Food and Drug Law Institute lays Law on Modified Risk Tobacco Products

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Between the 21and 23 October 2020, the FDLI conducted a conference on Tobacco and Nicotine Products Regulation and Policy, with a session dedicated to Modified Risk Tobacco Products or MRTP’s as the US FDA designates them – products that after concluding a thorough scientific assessment can be considered reduced risk, or reduced exposure as compared to cigarette smoke.

So far the products so termed by the FDA are non-combustible.

Keynote speakers included Ben Haas, Partner at Watham and Latkins LLP as well as Tryggve Ljung, Vice President of Scientific Affairs at Swedish Match North America.

For a product to qualify for a risk modification order, it needs to successfully conclude a lengthy evaluation by the FDA, during which science, consumers’ acceptance and products’ characteristics are checked.

The former adult smoker which switches to one of these products should either have the risk of disease diminished, or be exposed to less toxicants.

Also these products should wholly replace cigarette smoke and not appeal to minors or non-smokers.

All this has to be demonstrated by the producer and continuously checked by the FDA in order for a product to be considered to be appropriate to promote public health.

Authorisation of MRTPs
In the United States, Section 911 of the Federal Food, Drug, and Cosmetic Act provides a pathway for tobacco products to be sold as MRTP’s and grants qualifying products a 5 – year timeline for marketing.

This act stipulates strict post-market requirements intended to limit youth access and marketing exposure.

The act encourages producers and marketers of MRTPs to use strict age and identity controls for individuals purchasing online.

It also encourages the use of age restrictions at the first point of access for any product labelling, advertising, marketing and/or promotion appearing in their owned digital properties or any shared digital properties.

Further, all marketers must conduct real-time media tracking and measurement of all advertising impressions by channel, audience demographics, and by-product and provide periodic reports to the FDA.

Finally, all partners, influencers, bloggers, or other brand ambassadors who participate in product marketing must disclose their relationship to the company.

FDA Authorises Marketing of IQOS Tobacco Heating System
IQOS, Phillip Morris’s tobacco heating system (THS) has been granted marketing rights by the FDA for four years.

This ruling came to light on July 7th 2020 when PMI SA products received an exposure modification order for their IQOS Tobacco Heating System and Heatsticks.

The FDA determined that according to the available scientific evidence, these products merited issuance of exposure modification orders under section 911(g2).

The Food and Drug Law Institute (FDLI), founded in 1949, is a non-profit membership organization that offers education, training, publications, and professional engagement opportunities in the field of food and drug law.

As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation.

FDLI’s scope covers all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities in the U.S. and globally, including drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products.

The Independent Observer

John Sakala is a Journalist yearning for independent journalism

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