Daily Archives: May 11, 2017

On 27 April 2017, the Court of Justice of the European Union (CJEU) issued a judgment on the interpretation of Directive 2002/46/EC on food supplements (Directive) (case C-672/15). The CJEU ruled that the Directive and the provisions on the free movement of goods in the Treaty on the Functioning of the European Union (TFEU) preclude national legislation that does not provide for a mutual recognition procedure for the placing on the market of food supplements whose content in nutrients exceeds the national maximum daily doses and that are lawfully manufactured or marketed in another member state. Furthermore, the CJEU held that member states must set maximum daily doses for nutrients on a case-by-case basis after a comprehensive scientific assessment of the risk for public health. This must be based not only on national data, but also on available international scientific data.

Legal background

The Directive lays down rules for the placing on the market of food supplements (concentrated sources of nutrients or other substances with a nutritional or physiological effect marketed under a dosage form) in the EU. In particular, the Directive sets out lists of vitamins and minerals that may be used in the preparation of food supplements. Until the European Commission lays down harmonised maximum and minimum amounts for these nutrients, the member states may fix national amounts provided that, when exercising this competence, they comply with the principle of the free movement of goods and are guided by the criteria set out in Article 5(1) and (2) of the Directive, including the requirement for a risk assessment based on generally accepted scientific data.

Article 5(1) of the Directive requires that maximum amounts of vitamins and minerals be set per daily portion of consumption as recommended by the manufacturer, taking into account (i) the upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data (considering, as appropriate, the varying degrees of sensitivity of different consumer groups), and (ii) the intake of vitamins and minerals from other dietary sources. In addition, Article 5(2) states that, when the maximum levels are set, due account should be taken of reference intakes of vitamins and minerals for the population.

In France, Decree 2006-352 on food supplements (Decree), transposing the Directive into French law, allows the use of vitamins and minerals in food supplements under conditions laid down by ministerial order(s). An implementing inter-ministerial order of 9 May 2006 relating to nutrients that may be used in the manufacture of food supplements (Order) sets out the positive list of vitamins and minerals and their forms, as well as their maximum daily doses. In addition, the Decree provides for a simplified mutual recognition procedure for food supplements containing substances with a nutritional or physiological effect that are not included in the order(s) but that have been legally manufactured or marketed in another member state. This procedure does not, however, apply to food supplements containing vitamins or minerals.

Facts and referred questions

The preliminary ruling request stems from French criminal proceedings against Noria Distribution SARL (Noria) for having marketed food supplements containing vitamins and minerals in quantities exceeding the maximum daily doses set out in the Order, among other allegations. Noria did not contest the allegations but it claimed that the Order breaches EU law.

The District Court of Perpignan referred a preliminary ruling request to the CJEU asking the following questions:

1. whether the absence under French law of a simplified mutual recognition procedure for food supplements lawfully marketed in another member state whose content in nutrients exceeds the maximum daily doses set out in the Order is compatible with the Directive and the TFEU principle of the free movement of goods (first question);

2. whether the Directive and the principle of the free movement of goods allow the maximum amounts of vitamins and minerals to be set in proportion to the recommended daily allowances by adopting a value equal to three times the recommended daily allowances for nutrients presenting the least risk, a value equal to the recommended daily allowances for nutrients presenting a risk of the upper safe level being exceeded and a value below the recommended daily allowances or even zero for nutrients involving the most risk (second question); and

3. whether, in setting those maximum amounts, account should be taken not only of national but also of international scientific research concluding in favour of setting higher safe levels (under identical conditions of use) (third question).

Findings of the CJEU

On the first question, the CJEU reminded that member states remain competent to set maximum amounts of nutrients which may be used in food supplements, provided that they comply with the principle of the free movement of goods and are guided by the criteria laid down in Article 5(1) and (2) of the Directive, including the requirement for a risk assessment based on generally accepted scientific data.

In the CJEUs view, the French legislation constitutes a measure having an effect equivalent to a quantitative restriction (Article 34 TFEU), since a food supplement whose nutrient content exceeds the national maximum limits cannot be marketed in France even if that food supplement is lawfully manufactured or marketed in another member state. For said restriction to be justified (Article 36 TFEU), a national authorisation procedure must be in place for food supplements including nutrients in excess of national maximum limits that is readily accessible, able to be completed within a reasonable time, and subject to judicial review in case of refusal such refusal being justified only where there is a genuine risk to public health. Since the French legislation provides for a mutual recognition procedure for certain food supplements, but not for those with nutrients whose content exceeds the national maximum daily doses, the restrictions imposed by French law cannot be justified under Article 36 TFEU.

Regarding the second question, the CJEU did not respond on the merits, leaving it to the referring court to determine whether the method used by France to set maximum amounts of vitamins and minerals complies with EU law. However, the CJEU set out the relevant requirements for the referring court to make this determination. In particular, the CJEU held that national maximum amounts of vitamins and minerals must be set on a case-by-case basis and taking into account, among other things, the upper safe levels established after a comprehensive scientific assessment of the risks for public health based on relevant scientific data, and not on general or hypothetical considerations. Setting maximum amounts without taking into account all Article 5(1) and (2) criteria, on the sole basis of the nutritional needs of the population concerned or without carrying out a case-by-case analysis, is not compatible with the Directive or with the principle of the free movement of goods.

With respect to the third question, the CJEU held that the setting of maximum amounts of vitamins and minerals must take account of upper safe levels of these nutrients determined after a scientific risk assessment based on generally accepted scientific data, regardless of whether those data are national or international data. Therefore, if recent and reliable international scientific data are available on the date on which the scientific risk assessment is carried out, the assessment cannot be carried out without having regard to those data.

Original post:

Food Supplements: CJEU sets boundaries to national legislation imposing maximum amounts on nutrients - Lexology (registration)

Up to 170 million Americans take some form of supplement like a multivitamin or mineral supplement, but there are no standard regulations when it comes to them and there can be long lists of ingredients with complicated names.

Dr. Christopher D'Adamo, the director of research for the University of Marylands Center for Integrative Medicine in Baltimore does clinical research on supplements. He teaches his students that a lot of time whats on the label isnt actually in the bottle.

Supplements are not all created equally, and the price varies quite a bit, too, he said.

Dietary supplements are regulated by the FDA but as a food, not a drug, which means there is little oversight on health claims and ingredients.

How can a consumer make a good decision on which supplement to get? So, the first is to require that the product have third party lab verification for purity. So most supplements are safe. I think the bigger issue is that many supplements dont contain in the bottle what it says on the label.

In a statement to News4, the Council for Responsible Nutrition said, Overwhelmingly, dietary supplements are safe and play a valuable role in helping the more than 170 million Americans who take supplements each year to live healthy lifestyles. The industry is regulated by FDA, and the robust regulations give the government the ability to remove unsafe products from the market. Mainstream dietary supplement companies are invested in ensuring product quality as they have a stake in their customers health, and so we recommend that consumers look for reputable brands and buy from trusted retail sources.

One of the great resources for this is from the National Institutes of Health, their office of dietary supplements.

One of the main goals of DAdamos seminars, which he holds regularly, is to educate consumers and give them the tools to research claims and questions. The NIH Office of Dietary Supplements website has fact sheets for consumers and health professionals, as well as the labels of all the supplements in the U.S., and it provides detailed information on ingredients and blends.

In addition to consumers, many of the people in D'Adamo's seminars are medical professionals hoping to learn more.

All I know is about medications, nursing student Maria Garay said. They don't really give us any tips on dietary

Supplements, and when I ask my professors about those, they don't really know much.

DAdamo and the Council for Responsible Nutrition advise letting your doctor know what supplements you are taking and discussing with them what you learn.

Published at 5:42 PM EDT on May 9, 2017 | Updated at 7:23 PM EDT on May 9, 2017

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How to Choose the Right Dietary Supplement - NBC4 Washington

As more foods and supplements are being altered to meet the demand for healthier products, some people are experiencing side effects that are less than ideal.

Do you deal with frequent headaches or gas and bloating? What about more severe side effects, such as loose stool and abnormal bleeding?

Know what youre putting in your body. Below are food products that could be causing you distress.

Protein powders

With protein in the diet spotlight these days, more and more food companies are using whey or soy protein powders to load their products. Breads, pancake mixes, cereals, granola bars, protein bars and even ice creams are being beefed up with protein powder, providing us with an abundance of supplemental protein.

The problem with this fortification is not the increased protein intake, but the stress it puts on the digestive system. The processed quality of these protein powders, particularly the isolate forms, can cause uncomfortable gas and bloating.

The typical U.S. diet is not protein deficient, so to manage these symptoms ease up on the protein-fortified products. Eat foods that naturally contain whey protein such as low-fat cottage cheese and milk, cheese, and Greek or natural yogurt. Edamame, tofu and tempeh are natural foods that provide soy protein.

Sugar alcohols

If you drink or eat something sweet with zero calories, chances are it contains sugar alcohols. Because these non-digesting sweeteners are versatile and provide a very likeable flavor, they are in a variety of products. A small portion of sugar alcohols does not seem to cause harm, however in higher quantities they can lead to gas, bloating and even loose stools.

If you have been struggling with an upset stomach or gas and bloating, check the ingredient lists of everything you eat and drink. Look for words like mannitol, xylitol, erythritol and sorbitol, and start cutting back on the products that contain these sugar substitutes to relieve your symptoms. About 8 ounces of a 0-calorie drink seems to be an amount most people can tolerate.

Herbal mixes or proprietary blends

The Food and Drug Administration considers supplements, including those with herbal mixes and proprietary blends, to be non-food items. Therefore, there is no government regulation on these products. Herbals have been used for centuries as treatment, but in the wrong combinations or concentrations they can bring on negative health effects.

During my years of nutrition counseling, I have seen the discontinuation of certain supplements relieve chronic or frequent headaches, increased blood pressure, symptoms related to dry mouth and excessive bleeding from minor cuts and scrapes.

Before taking any supplement, make sure you know exactly what you are putting in your body.

Consult your physician with any concerns.

Link:

Food products that might be making you sick - Omaha World-Herald (blog)