Background
This Ruling forms part of a wider piece of work on advertising claims about the health benefits of intravenous nutritional therapy (IVNT), identified for investigation following complaints received and intelligence gathered by the ASA. See also related rulings published on 20 December 2023.
When the ASA received the complaint the advertiser’s registered company name was The IV Clinic (NW) Ltd. During the course of the ASA’s investigation the registered company name was changed to GMG Pharmacy Ltd.
Ad description
The website for The IV Clinic, www.iv.ghoshmedicalgroup.com, seen 1 April 2019, featured a section on its homepage titled “IV DRIPS MENU” which listed the intravenous (IV) drips services it offered: “ANTI-AGEING Hair, Nail & Skin Support”; “GLUTA GLOW Brighter, Clearer Skin”; “THE RED CARPET Hydration & Energy”; “DIET & DETOX Detox/Fat Burning”; “BODY BUILDER Muscle Builder”; “AFTER FIGHTER Muscle Recovery”; “PRE-FIGHTER Energy Release”; “THE BURNER Burst of Energy”; “CLASSIC MYERS’ The original IV”; “IMMUNO-BOOST Immunity Support”; and “THE CALMER Calm your mind”. Hovering the cursor over the name of each drip brought up additional claims about its health benefits.
Issue
The complainant challenged whether the claimed health benefits of the IV drips were misleading and could be substantiated.Response
GMG Pharmacy Ltd t/a The IV Clinic said the IV drips they used were manufactured by the company IntraVita and contained high doses of vitamins and amino acids naturally present in the human diet. They provided a copy of the IntraVita training manual and a Public Health England document titled Government Dietary Recommendations, which laid out government recommendations for energy and nutrients. The IV Clinic said they conducted full blood tests for patients before recommending an IV drip and only highly trained staff administered the drips.They said that GMG Pharmacy Ltd no longer provided IV drips to the general public; the service was instead provided by Ghosh Medical Ltd, trading as Ghosh Medical Group. They had made amendments to Ghosh Medical Group’s advertising as a result of the ASA’s investigation.Anti-Ageing dripThe IV Clinic said the Anti-Ageing drip contained biotin (vitamin B7), which research had indicated could encourage healthier hair, nails and skin. They did not provide further details of the contents of the drip, although the ad suggested it contained biotin and proline. To support the advertising claims they provided copies of four studies, six literature reviews, a medical journal article and a news article, which variously related to vitamin B7, B vitamins generally, vitamin C, amino acids (particularly leucine), magnesium, calcium and lipoic acid.Classic Myers’ dripIn relation to the Classic Myers’ drip, they said studies showed that B vitamins could help boost energy levels. They said the drip contained vitamins B2, B3, B5, B6 and B12, magnesium chloride-hexahydrate, calcium chloride-dihydrate, calcium chloride, sodium selenite-pentahydrate and zinc. In support of the advertising claims they provided a journal article about the history of the Myers’ Cocktail (an IV infusion developed by a US physician), a report of a randomised controlled trial (RCT) relating to the Myers’ Cocktail and an RCT relating to zinc magnesium aspartate (ZMA). They also provided a review of evidence regarding how levels of selenium might affect different types of immunity.Immuno Boost dripIn relation to the Immuno Boost drip, they said research suggested that when an individual was deficient in vitamins such as C, D and A, their immunity might be compromised. They said the drip contained vitamins B1, B2, B3, B5, B6 and B12, and lysine, cystine, ornithine and taurine. They provided two RCTs, an in vitro study, a literature review and a journal article. They also provided an observational study on the effects of IV vitamin C on the quality of life of cancer patients, and a review of evidence relating to the role of vitamin C in infection and immunity.Gluta Glow dripThe IV Clinic said the Gluta Glow drip contained ascorbic acid (vitamin C) and glutathione. They referred to the literature review relating to the role of vitamin C in skin health referenced above in relation to the Anti-Ageing drip and provided copies of an RCT and literature review relating to the use of glutathione for skin lightening.Red Carpet dripThe IV Clinic did not provide details of the contents of the Red Carpet drip, although they provided one RCT and three literature reviews, relating to collagen and proline, water, and vitamins B6, B9 and B12, in support of their advertising claims.Diet & Detox dripThe IV Clinic also did not provide details of the contents of the Diet & Detox drip, although the ad referenced “a blend of nutrients, vitamin[sic] and amino acids”. They provided a copy of an article about the medical management of constipation, a review of research into amino acid supplementation and metabolic health, and a review looking at the role of the amino acid arginine in the body.Burner dripThey also referred to the review looking at the role of arginine in the body in relation to the Burner drip, as well as: copies of two conference papers that summarised evidence relating to the metabolic roles of the amino acid leucine and its potential role in weight loss diets; a review of evidence relating to niacin as a treatment for lipoprotein abnormalities; and a meta-analysis of evidence relating to the effects of inositol supplementation on lipid profiles in people with metabolic diseases.Body Builder dripThe IV Clinic said the Body Builder drip contained vitamins B1, B2, B3, B5, B6 and B12, and lysine, leucine, isoleucine, valine, glycine, carnitine and methionine. They provided copies of two RCTs, which looked at the potential role of leucine-rich amino acid supplementation in addressing muscle wasting in the elderly, and a study which investigated indicators, other than BMI, for the propensity for obese women to develop metabolic disorders.Pre-Fighter dripThey did not provide details of the contents of the Pre-Fighter drip, but referred to the previously referenced review looking at the role of arginine in the body and a RCT looking at the effect of ZMA supplementation in resistance-trained men, as well as an article summarising the role of folate (vitamin B9) in the body and the levels required to avoid deficiency.After Fighter dripWith regard to the After Fighter drip, they did not provide details of its contents, but provided copies of a study looking at the effects of a topical gel containing hyaluronic acid and amino acids, and an RCT which investigated collagen and muscle protein synthesis after exercise that they had also provided in relation to the Red Carpet drip.Calmer dripThey did not give details of the contents of the Calmer drip, but provided an RCT which investigated the role of dopamine in depression, and a study looking at resistance to seizures in mice that were fed taurine.Assessment
UpheldThe ad described 12 IV drips offered by The IV Clinic, including a range of claims about the health benefits provided by each drip. In the descriptions of the drips, the ad also included claims about the role that some of the specific substances in the drips played in the body and the health benefits they provided. The ASA considered that consumers would therefore understand that the health benefits associated with those specific substances would be provided by the described drip.We considered that the average consumer who viewed the web page relating to the advertiser’s IV drips, and to whom the claims were clearly addressed, would be generally healthy, but interested in products which might support or enhance specific aspects of their health and wellbeing, or support their preparation for or recovery from specific events, including intensive exercise. We considered those consumers would have some understanding that the body required certain levels of vitamins, minerals and other substances to support its normal functioning.We noted that the ad included a section at the bottom of the web page, headed “A NUTRITIONAL APPROACH TO IV THERAPY” which included the subheadings “How Effective Is an IV Drip?” and “What Are the Benefits?”. Bullet points summarised the health benefits that were referred to in the descriptions of the individual IV drips. Text stated that the drips contained vitamins, minerals, antioxidants and amino acids which could not be produced by the body on its own (known as ‘essential nutrients’), that “Maintaining a healthy, balanced diet is difficult, leaving many people lacking in some essential nutrients”, that “up to 85%” of the active ingredients of oral supplements were rendered “useless” by the digestive process, that IV drips achieved “up to 100% absorption and at a much higher level of concentration” and that “By the time illness, disease or tissue damage manifests, it is often too late for oral vitamins & minerals to make an effective change for the better. Intravenous […] therapies provide the quickest route to provide the bodies[sic] cells with maximum nutrition to achieve optimal cell health”.IV drips were delivered via an invasive method which we considered consumers would generally associate with medical uses, and single drips were offered by IV clinics in the UK at prices generally ranging from around £100 to around £400. At the time the ads were viewed, The IV Clinic’s prices ranged from £180 to £550 for a single drip. In that context, and in the context of the claims referenced above, we considered consumers were likely to expect that an IV drip was an instantaneous, and therefore more effective or superior way, of delivering essential nutrients to normally healthy people than other methods (such as through diet or regular oral supplementation) and therefore would also provide superior health benefits more quickly than the same nutrients administered through such other methods.We considered consumers would understand that the nutrients delivered via a single IV drip would result in a one-off increase in the availability of those nutrients to be utilised by the body, whereas diet and oral supplementation provided a daily regular, ongoing source of those nutrients. However, consumers would be unlikely to have knowledge of how long the various nutrients administered via a single IV drip would be available for utilisation by the body or how long the claimed health benefit might therefore last. As a result they were likely to base their understanding of how long the health benefit might last on information in the ad, where relevant information was included. This could include, for example, references to a course of drips or recommended frequency of administration, the overall impression created by the claims, the name of the drip or other elements of the ad.We understood that human nutritional needs were complex, requiring different amounts of different nutrients at differing frequencies to ensure normal functioning of the body, and these needs varied from person to person depending on a range of factors such as biological sex, age, levels of physical activity and so on. Human nutritional needs were answered through diet and, in the case of vitamin D, exposure to the sun.We took expert advice on what type and standard of evidence would be relevant to claims about the health benefits of IVNT drips.The expert firstly referenced evidence for advertising claims about the health benefits of IVNT drips which did not include that IVNT would provide superior health benefits compared to diet or oral supplementation. For such claims, they advised that evidence relating to the health benefits of oral supplementation could be relevant to support claims relating to IVNT. Such evidence would, however, have to provide robust evidence of the correlation between a particular dose of a nutrient (i.e. the quantity provided, frequency of provision and duration of provision) and a particular health benefit. The IVNT drip would have to be of the same or greater dose than the oral supplement. The advertiser would have to demonstrate that the particular formulation of the drip did not include other nutrients or components which could adversely affect the effectiveness of the key nutrient (e.g. amino acids that bound to zinc or copper). They would also have to demonstrate that interaction with the gut microbiome was not necessary to achieve the health benefit, which may be the case for some nutrients such as polyphenols and glucosinolates.The expert secondly referenced evidence for advertising claims that IVNT would provide superior health benefits compared to other methods of administration of the same nutrients such as through diet or oral supplementation. IV administration would achieve peak plasma concentrations of a substance more quickly than oral administration, although the speed at which this was achieved would vary between nutrients. It also achieved 100% bioavailability under the pharmacological definition (the fraction of the administered drug that reached the systemic circulation), but there was a lack of consensus as to the definition of bioavailability in relation to nutrients. Consequently, they considered there was not sufficient evidence to support assertions that IVNT offered superior bioavailability compared to oral administration for all nutrients.For claims that IVNT would provide superior health benefits to other methods of administration, they advised that evidence would need to relate to the immediate and superior efficacy of the specific drips the advertiser sold, or substances contained in them. Such evidence would ideally consist of appropriately designed RCTs comparing the health benefit effects of IVNT with a placebo drip and with oral supplementation with the same formulation and at the same dose. Alternatively, such evidence could consist of appropriately designed observational studies comparing reported or measured health end-points of users of IVNT with individuals who routinely took the same nutrients in a different form, at similar doses. Those studies would also have to be adequately controlled in terms of inclusion criteria and other likely mitigating variables. Such evidence should have clinically significant outcomes that were directly relevant to the health benefits claimed in the advertising. Evidence relating to the health benefits of regular oral supplementation would not be sufficient, but evidence relating to intramuscular injection could be, as its mode of delivery was similar to IV drip.The expert further advised that evidence relating to the effects of nutrients on individuals suffering from a deficiency of that nutrient would not be relevant to claims about the health benefits of IVNT in normally healthy individuals, regardless of the method by which the nutrient was administered. Evidence relating to the effects of nutrients on individuals suffering from a medical condition that was not a nutrient deficiency could be adequate to support claims about the health effects of IVNT, whichever method of administration was used. However, such evidence would have to show that the provision of the nutrient led to improvements in a measure that was not related to the medical condition or to symptoms caused by side effects of any ongoing medical treatment. The expert understood that such evidence was likely to be scant.The ASA understood that IV administration delivered 100% of a nutrient to the systemic circulation and achieved peak plasma concentrations more swiftly than via oral supplementation. However, we understood that the speed at which peak plasma concentration would be achieved varied between nutrients, and that a range of other factors, including the composition of the particular IV drip formulation, could affect the body’s use of those nutrients and the delivery of any health benefits.We considered the type and standard of evidence we would expect to see, taking into account the context of how consumers would interpret the advertising claims as outlined above: that IVNT would provide a superior way of delivering essential nutrients to normally healthy people than other methods and therefore would also provide superior health benefits more quickly than the same nutrients administered through such other methods.We therefore expected to see evidence which related to the immediate and superior efficacy of the specific drips sold by the advertiser, or drips with the same formulation and dosage as referenced in the ad (including regularity of administration), preferably in humans who were normally healthy. Evidence relating to people with a clinical nutrient deficiency or which examined the effects of a nutrient as a treatment for a medical condition would not be relevant to advertising claims directed at generally healthy consumers. Evidence relating to people with a medical condition would only be relevant if it clearly established that the measures by which health benefits were assessed were unrelated to either the medical condition or to symptoms caused by associated medical treatments. We expected all evidence, whether consisting of RCTs or observational studies, to be methodologically robust with clinically significant outcomes that were directly relevant to the health benefits claimed in the advertising.The IntraVitra training manual provided by The IV Clinic included references to evidence which related to the health benefits of substances included in their drips. However, a section of the manual, titled Efficacy, stated “Evidence of intravenous nutrient therapy (IVNT) efficacy is based mainly on anecdotal clinical experience with limited clinical trial publications on combination intravenous micronutrient therapy in peer review [sic] journals”. It then briefly summarised evidence which related to the use of IVNT in treating the medical conditions fibromyalgia, asthma and cardio-vascular disease, and of oral supplementation in aiding wound healing. As referenced above, we considered that evidence which related to use of a nutrient as a treatment for a medical condition, including by oral supplementation, was not relevant to the claims in The IV Clinic’s advertising, which related to the efficacy of IVNT in normally healthy individuals. We further considered that anecdotal accounts of clinical experience were not adequate to support claims that IVNT had immediate and discernible health benefits for normally healthy individuals.In addition to documentation provided by The IV Clinic in support of their advertising, we also reviewed other relevant evidence we had seen which related to the claims in their advertising.Anti-Ageing dripThe description of the Anti-Ageing drip stated “Hair, Nail & Skin Support. Maximum support for collagen and elastin, helping to nourish, rehydrate and leave you with great looking skin. Biotin is used for strengthening hair and nails – excellent for those worried over thinning hair or brittle nails. Proline helps the body break down proteins for use in creating healthy cells in the body. It is essential to the development and maintenance of healthy skin and connective tissues […]”. We considered consumers would understand from those claims that the drip would have a general anti-ageing effect on the body and particularly on hair, skin and nails, including that it would strengthen hair and nails which would result in hair and nails breaking less, as well as reduced hair loss. We considered there was nothing in the ad that indicated how long those benefits may last, and consumer expectations of the longevity of the benefits would therefore likely range from days to weeks.The IV Clinic said the drip contained vitamin B7 and proline, but also provided documents relating to vitamin C, magnesium, calcium, lipoic acid and B vitamins generally.The claims in the ad did not relate to the effects of ageing on cognition, so a literature review on the role of B vitamins in cognition and ageing was not relevant. A literature review surrounding the roles of vitamin C in skin health compared the efficacy of oral supplementation to that of topical application, but did not refer to any research into the efficacy of IV vitamin C, and it summarised that there was little evidence concerning a relationship between vitamin C and general skin ageing although there was some evidence that general good nutrition led to better skin condition. Two small RCTs on women with hair loss related to the efficacy of an oral supplement, which we understood contained vitamin C and magnesium stearate as well as other substances. However, because the effects described in both studies related to a specific oral supplement rather than to IV drips we considered they were not adequate to support claims to strengthen hair or reduce hair loss. Two literature reviews focused on the possible role of vitamin C in combatting oxidative stress and how that could affect the development of Alzheimer’s disease. Because those documents related to the role of substances in the treatment or prevention of medical conditions rather than to health benefits in generally healthy people we considered they were not relevant to support the claims in the ad.A short medical journal article discussing in vitro studies relating to magnesium deficiency and ageing was not adequate evidence as we were not able to assess the methodology or findings of the research described, and it related to in vitro findings and to deficiency. An RCT relating to the effect of oral magnesium supplementation on physical performance in healthy elderly women related to physical performance and did not relate to efficacy of magnesium as delivered by IV drip. A literature review relating to the role of calcium in human ageing supported the importance of achieving sufficient calcium intake, but advocated doing so through diet rather than oral supplementation and did not refer to IV drips. An in vitro study which related specifically to the possible role of calcium in certain cells in the heart was not relevant to support the anti-ageing claims in the ad.A short literature review on the metabolism of amino acids and their regulatory effects on ageing focused on the potential ways that amino acid metabolism could be improved in the elderly, but it was not adequate or relevant to support claims that amino acids, delivered by IV drip, could have an anti-ageing effect. We considered that a news article, describing research conducted on mice into lipoic acid as an anti-ageing compound relating to research conducted on animals, was not adequate evidence to support the claims in the ad, both because it related to research conducted on animals and because it was a news article.We concluded we had not seen adequate evidence to support the claims that the Anti-Ageing drip would have a general anti-ageing effect on the body and on hair, skin and nails, including that it would strengthen hair and nails resulting in hair and nails breaking less, and reduced hair loss, over any time period.Classic Myers’ dripThe description of the Classic Myers’ drip stated “[…] Good for mood, energy and general immunity […] The ‘Myers’ cocktail as it is now known, is a specific combination of nutrients including vitamin C, calcium, magnesium and a complex of various B vitamins”. We considered consumers would understand that the particular combination of substances in the drip would help to maintain good mood and mental wellbeing, provide an increase in energy levels, and improve a person’s immune resistance to infection and disease. We considered there was nothing in the ad that indicated how long those benefits may last, and consumer expectations of the longevity of the benefits would therefore likely range from days to weeks.The IV Clinic said the Classic Myers’ drip contained vitamins B2, B3, B5, B6 and B12, magnesium chloride-hexahydrate, calcium chloride-dihydrate, calcium chloride, sodium selenite-pentahydrate and zinc. The ad also referenced vitamin C as being included in the Myers’ Cocktail formulation. We therefore reviewed documents relating to all those substances.The IV Clinic had provided two documents relating to the use of the Myers’ Cocktail for health. The journal article provided anecdotal accounts of a doctor’s experience of using the Myers’ Cocktail in his treatment of patients with a range of medical conditions. This included a reference to the IV infusion providing an “energy boost” for an athlete, but this was in the context of the drip being administered as a treatment for a flu-like illness. One of the accounts related to the treatment of a man who presented with depression and anxiety. An RCT examined the safety, feasibility and efficacy of the Myers’ Cocktail in treating fibromyalgia. We considered that anecdotal evidence of a doctor’s experience was not adequate, and evidence relating to the role of substances in the treatment of medical conditions was not relevant, in supporting the advertising claims.In relation to the claim the drip could improve a person’s immune resistance to disease and infection, we had seen a range of evidence about the role of vitamin C. A literature review described the chemical and biochemical processes by which high dose IV vitamin C might have an impact as a cancer treatment, and a study examined the action of ascorbate on cells infected with HIV. A further study examined whether high-dose vitamin C oral supplementation impacted on the steady-state concentration of a drug used to treat HIV. We had also seen a small, prospective observational study on the effects on quality of life in cancer patients of IV vitamin C, and two literature reviews which focused on vitamin C and the possible role of oxidative stress in the development of Alzheimer’s disease. Because those documents related to the role of substances in the treatment or prevention of medical conditions rather than to health benefits in generally healthy people they were not relevant to support the claims in the ad.We had also seen four literature reviews and the abstract of a journal article in relation to vitamin C’s role in the functioning of the immune system. We considered the literature reviews together confirmed that research had established that vitamin C was important to the normal functioning of the immune system due to its role in protecting cells against oxidative stress, and noted that one review stated that epidemiological studies had shown that eating fruit and vegetables could help to protect against some diseases, although that could not be directly attributed to vitamin C. However, those documents were not sufficient evidence that vitamin C IV infusions could help normally healthy people protect themselves against illness or that it improved the functioning of the immune system. The abstract did not provide sufficient information for us to assess its relevance.In relation to the role of B vitamins in immune function, we had seen a textbook chapter about vitamin B2 deficiency, two documents which provided information about the roles of various B vitamins in the immune system, including B2, B3, B5, B6 and B12, and an article which provided information about the immune-related functions of vitamin B6. We had seen four review articles relating to vitamin B12 which summarised the causes and health implications of vitamin B12 deficiency and confirmed its importance for the normal functioning of the body, particularly the nervous system and blood cell formation. They also highlighted the need to maintain adequate levels in the body, particularly for vegans and vegetarians who were more likely to have inadequate levels of vitamin B12 in the body as it was primarily found in animal products. We considered the documents demonstrated that adequate intake of the B vitamins included in the Classic Myers’ drip were necessary for the normal functioning of the immune system. However, they were not sufficient evidence that an IV drip containing those vitamins could help normally healthy people protect themselves against illness or that it improved the functioning of the immune system.We had seen an article and three evidence reviews relating to the role of selenium in immune function. We considered they established that adequate levels of selenium were needed for the normal functioning of the immune system and that selenium deficiency could contribute to greater susceptibility to viral infectious diseases, but that its role was complex and interdependent on other substances and high levels in the body did not necessarily correlate to better health. A small study, which was referenced in one of those reviews, suggested that dietary intake of selenium may help improve immune function in people with lower selenium plasma levels. However, the evidence was not sufficient to demonstrate that selenium, when delivered via IV drip, could improve immune function in normally healthy people.We had seen a small RCT which looked at the effects of zinc or zinc and lysine oral supplementation on infection rates in elderly people. It did not appear to find significant effects for either supplement over a placebo, and in any case we considered it was not relevant to claims relating to the effects of IV drips on immune function in the general population. Two studies compared the effects on serum magnesium concentrations of oral and IV infusions of magnesium sulfate when used as a treatment for asthmatics suffering an asthma attack. We considered they were not relevant to the effects of magnesium on immune function in generally healthy people.Two further literature reviews related to the roles of various micronutrients in immune function, including vitamins B6, B12 and C, and zinc, magnesium and selenium. An article related to the role of various vitamins and minerals in the prevention and treatment of Covid-19, including vitamins B2, B3, B6, B12 and C and the minerals calcium, magnesium, selenium and zinc. The documents confirmed that those vitamins and minerals played a role in immune function, but they were not sufficient or relevant evidence that an IV drip containing those nutrients could help normally healthy people protect themselves against illness or that it improved the functioning of the immune system.With regard to the claim that the drip provided an increase in energy, while we had seen evidence (referenced above) that the B vitamins in the Classic Myers’ drip were important for the normal functioning of the body, they did not support claims that the drip could increase energy levels in normally healthy people.We had seen three additional documents which specifically related to the effects of vitamin C on energy/fatigue levels. An article examined data from a largescale observational study (20,000 participants) in the UK to identify risk factors for vitamin C deficiency and found a correlation between low vitamin C levels and self-reported poorer physical health. Risk factors were: being older, male, of lower socioeconomic status and educational attainment, no alcohol intake, being a smoker, and having low levels of physical activity. The authors reported that the findings suggested that vitamin C supplementation was likely to only have an impact on those with the lowest levels of vitamin C and we considered that many of the risk factors they identified for low vitamin C levels were less likely to be present in the audience for the ad. A study assessed the effects of 6g of oral vitamin C on fatigue in normally healthy office workers over a two-week period, but because it was not controlled or blinded and did not relate to IV administered vitamin C it was not adequate evidence for advertising claims relating to IV vitamin C.An RCT examined the effects of an IV drip containing 10mg of vitamin C on fatigue and oxidative stress in normally healthy office workers in the Republic of Korea. The RCT was randomised, placebo-controlled and double-blinded: 73 were in the treatment group and 74 in the control group, who were administered IV saline only. Participants were aged between 20 and 49 years and had no vitamin supplement intake in the two days before enrolment in the study. Each participant was administered one drip. The primary outcome measures were the differences in self-reported fatigue score at two hours and at one day after the intervention, comparing between the groups. Secondary outcome measures were between-group comparisons of oxidative stress levels at two hours and at one day after the intervention, and a between-group comparison of plasma vitamin C concentration at two hours after intervention. The authors reported that fatigue score was significantly decreased in the vitamin C group compared to the placebo group at both two hours and one day after intervention, although this was evident in subjects with a lower vitamin C level at baseline but not for those with a higher level. However, the fatigue score was reported on a zero to ten scale and the difference between mean score for the groups was, even specifically for those with lower vitamin C levels at baseline, only 0.43 at two hours after intervention and 1.14 one day after intervention. We considered the study did not demonstrate that such differences on a ten-point scale constituted a clinically significant difference. The authors also reported that oxidative stress was lower in the treatment group at two hours compared to the placebo group, but not at one day. They concluded that there was no significant relationship between fatigue and oxidative stress. While the RCT was well-designed, we considered its findings did not constitute adequate evidence that a vitamin C IV drip of any dose improved energy levels or decreased fatigue.The IV Clinic had provided an RCT which examined whether dietary zinc magnesium aspartate (ZMA) supplementation in resistance-trained men, administered during training, had an effect on training adaptations (as well as other outcome measures less relevant to claims to increase energy levels). We understood that ZMA, a food supplement, contained zinc, magnesium aspartate and vitamin B6. While The IV Clinic’s drip contained zinc, vitamin B6 and magnesium chloride-hexahydrate we considered that one small RCT relating to the effects of an oral supplement on resistance-trained men, which showed no significant differences in the results of its three outcomes measures, was not adequate evidence to support the advertising claim.We had seen five documents which explored links between levels of hydration and energy: a clinical review of febrile illnesses in athletes and a series of four articles describing levels of dehydration in professional football players in Chile, how dehydration was thought to affect performance in training and matches, and strategies for recovery, although we had not seen full copies, in English, of two of those documents. However, the first of those documents related to the use of saline as a treatment for a medical condition, and all of those documents related to high performance athletes. We considered they were therefore not adequate to support the claim in the ad.We had not seen any documents which related to the individual nutrients included in the Classic Myers’ drip and their effects on mood and mental wellbeing.We concluded we had not seen adequate evidence to support the claims that the Classic Myers’ drip would help to maintain mood and mental wellbeing, provide an increase in energy levels, or improve a person’s immune resistance to infection and disease over any time period.Calmer dripThe IV Clinic provided two documents relating to mood with regard to the Calmer drip. The description for that drip featured an icon of a person, with a green head, in the lotus position, and stated “Calm your mind. Busy hectic lifestyle can often lead to negative thoughts and impact on our overall wellbeing. Calm your mind from the hustle and bustle of life this positive IV which will help you unwind from life’s stresses [sic]”. We considered consumers would therefore understand that the drip would help to maintain mood and improve mental wellbeing, in particular by having a calming, relaxing effect. We considered there was nothing in the ad that indicated how long those benefits may last, and consumer expectations of the longevity of the benefits would therefore likely range from days to weeks.We had not been provided any information about the formulation of the Calmer drip. It was therefore not clear whether the Calmer drip contained any of the substances referenced in the evidence provided. Notwithstanding that, one of the documents related to whether taurine affected seizures in mice, and therefore was not relevant as evidence for the advertising claims. The RCT which investigated the role of dopamine in depression induced acute phenylalanine and tyrosine depletion in its treatment group, hypothesising that it would result in a reduction in mood and cognitive function. It therefore related to the effects of those substances in a medical condition rather than the effect on mood of IV drips administered to normally healthy people. As referenced above in relation to the Classic Myers’ drip, a journal article gave an anecdotal account of a doctor’s experience of using the Myers’ Cocktail to treat a man who presented with depression and anxiety. It was anecdotal evidence, relating to the use of IVNT to treat a medical condition. The documents were therefore not relevant to claims that the Calmer drip could maintain mood and improve mental wellbeing.We concluded we had not seen adequate evidence to support the claims that the Calmer drip would help to maintain mood and improve mental wellbeing, in particular by having a calming, relaxing effect, over any time period.Immuno Boost dripThe description of the Immuno Boost drip featured an icon of a ‘medical’ cross on a green background, between two hands, and stated “Immunity Support. Reboot your immune system with this formulae aimed for those who wish to keep their immune system at optimal levels. Aids returning to full health and shakes off sluggishness that comes from feeling off-colour and gives a boost to overall health. A heavy IV loaded with vitamins and amino acids – not ideal for the 1st time user”. We considered consumers would understand that to mean that the drip would provide a ‘boost’ or improvement in the functioning of their immune system, providing greater protection against infection and disease as well as helping them to recover more quickly after an illness. In the context of the references to “returning to full health”, “feeling off-colour” and a “boost to overall health” we considered consumers were likely to expect those benefits to last a few days to several weeks.We noted The IV Clinic’s comment that if an individual was deficient in vitamins such as vitamin C, D or A, their immunity might be compromised. However, we considered that because the ads were targeted to a general audience, rather than to those who had been diagnosed as having a specific vitamin deficiency, we expected to see evidence which showed that the drips would have the claimed effects for normally healthy people. Additionally, it was not clear that the drip contained either vitamin A or D. While they had provided evidence relating to vitamin C, it was not in the list of nutrients included in the drip formulation they had provided to us, which comprised: vitamins B1, B2, B3, B5, B6 and B12, and the amino acids lysine, cystine, ornithine and taurine.We reviewed documents The IV Clinic had provided in support of claims about immune function, notwithstanding that it was not clear whether the drip contained all the substances that this evidence related to. We also reviewed other documents we had seen which related to the same substances and immune function, and substances they had stated were included in the drip formulation.We had reviewed evidence relating to the effects of vitamins B2, B3, B6, B12 and C, selenium, zinc and lysine on immune function in relation to the Classic Myers’ drip. Six of those documents also referenced additional substances. One review article summarised the causes and health implications of vitamin B9 deficiency, two literature reviews related to the role of vitamin B9 in immune function, and the article about the role of various nutrients in the prevention and treatment of Covid-19 included discussion of vitamins B1 and B9. One document provided information about the role of vitamin B1 in the immune system, and a further document provided information about the roles of vitamins B1, B4 and B7 (biotin), and the amino acid carnitine, in the immune system. The documents confirmed that those B vitamins and carnitine played a role in immune function but they were not sufficient or relevant evidence that an IV drip containing those vitamins could help normally healthy people protect themselves against illness or that it improved the functioning of the immune system. We further understood, from an article relating to the levels of zinc and copper needed in total parenteral nutrition (complete replacement of oral food intake) that metabolism of those minerals could be negatively affected by the presence of the amino acids cysteine, cystine and histidine in the same formulation. The IV Clinic had stated that the Immuno Boost drip contained cystine and we understood it may also contain zinc.The IV Clinic had also provided: a review looking at the importance of vitamin B9 in the immune system of mice and an in vitro study into the relationship between vitamin B7 deficiency and inflammatory responses. We considered that in vitro studies and evidence relating to studies on animals, which did not relate to IV drips, were not adequate to support claims that the advertised IV drips could improve immune function.We concluded that the claims that the Immuno Boost drip would improve immune system function, providing greater protection against infection and disease and quicker recovery after illness, over any time period, had not been substantiated.Gluta Glow dripThe description for the Gluta Glow drip stated “Brighter, Clearer Skin. Aids in Brighter Clearer Appearance of Skin. Full of powerful antioxidants to help reduce pigmentation, leaving your skin looking bright, fresh and glowing. Ideal for those with darker or Asian skin types wanting a brighter overall complexion”. We understood that many consumers interested in IV drips advertised for skin health would be aware that glutathione was purported to have skin lightening properties. In that context we considered consumers would understand the word “Gluta” in the drip name to refer to glutathione, and the references to “brighter” skin and the reduction of pigmentation to mean that the drip could lighten skin pigmentation. We considered the references to “clearer” and “fresh and glowing” skin would be understood to mean that the drip would also help to improve the general appearance of skin. We considered there was nothing in the ad that indicated how long those effects may last, and consumer expectations of the longevity of the effects would therefore likely range from days to weeks.We had seen five documents that related to the effects of glutathione on skin appearance and condition, and/or its skin lightening effects. The literature review provided by The IV Clinic, which was published in 2016, stated that there were no RCTs which looked at the use of IV glutathione for skin lightening despite its common use for that purpose, and that there were only two RCTs relating to its use for skin lightening via oral supplementation (one of which we had seen in abstract form) and one relating to its topical application (of which we had seen a full copy). We had seen two RCTs published after the literature review. The first RCT, provided by The IV Clinic, related to the antimelanogenic and anti-ageing effects of oral glutathione supplementation, and the second also related to the effects of oral glutathione supplementation. We considered that evidence relating to oral supplementation and topical application of glutathione was not relevant to claims made about the effects of an IV drip.With regard to the effects of vitamin C on improving the general appearance of skin and lightening skin pigmentation, we had not seen any evidence additional to that reviewed in relation to the Anti-Ageing drip.We concluded we had not seen adequate evidence to substantiate the advertising claims that the Gluta Glow drip could have an effect on skin pigmentation or improve the general appearance of skin, over any time period.Red Carpet dripThe description for the Red Carpet drip stated “Hydration & Energy. The IV to have prior to a night out. Helps to hydrate the skin leaving you looking your best for any major event. This helps to give you the energy to enjoy your event keeping you hydrated through the night”. We considered that consumers would understand from the description that the drip should be administered during the day leading up to an evening event, because it would provide an immediate and noticeable improvement in the appearance of their skin and energy levels, which would last from several hours up to around a day.The IV Clinic had not confirmed the contents of the drip, so it was not clear whether any of the evidence they had provided was relevant to the claims in the ad. We nonetheless reviewed the relevance and adequacy of the evidence on the basis that the drip might contain the substances referenced in the evidence (collagen and proline, water, and vitamins B6, B9 and B12) as well as any additional documentation we had seen of relevance to the advertising claims made for the Red Carpet drip.The RCT provided by the advertiser examined how certain muscles synthesised collagen and protein after exercise, using IV drips containing proline. However, the RCT investigated muscle recovery after exercise and the proline was used as a measurement method; the study did not measure its effects. We considered it was therefore not relevant to the claims in the ad. One literature review summarised research into the role of B vitamins in brain health, and a second summarised the causes, and health implications, of vitamin B12 deficiency. A further article provided a general overview of research on hydration and health but did not comment on the value of IV drips for any specific health benefit. We therefore considered those documents were not relevant to claims relating to the appearance of skin or energy levels in normally healthy people.We had reviewed documents relating to the effects of B vitamins, vitamin C, amino acids, lipoic acid, magnesium, calcium and glutathione on skin health/appearance in relation to the Anti-Ageing and Gluta Glow drips. We had reviewed a range of documents relating to the role of the Myers’ Cocktail, saline, B vitamins, vitamin C and ZMA on energy levels in relation to the Classic Myers’ drip. We had not seen sufficient evidence to support claims to improve the appearance of skin or increase energy levels.Finally, we reviewed a number of documents relating to hydration. A chapter from a medical manual about volume depletion (dehydration) provided an overview of the condition and recommended that IV saline be given to patients with severe dehydration or when oral fluid replacement was impractical. A journal article provided an overview of the conditions hypernatremia and hyponatremia (abnormally high and low sodium levels) and recommended IV infusion as a treatment. Two articles described the conditions lactic acidosis and rhabdomyolysis and recommended IV saline as a treatment. We had also seen the clinical review of febrile illnesses in athletes referenced above in relation to the Classic Myers’ drip. Those documents focused on the use of saline as a treatment for medical conditions and therefore were not relevant to advertising claims aimed at generally healthy people.We had also seen the series of four articles about dehydration in professional football players in Chile, reviewed in relation to the Classic Myers’ drip, which did not relate to hydration via IV drip and in any case related to dehydration in professional athletes rather to the normally healthy general population.Finally, we reviewed a study that examined the impact of food intake on the gastrointestinal absorption and effectiveness of an anti-diuretic medicine. Saline IV drips were used to hydrate the healthy participants in a study design which, for the purpose of accurate measurement, required that participants did not drink anything (or eat anything other than specific meals) during the trial. We considered the study demonstrated the use of saline IV drips as a method of hydration by researchers but noted that IV administration was used rather than oral rehydration in order to make precise measurements relevant to the outcome measures of the study.We considered the evidence demonstrated that maintaining adequate levels of hydration was important to the normal functioning of the body, but that it did not demonstrate that IV drips provided benefits over and above oral fluid intake in maintaining (or restoring) adequate levels of hydration in normally healthy people undertaking normal levels of physical activity, or that heightened levels of hydration were needed to improve energy levels or improve the appearance of skin.We concluded we had not seen adequate evidence to support the advertising claims that the Red Carpet drip would provide a noticeable improvement in the appearance of skin and improve energy levels over any time period.Diet & Detox, Burner and Body Builder dripsThe description for the Diet & Detox drip featured an icon of a torso, with arrows on either side pointing in at the waist, and stated “Detox/Fat Burning. A blend of nutrients, vitamin and amino acids to help reduce toxins on your body [sic]. Aids the body functions and aids digestion. Ideal for those dieting or trying to lose weight as it helps to burn off stubborn fat”. We considered consumers would understand that the drip would improve the body’s ability to eliminate toxins, aid digestion, and burn fat, resulting in weight loss. We considered there was nothing in the ad that indicated how long those benefits may last, and consumer expectations of the longevity of the benefits would therefore likely range from days to weeks.The description for the Burner drip stated “Burst of Energy. The ideal IV for those looking to lose weight or for a fast burst of energy”. We considered consumers would understand that the “Burner” drip would help them lose weight, but that there was nothing in the ad that indicated how long that benefit may last; consumer expectations of the longevity of the benefit would therefore likely range from days to weeks. We considered consumers would understand from the ad’s references to a “Burst of Energy” and “fast burst of energy” that the drip would provide an immediate improvement in their energy levels that would likely last from several hours up to around a day.The description for the Body Builder drip featured an icon of a hand weight and stated “Muscle Builder. Aimed at those who wish to have the ultimate amino acid infusion to aid their muscle building nutrition. It will help in the synthesise[sic] of protein and burning of fat to help improve muscle size and strength. Can be given weekly”. Because the ad referenced that the drip could be given weekly, we considered consumers would understand that a single drip would help them reduce their levels of body fat and build muscle mass and, as a consequence, increase their strength, with the effects lasting for approximately one week. We further considered they would expect that regular weekly administration of the drip would result in sustained reduction of body fat and increased muscle mass. We considered that the drip as described was likely to be of particular interest to consumers who were already engaging in strength and resistance training.The IV Clinic had said the Body Builder drip contained vitamins B1, B2, B3, B5, B6 and B12 and the amino acids lysine, leucine, isoleucine, valine, glycine, carnitine and methionine. They had not confirmed the contents of the other drips but had provided evidence relating to saline, amino acids and arginine in relation to the Diet & Detox drip, and vitamins B3 and B8 and arginine and leucine in relation to the Burner drip.Given that the ad made similar claims that the Diet & Detox, Burner and Body Builder drips could aid in fat burning and/or weight loss, we reviewed all the evidence provided to support those claims together.The article about the medical management of constipation did not make any reference to IV drips and therefore was not relevant to claims that an IV drip could aid weight loss. The review of research into amino acid supplementation and metabolic health hypothesised that dietary amino acids could affect the gut microbiota and therefore have an impact on metabolic health and weight control. However, it was not clear how that hypothesis extended to amino acids delivered via IV drip. A further literature review looked at the role of the amino acid arginine in the body. It stated that oral administration of arginine was not optimal because 40% of dietary arginine was degraded by the small intestine, and suggested that arginine could be a novel therapy in treating obesity and metabolic syndrome. However it did not cite robust evidence which supported claims that IV arginine would aid weight loss.Two conference papers which summarised evidence relating to the metabolic roles of the amino acid leucine, which was present in dietary protein, and its potential role in aiding weight loss in those on high protein/low carbohydrate reduced-calorie diets were not relevant because they did not relate to leucine as provided by IV drips. One small, non-blinded RCT involving older women looked at the short-term effects on muscle protein synthesis (the process by which protein was produced to repair muscle damage caused by intense exercise) of taking a leucine-enriched essential amino acid supplement immediately after exercise. It concluded that such supplements could help to generally raise muscle protein synthesis and so help to protect against age-related muscle degeneration and frailty. Another small, 12-week RCT which looked at the effects of daily leucine-rich amino acid supplementation combined with moderate training in the elderly found that strength loss caused by muscular fatigue was less pronounced for the treatment group compared with the placebo group at the end of the study period. Neither of the studies reported on the effects of the substances on rates of fat burning or weight loss.A review of evidence relating to niacin (vitamin B3) as a treatment or combination treatment for lipoprotein abnormalities and a meta-analysis of evidence relating to the effect of inositol (vitamin B8) supplementation on lipid profiles in patients with metabolic diseases were not relevant because the evidence related to the use of those substances in the treatment of medical conditions. We had also seen a small study of obese women that investigated which measurements, other than basic BMI measurements, might be indicators for a propensity to develop metabolic disorders. The study suggested that isoleucine may be found in higher concentrations in obese women, but it was not relevant to support claims that IV drips could aid weight loss.We had also seen a trial in which ten people were given 1g of the amino acid l-carnitine as an oral supplement with every meal for ten days, which found that it increased fatty acid oxidation. However, it was of a small size, was not randomised, controlled or blinded and did not relate to IV administration and therefore was not adequate to support advertising claims relating to fat burning or weight loss.The IV Clinic did not reference any specific evidence with regard to the claims that the Burner drip could provide an immediate improvement in energy levels. We had reviewed evidence in relation to energy boosting claims for the Classic Myers’ and Red Carpet drips in relation to various substances. Additionally, we had seen a literature review examining the relationship between oral glutamine supplementation and fatigue in the context of physical exercise. It concluded that glutamine could be seen to improve some fatigue parameters, but that it seemed to have limited effects on physical performance. We concluded it was not adequate to support the claims because it did not relate to IV-administered glutamine. We had also seen an RCT which found that six months of l-carnitine oral supplementation increased capacity for physical (and cognitive) activity by reducing fatigue, compared to placebo, in centenarians. As it related to oral supplementation and involved very elderly participants, we considered it was not relevant to the advertising claim.We considered that the two articles which described the conditions lactic acidosis and rhabdomyolysis (referenced in relation to the Red Carpet drip) and the article about the medical management of constipation (referenced above in relation to claims for weight loss) were somewhat relevant to the claims to eliminate toxins. The latter article, and the review of research into amino acid supplementation and metabolic health (also referenced above in relation to claims for weight loss) were also somewhat relevant to the claims that the Diet & Detox drip could aid digestion. However, for the reasons referenced above we considered they were also not adequate evidence to support those claims.The IV Clinic had also highlighted the two RCTs on amino acid supplementation in elderly people, and the study of obese women, in support of the claims that the Body Builder drip could build muscle mass and strength. While one of the RCTs reported on the effects of amino acid supplementation on strength, none of the three studies measured the effects of such substances on muscle size or growth. None of the studies related to the effects of amino acids as delivered by a single IV infusion.We concluded we had not seen adequate evidence to support the claims that the Diet & Detox, Burner and Body Builder drips would improve the body’s ability to eliminate toxins, aid digestion, reduce body fat and aid weight loss, build muscle mass resulting in increased strength, or provide an immediate improvement in energy levels, lasting for any time period.Pre-Fighter dripThe description of the Pre-Fighter drip featured an icon of a flexed arm with bulging biceps, and stated “Energy Release. Excellent IV to release energy and help provide optimum performance prior to an event”. We considered consumers would understand from the description that the drip should be administered in the hours before a sporting event to provide an immediate increase in energy levels, and that it would help them to perform to their highest ability. In that context, we considered they would expect the benefits to last from several hours up to around a day.The three documents referenced by The IV Clinic (relating to vitamin B9 and to ZMA), and additional documents we had reviewed in support of energy boosting claims, were not adequate to support such claims as summarised in relation to the Classic Myers’, Red Carpet and Burner drips.After Fighter dripThe description for the After Fighter drip featured an icon of a water droplet with a blue ‘medical’ cross on it, and stated “Muscle Recovery. Specifically formulated for after sports performance to help the body rebuild and eliminate toxins which can occur from lactic acid build up in your muscles. Ideal after a major sporting event and for those after a heavy training session”. We considered consumers would understand that, if administered within several hours after a sporting event or demanding exercise, the drip would provide quicker, more effective recovery for muscles, including by eliminating toxins and lactic acid. That would be noticeable through, for example, experiencing reduced muscle soreness over a shorter time period than they would otherwise have experienced.The IV Clinic had not confirmed what substances were included in the formulation of the After Fighter drip. We reviewed the two documents they had referred to as well as other documentation we had seen which related to the same substances or to similar advertising claims.With regard to the documents referred to by The IV Clinc, the study looked at the effects of a topical gel containing hyaluronic acid and four amino acids on wound healing. We considered it was not relevant to claims relating to the use of IV drips in normally healthy individuals. We had reviewed the RCT which looked at how muscles synthesised collagen and protein after exercise in relation to the Red Carpet drip. It was not relevant because it did not investigate the effects of proline (which we assumed was contained in the After Fighter drip) on muscle recovery after exercise.We had reviewed a range of documents in relation to the Classic Myers’, Red Carpet and Burner drips regarding hydration and energy which also had some relevance to claims about recovery from exercise. However, they were not sufficient to support the claims in the ad because, as referenced above, they related to the use of saline as a treatment for medical conditions and/or did not relate to IV drips. The two articles about the treatment of lactic acidosis and rhabdomyolysis using IV saline, reviewed in relation to the Red Carpet drip, were also relevant to claims about the elimination of toxins from the body and from muscles in particular, but related to the use of saline as a treatment for medical conditions.In relation to the Diet & Detox, Burner and Body Builder drips we had reviewed two RCTs provided by The IV Clinic in which older people were given leucine-rich amino acid oral supplementation. The first RCT examined its effects on muscle protein synthesis, and the second examined its effects on muscular fatigue, which were of relevance to the advertising claims made about the After Fighter drip. However, the RCTs related to oral supplementation rather than IV infusion, and because the participants were elderly people they were not relevant to advertising claims about muscle recovery after a sporting event or demanding exercise.We also assessed a review article which looked at the roles of glutathione and n-acetyl-cysteine (NAC) in exercise-induced oxidative stress. However, with regard to glutathione the evidence related to glutathione produced by the body; it noted that oral supplementation was an ineffective way of providing glutathione and that there was no relevant evidence relating to its administration by IV. The reviewed studies relating to the role of NAC were largely conducted using IV administration, but the article did not contain sufficient information for us to evaluate their methodological robustness or relevance to the claims made in relation to the After Fighter drip.We concluded we had not seen sufficient evidence to support the claims that the After Fighter drip would provide quicker, more effective recovery for muscles after a sporting event or demanding exercise.Because we had not seen evidence which was adequate to support the advertised health benefits of the IV drips, or the substances in them when delivered via IV infusion we concluded that the claims were misleading and breached the Code.The ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).Action
The ad must not appear again in the form complained of. We told GMG Pharmacy Ltd t/a The IV Clinic not to make any claims, explicit or implied, that their IV drips or the substances in them could provide any health benefits, over any period of time, until such time as they held evidence relating to the use of IV drips in normally healthy humans that was adequate to support such claims. This included, for example, claims that the drips or substances in them could: improve immune function; improve skin, hair and nail health; maintain mood or improve mental wellbeing; improve recovery from exercise; aid weight loss, fat burning, digestion or the body’s ability to eliminate toxins; boost energy levels; and change skin pigmentation.
