This article specifically relates to the views of NHS bodies throughout the United Kingdom regarding Halal statuses of Vitamin D products.
Vitamin D is essential for healthy bones, and we get most of our Vitamin D from exposure to sunlight. Everyone needs Vitamin D to absorb calcium and phosphorus from their diet. These minerals are important for healthy bones. A lack of Vitamin D – known as Vitamin D deficiency – can cause bones to become soft and weak, which can lead bone deformities. For example, in children, a lack of Vitamin D can lead to rickets. In adults, it can lead to osteomalacia, which causes bone pain and tenderness. It has been suggested that Vitamin D deficiency has also be associated with many other conditions including diabetes, cardiovascular disease, cancer, MS, fertility, tuberculosis, muscle pain, tiredness and depression.
Vitamin D deficiency is very common. A recent survey in the UK showed that more than half of adults in the UK did not have enough Vitamin D. In the winter and spring months about 1 in 6 people have a severe deficiency. It is estimated that about 9 in 10 adults in the UK of South Asian origin may be Vitamin D deficient. Most affected people don’t have any symptoms or may suffer from tiredness; vague aches and pains but are unaware of the problem.
Vitamin D is needed for normal growth and development of bone in children.
Halal Treatments have spent the last year researching and gathering evidence about Vitamin D availability, in particular, independently officially certified Halal Vitamin D. Our findings have shown a lot of misunderstanding regarding the term Halal in the healthcare environment.
Internationally recognised guidelines regarding Halal Medicines and Supplements are very clear and thoroughly established. All raw active ingredients and excipients require individual Halal certification. They must be produced on a dedicated Halal production line, which is free from any possible form of contamination. The premises and the processes (production, QC and packaging as well as dispatch) must endure a rigorous and regular audit by a recognised Halal Certification organisation. Finally, the finished product will receive an official Halal Certificate that must be renewed annually to ensure on going Halal compliance.
NICE Guideline – Vitamin D increasing supplement use among at-risk groups
NICE, (National Institute for Health and Care Excellence) is a governmental organisation that produces guidance for healthcare professionals in England on all things medical.
In November 2014, NICE produced guidelines to promote the need for increasing Vitamin D supplement use among at-risk groups.
The guideline is for; commissioners, managers and other professionals with public health as part of their remit, working within the NHS, local authorities and the wider public, private, voluntary and community sectors. It is also aimed at manufacturers and providers of Vitamin D supplements.
The guidelines clearly outline who are considered most at-risk of Vitamin D deficiency including:
- All pregnant and breastfeeding women, particularly teenagers and young women
- Infants and children under 5 years
- People over 65
- People who have low or no exposure to the sun. For example, those who cover their skin for cultural reason, who are housebound or confined indoors for long periods of time.
- People who have darker skin. For example, people of African, African-Caribbean and South Asian origin.
Statistics show that the Asian and black population are very prone to Vitamin D deficiency. Half of the UK’s white population, and up to 90% of black and Asian population in the country are affected by Vitamin D deficiency.
Muslim women are shown to be particularly at risk. This finding has been supported by numerous studies around the world.
In the report, NICE emphasised the need for Halal options for prescriber’s of Vitamin D supplementation.
NICE definition of Halal
Halal refers to foods or non-food items such as cosmetics or pharmaceuticals permitted by and prepared according to Islamic law.
The key words in the NICE definition of Halal include “permitted by” and “prepared.”
This definition is in line with internationally recognised Halal standards for manufacturers of Halal medicines and supplements. It gives clear direction to healthcare professionals to seek and recommend officially certified Halal products that have been independently confirmed as being permitted and prepared in a Halal compliant manner.
Who is responsible for implementing the recommendations of the NICE guidelines?
In England, it is primarily the responsibility of Clinical Commissioning Groups (CCGs) to establish a Vitamin D supplementation policy and prescribing guidelines. They must use relevant NICE guidelines as a basis for their actions. General Practitioners and other healthcare professionals very much rely on CCGs and their Medicines Management Teams, to provide direction in this area. The role of the Medicines Management Team is specifically to dedicate their time to interpret and report on what NICE recommends and to relay those recommendations into their formularies for their CCGs and ultimately their healthcare professionals.
It is very important that the Medicines Management Teams have a clear understanding of the term Halal if they are serious about fulfilling their responsibilities outlined in the NICE guidelines.
Attitude of CCGs on Halal options
In the course of our research we encountered differing views and attitudes by NHS officials, Medicines Management Teams within Clinical Commissioning Groups in the United Kingdom regarding Halal Vitamin D products. Indeed, many local guidelines do not reflect directions given in the NICE guidance on Vitamin D and at-risk groups. Some Commissioning Support Units (CSU) that guide the CCG, have completely different attitudes when it comes to treating at-risk patients who follow specific diets/beliefs. One CSU in particular, has no Vitamin D options for patients that follow Halal diets and some have no plans to include a Halal option despite being familiar with the guidelines.
Some CCGs remain confused about the term Halal and the need for a product claiming to be Halal to be fully certified as Halal by a recognised independent Halal certification organisation. This is a concept that has been established in the food industry for decades so why the confusion amongst CCGs? Many NHS organisations still describe some non-certified products as being Halal and have been doing so for a considerable period of time. Some choose to attach a disclaimer to the formularies but this is absolutely unacceptable. Their description of products will form the basis of use/non-use of the products by practitioners and patients. Why don’t they simply ask for a product Halal certificate and check that the certifying body is recognised?
There are a number of officially recognised Halal certification organisations in the UK that can offer Halal certification of the finished product after rigorous checks of ingredients and manufacturing processes and sites. The Halal Monitoring Committee (HMC), The Muslim Food Board (TMFB), Halal Food Authority (HFA) and the Halal Authority Board (HAB), are just a few examples of the main recognised and respected Halal authentication bodies in the UK.
Many manufacturers claim Halal status for popular products but are NOT officially Halal certified for their finished products.
The Prescription Medicine Code of Practice Authority (PMCPA) case demands Halal Certification for Halal products and sets precedence.
The PMCPA recently considered a case against the manufacturer, ProStrakan who claimed Adcal-D3 Caplets were suitable for a Halal diet, without having prior official Halal certification. They ruled that official Halal certification is a prerequisite to claiming Halal status for any item used in a healthcare environment. It also concluded that only official certification could ensure that Halal products contained acceptable ingredients and were prepared in a Halal environment. This reiterates the ‘permitted and prepared’ clause in the NICE definition of Halal.
[Read more on the case – http://www.pmcpa.org.uk/cases/Pages/2481.aspx]
Summary of research
We contacted most NHS authorities in England, Scotland and Wales, many of who have high population of Muslim patients. We received a broad spectrum of differing opinions about Halal Vitamin D products on formularies. We provided them with guidance on the term Halal and evidence to support this.
Much of the following information we received has been provided by the CCGs under the Freedom of Information act (FOI).
London and the South of England CCGs
NHS authorities in and around London were keen to understand the Halal concept and were generally quick to change or remove any incorrect information that was attached to products on their formularies.
Some resistance to introducing an officially Halal certified Vitamin D option was demonstrated in Slough. We felt it necessary to provide evidence on Halal suitability of products and provided details of the 2011 Census information indicating a high Muslim population to demonstrate a need for an independently certified Halal option. Slough CCG chose to include an officially certified Halal option (Pro D3) as their main Halal option. The product Pro D3 appears to be the main Halal option for much of the London region.
However, there still remains a degree of misinformation about the Halal status of certain products. Some London CCGs still incorrectly describe products such as InVita D3 and Fultium D3 as being Halal but they are actively working to correct this.
Recent example – Camden CCG removed all information regarding Vitamin D products in order to redefine and to correctly upload information on Vitamin D products and their certified Halal status.
The Midlands have a high proportion of Muslim patients who are Vitamin D deficient. Despite this, some Midlands based CCGs remain reluctant to include an officially certified Halal option on their formularies. Many continue to incorrectly describe the Halal status of products on their respected formularies.
Birmingham Cross City CCG were directed towards evidence in considering Halal options and asked about the misinformation of Halal on their Vitamin D formulary. They failed to respond. Birmingham Cross City includes Fultium D3 and Densunin as their main formulary options. They incorrectly describe the non-Halal certified products Fultium D3, Hux D3, and BioVitamin D3 as Halal thereby misleading practitioners and ultimately Muslim patients.
Birmingham South City CCG have officially recognised Halal certified options like Pro D3 and Adcal-D3 but also again include products that are incorrectly labelled as Halal options such as Fultium D3.
Sandwell and West Birmingham CCG has declined to change anything on their formulary despite evidence provided regarding incorrect Halal status of their product options.
Walsall CCG has the correct status regarding Halal Vitamin D products on their formulary. Walsall CCG has also removed any reference to the term Halal incorrectly attached to non-Halal certified products.
Dudley CCG has not considered any Halal option on their formulary and is not planning on updating their local guidance any time soon.
Leicester CCG and its surrounding CCGs of the region have at least one recognised and certified Halal option with Pro D3 being the most prominent, and have removed/in the process of removing any Halal references to other products such as Hux D3 (which was formerly advertised as Halal).
Solihull CCG responded by insisting that they consider Fultium D3 as their Halal option despite receiving evidence to the contrary.
Wolverhampton CCG and Stoke CCG have no reference to the term Halal on their formulary.
Scotland and Wales NHS authorities
Wales have their own National Formulary. Within this formulary they consider Pro D3 (correctly) and Hux D3 (incorrectly) as their Halal options for Vitamin D prescriptions. However, they are more inclined to be part of the Healthy Start scheme.
Scotland also has a separate National Guideline and a Scottish National Formulary. They agree that there should be an official independent certification organisation for Halal medication or in this case supplementation. NHS Scotland and local Scottish CCG authorities agree that products such as Hux D3 and Invita D3 that appear on their formulary should not be considered as Halal as they have not achieved full official Halal certification for a finished product. They concluded that products officially Halal certified finished product like Pro D3 and Adcal-D3 should be the only Halal options. NHS Scotland understands that having one certified Halal ingredient in a product does not make the entire product Halal. However, they stressed that they are not under the jurisdiction of the NICE guidelines and ultimately do not consider introducing a Halal option a priority at present.
NHS Forth Valley and NHS Dumfries & Galloway have stated their desire to add ONLY official independent certified Halal options to their formularies.
The general consensus from NHS Scotland authorities was that “NICE applies directly to England, however in Scotland they will take careful note of the guidance.”
North of England CCGs
Yorkshire, Lancashire and Greater Manchester based CCGs with a high proportion of Muslim patients have been quick to update their guidelines and formularies. Non-Halal certified products such as Hux D3 have been categorised as not Halal on many formularies throughout the region to correct previously misleading information.
Salford CCG, Bradford CCG, Bury CCG, Bolton CCG, Heywood, Middleton & Rochdale CCG, Sheffield CCG, Vale of York CCG, Wigan Borough CCG and Oldham CCG along with South Manchester CCG, North Manchester CCG and Central Manchester CCG include the officially certified Halal option Pro D3 as its Halal certified option.
Greater Manchester Medicines Management Group (GMMMG) is in the process of updating information regarding the Halal status of popular Vitamin D products on their formulary.
Many Vitamin D manufacturers are incorrectly claiming their products are Halal without being officially certified by an officially recognised Halal certification organisation. These products include, Fultium D3, Aviticol, Accrete-D3, Plenachol, Hux D3 and InVita D3.
A few have some Halal credentials such as a Halal certified active ingredient or Halal certified capsule shells, but having one aspect of your product as certified Halal DOES NOT make the entire and finished product a Halal product.
Aviticol had initially stated their ingredients clearly, but once questioned about a Halal certificate, their response was swift and quite prompt with a simple, “no Halal certification has been sought for Aviticol.”
Hux D3’s manufacturers had confirmed that the products ingredients were Halal compliant but had not sought Halal certification for them and informed us that their product was NOT being manufactured in a dedicated Halal facility.
The manufacturers of Plenachol claim their product is Halal certified. They appear to have purchased their Halal certificate using the Internet based Halal Certified Association (HCA) [http://www.Halalcertified.org.uk/].
HCA boast an image of Calpol® on their webpage which makes the reader assume that they have certified Calpol® as Halal. We contacted the manufacturers of Calpol®, Johnson & Johnson Limited, they made it perfectly clear that Calpol® is NOT Halal and that the HCA should not have an image of Calpol® on their website.
HCA offer a three-day Halal certification service without any form audit or monitoring which completely contradicts the well-established requirements of ANY recognised Halal certification organisation.
The CEO of the Halal Foods Association (HFA) stated that, “…it is very shocking to see that individuals and organisations operate in this manner to sell Halal certificates.” He further stated that, “I am sure that the Halal certificates issued by Halal Certified will be unacceptable to mainstream and export Halal markets. It appears that national or global recognition is also unlikely for this type of modus operandi…”
The manufacturers of Plenacol, a licensed product may have been mislead into believing that their product is Halal however it is our opinion that they should withdraw their Halal status claim in its present form. The Halal claim for their product is outside the officially approved Summary of Product Characteristics (SPC) for this licensed product and should be made without official approval.
Furthermore as previously stated the PMCPA case regarding Adcal-D3 (ProStrakan) clearly demonstrates that promoting a product as being Halal compliant without official certification by an officially recognised Halal certification organisation is contrary to accepted practice. At the time (2012), ProStrakan had NOT obtained Halal certification from a recognised Halal certification organisation.
ProStrakan recently informed us that they have obtained a Halal certification (May 2015) from a recognised Halal certification authority for ONE of the licensed Calcium and Vitamin D variants in their range.
ProStrakan’s Adcal-D3 Vitamin D Caplets can be considered Halal, however it has been consistently commented that the calcium content of this product may be a barrier to using this licensed product as a Halal certified first line option.
The manufacturers of the Pro D3 range, confirmed that they have been accredited with an officially recognised Halal certificate by the UK based Halal Monitoring Committee (HMC) and that HMC have certified their finished product, production facility and processes as being Halal. All products in the Pro D3 range are Halal certified.
Advice for Practitioners
The Royal College of General Practitioners (RCGP) recently conducted a presentation to its members. [RCGP Presentation]
The presentation went into great detail regarding what Vitamin D is, why it is needed and analysing three very descriptive case study scenarios.
Doctor Sally Higginbottom, created this presentation with the NICE November 2014 updated Vitamin D guidelines in mind, going into detail on certain Vitamin D treatments with particular regard to the Halal status of popular Vitamin D products. Within the presentation, Dr. Higginbottom considers the Halal status of the three most commonly used Vitamin D products, Hux D3, Pro D3 and Fultium D3. It is often thought that all three of these popular products have achieved official certified Halal status but as Dr. Higginbottom states regarding Hux D3, “Beware this is non-Halal” and confirms that Pro D3 is the only Halal option amongst the three products.
It is disappointing that there remains a misunderstanding about the term Halal and the Halal status of products used within the NHS. It is shocking to see that some CCGs with a high proportion of Muslim patients for example, Birmingham Cross City CCG continue to ignore providing accurate information about Halal Vitamin D options.
The PMCPA case clearly demonstrates that official Halal certification is a prerequisite to claiming Halal status. Too many manufacturers are exploiting the Halal term for a quick return and clearly our practitioners are not being informed on the differences between Halal and non-Halal products. NICE have given manufacturers recommendations on what their products need to follow in order to comply to a Halal diet. It about time that misinformed Medicines Management Teams and CCGs and other NHS authorities take note of the guidelines and update their formularies with the correct information.
If the Medicine Management Teams and CCGs do not act, then who looks bad? The health professionals? The GP? The Pharmacist? Patients trust and rely on health professionals to prescribe and recommend medication and supplementations, and these health professionals should have the necessary information and guidance to be able to prescribe and recommend medication and supplementation in accordance with patients’ beliefs to ensure compliance.
Check back very soon and read our article on how some cosmetics manufacturers attempt to exploit international markets with their implied “Halal” certification.