This article was published in the Aesthetic Journal. We would like to thank Holly Carver and the Aesthetic Journal for sharing it with the IMCAS community.

Lemon Bottle Concerns

Since late 2023, fat dissolving product Lemon Bottle has garnered heavy media attention. Having been mostly promoted by influencers on social media platform TikTok, with 81.5m views by the end of 2023, it has come under fire from the medical aesthetic community in the UK for allegedly lacking clinical evidence. The product claims to be a high-concentration fat dissolving solution that combines riboflavin, lecithin and bromelain to create fat decomposition by accelerating metabolism of fat cells.

Last month the Swiss Agency for Therapeutic Products (Swissmedic) issued a warning on the product, stating, “No medicinal effect has been scientifically proven, the quality of the ingredients has not been tested and using the product may therefore pose a health risk.” The regulator also analysed samples of Lemon Bottle and found that ingredients varied from one sample to another. “As the quality of the ingredients is not controlled, the use of Lemon Bottle may present health risks,” Swissmedic warns. It also stated that the product should not be sold or used within the country.

Although it is classed as a medicinal product in Switzerland, it is currently classified as a cosmetic product in the UK, so it is outside the remit of the Medicines and Healthcare products Regulatory Agency (MHRA), despite some requests from the medical aesthetic community to intervene.

The MHRA told the Aesthetics Journal, “The MHRA is aware of the product marketed as Lemon Bottle and has reviewed its status as a medicinal product under the definition set out in Human Medicines Regulations 2012, as well as its status as a medical device under the definition set out in UK and EU medical devices legislation, and determined that it is not captured within the definitions of a medical product or medical device. In the absence of any medicinal claims, an injectable fat lipolysis product isn’t considered a medicinal product unless it contains phosphatidylcholine or another active pharmaceutical ingredient.” The MHRA stated that it could not speculate whether or not there are plans to regulate any such product in the future. As it is a cosmetic and not a medical product or device, Lemon Bottle also does not need a UKCA/CE mark to be sold in the UK.

The Aesthetics Journal contacted the Office for Product Safety and Standards, the UK’s national product regulator that covers cosmetic products, for comment, but it did not respond.

So, taking into consideration Swissmedic’s warning, what should the medical aesthetic community consider when it comes to this product?

The issues

According to aesthetic practitioner Dr David Eccleston, advertising and promotional activity on social media by influencers have created a perfect storm of expectation and given the illusion that Lemon Bottle is a mainstream, clinically proven and safe product. Aesthetic practitioner and trustee of the British College of Aesthetic Medicine Dr Sophie Shotter explains, “Lemon Bottle appeared out of nowhere via social media. When I first started seeing the before and after photos, I searched for the product to try and find an ingredient list – all I could find was a brief mention of a ‘blend of vitamins’ and ‘pineapple enzymes’. A little later I found an abbreviated list, but with no mention of any effective, evidence-based lipolytic agents on the ingredient list.”

She adds that whilst before and after photos at first glance look amazing, she believes there currently exists zero evidence of efficacy or safety. “They are claiming Lemon Bottle is an injectable procedure which, despite the claims of no downtime, in my clinical view, does come with potential risks and downtime,” she says.

Dr Eccleston also believes that the product is currently being used mainly by non-medical injectors, which he thinks is a risk to public safety. He comments, “It’s predominantly offered by injectors with no medical training or a prescribing licence, and the problem is that there is no ability to manage medical side effects or complications.”

Although the MHRA’s stance is that the product is non-medical, Dr Eccleston believes it should follow suit from Swissmedic’s classification and should be re-classified. “Prescription medication cannot be promoted to the public, so this non-prescription product exploits a loophole that exposes those treated with it to a serious risk of complications,” he says.

Industry guidance

In light of concerns from the specialty, we spoke to the Joint Council of Cosmetic Practitioners (JCCP) to receive guidance on the product going forward. The JCCP notes that due to the lack of clinical evidence about the product at present, it would, “Suggest that this product is not a first-line choice and advise that appropriate caution should be exercised.” It adds that products that fall within the MHRA remit provide significantly higher levels of confidence for practitioner use.

Although there are concerns about how the product is regulated, the JCCP confirms that for any product regulated under the General Product Safety Regulations enforced by the Office or Product Safety and Standards, including Lemon Bottle, you can and should report any concern to your local authority trading standards department. If practitioners are unsure of what to do, the JCCP encourages you to share your concerns with them so they can advise you on how to report any product concerns appropriately.

The manufacturer perspective

The Aesthetics Journal reached out to the manufacturer of Lemon Bottle, Sid Medicos, to gather its perspective on the recent controversy surrounding the product. A spokesperson for the company said that Lemon Bottle has passed relevant safety qualifications for the 60 countries it is available in, including the UK and EU. They added, “As a responsible company, we take our duties over safety very seriously and are constantly seeking ways to improve the product. We run 250 training centres globally which conduct accredited training on the application of the product to maximise its effectiveness and safety. In the UK, Lemon Bottle is used by a growing number of cosmetic doctors, and we are proud to have received testimonials from a number of these doctors, other experts, and customers.”

One of these medical practitioners, Dr Vahe Karimyan, said, “Lemon Bottle is very good for various areas which I regularly treat, including the chin, abdominal area, love handles and underarms. It’s been a great addition to the market. My patients have been very pleased with the results, which is the key thing – I have treated more than 200 people in my clinics so far. One of the plus points I have found is that the treatment is fairly painless, there is not a great deal of swelling after application, and patients can go about their daily lives after the treatment.”

The spokesperson for Sid Medicos also states that all of the ingredients for the product are clearly displayed on its website, and that the exact percentages of each ingredient have been fully disclosed to their relevant bodies, such as the Submit Cosmetic Product Notifications, and their distributors. In regards to claims of zero downtime, Sid Medicos clarified, “This is due to Lemon Bottle causing less swelling compared to other fat dissolvers. We believe the reduced swelling makes it possible for patients to return to their daily lives more quickly.”

According to the company, Lemon Bottle has also been fully insured by companies such as Insync, Policybee, Beazley, Finch, and Beauty Insured. Insurance company Hamilton Fraser told the Aesthetics Journal, “We insure this treatment for medical professionals as outlined: doctor, surgeon, dentist, dental hygienist, therapist, nurse, paramedic, independent prescriber pharmacist, and pharmacist. This is subject to completing a satisfactory training course run by a medical professional.”

Sid Medicos adds that the company is currently engaging in discussions with reputable institutions in Europe to conduct clinical trials on Lemon Bottle products, to provide more evidence behind its safety and efficiacy. “We believe that the fact that Lemon Bottle, which does not contain anydeoxycholic acid or phosphatidylcholine component, has initiated its clinical trial process is a significant development in fat reduction treatment,” Sid Medicos stated.

Considerations for choosing new products

According to Dr Shotter, Lemon Bottle is just one of the many cosmetic products available to patients that she believes have questionable safety and efficacy data. She says, “Substances with zero evidence are being sold for home injection as ‘food supplements’, for example.” To protect patients as best as possible, Dr Eccleston explains that when looking out for new products, medical practitioners should ignore any media hype and ensure that all products have robust safety and efficacy data, as well as the correct licensing approvals. He says, “I advocate that all injectable products should be CE marked and approved for use in the UK with clinical evidence to support their safety and efficacy, as well be approved by the MHRA if they have a medical claim.”

Dr Shotter emphasises there is nothing more important than evidence. She says, “Scientific studies published in peer-reviewed publications should always be the gold standard. It’s also useful to speak to other reputable medical practitioners who have experience with a product,” she says. Dr Eccleston and Dr Shotter both note that due to Swissmedic’s warning, and because they do not feel there is enough clinical data/evidence on safety and efficacy, they are choosing not to use this product until there is more data available from the manufacturer. Dr Shotter adds that in the absence of robust clinical evidence, she is choosing to enlighten patients about what is possible with other injection lipolysis products. She says, “We need to educate them on the right questions to ask to ensure they’re being injected with a product that is proven to be both safe and effective. This could be through direct patient interaction, videos on social media platforms or writing blogs and newsletters.”