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FDA step up age checks for online sales

To better protect children the FDA are checking more and more online stores that sell electronic cigarette and vaping products for their compliance in blocking underage customers.

The Food and Drug Administration (FDA) have recently stepped up their enforcement of the age of buyers, and UK based companies are often finding themselves the targets of these checks.

We have heard cases of the FDA making test purchases on UK based websites with shipping to the US using the details of someone that would appear underage to a website that had checks in place. Where these checks have failed or not even taken place, the FDA have started to issue proceedings against the company.

ADACT Director, Michelle Bové, said “Checking the age of customers when shopping online can be done very easily with minor website alterations. Relevant age checks should be implemented on all online stores selling electronic cigarette and vaping products to better protect children and show our industry’s commitment on the issue.”

To book a face to face or virtual meeting about preparing your website for FDA age checks, please call ADACT on +44(0)1302 986 088 or email sales@adactmedical.com. The ADACT team are working as normal with extra safety precautions in place and look forward to hearing from you soon.

 

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ADACT announce over 1,000 PMTA submissions

We are proud to announce the successful submission of over 1,000 applications on behalf of 20 major electronic cigarette and vaping brands.

Following the FDA’s decision to push back the introduction of the Premarket Tobacco Product Application (PMTA) from 12 May to 9 September, the ADACT team have worked tirelessly to deliver the documentation required for companies continued sales in the United States of America.

ADACT’s Chief Regulatory Officer, Damien Bové, said “PMTA has been an incredible challenge for the industry in terms of both understanding the initial requirements and filing the subsequent applications.

“Even though we were able to use our experience with Tobacco Products Directive (TPD) to streamline our working processes for PMTA, these initial applications represent thousands of hours work and are a major achievement for our incredible team.”

The world class regulatory compliance knowledge held by the ADACT team attracted many new electronic cigarette and vaping brands to work with us for the first time on their PMTA submissions. To these and our many existing clients, we can only say we are proud to have been entrusted with this huge responsibility and look forward to working with you on future regulatory compliance challenges.

Read more about ADACT’s PMTA programme here…

To book a face to face or virtual meeting about PMTA, please call ADACT on +44(0)1302 986 088 or email sales@adactmedical.com. The ADACT team are working from our Doncaster centre as normal with extra safety precautions in place and look forward to hearing from you soon.

 

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New Business Manager joins ADACT

ADACT Medical Ltd has appointed Jane Wragg as its new Business Manager. Jane is a seasoned sales and marketing professional and is well qualified to pick up the mantle having worked across pharmaceutical and healthcare sectors for many years.

Jane said “ADACT is a dynamic and successful company working in an exciting and growing sector. The depth and breadth of its regulatory compliance expertise is second to none, and the team’s approach of scientific excellence and unrivalled customer support is well known.”

She joined the company in the pivotal lead up to the introduction of PMTA on 9 September 2020 and has already had a positive impact on the business in her short time with ADACT.

Jane continues “I look forward to working with Damien and the team to ensure that our customers can provide their consumers with the best product quality and safety standards. By capitalising on increasing global regulations and the tightening safety requirements around electronic cigarettes and vaping, we can help drive the sector forward.”

To contact Jane, please call +44(0)1302 986 088 or email jane@adactmedical.com

 

 

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Germany updates nicotine free rules for 2021

On the 2 June 2020, the German government voted to further tighten the national rules that regulate electronic cigarette and vaping products, with extra implications for short fill, long fill and 0mg nicotine free products.

The changes to the act largely see the rules for nicotine free products becoming more in line with those for products which contain nicotine.

From the start of next year on 1 January 2021, ingredients such as acetylpropionyl, diacetyl and formaldehyde which are currently prohibited in nicotine containing products will also prohibited in nicotine free products.

Nicotine free products that are intended for use in electronic cigarettes and vape products will now have to go through the same Tobacco Products Directive (TPD) registration process including emissions testing as products which contain nicotine. These rules apply to any affected products which are on the German market by 31 December 2020. As with nicotine containing products, these will also have to be include a contraindications document and be subject to a six month waiting period from initial submission to the product going on sale.

Any products on sale which do not comply with the new rules can continue to be sold until 31 March 2021.

In terms of how the updates will affect your ability to advertise, brands selling online will need to stop all online advertising from 1 January 2021. From this date, all adverts for short fill, long fill nicotine free products intended for use in electronic cigarette and vape products are banned, bringing the rules in line with those for nicotine containing products. Further into the future, at the start of 2024 all advertising in outdoor and public settings for electronic cigarette and vaping products will be banned.

If you believe Germany’s new zero nicotine rules will affect your brand, please contact ADACT today by calling +44 (0)1302 986 088 or emailing sales@adactmedical.com.

 

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How are short fill products regulated?

General product safety is of fundamental importance to every business.  In the worst case scenario, the very viability of a business can be at stake.  The European Union has long had product-specific safety legislation.  Since 1992 it has had more general safety legislation designed to “sweep-up” any products not otherwise caught by European safety legislation.  The current legislation is the General Product Safety Directive (Council Directive 2001/95/EC of 3 December 2001) (OJ L 11/4 of 15 January 2002) which in the United Kingdom is implemented by the General Product Safety Regulations 2005 (SI 2005 No. 1803).

Other directives of the European Union regulate specific products.  The General Product Safety legislation is different in that applies to all products unless “there are no [other] specific provisions governing the safety of the product” in European law.  

The European Union Tobacco Products Directive 2014, enacted in the United Kingdom by the Tobacco and Related Products Regulations 2016 applies only to products which contain tobacco or nicotine no matter what the concentration of the tobacco or nicotine.  The safety of a product which contains no tobacco or nicotine is therefore not governed by that legislation but by the General Product Safety Regulation.  A so-called “short fill product” (nicotine-free flavoured e-liquid) is designed to be vaped in an e-cigarette even though it contains no nicotine.  Accordingly, since it is not caught by the Tobacco and Related Products Regulations 2016, its advertisement and sale will be governed by the General Product Safety Regulation.  

TPD regulation for short fills in selected European countries
In Greece, The Netherlands and Austria, zero-nicotine products are regulated through the TPD system. From January 2021, Germany will follow suit. In all these countries businesses can notify zero MG nicotine products in larger bottle sizes, except for The Netherlands, which still holds zero-MG to the 10ml bottle limit.

Safety under the General Product Safety Regulation
Under the General Product Safety Regulation a “safe product” has a complex definition.  It is a product “which, under normal or reasonably foreseeable conditions of use … does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons”.  In determining that test the characteristics, presentation, labelling and any warnings or instructions on the product are all relevant.  A further relevant factor is “the effect of the product on other products, where it is reasonably foreseeable that it will be used with other products”.  

Where there is a European or national law or a standard governing the product, it can be presumed to be “safe”.  If there are none, the safety should be determined having regard to, for example: the product safety codes of good practice in the sector concerned; the state of the art and technology; and reasonable consumer expectations concerning safety.  

Applying these provisions to “short fill products” leads to the following relevant factors:

  • Short fill products are widely advertised for use with separate nicotine shots.  Since consumers look to use separate nicotine shots with a short fill product, this cannot be ignored when considering the safety of short fill products.  
  • While there are no standards applying to “short fill products” there are standards applying to usual e-cigarette liquid which are relevant ie. TPD and TRPR being “safety codes of good practice in the sector concerned”.  
  • The “reasonable expectations of consumers” would indicate that the standards for the usual e-cigarette liquids should be applied even for “short fill products”.  
  • Since the state of the art and technology easily allow the application of the standards for the usual e-cigarette liquids to be applied even for “short fill products”, that further indicates that they should be applied.  

The only mitigating factor is that the nicotine shots are themselves a regulated tobacco product.  Nevertheless, the bulk of these factors point towards the appliance of a high standard for e-cigarette liquids even for “short fill products”.  

Enforcement
Of course the primary obligations to apply these standards is that of the “producer” of the product.  In European law, this will be the manufacturer, or where the manufacturer is outside the European Union, the manufacturer’s representative.  Where the manufacturer fails to appoint a representative, the importer becomes responsible as if it were the “producer”.  The producer commits a criminal offence where it places an unsafe product on the market.  

However, the distributor must not sell or advertise for sale a product which he knows or ought to have known is not a safe product.  A distributor would be well advised to seek assurances from the manufacturer on these issues.  The legislation is backed up by criminal law.  Both a company and individual directors can suffer criminal penalties.  The current maximum penalty is a fine of up to £20,000 and imprisonment for up to three months.  The only defence available is that of “due diligence”.  This applies only where the company or person who is prosecuted can show that he or she took all reasonable steps and exercised all due diligence to avoid committing the offence.  

Conclusions
ADACT’s Chief Regulatory Officer, Damien Bové, said “The popular conception that “short fill products” are unregulated is false.  Since “short-fill products” are not directly covered by any specific European Union legislation, such as the Tobacco Products Directive, their safety is governed by the General Product Safety Regulations.  That requires a consideration of how they are advertised as well as the standards expected by consumers and the standards applicable to other products in the sector.  These factors indicate that those affected by the legislation, including manufacturers and distributors should have regard to the Tobacco Products Directive, even though it only applies directly to products which actually contain tobacco.”

If you have any questions about Zero Nicotine Short fill Testing or E-liquid TPD Testing, please contact us today by calling +44 (0)1302 986 088 or emailing support@adactmedical.com.

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Vaping in 2020

Today we’ll be reviewing the latest findings from Public Health England (PHE) on vaping in England at the start of 2020. PHE post these regular updates as despite the reduction in the prevalence of smoking, it remains the biggest single cause of preventable death and disease and a leading cause of health inequalities and vaping is seen as an excellent route to help people quit smoking. PHE constantly promote that alternative nicotine delivery devices, such as vape products, are less harmful and could play a crucial role in reducing the health burden on the NHS.

Vaping among young people
The prevalence of young people vaping in England has remained reasonably steady over the last few years, with recent estimates stating just 5% of 11 to 18-year-olds in 2019 vape weekly or even less frequently. The numbers increase by age, starting with less than 1% of 11-year-olds and rising to 11% of 15-year-olds. These young people typically had experience of smoking and less than 1% had never smoked before trying a vape product.

When it comes to sourcing their vaping products, almost 60% of 11 to 15-year-olds who vaped regularly (more than once a week) reported being given the products, mostly by friends. Many also reported buying vaping products from other people, including unscrupulous brick and mortar shops or online stores.

The perception of the relative harms of vaping compared to smoking are out of line with the scientific evidence. The proportion of 11 to 18-year-olds who thought that vaping was less harmful than cigarettes declined from 68% in 2014 to 52% in 2019.

Vaping among adults
Current vaping prevalence among adults in England has remained stable since 2014, and in 2019 was between 5% and 7%. For those who identified as smokers, vaping prevalence varied between 14% and 20%, again showing little change since 2014. Those most likely to vape are still likely to be a smoker or a former smoker, with under 1% of people who have never smoked saying they currently vaped.

As with vaping among young people, the perceptions of harm from vaping are increasingly out of line with the evidence. The proportion who thought vaping was less harmful than cigarettes declined from 45% in 2014 to 34% in 2019. 

One interesting piece of information is that vapers said that banning flavoured liquids would deter them from using vaping products to help them quit or reduce their smoking, and could push current vapers towards illicit products.

In general news, smoking among adults in England has continued to decline over the past 10 years and in 2019 was around 15%. This is fantastic news for the vaping industry as the use of vaping products was identified as one of the most popular ways people used to help them quit smoking.

ADACT’s Chief Regulatory Officer, Damien Bové, said “Overall it is positive that as an industry we are seeing slight increases in the use of our products as an aid in stopping smoking. My main points of concern are that there is still an alarming number of people under 18 who have access to vape products, and there is a worrying trend in communicating the health benefits of vaping over smoking. Much more work needs to be done to effectively communicate this to both a younger and adult audience and bring public perception back in-line with scientific findings.”

You can read the report in full along with extra information on vaping among people with mental health conditions and vaping during and after pregnancy on the Public Health England website at https://www.gov.uk/government/publications/vaping-in-england-evidence-update-march-2020/vaping-in-england-2020-evidence-update-summary#vaping-among-young-people 

Source: Public Health England

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Belgium’s new TPD rules

Companies with new e-liquid products launching soon in the Belgian market are now required to complete additional testing.

For product ranges sold across Europe, it has been standard practice to test just the highest nicotine strength for emissions and use that data to support the notifications for all other weaker nicotine strengths. 

This week, Belgian authorities now require each individual nicotine strength of an e-liquid to be tested separately for Tobacco Products Directive (TPD) notification in their country. The change has been made because they feel that too many parameters can distort the result.

To date, this new requirement has not been rolled back to cover historic filings, however this is a situation we will be watching closely.

If you believe Belgium’s new TPD emissions testing rules will affect your brand, please contact ADACT today by calling +44 (0)1302 986 088 or emailing sales@adactmedical.com.

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Menthol cigarette ban to accelerate the switch to vaping

Menthol smokers are the choice of 18% of the UK’s 7.2 million smokers. However, this type of cigarette will no longer be seen on sale after 20 May 2020 following a ban in the United Kingdom and European Union.

The UK Vaping Industry Association (UKVIA) believe the ban is set to lead to a spike in adult smokers adjusting their habits, which presents a major public health opportunity. Research conducted by one of the UK’s largest online vape retailers revealed that 39% plan on quitting smoking, with nearly a fifth (18%) indicating they will transition to vaping products.

Menthol is one of the vaping sector’s most successful offerings, and many of ADACT’s most successful offerings, and many of ADACT customers know from experience that menthol cigarette smokers have switched directly to much less harmful menthol flavoured vaping products with great success.

John Dunne, director at the UKVIA, said: “The UKVIA and its members are fully prepared for this landmark change to UK regulations and are ready to provide smokers looking to switch, and existing vapers, with a range of viable menthol smoke-free alternatives to see them through this transition.”

The potential for improvements in public health through smokers’ quitting and switching to vaping is backed by Public Health England, which continues to state that vaping is at least 95% less-harmful than smoking.

Source: UKVIA

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Sweden requires new notification

Companies are required to take urgent action if they wish to keep their products on sale in Sweden.

Until recently, to have products on sale in Sweden only required standard EU-CEG notification. On 31 March 2020 this changed. Sweden now require companies to notify The Public Heath Agency of Sweden (https://www.folkhalsomyndigheten.se/the-public-health-agency-of-sweden/) via the EU-CEG system in addition to the rest of Europe.

The information required includes:

  • Comprehensive data on sales volumes by brand name and type of the product.
  • Information on consumer preferences, including; young people (29 years and younger), non-smokers, and the main types of current users.
  • The mode of sale of the products – typically online or retail.
    Executive summaries of any market surveys carried out.
    The information above must be submitted annually and no later than the 31 March for the previous year.

Companies that fail to complete this reporting obligation, will not be to sell their products in Sweden. The Agency has said that they plan to carry out controls of the annual reporting obligation during 2020 and will take appropriate action for failure to comply with the new rules.

ADACT’s Chief Regulatory Officer, Damien Bové, commented, ‘It is essential companies comply with the new regulations as soon as possible as random checks are already taking place. You have probably already trusted ADACT to deal with your European notifications, so we are ideally placed to complete the new Swedish notifications too. We would also take this opportunity to remind you to keep your contact details for the European Union updated in EU-CEG.’

Please contact us today by calling +44 (0)1302 986 088 or emailing sales@adactmedical.com. We are operating largely as normal during the pandemic and look forward to hearing from you soon.

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Pandemic delays PMTA

The deadline for the upcoming Pre-Market Tobacco Agreement, which was set to come into force on 12 May 2020, has been extended by the Food and Drug Administration (FDA) due to the COVID-19 pandemic. 

To give the worldwide e-cigarette and vaping industry some time to breathe during the current crisis, the FDA requested US law makers extend the deadline by 120 days. Late last month, this was approved by a Maryland judge meaning that your PMTA applications must now be completed no later than 9 September 2020.

ADACT’s Chief Regulatory Officer, Damien Bové, commented, “The extension will come as a huge relief for the many companies struggling to operate as normal during this time. While the extension has been granted, the FDA have requested and recommended that people don’t wait until the deadline if they are already in a position to file their PMTA. This extended deadline will be of huge benefit companies that had not yet tackled their PMTA applications and is an excellent opportunity to get up-to-date with the legislation for continued sales in the crucial US market.”

Our prices for PMTA applications are more affordable than you may think – so we encourage you to join the many other companies trusting ADACT with their PMTA applications and get in touch to discuss our full service package.

Please contact us today by calling +44 (0)1302 986 088 or emailing sales@adactmedical.com. We are operating largely as normal during the pandemic so look forward to hearing from you soon.