The Norwegian Consumer Authority’s guidelines for the marketing of traditional and complementary medicine

1. Introduction

The Consumer Authority supervises that traders’ contract terms and conditions and marketing directed at consumers do not violate the Marketing Control Act.[1]

The Consumer Authority shall also, in the interests of consumers, oversee that marketing by providers of traditional and complementary medicine (T&CM) complies with the Act relating to such treatment (the ‘Alternative Treatment Act’)[2] and the pertaining Regulations,[3] adopted pursuant to the Act’s Section 8 seventh paragraph.[4]

By issuing these guidelines, the Consumer Authority aims to give providers of T&CM a simple overview of the most important requirements that apply to the marketing of their activities and forms of such treatment. The Consumer Authority underlines that the guidelines are not regulations, and they are not exhaustive.

2. Delimitations

By ‘traditional and complementary medicine (T&CM)’ is meant health-related treatment that takes place outside the established health services and is not provided by authorised health care professionals. Treatment provided by the health services or by authorised health care professionals is nonetheless covered by the term ‘T&CM’ when it involves modalities that are primarily used outside the established health services, cf. the ‘Alternative Treatment Act’ Section 2 third paragraph. The term ‘health care professional’ is defined in the ‘Health Personnel Act’ Section 3.

That the Act only applies to health-related treatment means that, as a rule, beauty treatment, wellness treatment, personal development etc. will in principle fall outside the scope of the Act. The more detailed delimitation in relation to services that cannot be said to constitute ‘health-related treatment’ must be based on a concrete overall assessment.

The treatment is covered by the term ‘T&CM’ even if research exists that proves or indicates that the modality used has an effect that is significant to the patient.

In Market Council case 2014/1115, the Market Council agreed with the Consumer Authority’s argument that it is not relevant to the question of what is deemed to constitute T&CM whether documentation exists that shows that low level laser therapy (LLLT) has a positive effect on specific diseases and disorders.

The term ‘treatment’, as used in the Act, is wide-ranging. This means that it also covers situations that do not involve personal contact between the T&CM provider and the patient, for example distance healing. Correspondingly, a practice will also be deemed to constitute T&CM treatment in the sense of the Act if various tests, apparatuses or other aids are used.

In Consumer Authority cases 06/958 and 07/914, treatment using a flotation tank and a sunbed, respectively, were deemed to constitute T&CM treatment in the sense of the Act. The same was found in Consumer Authority case 08/834, which concerned a food intolerance test.

3. Marketing of traditional and complementary medicine

3.1 General information

The ‘Alternative Treatment Act’ applies to ‘persons offering or practising T&CM treatment in Norway’, cf. Section 2 first paragraph. The rules, including the Regulations to the Act, will apply as long as the treatment is offered or provided in Norway.

In Market Council case 2015/1837, the claimants argued that the marketing was not illegal because it was directed at foreign consumers. The Market Council did not agree. It referred to how the company was a Norwegian-registered foreign enterprise (NUF) with its registered address in Sandvika, and that it had branches offering laser therapy in several locations in Norway. The Market Council then stated: ‘The website is available to Norwegian consumers. The fact that the website is in English is not decisive, because the marketing is clearly directed at Norwegian consumers here in Norway.’

The provisions of the Regulations apply to advertising and marketing of any nature and in any media. In other words, the same rules apply to everything from marketing on business cards, stands, window posters in the place where the treatment is provided, advertisements in newspaper and magazines, TV advertising, online banner advertising, marketing via email/text message and via social media, such as blogs and Facebook. At the same time, the distinctive nature of the media may result in different assessments.

The main rule is that all information provided in the marketing is regarded as a statement made by the advertiser. The advertiser must therefore be able to answer for all the information used in the marketing.

In principle, the provisions of the Regulations will also apply to marketing that takes place in a treatment context. They apply in relation to the concrete treatment situation, for example if certain services or products are promoted, and in cases where the T&CM provider directs marketing at former patients or patients undergoing a course of treatment. A distinction must nonetheless be drawn between marketing and what is deemed to be treatment information that the T&CM provider finds it necessary to give to individual patients. The more detailed delimitation must be based on a concrete overall assessment.

The marketing shall be assessed on the basis of, among other things, the immediate impression created in the average consumer, cf. the Regulations Section 4.

All marketing must be presented as marketing, and consumers must immediately be able to distinguish it from editorial and entertainment material, cf. the Marketing Control Act Section 3 first paragraph.

Pursuant to Section 5 of the Regulations, the therapist’s name, address, telephone number and other necessary contact information shall always be clear from the marketing.

If the T&CM provider is a member of a providers’ organisation, the name of the organisation shall be stated.

Only persons registered in the voluntary Altbas official registry may use the designation ‘registered’ along with their professional title of T&CM provider, cf. the Alternative Treatment Act Section 8 fourth paragraph.[5]

The term ‘registered’ cannot be used in combination with certain titles or similar that give the impression that the person is authorised/licenced as a health care professional or that being registered entails official approval of the individual T&CM provider or modalities offered.

In Consumer Authority case 11/1711, the use of ‘off. godkjent’ (officially approved) in the title ‘Reg.off.godkjent HEALER MDNH’ was deemed to be in breach of the requirement for objectivity in the Regulations Section 2, cf. the Alternative Treatment Act Section 8.

3.2 Main rule, the Regulations Section 1 and Section 2 first paragraph

Section 1 sets out the purpose of the Regulations. It reads as follows:

‘The objective of these Regulations is to help to ensure that marketing of T&CM is carried out in an objective and factual manner and in a manner which helps to safeguard the patient’s safety.’

Section 2 first paragraph specifies that:

‘In marketing their activity, persons offering T&CM may only give an objective and factual description of the nature of that activity’

The term ‘nature of the activity’ is used to mean information of a more commercial nature, in addition to information about the different modalities the T&CM provider offers, what they entail and how they are carried out, as well as an objective description of the conditions they are used for.

Among other things, importance shall be attached to whether the marketing can contribute to taking advantage of people’s lack of knowledge, for example if information is withheld about any unfortunate harm or undesirable effects of the modality. Another example is if a T&CM provider emphasises his or her treatment as more suitable than other comparable forms of treatment.

Following a concrete assessment, it may also be deemed to be misleading if a T&CM provider does not inform the patient about religious elements that are included in or form the basis for the treatment, or within the context of which explanatory model or understandings of reality the treatment is provided.

That factual descriptions must be used in the marketing entails in particular a requirement that the marketing must not be designed in a way that, in an improper manner, undermines or weakens trust in the ordinary health service, health care professionals, other forms of T&CM or other providers of such .

In Consumer Authority case 15/1358, the Consumer Authority found that the marketing was in breach of the Regulations on several points. A blog post included a comparison between colloidal silver and antibiotics. In the Authority’s view, the comparison gave the impression that colloidal silver would be a more suitable product than approved pharmaceuticals in the treatment of specific diseases. Claims were also made that were capable of weakening trust in the ordinary health service. The marketing was therefore found to violate the requirement for an objective and factual description of the nature of the activity. The marketing also left the impression that colloidal silver could be used in the treatment of HIV, which was deemed to be in breach of Section 2 third paragraph of the Regulations. This prohibition is discussed in more detail in the next section.

3.3 Prohibition against the marketing of treatment against certain types of diseases, the Regulations Section 2 third paragraph

It is prohibited to market the treatment of diseases and disorders that T&CM providers are not entitled to treat, cf. the Alternative Treatment Act Sections 5–7.

These provisions prohibit providers of T&CM from performing medical procedures or treatment that can involve serious health risks, and from treating serious and communicable diseases hazardous to public health.

Serious diseases are typically diseases that are complicated to treat. A disease is more likely to be considered serious if the treatment must be provided by highly specialised health care professionals. Among other things, importance shall be attached to how painful the disease normally is, how sick patients suffering from the disease will normally be, whether the disease leads to functional impairment or disability, or whether the disease will lead to loss of important bodily functions or senses. The extent to which effective treatment is available in the established health services may also be relevant. This must be seen in conjunction with the normal prognosis for the disease if left untreated, and what consequences not receiving treatment will have for the patient. The following, among others, are considered serious diseases:

  • Amyotrophic lateral sclerosis (ALS)
  • Diabetes
  • Human immunodeficiency virus (HIV)
  • Cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Chronic kidney failure (uremia) or other organ failure
  • Multiple sclerosis (MS)

The prohibition against the marketing of T&CM treatment also applies to serious mental disorders. Serious mental disorders are characterised by highly specialised expertise being needed to diagnose and treat the disorder. Serious mental disorders may mean that patients are unable to look after themselves, or that patients are a potential danger to themselves or others.

The Regulations relating to Communicable Diseases Hazardous to Public Health,[6] adopted pursuant to the Communicable Diseases Control Act Section 1-3, contain an up-to-date overview of what communicable diseases are covered by the prohibition.

3.4 Design of the marketing

Pursuant to Section 2 second paragraph of the Regulations, persons offering alternative treatment may not make

‘claims that a T&CM modality is effective against specific diseases or disorders or in other manner formulate the marketing of their activity in a way which gives that impression

The more specific the conditions mentioned in the marketing, the more cautious one must be about describing what the treatment can achieve.

When assessing whether a marketing measure is in accordance with the Regulations, it is important to look at the relationship between the description of what the T&CM modality can achieve and the description of the condition the treatment can be used for. These two factors influence each other.

In order to decide whether a marketing measure is in accordance with the requirements set out in the Regulations, all aspects of the measure must be considered.

3.4.1 Description of what the treatment can achieve

It is important to be cautious when describing in the marketing material what the T&CM treatment can achieve, as it may easily come into conflict with the requirements for objective and factual claims (see above).

Some descriptions of what can be achieved are so strongly worded that they will, as a main rule, not be permitted in the marketing of T&CM, because they are capable of giving consumers the impression that the treatment has a documented or guaranteed effect.

Examples of such expressions include:

  • Effective
  • Effect
  • Heals
  • Cures
  • Removes
  • Treats
  • Gets well
  • Good results
  • Neutralises
  • Combats
  • Prevents
  • Counteracts

and words with a similar meaning.

In Market Council case 2005/13, the Market Council found, among other things, that it was in breach of the Regulations to say that thought field therapy has ‘very good results’ on many types of obsessive-compulsive disorders, a ‘fantastic effect’ on phobias and fear, that the treatment ‘is very effective in alleviating anxiety’ and can ‘cure’ tension headache.

Less strong and more neutral descriptions of what the T&CM treatment can achieve may be permitted, however.

Examples of words that may be permitted, depending on the circumstances, include:

  • used for
  • used against
  • experience of using
  • suitable for
  • reduces
  • alleviates

and words with a similar meaning.

Whether or not they are permitted will depend on the context they are used in, for example how specifically the condition they are linked to is identified. ‘Used for’, for example, can be permitted when it is accompanied by a general description of a condition, for example ‘used for muscular pain’. On the other hand, in the Consumer Authority’s view, it will be in breach of the Regulations to say that a T&CM modality can be ‘used for’ a specific disease or disorder such as ’pollen allergy’ or ‘asthma’.

In Market Council case 2005/13, the Market Council stated that it is in breach of the Regulations to say that one has ‘good experience of treating all types of trauma, such as childhood abuse, incest, random violence, domestic violence, shooting incidents, robbery, rape etc.

3.4.2 Description of conditions

It is important to exercise caution when describing what conditions T&CM treatment can be used for; cf. the prohibition stipulated in the Regulations against stating that such a modality is effective against specific diseases or illnesses.

Some descriptions of conditions are so specific that, in practice, it will be difficult to use them to market T&CM treatment without violating the provisions of the Regulations. This applies, for example, to medical diagnoses and more commonly used names of specific diseases and disorders, both physical and mental.

In Market Council case 2005/13, the Market Council prohibited the marketing of T&CM as effective against anxiety, depression, phobia and traumas. The Market Council reacted to the fact that the ‘top of the front page contains…links to headings such as “anxiety”, “depression”, “phobia”, “pain” and “trauma”, where the main message is clearly that thought field therapy has a positive effect on such disorders’.

In Market Council case 2014/1115, a prohibition was issued against marketing the treatment as effective against the following specific physical diseases and disorders:

  • allergies
  • arthrosis
  • periostitis
  • burns
  • bursitis
  • diabetic ulcers
  • facial paresis
  • fibromyalgia
  • frozen shoulder
  • golfer’s elbow
  • headache
  • sciatica
  • carpal tunnel syndrome
  • lower back pain (lumbago)
  • herniated discs
  • rosacea
  • tendinitis
  • tennis elbow
  • tinnitus
  • whiplash

Below is a (non-exhaustive) list of other diseases and disorders that are usually not permitted for use in marketing of T&CM:

  • asthma
  • sinusitis
  • candida
  • endometriosis
  • tonsillitis
  • shingles
  • cardiovascular diseases
  • hyperthyreosis (overactive thyroid gland)
  • hypothyreosis (underactive thyroid gland)
  • impingement syndrome
  • impotence
  • infertility (male and female)
  • chronic fatigue syndrome (CFS)
  • hypertension/hypotension (low or high blood pressure)
  • leukopenia
  • migraine
  • repetitive strain injury
  • myalgic encephalomyelitis (ME)
  • neuralgia
  • paralysis
  • plagiocephaly (flat head syndrome)
  • pollen allergy
  • disc herniation
  • runner’s knee
  • Schlatter’s disease
  • bursitis
  • tension headache
  • tennis elbow
  • urinary tract infection
  • otitis (inflammation of the ear)

More general descriptions of conditions will be more likely to be permitted. Whether or not they are permitted will depend on the context they are used in, for example how strong words that are used to describe what can be achieved with the treatment.

Examples:

  • back and neck problems
  • gastrointestinal problems
  • sore muscles
  • problems/ailments/pain/discomfort
  • indigestion
  • fatigue/weakness
  • impaired immune system
  • mental health problems

Each marketing measure must be subject to a concrete assessment, and there is a gliding transition between claims that are permitted and those that are not permitted in marketing.

3.4.3 The use of sources in marketing

The use of authoritative sources can easily be perceived as a claim that T&CM treatment is effective, and is generally not permitted.

Examples include scientific studies and research involving the therapist or the form of treatment in question. The same applies to statements, recommendations and conclusions from scientific journals, research institutions etc.

In Market Council case 2014/1115, the Market Council prohibited references to scientific studies, research and other research results to document the effect of the T&CM treatment. In the case in question, the company had cited and made extensive references to authoritative sources in marketing on the company’s website and Facebook page.

Statements in which health care professionals vouch for a T&CM modality can easily give the impression that it is effective. Such statements are not permitted in marketing.

Statements from satisfied customers, user surveys etc. that give the impression that treatment T&CM modality is effective against specific diseases or disorders are also not permitted in marketing. The prohibition also applies to references to articles in magazines, daily newspapers etc.

In Market Council case 2005/13, the Market Council prohibited ‘making reference to statements from satisfied customers or health personnel’. The same conclusion was made in Market Council case 2014/1115. In this case, the company had made reference on its Facebook page to an article in the Norwegian Back Pain Association’s members’ magazine – ‘Ryggstøtten’ – which contained a number of statements from satisfied customers who stated that the treatment they had received at the clinic in question had had a positive effect on, among other things, herniated discs and tendinitis.

It shall not be possible to bypass the prohibition against efficacy claims by making reference to sources outside the individual T&CM provider’s marketing.

Links to other websites will, as a rule, be considered part of the T&CM provider’s marketing. Such links should therefore be used with caution.

3.4.4 ‘The blacklist’

The Regulations relating to Unfair Commercial Practices,[7] also referred to as ‘the blacklist’, include a list of commercial practices, including marketing practices, that shall under all circumstances be considered unfair and thus also prohibited pursuant to the Marketing Control Act Section 6 first paragraph.

Section 1 (17) of the Regulations can be relevant in relation to the marketing of alternative treatment. Pursuant to this provision, it is prohibited to ‘falsely claim that a product is able to cure illnesses, dysfunction or malformations’.

Consumer Authority case 15/1358 raised the question of whether the company’s marketing was in breach of this provision.

3.4.5 Marketing of T&CM treatment of children

Chapter 4 of the Marketing Control Act contains special provisions relating to the protection of children. When marketing is directed at children, or may be seen or heard by children, particular care shall be exercised with regard to the impressionability, lack of experience and natural credulity of children, cf. the Marketing Control Act Section 19. If marketing of T&CM treatment is directed at children, it is likely to be illegal. Even in cases where children are not the target group for the marketing, consideration must be given to whether children may be exposed to the advertisement.

Marketing of T&CM treatment of children directed at adults that plays on a guilty conscience, fear or similar, is more likely to be found to violate the requirement for an objective description of the nature of the activity set out in the Regulations Section 2 first paragraph.

4. Supervision and sanctions

The Consumer Authority supervises non-authorised health personnel’s marketing of T&CM modalities, but may also have the competence to supervise the marketing of T&CM treatment provided by the health services or by authorised health care professionals, when it involves methods that are primarily used outside the established health services.

The Norwegian Board of Health Supervision (Statens helsetilsyn) and the county governors (Fylkesmannen) carry out general supervisory activities in relation to health personnel, including their marketing, cf. the Health Personnel Act Section 13. The supervisory responsibilities of the Consumer Authority and the Board of Health Supervision may therefore overlap.

The Norwegian Radiation Protection Authority (Statens strålevern), the Norwegian Food Safety Authority (Mattilsynet) and the Norwegian Medicines Agency (Statens legemiddelverk) also oversee regulations that may be relevant to providers of T&CM. The Norwegian Radiation Protection Authority stipulates requirements for lasers and enterprises’ use of lasers, while nutrition and health claims must follow the regulations that the Norwegian Food Safety Authority oversees. The Norwegian Medicines Agency oversees the advertising of pharmaceuticals.

No authority is responsible for supervising the actual activities of providers of T&CM, but unsafe treatment may be a criminal offence. Public prosecution may be instituted if this is in the public interest or by petition of the Norwegian Board of Health Supervision, cf. the Alternative Treatment Act Section 9 fifth paragraph.

The Consumer Authority shall seek to encourage traders to follow the provisions of the Marketing Control Act and other rules and regulations that the Consumer Authority supervises (Section 36).

In the event of a breach of the Marketing Control Act or other legislation we enforce, the Consumer Authority may decide to impose a prohibition (Section 40), orders (Section 41), enforcement penalties (Section 42) and, in certain cases, infringement penalties (Section 43), cf. the Marketing Control Act Section 39. The Consumer Authority’s decisions can be appealed to the Market Council (Section 37).

Decisions may also be directed at accessories (Section 39 third paragraph). The accessory liability includes natural persons, for example the general manager, chair of the board or board members of a company. It also applies to other companies that have contributed to the offences, for example advertising agencies that have assisted in designing the unlawful marketing material, and media or platforms that have communicated it.

In Market Council case 2014/1115, a decision to impose a prohibition was made and an enforcement penalty of NOK 100,000 issued to the general manager for complicity to the company breaching the Act and Regulations.

In Consumer Authority case 15/1358, the Consumer Authority sent letters to two media companies about the liability that rests on them in such cases.

Enforcement penalties (Section 42)

To ensure compliance with decisions made pursuant to Sections 40 and 41, an enforcement penalty shall be imposed on the person the decision concerns to be paid if the decision is not complied with (Section 42). The stipulation of enforcement penalties may be omitted if special circumstances so indicate.

The penalty may be stipulated as a lump sum, a sum per violation or as a running charge (e.g. per day or week until the trader complies with the decision).

The size of the penalty shall be decided based on a concrete assessment in each individual case. Emphasis shall be given to ensuring that it must not be profitable to violate the decision (Section 42 second paragraph final sentence). Other relevant factors in the assessment are the nature of the case and the defendant’s financial situation.

Infringement penalties (Section 43)

The Consumer Authority may decide to impose an infringement penalty in the event of infringement of e.g. the prohibition against unfair commercial practices in the Marketing Control Act Section 6, direct marketing in breach of the provisions of e.g. Chapter 3, and in the event of breach of the Regulations relating to Unfair Commercial Practices (Section 43). The conditions for imposing an infringement penalty is that the infringement is intentional or negligent, and that it is considered material or has taken place repeatedly.

A decision to impose an infringement penalty may be made on an independent basis, but it may also be made at the same time as a decision to impose an enforcement penalty pursuant to Section 42.

Like enforcement penalties, infringement penalties shall be stipulated on the basis of a concrete assessment in each individual case. An overriding principle is that the infringement penalty should be high enough to ensure that it is not financially profitable to breach the law. When stipulating the size of the penalty, consideration shall be given to, among other things, the severity, scope and effects of the infringement (Section 43 second paragraph).

Investigation and duty of disclosure (Section 34)

All persons are obliged to provide the Consumer Authority with the information it requires, and the Consumer Authority may also conduct investigations and demand that documents etc. be disclosed (Section 34).

To ensure that orders to disclose information are complied with, the Consumer Authority may stipulate an enforcement penalty (running charge or lump sum) that the person concerned must pay if the order is not complied with (Section 42 third paragraph).

Footnotes

[1] Act of 9 January 2009 No 2.

[2] Act of 27 June 2003 No 64.

[3] Regulations of 11 December 2003 No 1501.

[4] Previously fifth paragraph.

[5] See the Regulations relating to the voluntary registration scheme for practitioners of alternative medicine of 11 December 2003 No 1500.

[6] See the Regulations of 1 January 1995 No 100.

[7] Regulations of 1 June 2009 No 565. The Regulations were adopted under the legal authority of Section 6 fifth paragraph of the Marketing Control Act.

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