- What is Bio-identical Hormone Replacement Therapy?
Bio-identical Hormone Replacement Therapy (BHRT) is a treatment for the symptoms of the menopause, and other hormonal conditions. The description “bio-identical” typically refers to hormones which are identical in molecular structure to hormones in the body. BHRT is typically advertised as an alternative to conventional non-bio-identical HRT. Conventional licensed hormone treatments are also often bio-identical but do not always advertise themselves as such.
- What is the difference between compounded and non-compounded HRT?
BHRT will often refer to a compounded form of HRT, involving bespoke treatments created by clinics, which are not routinely available.
BHRT is also offered in a non-compounded form, where the treatments are not individualised and tend to relate to more traditional means of treating symptoms of the menopause. These also tend to be licensed medicines. Non-bio-identical HRT will also likely come in an uncompounded form as a licensed medicine.
- Which claims are likely to be acceptable?
There is an established weight of scientific evidence that HRT, including BHRT, is effective in treating symptoms of the menopause. Therefore, straight-forward claims to treat menopausal symptoms using the therapy are likely to be acceptable.
- Which claims are likely to be a problem?
The Advertising Standards Authority (ASA) has previously considered claims that a product is “natural” to be misleading where the source of that product was natural but where the processes involved to make the product suitable for human consumption rendered that “natural” claim misleading (President Properties Ltd, 16 July 2014).
Whilst the ASA has not considered the use of “natural” for this type of treatment, there is a risk that a claim that the hormones used in bio-identical HRT are “natural” may be problematic because the hormones used in the therapy are not found in a bio-identical form in nature, but are synthesized from chemicals found in plant sources like yams and soy. Although derived from natural sources, the process of synthesis involved in developing the treatment may render a “natural” descriptor misleading.
The ASA and Committee of Advertising Practice (CAP) have not yet seen evidence to support claims that compounded HRT is more effective than uncompounded HRT or implied claims about the effectiveness of compounded HRT. As such claims like “we can tailor the treatment to your specific needs” are unlikely to be acceptable (Stratford Dermatherapy Clinic, 6 September 2017).
Claims that compounded HRT is safer than uncompounded HRT should also be avoided. The ASA understands that there are no requirements for safety testing for HRT in compounded form, meaning that the relative safety of bespoke forms of HRT is unknown.
Safety comparisons between uncompounded BHRT and uncompounded non-bio-identical HRT should be made with care. The evidence the ASA has seen to date only demonstrates the comparative safety in relation to the risks of developing breast cancer when BHRT containing progesterone is used. Marketers are therefore advised against making safety comparisons that go beyond this unless they hold a robust body of evidence (Stratford Dermatherapy Clinic, 6 September 2017).
- What about advertising specific HRT medicines?
Medicines must be licenced by the Medicines and Healthcare products Regulatory Agency (MHRA) before being sold and advertised. Treatment claims should accurately reflect the Summary of Product Characteristics (SPC) that accompanies the licence.
Marketers are reminded that if specific HRT medicines have been classed as prescription-only medicines they must not be advertised to the public (See CAP Advice on Healthcare: Prescription-only medicines).
- Is the menopause a medical condition?
Whilst the menopause itself is obviously not a medical condition, the ASA is likely to consider the symptoms of the menopause to be conditions for which medical supervision should be sought. Claims to treat those symptoms are likely to discourage essential treatment, unless that treatment is carried out under the supervision of a suitably qualified health professional.
Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the ASA. CAP’s AdviceOnline entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.
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