A page on REVIV’s website, https://gb.revivme.com/, seen on 4 March 2020, headed “Coronavirus & The Real Pandemic” began “Help protect and prevent against the new strand of virus (known as the Coronavirus) with a REVIV Megaboost® IV Therapy containing a high dose of Vitamin C”. This was followed by discussion of the impact of the virus worldwide, government and public responses to it and government and medical advice about good hygiene and social distancing practices, and the text “More recently we are also witnessing clinical trials in hospitals treating coronavirus using high intravenous doses of the powerful antioxidant, Vitamin C, with some initial positive results".
It continued "As a doctor, I truly believe in the power of prevention and REVIV, one of the largest global preventative healthy movements currently in existence. It should not take an outbreak of a highly infectious virus for us to wake up to take precautions to protect our health”, referenced a range of health measures, and stated “If we ... feed our bodies correctly with more of the right nutrients and less of the wrong nutrients, then we can ensure that our immune system is working at a protective and effective level. Countless studies point to key vitamins and antioxidants that can promote better immune function especially when given in high doses”.
The complainant challenged whether the stated and implied claims that the advertised Megaboost IV drip could help to prevent coronavirus/COVID-19 were medicinal claims for a product which was not licensed as a medicine by the MHRA.
REVIV UK Ltd said that the ad was a blog post which was written in response to customer queries about vitamin C, and it was intended to be purely educational. It was not intended to be an ad but they appreciated that because the post referenced their Megaboost drip it was promotional material. They said they had removed it from their website.
They said that the Megaboost drip was not in itself a product; it was the trade name for a specific formulary for intravenous infusion used within their clinics. They said it was comprised of Hydroxocobalamin (vitamin B12), Acetylcysteine, Ascorbic Acid (vitamin C) and Pabrinex. They said the drip was not intended for the treatment of any medical conditions and that was clearly stated in their marketing material; any preventative health statements made in their advertising were made on the basis of the ingredients included rather than in respect of Megaboost as a product.
REVIV said that the Ascorbic Acid in the Megaboost drip was a licensed medicine in the UK. They highlighted that the Summary of Product Characteristics (SPC) for the product included that it was indicated for “conditions requiring vitamin C supplementation”. They provided links to a number of journal articles and press articles, and a YouTube video. They said the studies stated that vitamin C was a recommended supplement for the prevention of viral illness, and in the most recent studies for coronavirus/COVID-19 specifically.
It was their understanding that where there were studies in the public domain they could share that information with their clients. They said they did not make any claims in their advertising in relation to the Acetylcysteine or Pabrinex included in the Megaboost drip, but provided information relating to the SPCs for those medicinal products.
The CAP Code required that medicinal claims and indications could be made only for a medicinal product that was licensed by the MHRA or under the auspices of the European Medicines Agency (EMA). Marketing communications for licensed medicines must conform with the licence and the product’s SPC. A product could be rendered medicinal by its functional effect on the body, or by presenting itself as having properties for treating or preventing disease.
A medicinal claim was a claim that a product or its constituents could be used with a view to making a medical diagnosis or could treat or prevent disease, including an injury, ailment or adverse condition. The ad began “Help protect and prevent against the new strand of virus (known as the Coronavirus) with a REVIV Megaboost® IV Therapy containing a high dose of Vitamin C” and included references to vitamin C as a potential treatment for the disease, such as “More recently we are also witnessing clinical trials in hospitals treating coronavirus using high intravenous doses of the powerful antioxidant, Vitamin C, with some initial positive results".
The ASA sought the view of the MHRA regarding the claims. The MHRA said that any mention of coronavirus/COVID-19 in the promotion of an IV drip product would bring the product under medicines regulations, as would any claim that implied treatment of, or protection from, the virus.
We considered that consumers would interpret the claims in the ad to mean that an IV drip containing a high dose of vitamin C, and in particular the Megaboost IV drip offered by REVIV, could help to prevent people from catching coronavirus/COVID-19. We concluded the ad therefore made a medicinal claim that the Megaboost product or its constituents (particularly, but not limited to, vitamin C) could prevent a disease.
We therefore reviewed whether the Megaboost drip or its constituents were licensed medicinal products and, if so, whether the medicinal claim in the ad conformed with the SPCs for those medicinal products. The Megaboost drip was not a licensed medicinal product, although it contained four licensed medicinal products: ascorbic acid (vitamin C); pabrinex, which included a combination of ingredients including ascorbic acid; hydroxocobalamin (vitamin B12) and acetylcysteine. The SPC for the ascorbic acid medicinal product stated that it was indicated for the “prevention and treatment of scurvy, or other conditions requiring vitamin C supplementation, where the deficiency is acute or oral administration is difficult”.
The existence of clinical studies which investigated the role of vitamin C in the prevention or treatment of illnesses including coronavirus/COVID-19 (many of which were experimental and not yet peer-reviewed) did not establish that vitamin C supplementation was required for the prevention of coronavirus/COVID-19. The ascorbic acid medicinal product was therefore not indicated for the prevention or treatment of coronavirus/COVID-19 and it was therefore not permissible to make the medicinal claim in the ad based on the inclusion of the ascorbic acid medicinal product in the Megaboost drip.
We also reviewed the SPCs for pabrinex, hydroxocobalamin and acetylcysteine. The SPC for pabrinex stated that it was indicated for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C: particularly in alcoholism; after acute infections; post-operatively; in psychiatric states; and that it was also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis. The SPC for hydroxocobalamin stated that it was indicated for: the treatment of Addison pernicious anaemia; prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency; treatment of tobacco amblyopia; and treatment of Leber’s optic atrophy.
The SPC for acetylcysteine stated that it was indicated for the treatment of paracetamol overdose in patients. None of those medicinal products were therefore indicated for the prevention or treatment of coronavirus/COVID-19 and it was therefore not permissible to make the medicinal claim in the ad based on the inclusion of pabrinex, hydroxocobalamin or acetylcysteine in the Megaboost drip.
We noted that small print in the footer of the web page included the text “These products are not intended to diagnose, treat, cure or prevent any disease. The material on this website is provided for informational purposes only and is not medical advice …”. We considered that this text did not ameliorate or negate the medicinal claim made in relation to the Megaboost drip. The ad included a medicinal claim that the Megaboost drip and the vitamin C in it could help to prevent people from catching coronavirus/COVID-19. However, the Megaboost drip was not a licensed medicine and the licensed medicines contained in it were not indicated for the prevention or treatment of coronavirus/COVID-19.
We concluded the ad therefore breached the Code. The ad breached CAP Code (Edition 12) rules
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. and 12.11 12.11 Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule 12.2.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in the form complained of. We told REVIV UK Ltd to remove medicinal claims for unlicensed products from their advertising and not to use them in future. We also told them to remove medicinal claims for licensed products that were not in conformity with the products’ marketing authorisation from their advertising and not to use them in future. These included stated or implied claims that their IV drips, or their constituent ingredients, could prevent or treat coronavirus/COVID-19.