Health Politics

British American Tobacco Supports Robust Product Quality Standards, USA Youth Access Prevention Measures And Stands Ready To Make PMTA Applications

LONDON, Sept. 12, 2019 /PRNewswire/ —

Kingsley Wheaton, Chief Marketing Officer, British American Tobacco, said:

“We welcome the USA’s Food & Drug Administration (FDA) shining a spotlight on the important issue of preventing youth access to vapour products and consumer safety. We wish to work with governments and regulators worldwide to ensure clear and responsible regulatory frameworks are developed, which take account of all industry stakeholders – including consumers, regulators and the industry.

“We have always been clear that children should not use vapour products and we have had stringent measures in place to address this issue for some time. Accordingly, we share the FDA’s concern that the marketing of some flavours could resonate with children. At the same time it is hard to overestimate the role that the responsible marketing of flavours plays in helping adult consumers move on from combustible products to alternative tobacco and nicotine products.

“As a responsible company, we have supported measures to remove products which could be attractive to, or targeted at, children. We also have procedures in place to ensure our products are only ever marketed to adult smokers and vapers.

“We look forward to receiving the FDA’s final guidance on flavours and our US business will work with them regarding the proposed changes.

“Given the tragic cases reported in the US recently, we fully support the FDA’s efforts to ensure the safety of those consumers who use vaping liquids and devices. As the world’s second largest vapour company, providing high quality products to more than 9 million consumers worldwide, we take our consumer safety responsibilities very seriously.

“We have invested billions of dollars in the research and development of our potentially reduced products and the ingredients and components used in these products have been scrutinised by our team of 50 toxicologists for their suitability for vaping. Consistent with this, we do not include oils containing THC or Vitamin E Acetate.

“We are confident that our planned Pre-Market Tobacco Applications (PMTA) for our four main VUSE products in the USA will be submitted before the FDA’s deadline of May 2020 which, if approved, will enable our Reynolds business to continue selling its VUSE branded vaping products within the new USA regulatory framework.”

Notes to editors

Measures Reynolds already have in place in the USA to address youth access prevention:

  • Reynolds has taken a responsible approach to developing, and subsequently naming, its flavours to ensure they appeal to adult consumers and not children.
  • Reynolds age verifies through a third-party vendor that all potential online purchases are 21 or older.
  • Reynolds is a founding member of ‘We Card’, an organization nationally recognized for retailer education and training for age-restricted products. In 2017, We Card was recognized by 38 state governors.
  • Reynolds funds ‘Right Decisions Right Now: Be Tobacco Free’ (RDRN), a youth tobacco prevention education program which was started in 1991 and is an evidence-based, independently tested program for use by middle-school educators, parents and community groups.
  • Reynolds currently has a purchase limit of $200 per transaction and plans to implement a more stringent limit of $80 per week and three devices per quarter while instituting purchase pattern monitoring.
  • Reynolds has voluntarily implemented specific guidelines that restrict the content of marketing and advertising materials for our vapor products:
    • No testimonials by sports figures or celebrities or any person with special appeal to persons under 21 years of age;
    • No person appearing in any advertising materials shall be under age 25 or be styled to look under age 25;
    • Content shall not include characters, images, or themes designed to target youth;
    • Content shall not be related to youth or youth-oriented activities;
    • Content shall not suggest that use of R.J. Reynolds Vapor Company’s (“RJRV”) products is essential to social prominence, distinction, success or sexual attraction, nor shall any content picture a person using any RJRV products in an exaggerated manner; and
    • Content shall not depict persons participating in, or obviously just having participated in, a physical activity requiring stamina or athletic conditioning beyond that of normal recreation.

USA Pre-Market Tobacco Application (PMTA) Process

  • In May 2016, the US FDA finalised their ‘deeming’ rule, which placed vapour products (among others, including cigars) under their regulatory authority.
  • As a result, manufacturers of vapour products must submit Pre-Market Tobacco Product Applications (PMTAs) for consideration of their products to be approved for sale.
  • To receive approval, PMTAs must demonstrate that products are appropriate for the protection of public health. This is determined by evaluating the relative risks of the new product versus pre-existing tobacco/nicotine products, the likelihood that existing tobacco/nicotine users will stop using such products, and the likelihood that those who do not use tobacco/nicotine products will start using the new product.
  • In July 2019, a Federal Judge ordered the FDA to impose a deadline of May 2020 for PMTA applications to be submitted.

British American Tobacco’s preparations are well advanced and as such, we are very well positioned to meet the May 2020 deadline.

Forward looking statements

This is a release by British American Tobacco p.l.c. Associate companies are excluded. References to ‘British American Tobacco’, ‘BAT’, ‘we’, ‘us’ and ‘our’ when denoting opinion refer to British American Tobacco p.l.c. (the Company, and together with its subsidiaries, the “Group”), and when denoting tobacco business activity refer to Group operating companies, collectively or individually as the case may be. This release contains certain forward-looking statements, made within the meaning of Section 21E of the United States Securities Exchange Act of 1934, regarding our intentions, beliefs or current expectations reflecting knowledge and information available at the time of preparation and concerning, amongst other things, prospects, growth and strategies. BAT undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

These statements are often, but not always, made through the use of words or phrases such as “believe,” “anticipate,” “could,” “may,” “would,” “should,” “intend,” “plan,” “potential,” “predict,” “will,” “estimate,” “strategy” and similar expressions. It is believed that the expectations reflected in this release are reasonable but they may be affected by a wide range of variables that could cause actual results to differ materially from those currently anticipated.

SOURCE British American Tobacco Plc

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