BREAKING NEWS – EU Commission willing to set legal limits on trans fats

The European Commission has adopted today a report on trans fats (TFA) in food and in the overall diet of Europeans. This issue is a worldwide concern as the United States Food and Drug Administration (FDA) have notably adopted a decision last June to remove partially hydrogenated oils from foods within three years. The Commission’s preliminary report suggests that setting a legal limit for industrial TFA content would be the most effective measure in terms of public health, consumer protection and compatibility with the single market. The way in which such legal limit could be technically put into practice would require further investigation. The report notes that there are food products with high industrial TFA content available on the European market and there are public health gains to be reaped by reducing intake.

Heart disease is the leading cause of death in the EU and a high intake of TFA seriously increases the risk for heart disease – more than any other nutrient on a per calorie basis. Although average intake in the EU has been reported below national and international recommended levels, this cannot be said for all groups of population.

This report analyses how effective different EU wide measures could be on the potential health benefits for consumers but also the potential burdens for food producers. The options that were investigated included mandatory labelling of TFA, setting legal limits of TFA content in food and voluntary approaches to food reformulation. So far, TFA labelling is not well understood by consumers and increases the complexity of identifying healthier food choices. The effectiveness of voluntary approaches to food reformulation could be limited as it would clearly depend on the scope of industry participation and the coverage of food products on the market.

The Commission will shortly launch a public consultation and carry out an impact assessment to collect more information and build on the analysis provided by today’s report. This process will inform the Commission’s policy decision in the near future.

Trans fats are a particular type of fats that may notably be produced industrially as partially hydrogenated oils.

More information:

FDA Warning Letter – Misbranding – Whole grain benefits and not authorised claims

Here’s the FDA position about not authorised digestive claims in USA:
FDA WARNING LETTER – MAR 10, 2015
The Food and Drug Administration (FDA or we) reviewed the label for your Post Great Grains Digestive Blend (vanilla graham) product in September 2014. Based on our review, we have concluded that your Post Great Grains Digestive Blend (vanilla graham) product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21, United States Code (U.S.C.), sections 301 et seq.] and the applicable regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
Your Post Great Grains Digestive Blend (vanilla graham) product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that the labeling bears health claims that were not authorized by FDA.
Your product label bears claims that characterize the relationship of a nutrient to a disease or health-related condition. Specifically, your product label bears the following claims: “By consuming at least 48 g of whole grains per day you can support healthy digestion and reduce the risk of several chronic diseases like heart disease and diabetes. New Great Grains Digestive Blend cereal has 41 g of whole grain which is more than 85% of the daily recommended amount!”
A health claim expressly or by implication characterizes the relationship between a substance and a disease or health-related condition [21 CFR 101.14(a)(1)]. Substance means a specific food or component of food [21 CFR 101.14(a)(2)]. The whole grains that are a component of your product are substances within the meaning of 21 CFR 101.14(a)(2), and your label characterizes the relationship of these substances to diseases or health-related conditions (i.e., heart disease and diabetes). Because the product label bears health claims that were not authorized by FDA either by regulation [see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]], the product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
FDA has authorized health claims linking the consumption of whole grain foods to reduced risk of heart disease through the notification procedure in section 403(r)(3)(C) of the Act. Of those authorized claims, the ones closest to the claims on your product label are as follows:
  • “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers.”[1]
  • “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.”[2]
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like heart disease…” is not consistent with either of the above-cited claims that are authorized under section 403(r)(3)(C) of the Act. For example, your claim leaves out any reference to other plant foods and to foods low in saturated fat and cholesterol.
In addition, in a September 11, 2013, letter announcing that FDA would consider the exercise of enforcement discretion[3], FDA articulated two claims for which the agency intends to consider the exercise of enforcement discretion, each of which references the “very limited scientific evidence” linking the consumption of whole grains with a reduced risk of type 2 diabetes. Those claims are as follows:
  • “Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.”
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like…diabetes…” is not consistent with either of the above-cited claims for which FDA announced it would consider the exercise of enforcement discretion.   For example, your claim leaves out any reference to the very limited scientific evidence linking the consumption of whole grains with a reduced risk of type 2 diabetes.
For all of the above-noted reasons, your product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
If you are aware of additional evidence that would support a health claim by regulation or a qualified health claim, we encourage you to submit a petition pursuant to section 403(r)(4) of the Act [21 U.S.C. § 343(r)(4)]; see also FDA’s guidance on qualified health claims, which includes the procedures for submitting qualified health claim petitions.
(Source: FDA website)