Tag: MHRA

  • Elf Bar Comments on E-Liquid Controversy

    Elf Bar Comments on E-Liquid Controversy

    Image: carmenbobo | Adobe Stock

    After U.K. retailers announced they would remove Elf Bar 600 products from shelves due to illegal levels of e-liquid, Elf Bar called a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA). Elf Bar subsequently released a statement regarding the controversy.

    “Recent press reports alleged questions around the compliance of the Elf Bar 600 on the U.K. market,” a company press release stated. “Subsequent to these allegations, we immediately initiated a full investigation of the Elf Bar 600 in the U.K. market and have found that some products exceeded the permitted e-liquid fill level. Although this issue means the products are not compliant in full with U.K. regulations, we did not find any issues with nicotine strength or anything that might mean the products’ safety is compromised in any way.

    “MHRA indicated that their recommendation is for the product to be withdrawn from the market.

    “We agree with this recommendation and will voluntarily carry out a withdrawal of noncompliant Elf Bar 600s from the U.K. market. We will be assisted in ensuring the withdrawal is carried out effectively, and without causing any unnecessary market disruption, by a Trading Standards Primary Authority. We will update all of our distribution and retail partners when we have agreed how this corrective action will be enacted.

    “Although the investigation and definition of corrective actions for the Elf Bar 600 has been undertaking, we have also committed to investigate all other vape products that we export to the U.K. We will take any actions we deem to be required to ensure compliance across our entire product set.”

    Elf Bar was joined by the U.K. Vaping Industry Association (UKVIA) and the IBVTA in the meeting.

    “Although Elf Bar is not a member of the UKVIA, as the industry’s lead trade association, it was key that we were present at such a critical meeting to represent the interests of all businesses in the sector impacted by this highly regrettable situation,” the UKVIA said in a statement. “The decision by Elf Bar to voluntarily withdraw its noncompliant products, recently highlighted in the media, is absolutely the right one.

    “If the industry is going to be accepted as playing a leading role in helping Britain achieve its smoke-free targets, it has to demonstrate the highest levels of compliance, standards and responsibility, which the UKVIA expects.”

  • ‘Medical Licensing Realistic Only For Tobacco Companies’

    ‘Medical Licensing Realistic Only For Tobacco Companies’

    Photo: goodmanphoto

    The U.K.’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) recent update to its guidelines to make vapor devices available via medical prescriptions may favor the traditional tobacco industry, reports ECigIntelligence, citing experts.

    According to Christopher Snowden of the Institute of Economic Affairs, it’s likely that only tobacco companies will succeed in gaining licensing for their products.

    Robert West, professor of health psychology and director of tobacco studies at the University College London, stated that he is not confident “any e-cigarette manufacturer independent of the tobacco industry will have the resources to overcome these hurdles.”

    “This could very easily lead to a situation where tobacco company e-cigarettes can be prescribed while others cannot,” West said.

    “I am worried that the MHRA may have missed an opportunity here and has not made the process simple enough to generate more successful applications,” said Clive Bates, director of The Counterfactual. He expressed concern that the agency has made the licensing process too complicated by asking for information that is “either unnecessary or too difficult to produce cost effectively.”

    Another concern is consistent dosing—many feel that in order to remain consistent with dosing, closed systems will be favored over open systems, where consumers can control the strength of nicotine.

    “It would be essential for the MHRA to evaluate the device and liquid together. That favors sealed disposable units and pod-based systems,” said Bates.

    Once a company submits a marketing authorization application, the standard timeline is 150 days plus any time needed by the company to answer questions that arise, according to the MHRA. The pathway has been available since 2013 but was “expensive and time-consuming.”

  • U.K. Regulatory Agency Clarifies E-Cig Rules

    U.K. Regulatory Agency Clarifies E-Cig Rules

    Photo: Steheap

    The government agency overseeing the U.K.’s e-cigarettes and refill containers notification scheme as well as implementing the Tobacco and Related Products Regulations (TRPR) has updated guidance on the sale of vaping products following discussions with the U.K. Vaping Industry Association (UKVIA) and Trading Standards.

    The UKVIA decided to intervene after being approached by a significant number of vape product manufacturers, distributors and retailers confused about what could and could not be legally sold in shops, particularly following the recent surge in new disposable vapes entering the U.K. market.

    As a result, the Medicines and Healthcare Products Regulatory Agency (MHRA) has now clarified its advice to both manufacturers and distributors of e-liquids and devices and vaping retailers.

    The UKVIA took part in discussions with the MHRA and Trading Standards following concerns raised by retailers unsure of their compliance requirements and wary of falling foul of the law.

    “Due to the numerous [inquiries] we received about the legality of stocking new-to-the-market products, in particular the surge in new disposables, we decided it was imperative to talk to Trading Standards and raise this with the MRHA to seek clarification,” said John Dunne, director-general of the UKVIA, in a statement.

    “Since then, we have been working with the MHRA to clarify the process around when products can legally be placed on the market for sale.

    “The first part saw the MHRA issue an e-bulletin clearly setting out the process and making it unambiguous that it is illegal to place products into the market until the ‘ECID’ numbers are published on the MHRA website as ‘approved/declared.’

    “Next the MHRA updated its online advice for retailers, which is a highly satisfactory outcome as it effectively closes the loophole for when brands can place the product on the market and when a retailer can legally sell the product.”

    The MHRA’s guidance for vaping retailers previously read:

    “When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of Notified Products.

    “If you cannot find the product on the MHRA’s website, ask your supplier to confirm that the product complies with the TRPR and has been notified to the MHRA. If a producer has not notified the product or it does not comply with the TRPR, they may not supply it to you.”

    The new wording says:

    “When sourcing new supplies of any e-cigarette or e-liquid product, check that a compliant notification has been published in one of the Notified Product lists above.

    “If you cannot find the product on the MHRA’s website, ask your supplier to confirm that it has been published and provide details to enable you to confirm the product’s status. If a product has yet to achieve publication status, they may not supply it to you.”

    Dunne said the clarification demonstrates the effectiveness of open dialogue.

    “We want our sector to be known for upholding strict standards when it comes to the manufacture, distribution and sale of vaping products, and this clarification from the MHRA can leave no one in any doubt about where their responsibilities lie,” he said.

    The MHRA’s full wording on the sale of vaping products is available here.