Advertising dietary supplements: prove that you are not lying!

What is allowed to advertise dietary supplements: European experienceE.A. Volskaya, O.Y. Alexandrova, I.M. Sechenov MMA

Remedium Magazine No. 5-2010

Currently, the attention of specialists in the European pharmaceutical and related markets is focused on the efforts of regulatory authorities to evaluate advertising claims related to food, including biologically active food additives. According to the current EU legislation, since recently, only those statements concerning the health of people who have been examined for authenticity and officially authorized by the authorized body can be used in advertising. In fact, we are talking about censorship of advertising of food products, the producers of which claim a place in the colossal health market.

The legal basis for a strict approach to restricting food advertising was laid down by Resolution No. 1924/2006 of the European Parliament and the Council of December 20, 2006. "On information on food products related to nutritional value and health." The adoption of this Resolution was largely due to the reaction of pharmaceutical market experts and the medical community to large-scale and rather aggressive campaigns to promote food additives through the very free use of advertising statements concerning human health.

The developers of the draft of this normative act of direct action proceeded, firstly, from considerations of public safety, the right of people to reliable information. Secondly, the concern of pharmaceutical market participants about the growing competition from food products, to which their manufacturers attributed medicinal properties, also played a certain role. It is enough to recall the trial that lasted for several years, which was conducted by the Association for the Struggle for Honest Advertising Integritas against the manufacturer of yogurt with the addition of St. John's wort, whose advertising assured of the soothing effect of this dairy product.

In such an environment, a resolution was adopted that surpassed similar regulations on the promotion of goods, including even medicines, in rigidity. Actually, one of the tasks of the Decree 1924/2006 is to protect the main privilege of medicines in the advertising field – the ability to talk about diseases, their treatment, prevention, etc.

The Sword of Damocles of Censorship4 years before the Resolution, European legislators had already attempted to regulate the promotion of food additives.

Then Directive No. 2002/46/EC "On the harmonization of the legal norms of the Member States in relation to food additives" was adopted. Article 6 of the Directive prohibited attributing dietary supplements in packaging design, labeling or advertising properties for the prevention, treatment or improvement of a person. This is how the principle of prohibiting the use of information related to diseases (disease related claims) in the promotion of dietary supplements was implemented. This opportunity is given only to medicinal and medical products. Dietary supplements and other food products were still able to be advertised only with the help of health-related claims (heals related claims).

However, this was enough for them. Perhaps the indirect effect of the Directive, the need to implement its norms into national legal acts weakened the expected effect. In any case, the manufacturers of dietary supplements turned out to have enough of the permitted arsenal to promote their products as able to preserve health. According to many experts, the connection with such a value as health is perceived by the population with greater willingness and loyalty than reminders of diseases in the advertising of medicines.

Resolution 1924/2006, developed taking into account the accumulated experience and current practice, dealt tangible blows to freedom of speech in the promotion of food. Not only dietary supplements, but all food products, the promotion of which is substantially based on preventive properties, and the image includes values associated with reducing the risk of diseases, have now come under this blow.

The main legislative requirement introduced by Resolution 1924/2006 is that information related to human health should be based on generally recognized scientific data and have an evidence base confirming their reliability (Article 6 of the Resolution). The decree states that health-related statements are allowed on the territory of the EU only after verification for authenticity, and those that speak of reducing the risk of diseases are subject to strict scientific examination. To ensure a unified scientific approach in assessing these claims, it will be produced by the European Food Safety Authority (EFSA). That is, a mechanism is being introduced to control the reliability of advertising statements and information.

Advertising statements that have not passed the reliability test are not allowed. "Statements related to health are prohibited if they do not meet the general requirements of this Resolution (Chapter 2), are not allowed in accordance with the procedure and are not included in the list of permitted statements," reads article 10 of the Resolution. For many manufacturers, this means not only repositioning their products, but also, under certain circumstances, abandoning their production.

The permitting procedure introduced by the Resolution is as follows. A manufacturer of a food product that wants to use any claims about health benefits in its advertising on the territory of the EU must submit an application to the regulatory authority of their country. At the same time, under the term "claim" (claim) The Resolution understands not only verbal statements, but also "illustrations, graphic elements or symbols in any form, through which it is explained, suggested or indirectly creates the impression that a food product has special properties" (Article 2 of the Resolution).

The application must contain a justification for the reliability of the advertising statement, including the evidence base. Namely, copies of research reports (analytical reviews), including, if possible, Peer-Review studies on health-related information, as well as any other materials that confirm that the approval meets the criteria of the Resolution (Article 15).

The Peer-Review method is the examination of scientific papers by independent experts of equal qualifications (so-called Peer) in order to confirm the quality of the scientific product.

National authorities form a pool of such applications and send them to the European Food Safety Agency. A special expert group verifies the evidence of the information sent and gives an opinion on the reliability of the statement relating to health, or its unreliability. By the term "statements related to health", the Resolution means "any information by which it is explained, suggested or indirectly creates the impression that there is a connection between a category of food, a food product or its component on the one hand and human health on the other hand."

In case of a positive decision, the expert group can give its recommendations or clarifications, for example, in what doses the substance acts or for which population the statement is true. The European Agency, based on the conclusions of the expert group, prepares registers of approved and rejected claims. These registers are approved by the European Commission in the form of resolutions and published in the official bulletin of the EU.

The relaxation is made only for the so-called other statements (not affecting the topic of reducing the risk of diseases). They may relate to the importance of a nutrient for growth, development, body functions, increasing the feeling of satiety or reducing hunger, if they are based on generally accepted scientific data and expressed in a form that the average consumer is able to correctly understand. Such statements may not undergo an examination and a full control and authorization procedure, but their lists must be submitted by the Member States to the European Food Safety Agency.

In addition to the licensing procedure, the Decree imposed direct restrictions on the dissemination of information and statements concerning human health in relation to food. According to article 12, the following information is not allowed:

a) information that gives the impression that refusal to consume this product may harm health;
b) information about the amount of weight loss for a certain period of time;
c) information with reference to the recommendations of individual doctors or representatives of medicine.

There are limited opportunities to refer to a reduction in the risk of developing diseases, namely, any information through which it is explained, suggested or indirectly creates the impression that the consumption of a category of food, a food product or its component significantly reduces the risk factor of developing a disease in a person (Article 2). In addition, all such statements must undergo a licensing procedure the labeling and advertising of the product should contain explanations that the disease that this risk reduction statement concerns is caused by several risk factors and that the reduction of one specific risk factor may have a positive value, but may not affect the development of the disease.

According to the Resolution, the EU Member States had to submit to the Commission lists of allegations with justifications by January 31, 2008. No later than January 31, 2010, a single European list of permitted statements related to health and disease risk reduction should have been published. But life has made its own adjustments: the Food Safety Agency and its expert group simply could not cope with a huge number of examinations in a relatively short time.

In fact, a total of 4,000 applications were received for examination at the same time. Meanwhile, it turned out that the examination of the reliability of statements and the evidence of the presented justifications is akin to the examination of the results of preclinical and clinical studies when registering medicines, in any case, experts use the same time-consuming methods and are guided by the principles of evidence-based medicine. Therefore, it was decided not to wait for the compilation of a single list, but to publish the results of ready-made examinations as decisions are made on the authorization and prohibition of approvals.

The general public saw the first results of the expert activity at the end of 2009, when 4 European Commission Resolutions on Permitted and Not permitted statements were published at once – under the numbers 983/2009 and 984/2009 (both dated October 21, 2009), 1024/2009 and 1025/2009 (dated October 29, 2009). These regulations are valid not only on the territory of the EU member States, but also on the territory of the EEC members.

Procrustean Bed of EvidenceThe titles of the Resolutions clearly define the subject of their regulation: two of them are called "On the authorization or refusal to authorize certain health-related statements about food products regarding the reduction of the risk of diseases, as well as the development and health of children" (Nos.983/2009 and 1024/2009).

Others are entitled "On the refusal to allow certain other health-related statements about food, in addition to statements about reducing the risk of diseases, as well as the development and health of children" (Nos. 984/2009 and 1025/2009).

The annexes to the Resolutions contain lists of permitted and not permitted statements. A total of 41 decisions were announced. Only 9 of them are positive, the rest are negative. For each decision, the Resolutions provide a clear justification based on the detailed conclusion of the expert group. At the same time, not only nutrients or substances are provided, but the trademarks of products and the names of their manufacturers.

The European Food Safety Agency, based on the conclusions of an expert group, recognized the proven effect of phytosterols, phytostanolesters, chewing gum with 100% xylitol in relation to reducing the risk of developing diseases; in relation to the effect on the development and health of children – alpha-linolenic and linoleic acids, calcium, proteins, vitamin D, phosphorus. However, in no case was there without instructions on how to include mandatory information in the labeling and instructions (Table).

Table. Permitted health claims

Among the rejected claims in the published lists, the majority related to the positive impact on the development and health of children. The following statements, in particular, were found to be unsubstantiated:

– dairy product with additives XXX – supports, stimulates and modulates the immune system of children in the growth phase;
– three servings of dairy product QQQ as part of a rational diet contribute to normal body weight in children and adolescents;
– dairy products (based on cheese and milk) promote healthy teeth in children;
– docosahexaenoic acid and arachidonic acid support the development of the nervous system of the eyes and brain;
– docosahexaenoic acid and eicosapentaenoic acid have a calming effect, contribute to the spiritual development of the child; ability to concentrate, thinking abilities;
– dairy product enriched with milk peptide and magnesia reduces the feeling of anxiety and fear in people prone to stress.

Claims regarding a number of foods containing lactobacilli have also been rejected. In particular, there is no evidence that dairy products fermented with lactobacillus helveticus reduce the increased tone of arterial vessels.

Attempts by manufacturers of dietary supplements for weight loss to justify their action with new scientific data were also rejected. One of the manufacturers stated in relation to their product, which includes conjugated linoleic acid, a mixture of plant extracts and cocoa extract, that "in clinical tests it was shown that the action of WWW manifests itself after 14 days. After 28 days, your whole figure will noticeably tighten, strengthen and acquire a beautiful silhouette." The EFSA's conclusion notes: "The specific effect of the product has not been sufficiently explained."

According to EFSA, a change in body shape is possible due to a decrease in the volume of fat deposits, in particular in the abdominal area, and a decrease in the fluid content in the body. Only the first factor has a positive effect on human health. A decrease in fluid in the body (except in cases of relevant pathologies) does not have a positive effect.

In randomized, double-blind, placebo-controlled interventional studies, which are referenced in the review, there is no proven causal relationship between the consumption of substances in the quantities in which they are contained in the food, and the duration of course consumption and changes in body weight, shape or volume of fat deposits." The manufacturer was denied permission for the desired statements and given a transitional period of 6 months to change the labeling and advertising of the product.

Forecast: return to the pharmaceutical market?So, the forecasts of pessimists among food producers working in the segment of maintaining health regarding serious problems have been justified.

Promoting your products in this blessed sector will no longer be easy. Many companies at one time developed whole lines of food products similar in properties attributed to them with preventive means, especially for healthy people. It has traditionally been more convenient to work in this segment: it promises greater profits than the drug market, due to its volume, does not require such significant investments in product development. At the same time, freedom of communication with consumers, the ability to manipulate concepts related to their own health and well-being of people, with such enduring values as children's health, are always able to ensure consumer loyalty and stable sales.

Now the situation has changed dramatically. The seriousness of the approach with which the EFSA experts undertook to assess the allegations left no doubt that unsubstantiated statements regarding health, maintaining the development of children, reducing the risk of diseases will sooner or later be suppressed. The evidence base, which is necessary to confirm the validity of the statements, as already noted, differs little from that required for medicines or medical products at the stage of their registration. Only for food, it will be required at the time of the start of the launch. That is, the difference is small. Even now, legal advisers recommend that food and dietary supplements manufacturers analyze the possibility of registering their products (in their new hypostasis) as means that can be easily promoted using concepts traditional for maintaining health and preventing diseases, i.e. as medicines or medical products.

In the summer of this year, the second "tranche" of EU regulations authorizing or prohibiting health-related statements for food products in the territory of the European Union and the EEC is expected. If its volume is significant, it will soon become clear how the new regulation will affect the market of food products presented as health products.

Portal "Eternal youth" http://vechnayamolodost.ru10.09.2010