Legal Regulation of Dietary Supplement Advertising in Russia

 

April 16, 2019

BRACE Law Firm ©

 

Currently, the consumption of dietary supplements (the "Dietary Supplements") among citizens is quite popular. Despite their prevalence and presence in every pharmacy across the country, they often face criticism from both the media and supervisory authorities.

The number of diverse Dietary Supplements grows every year; therefore, this process must be clearly regulated at the legal level. Furthermore, the popularity of Dietary Supplements leads manufacturers to pursue active advertising policies. Advertising of Dietary Supplements is subject to high requirements established by law, as their use impacts human health.

The Russian Dietary Supplement market faces significant challenges regarding advertising campaigns. Due to a massive volume of unfair and misleading advertising, consumers develop incorrect attitudes toward these products. On one hand, a large segment of the population views them as miraculous remedies, perceiving them as equal to medicinal products; on the other hand, more people are becoming completely disillusioned after not receiving the expected effect.

Although current advertising legislation imposes several restrictions on Dietary Supplement advertising, various violations still occur in practice. Moreover, initiatives have repeatedly been submitted to the State Duma of the Russian Federation to restrict Dietary Supplement advertising by requiring it to be placed only in medical publications or within events intended for pharmaceutical and medical workers. However, such initiatives have been consistently rejected on the grounds that existing restrictions are sufficient.

Specifically, the following violations are widespread in the advertising of Dietary Supplements:

• Advertising Dietary Supplements as highly effective treatments for specific diseases.
• Presenting deliberately false information about the consumer properties of the supplements.
• Indicating an area of application that does not correspond to the entry in the State Registration Certificate.
• Failing to include, or incompletely including, information required by advertising legislation in materials promoting Dietary Supplements.

Legal Distinction Between Dietary Supplements and Medicinal Products

Federal Law No. 29-FZ dated January 2, 2000, On the Quality and Safety of Food Products establishes that Dietary Supplements are classified as food products and consist of natural (or nature-identical) biologically active substances intended for consumption simultaneously with food or for incorporation into food products (Article 1).

One of the criteria used to separate Dietary Supplements from medicinal products is a formal one: was the product registered as a medicinal product? Consequently, if such registration has not occurred, advertising for a product that is a Dietary Supplement cannot contain any reference to medicinal properties.

When comparing requirements for advertising medicinal products versus Dietary Supplements, it is important to note that Federal Law No. 38-FZ dated March 13, 2006, On Advertising (the "Law on Advertising") establishes a requirement for medicinal products to indicate the presence of contraindications (Article 24). Advertisers are exempt from this requirement if the advertisements are distributed at medical or pharmaceutical exhibitions, seminars, conferences, and similar events, or in specialized print publications intended for medical and pharmaceutical workers. This exemption also applies to other advertising where the consumers are exclusively medical and pharmaceutical workers. No such warning is established for Dietary Supplement advertising, indicating that the legislator views Dietary Supplements as products lacking medicinal properties.

Failure to comply with Dietary Supplement advertising laws by referencing medicinal properties misleads potential buyers into perceiving the supplement as a medicinal product. Regarding this issue, a decision by the Supreme Arbitration Court of the Russian Federation established that:

"...the document confirming the fact of state registration of a medicinal product is a Marketing Authorization. Meanwhile, if it is established that a specific preparation is registered as a food product, manufactured for the food industry and for sale to the public for consumption as food, and is not registered as a medicinal product, it is not a medicinal product. This precludes the possibility of referencing the medicinal properties of this product in advertising, including preventive properties".

Due to the above, it is also difficult for non-professionals to distinguish medicinal product advertising from Dietary Supplement advertising. Quite often, Dietary Supplement packaging mentions medicinal properties, which is an undeniable violation of the law. This creates confusion among consumers regarding the nature and purpose of Dietary Supplements and their difference from medicinal products. Consumers often expect the promised medicinal effect from Dietary Supplements, losing time while treating their illnesses, and after failing to receive the effect, they file complaints with government authorities.

For instance, in one arbitration case, the court established that an advertisement created the impression that a Dietary Supplement was a medicinal product and possessed a medicinal effect by mentioning a pathogenic bacterium that causes diseases. This, in turn, required therapeutic and preventive measures to prevent or treat the disease. The court also found that the impression created—that the advertised product was a medicinal product with a medicinal effect—was confirmed by the results of a sociological survey.

Legal Requirements for Dietary Supplement Advertising

Article 25 of the Law on Advertising establishes the legal requirements that Dietary Supplement advertising must meet. Specifically, advertising for dietary supplements and food additives must not:

1. Create the impression that they are medicinal products and/or possess medicinal properties.
2. Contain references to specific cases of people being cured or their condition improving as a result of using such supplements.
3. Contain expressions of gratitude by individuals in connection with the use of such supplements.
4. Encourage the abandonment of healthy eating.
5. Create an impression of the advantages of such supplements by referencing the fact of mandatory research required for state registration, or use the results of other studies in the form of a direct recommendation for use.

Furthermore, general provisions of the Law on Advertising also apply to Dietary Supplement advertising. Specifically, Article 5 defines general requirements, such as the impermissibility of unfair and misleading advertising and the prohibition of using images of medical and pharmaceutical workers in advertising.

However, enforcement practice shows that Dietary Supplement manufacturers frequently fail to comply with these statutory restrictions. Dietary Supplements are often unfairly sold as medicinal products, with information provided regarding their therapeutic properties. Deception primarily affects elderly individuals who, due to their age and lack of complete information, are ready to believe positive promises from manufacturers to strengthen their failing health or to "clutch at a straw" when facing a serious illness.

Accordingly, Article 25 of the Law on Advertising contains a provision requiring Dietary Supplement advertising to be accompanied by a warning stating that the object of advertising is not a medicinal product. This notice is intended to prevent citizens from being misled when choosing and purchasing Dietary Supplements regarding the ability of the preparation to cure existing diseases. Phrases indicating that a supplement can alleviate a patient's condition, relieve symptoms, or speed up recovery (i.e., act as a supplementary treatment during illness) are also prohibited. In other words, from a legal perspective, Dietary Supplements cannot be used to treat any diseases. Using phrases such as "Product A reduces the severity of a cough" or "Product B speeds up recovery" creates the impression that the supplement possesses medicinal properties and can be used for medical purposes, which is impermissibility.

Additionally, the Law on Advertising provides specific minimum frameworks for such warnings:

• In radio programs, the duration of the warning must be at least 3 seconds.
• In television programs and during film and video services, it must be at least 5 seconds and occupy at least 7 percent of the frame area.
• In advertisements distributed by other methods, the warning must occupy at least 10 percent of the advertising area (space).

In practice, these requirements raise a question: if an advertising article is published, how is this size determined? For example, if an article covers two pages—is the calculation based on the entire spread, including margins, or only the area occupied by the text and its accompanying images?

Existing regulations and judicial practice do not provide a definitive answer. However, a literal interpretation of Part 1.1 of Article 25 of the Law on Advertising suggests that the advertising area is the space directly occupied by the advertisement; therefore, margins should not be included when calculating the size of the warning label.

In addition to these requirements, a letter from the Federal Antimonopoly Service dated February 19, 2016, No. AK/10443/16, On Warnings in Dietary Supplement Advertising, explains that the warning area (the inscription) should be calculated based on an analogy with the "font point size" used in the publishing industry.

According to Industry Standard OST 29.130-97, Publishing. Terms. Definitions, approved by Order of the State Press Committee of Russia dated April 7, 1997, No. 39, "font point size" is understood as the font size corresponding to the distance between the top and bottom faces of the type. Type is a metal block with a raised image of a printed character used in typographic composition.

If an advertisement contains multiple objects of advertising, including a product that requires a warning, the size of that warning is calculated based on the total advertising area.

Violation of the above prohibitions when advertising medicinal products or Dietary Supplements, in addition to measures to counteract improper advertising, results in liability for the guilty parties. Based on the current version of Part 6 of Article 38 of the Law on Advertising, only advertisers bear liability for violating requirements for Dietary Supplement advertising. They may be held administratively liable for violating the Law on Advertising under Article 14.3 of the CAO RF (Violation of Advertising Legislation). The sanction for violating advertising legislation for medicinal products is an administrative fine:

• On citizens: from 2,000 to 2,500 rubles.
• On officials: from 10,000 to 20,000 rubles.
• On legal entities: from 200,000 to 500,000 rubles.

Case Law on Violations of Dietary Supplement Advertising Legislation

Violations of Dietary Supplement advertising laws frequently involve references to medicinal properties. When determining whether an administrative offense has been committed, it is vital to identify the intent of the advertisement distributor, who is liable for violating Item 6 of Part 5 of Article 5 of the Law on Advertising, to attract attention to the Dietary Supplement specifically as a means of exerting a medicinal effect.

Nevertheless, some dishonest advertisers violate these provisions despite all established restrictions. Paragraph 23 of the Resolution of the Plenum of the Supreme Arbitration Court of the Russian Federation dated October 8, 2012, No. 58, On Certain Issues of the Practice of the Application of the Federal Law On Advertising by Arbitration Courts, establishes that courts should consider that Dietary Supplement advertising can be found to create an impression of medicinal properties, especially if the advertisement contains the name of a disease (or its symptoms) and simultaneous mention of the product as a means of providing a therapeutic or preventive effect.

From the court's position above, it follows that:

1. Dietary Supplement advertising can be found to create the impression that they are medicinal products.
2. Dietary Supplement advertising can always be found to create such an impression if it includes the name of a disease (or symptoms) and simultaneously mentions the product as a therapeutic or preventive agent.

As a practical application of these clarifications, consider case A19-21340/2016, heard by the Arbitration Court of the Irkutsk Region. In this case, "Rossiyskaya Gazeta" challenged a decision by the Irkutsk Regional FAS regarding an advertisement for the Dietary Supplement "AD-Norma" for violating Item 1 of Part 1 of Article 25 of the Law on Advertising.

The advertisement stated:

"AD-Norma — PRESSURE IS NORMAL! The AD-Norma herbal complex normalizes blood pressure, strengthens vessel walls, and improves heart function. NOT A MEDICINAL PRODUCT. Advertising. Dietary Supplement. Ask at pharmacies!"

The FAS found that this text creates an impression of medicinal properties, but the court disagreed. The court noted that if an advertisement does not contain information about the names of any diseases (or their symptoms), it cannot be found to create an impression that the supplement is a medicinal product based on the criterion of mentioning a disease and a therapeutic effect simultaneously.

Thus, such advertising must be evaluated based on whether it creates an impression of a medicinal effect. The appellate court opined that the statement that the supplement "normalizes blood pressure, strengthens vessel walls, and improves heart function" cannot be viewed as indicating symptoms of a disease, as the condition corrected by the supplement may apply to healthy individuals voluntarily monitoring their health in the absence of disease.

A medicinal effect consists of exerting a specific impact on restoring functions disrupted or lost due to disease, preventing disruptions caused by disease, and strengthening the body's adaptive capacity toward such diseases. Consequently, the court correctly concluded that the Authority failed to provide evidence that the evaluated advertisement creates the impression that the Dietary Supplement is a medicinal product.

Enforcement practice shows that the lack of registration as a medicinal product (Dietary Supplements are not subject to such registration and do not undergo clinical trials) precludes the possibility of referencing medicinal and preventive properties in advertising. For example, the following advertisement was found improper:

"Having completed this simple course of cleansing and protection, you will not need to worry about your liver function. Free from 'waste' and toxins, it will continue to work at full strength, and you can continue to enjoy all the joys of life. Fatty food, smoking, alcohol, taking medication, and poor ecology will no longer be causes for concern — because your liver will be reliably protected".

In another case, the court examined the following text:

"...Nootrop establishes neurosensory connections in the brain, thereby restoring its normal functional state. Nootrop helps improve memory, attention, and thinking, and positively influences brain function. A course of the Nootrop complex will help not only improve memory but also overcome absent-mindedness and increase the brain's endurance against mental stress. It also contributes to getting rid of dizziness and ringing in the ears".

The courts of the first, appellate, and cassation instances established that the disputed text advertised Dietary Supplements as medicinal products that had not passed state registration as drugs. The court concluded that the Dietary Supplement "Nootrop" creates the impression of being a medicinal product with therapeutic properties (relieving symptoms: dizziness and ringing in the ears) and, accordingly, is capable of positively influencing the course of diseases such as neurosis, atherosclerosis, and ear diseases. However, "Nootrop" capsules are registered as a Dietary Supplement and are not a medicinal drug. Therefore, the courts correctly established a violation of advertising legislation under Article 14.3 of the CAO RF.

Another curious example was an advertisement for the Dietary Supplement "VITACARD," which contained the following text:

"A FAITHFUL HELPER FOR THE HEART! My heart often hurts, my pressure jumps, I am afraid of a heart attack. What will help me? Finnish scientists created a unique natural preparation VITACARD. Its components nourish the heart, normalize the functions of the cardiovascular system, protect against several diseases (ischemia, atherosclerosis, hypertension, heart attack), delay heart aging, a universal source of energy..."

According to the Moscow FAS, this advertisement contained references to medicinal properties and created the impression that the supplement was a medicinal product.

Another example is the advertising for the Dietary Supplement "Polyderm forte," distributed in the newspaper "Argumenty Nedeli" in July 2012 under the headline "Psoriasis and Eczema are Treated from Within," which stated:

"One innovative medicine already exists in the USA, but it is not yet registered in Russia. In our country, the PHARMAS pharmaceutical concern recently began production in very limited quantities of an analogous preparation, 'Polyderm forte.' It cures psoriasis and eczema, but getting the preparation is currently very, very difficult".

The FAS Russia concluded that this advertisement provides information creating the impression that "Polyderm forte" possesses medicinal properties for various diseases.

Notably, FAS Russia authorities classify advertising as containing references to medicinal properties even if it includes a direct statement that "the Dietary Supplement is not a medicinal product".

References to the effectiveness of a supplement can be direct or indirect. Indirect references do not link to a specific treatment result but follow from the interpretation of the text (e.g., "a summer without pain").

However, the positive impact of Dietary Supplements on the human body or the treatment of specific diseases cannot be entirely ruled out. According to Paragraph 2.1 of SanPiN 2.3.2.1290-03, Hygienic Requirements for the Organization of Production and Turnover of Dietary Supplements, Dietary Supplements are used as an additional source of nutrients to optimize metabolism in various functional states, to normalize or improve the functional state of organs and systems, to reduce disease risk, and to normalize gastrointestinal microflora. Nevertheless, Item 6 of Part 5 of Article 5 of Law No. 38-FZ establishes an absolute prohibition on referencing medicinal properties (i.e., a positive influence on the course of a disease) in advertising, except for advertisements for medicinal products, medical services, and medical devices. Thus, even if a supplement can positively influence the body or the course of a disease, the law does not allow such information to be displayed in advertising.

In another example from judicial practice, the Supreme Court of the Russian Federation remanded a case concerning the sale of Dietary Supplements to an elderly woman for 365,000 rubles. Lower courts had denied the plaintiff's claim to recover these funds and receive compensation for moral damages.

The elderly woman's claims were based on the fact that when purchasing the supplements (information about which she heard on the radio), she was misled by the seller: she believed she was purchasing medicine, not supplements. Furthermore, the supplements did not exhibit the promised medicinal properties and did not improve her well-being.

The Supreme Court disagreed with the lower courts, noting that Dietary Supplement advertising must not create the impression that they are medicines or possess medicinal properties, and the plaintiff's arguments regarding the failure to meet this requirement were not verified by the court.

Therefore, every person must understand that medicinal products and Dietary Supplements are different things with different impacts on the body. Manufacturers and dealers must recognize the seriousness of the preparations they release and must not mislead consumers with unfair advertising to increase turnover. For this reason, the legislator established specific requirements for the advertising of medicinal products and Dietary Supplements, and violations should result in strict punishment.

In conclusion, Dietary Supplement advertising will not create an impression of healing if it lacks references to specific diseases and indicates that the supplement is intended to maintain and improve the state of a healthy body.

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References

1. Deputies allowed advertising of medical services. Rossiyskaya Gazeta. June 23, 2014. Economy section.
2. Resolution of the Presidium of the Supreme Arbitration Court of the Russian Federation No. 867/08 dated May 20, 2008.
3. Resolution of the Arbitration Court of the Moscow District No. F05-653/2018 in case No. A40-39521/2017 dated March 12, 2018.
4. Decision of the Arbitration Court of the Irkutsk Region in case No. A19-21340/2016 dated December 15, 2016.
5. Resolution of the Federal Arbitration Court of the West Siberian District No. F04-1425/13 in case No. A03-7483/2012 dated April 29, 2013.
6. Resolution of the Arbitration Court of the North-Western District No. F07-4019/2017 in case No. A56-52545/2016 dated May 2, 2017.
7. Dietary Supplement advertising should not contain references to the medicinal properties of the preparation. Website of the Moscow FAS Russia. April 23, 2013.
8. Decision of the FAS Russia in case No. 3-00-57/00-08-12 dated May 28, 2013.
9. Decision of the FAS Russia on the violation of advertising legislation in respect of Bioresource LLC. Available on the website of the St. Petersburg FAS Russia.
10. Ruling of the Judicial Collegium for Civil Cases of the Supreme Court of the Russian Federation No. 5-KG17-146 dated October 10, 2017 // Garant Legal Reference System.

April 16, 2019