutrition and Health Claims Regulation in 2006 to ensure that consumers were not misled by “unsubstantiated, exaggerated, or untruthful claims.” But we would ask: aren’t they misleading consumers into thinking that there aren’t benefits from food or dietary supplements, when the science overwhelmingly shows the opposite to be true? For example, we have the Harvard study that found a bioflavonoid in apples called rutin prevents clotting, and the studies indicating that medium chain triglycerides in coconut oil can prevent Alzheimer’s. But none of that would impress the EU unless a big company got behind it.
As ANH-International’s executive director, Robert Verkerk, noted on the BBC’s You and Yours program, some rules prevent you from claiming that fruit is beneficial, or that a diet rich in vegetables helps regulate body weight. Dr. Verkerk also said that big food companies, with their deep pockets, could play the system and claim health benefits for their food simply by inserting a small amount of an approved ingredient into a product.
As constitutional rights attorney Jonathan Emord points out, accurate health claims are a matter of safety. For example, the FDA would permit the following structure/function supplement claim: “This product supports healthy ranges of [blood sugar, blood pressure, or cholesterol]. But that doesn’t say enough. Someone on insulin should have clear information that a supplement could lower their blood sugar, in order to avoid a dangerous nutrient-drug interaction.
How will this new European regime of banning and forbidding affect American citizens? Potentially quite a lot. The EU is doing what the FDA wants to do and would do if it could. As it is, our system is not far behind the EU’s. For example, the current NDI draft guidance mirrors the EU’s Novel Food Regulation. The EU and the US have similar ways of determining “safe” upper levels of nutrient intake. And, as we reported last week, the EU is taking their anti-free speech position worldwide, insisting during Codex meetings that no language should be allowed indicating that food prevents disease, even in the case of nutrient deficiency illnesses.
This free speech issue is echoed in the POM Wonderful case, where the FDA attempted to bar a claim about the health benefits of pomegranate juice unless the company met a standard applicable only to drugs. As Jonathan Emord points out in a recent blog post, POM Wonderful’s court win could be reversed a month from now: the FTC has appealed the May 2012 ruling that POM’s structure/function claims don’t need to be supported by two random-controlled human clinical trials (RCTs). The final decision is expected on January 18. If the FTC wins, the two-RCT requirement could take effect in a little over a month.
What’s wrong with these trials? As we have noted many times, they are too expensive for most companies because the products ingredients are natural and cannot be patented. Without patents, there is no way to cover the exorbitant cost. The FTC and FDA know all this: they are just protecting drug companies, which in the case of the FDA pay much of the agency’s budget.
This is a reminder why the Free Speech About Science Act (FSAS) is so important. It will enable food and supplement companies to cite scientific evidence of benefits. It will ensure that free speech about science will be preserved, even while regulators and politicians such as Senator Dick Durbin and Congressman Henry Waxman try to bring EU regulations to the US.