"Health Claims in EU and US

Health Claims on food packaging ("This margarine lowers cholesterol levels") are popular with both consumers and producers: the former get a good conscience, and the latter substantial additional revenue. In the last 10 years, more and more products have come onto the market in the USA claiming specific health effects of their ingredients. However, both European and American manufacturers are increasingly facing strict regulations, and there is still ambiguity on both sides about what claims are allowed and which are not.

USA

FDA Controls Stricter

In early March of this year, the US Food and Drug Administration (FDA) cracked down on the type and scope of health claims: 17 companies received warning letters and must now redesign their packaging. The FDA found that the nutritional value of products was overstated or unhealthy fats were being disguised. Among the recipients were Gerber baby food, Juicy Juice, Dreyer's ice cream (all Nestlé companies), POM pomegranate juice, and Gorton's fish fillets (see FDA site).

Claims Allowed

In the USA, since 1993, certain foods have been allowed to make "disease risk reduction" claims. Targeted health claims are approved by the FDA based on "complete, publicly available scientific evidence and where significant claims are supported by qualified experts’ scientific consensus." According to the FDA, nutrient-related claims can also be based on "reliable statements" from the National Institute of Health, the Centers for Disease Control and Prevention, or the National Academy of Sciences.

The Nutrition Labeling and Education Act of 1993 (NLEA) specifies the amounts required for a product to be labeled as a "good source of Vitamin C," for example. The FDA even provides examples (FDA Health Claims Guidance 2008) of how claims should be made.

The FDA Modernization Act (FDAMA) of 1997 introduced another index. It points out the dangers of high potassium intake related to heart attack risk and the benefits of a whole-food diet. In 2003, the FDA established an initiative that led to "Qualified Health Claims," which allows more cautious claims for which there is no definitive scientific opinion. This list includes phospholipids like phosphatidylserine (which can slow the progression of Alzheimer's) and various nuts that may help with heart disease. The list extends from calcium and osteoporosis to folic acid and birth defects, the well-known effect of sodium on high blood pressure, and the positive effects of soy proteins on coronary heart disease.

No Claim on Risk Minimization

Whether backed by expert opinions or not, in the USA, packaging claims cannot suggest a reduction in disease risk. Simply combining a few ingredients is also not enough to earn FDA approval. Foods must contain at least 10% of the daily value of one or more of six important nutrients (Vitamin A, Vitamin C, Iron, Calcium, Protein, Fiber), which must not be added. Furthermore, there are limits on saturated fats, cholesterol, and sodium. So it's not surprising that only around 5% of all packaging in the USA contains health claims.

Europe

Health Claims in Europe

In Europe, health-related claims are also allowed in addition to functional-structural statements. For example, "Vitamin A promotes healthy vision," or "Protein builds your muscles." The EU Health Claims Regulation introduced in 2007 seems to be closely modeled on the NLEA. However, a comprehensive catalog of scientifically proven links between disease prevention and specific food ingredients (available here) still needs to be completed.

EFSA List

The European Food Safety Authority (EFSA) is the regulatory body for the European food industry. The basis for reviewing health claims is the Regulation EC No. 1924/2006 of the European Parliament and the Council of 20 December 2006 on nutrition and health claims made on foods. Since then, nutrition and health-related claims in the advertising and labeling of food products, including dietary supplements, are only allowed if they are explicitly approved by the "Health Claims Regulation." Claims not approved cannot be used. Only claims supported by recognized scientific evidence are allowed.

On the European market, health-related statements like "boosts immune defense," "lowers cholesterol," or "supports joint functions" are only allowed if they are listed in the EFSA's "general claims list," which has been authorized for a particular food or food ingredient.

However, this positive list is not yet complete: its publication was originally scheduled for 31 January 2010 but has been significantly delayed. After the publication of initial assessments by EFSA in October 2009 and February 2010, a publication date is now expected in October 2010 or later. An EU Commission spokesperson on the topic stated, "It will likely take until 2011."

Industry insiders believe the delay is due to the overwhelming number of claim submissions from the European industry (over 40,000). Although the European Commission has now reduced the list to one-tenth, it still includes over 4,000 claims about "general functions" (such as "Calcium is good for your bones"). These must all be reviewed by EFSA. Nearly 1,000 applications have already been processed.

However, manufacturers are also allowed to submit individual health claims. For this, they must provide extensive scientific evidence that EFSA will review. Based on this scientific assessment, the European Commission decides whether the health claim will be approved.

For individual claims, food companies have been more cautious. Around 280 applications have been submitted so far, about 80 of which have been processed, according to the EU spokesperson. Most of these were rejected, as EFSA found no scientific evidence to support claims like "children's chocolate helps with growth," "cranberry juice reduces the risk of bladder infections," or "black tea improves concentration." The few authorized claims are quite simple: "Omega-3 fatty acids are important for child development" and "Calcium, Vitamin D, and Phosphorus are needed for bone development."

Common Platform?

There is still no common platform for regulating health claims between the USA and the European Union, and some associations see the current EU regulations as a hindrance (Alliance for Natural Health). However, at least both trade blocs are discussing the issue: on 23 February, the FDA, EFSA, and Health Canada met to discuss the matter, and in May 2010, EFSA will host an international summit in Parma, Italy (EFSA Health Claims Summit). However, a short-term alignment of the different scientific methods and legal regulations for verifying health claims seems unlikely.

Christine Wezel