Therapeutic Claims: Guidance on Compliance with the Medicines Act
These guidelines are intended to provide advertisers and distributors with a practical interpretation of some aspects of current Medicines legislation to assist them in ensuring that their products and advertising comply with relevant legislation.
If the intention is to market products as dietary supplements, herbal remedies, nutraceuticals, cosmeceuticals, or cosmetic creams or balms rather than medicines, it is important to ensure they cannot be considered to be medicines as defined in the medicines legislation.
Because the composition, presentation and promotion of a product determine whether or not it is categorised as a medicine, it is important that companies make sure that their marketing strategy does not change the intended categorisation of their product to medicine. This is because it is unlawful to advertise or, with the exception of a few particular circumstances, supply a medicine that has not been approved for supply in New Zealand.
The Medicines Act 1981 is the legislation that defines and regulates medicines. In simple terms, a medicine is a product that is supplied and used for a therapeutic purpose. The term therapeutic purpose is defined in section 4 of the Medicines Act and includes (but is not limited to):
- Treating or preventing disease (including colds, influenza and parasites)
- Treating hair loss
- Assisting with general ailments such as pain and inflammation
- Effecting contraception
- Altering the shape, structure, size or weight of the human body
- Preventing or interfering with the normal operation of a physiological function
The term disease is further defined in the Medicines Act and includes any injury, ailment, deformity, disorder or adverse condition of body or mind.
In many cases a therapeutic purpose may be stated or implied in advertising material prepared for the product or on labels attached to the product. These are referred to as therapeutic claims. Other factors that can imply a therapeutic purpose include pictures, the product’s name or a product category statement at the retail outlet.
Therapeutic claims often include the following statements or combinations of words:
- Relieves; prevents; treats; a disease or symptoms of a disease or a disease state
- Increases; improves; enhances; a physiological condition or function
- Decreases; retards or slows the onset of a normal physiological condition or function
A therapeutic claim may also be made using the following statement types:
. References to method of treatment e.g. apply to affected area
. Mentioning that the product or any of its ingredients has been used traditionally for a therapeutic purpose
. Using testimonials or personal statements that refer to the product having a therapeutic purpose
. Information articles about disease prevention or other therapeutic purposes that includes a brand name of a product or an advertisement for a product on the same or facing page
. Informational websites with links to a product
. Quoting research or clinical trials
. Claims that the product assists in weight loss
. Claims that the product cures or prevents hair loss
. Claims that the product is an alternative to a medicine or group of medicines
The following terms generally indicate a therapeutic purpose for a product:
. Apply to the affected area
. Relieves the symptoms of….
. Temporary relief of…..
. Assists in the treatment of….
. May be useful for….
Examples of therapeutic claims
The following are examples of claims for a therapeutic purpose (this is not an extensive list).
Relieves arthritis or Relieves the pain associated with arthritis Relieves the symptoms of colds and flu Prevents winter viruses Treats eczema Soothing for burns and scalds Accelerates the healing of cuts and grazes Useful for cancer, diabetes, Alzheimer’s Disease Has antitumour; anticancer; antifungal; antiviral properties Boosts immunity Heart medicine A natural form of Viagra Assists with rapid weight loss (refer to Medsafe’s Guidelines for Weight Management / Weight Loss products)
Therapeutic claims only form part of a product’s presentation. The implication of a therapeutic purpose could be achieved or enhanced by accompanying pictures or even the product’s name. It is important to check all promotional material to ensure that there are no references to a therapeutic purpose. Promotional material includes any written or spoken words (including radio, TV and video material), product labels, product leaflets / instructions, in-store sales materials, websites, newsletters and direct promotion.
The addition of the qualifier may before the therapeutic claim or use of statements such as not intended to imply a therapeutic purpose do not negate a therapeutic claim.
Dietary Supplements and Cosmetics
Claims made for a product should be consistent with the relevant legislation.
If the product is intended to be marketed as a dietary supplement, any advertising must be consistent with the definition of a dietary supplement included in the Dietary Supplement Regulations 1985.
Products that are applied topically and are intended to be cosmetics need to comply with the Group Standard for Cosmetic Products (available from ERMA NZ, www.ermanz.govt.nz). In addition any claims must be consistent with the definition of cosmetic in the Medicines Act.
A claim that the product will help or support the body’s normal physiological processes and function may be acceptable.
Some examples include:
. For strong bones and teeth
. Contains antioxidants
. Supports the immune system
. Moisturises the skin
. Supports a healthy heart
. Aids the digestive system /aids digestion
A copy of the relevant legislation can be found at www.legislation.govt.nz or may be purchased from Bennetts Bookshops. The Advertising Standards Authority publishes its codes of practice and guidance on complying with these on their website www.asa.co.nz. Further advice can be obtained from the Therapeutic Advertising Pre-vetting System (TAPS) which pre-vets advertising material prior to publishing. This service attracts a fee. TAPS also publishes guidelines on the Association of New Zealand Advertisers website www.anza.co.nz. Further advice can also be obtained from a regulatory affairs consultant. A list of consultants is published on the Medsafe website ..\consultants.asp.
Information on the process for applying for consent to market a product as a medicine can be found in the Regulatory Section of the Medsafe website.