Deeming 2019-01-31T14:43:57+00:00

DEEMING

The term ‘Deeming’ identifies the reference legislation in force in the United States that regulates the marketing of tobacco products, including all vaping products and their components and, more generally, electronic devices that release nicotine (ENDS).

Food and Drug Administration (FDA) is the competent authority designated by the current federal law (Tobacco Control Act) for the application of the new regulation.

FDA regulation of the ENDS is still a process in progress. FDA has already estimated ways, times and costs for the marketing authorization process, but the indications given could be revised. In fact, downstream of those estimates, the 17 th Commissioner Scott Gottlieb announced a new comprehensive plan for tobacco and nicotine regulation.

Approaching FDA regulation may therefore seem premature and complex; but if your interest is to market new products in the US or continue to sell products already on the market, it is essential to start managing the already defined requests, in order to comply at the next scheduled deadlines.
To date, in fact, FDA indicates 6 obligations to be followed, some of which according to indications already defined and with impending deadlines.

The deadlines indicated in this timeline refer to products already on the market as of August 8, 2016 marketed by small-scale producers/importers (up to 150 full-time or equivalent employees and up to total revenues of $5,000,000). FDA regulation provides for different deadlines depending on the marketing date and the size of the company producing or distributing: below you can find more details.

Here are the 6 obligations required by FDA regulation and the related deadlines:

1. Registration of the establishment and list of products

FDA requires a procedure which provides the administrative and personal data of the establishments that produce or process ENDS in the US, and the complete list of products.

Deadlines:

MARKETING DATE BIG SCALE COMPANY SMALL SCALE COMPANY
ENDS already on the market on August 8, 2016 October 12, 2017
ENDS placed on the market after August 8, 2016 Immediately upon beginning manufacturing operations.

Have your products been placed on the US market before August 8th 2016? Have you already done the communication of the data required by this step? If you need assistance, contact us.

2. Health Document

It’s a dossier containing information on the toxicology and on the health effects of the finished products and their constituents.

Currently FDA requires the health documents drawn up between June 23rd 2009 and December 31st 2009. The documents drawn up at successive times must be kept available for future requests.

Deadlines:

MARKETING DATE BIG SCALE COMPANY SMALL SCALE COMPANY
ENDS already on the market on August 8, 2016 February 8, 2017 November 8, 2017 (May 8, 2018 in US areas

affected by recent natural disasters).

ENDS placed on the market after August 8, 2016 90 days before placing on the market.

Also for this step, in the case of products already on the market before August 8, 2016, the deadlines have passed (or they are imminent for particular geographical areas).

If you have not provided for the creation of this dossier and you are looking for someone to support you, contact us: we will put our expertise at your service.

3. Ingredient Listing

FDA expects producers and importers to send a document with the complete list, for each product, of all the ingredients present, including compounds and additives, quantities and related functions.

Deadlines:

MARKETING DATE BIG SCALE COMPANY SMALL SCALE COMPANY
ENDS already on the market on August 8, 2016 May 8, 2018 November 8, 2018
ENDS placed on the market after August 8, 2016 90 days before placing on the market.

The deadlines for communicating the ingredient listing for ENDS marketed before 8 August 2016 are approaching: it is important to start planning and drawing up this document for each product on the market. Also thanks to the experience developed in the TPD-II, we know how to optimize such a complex work: call us to find out more.

4. Requirements for labeling

Starting from August 10, 2018 new requirements for labeling will come into force; the distribution of products with non-compliant packaging will be allowed until September 10, 2018.

Deadlines:

BIG SCALE COMPANY SMALL SCALE COMPANY
Entry into force August 10, 2018
Distribution of non-compliant products allowed up to September 10, 2018

Do you already know the new requirements for product labeling? Our regulatory experts are at your disposal to give you more detailed information.

5. Harmful and Potentially Harmful Constituents

The current regulations requires a dossier that provides, for each product, the quantities of substances identified as harmful or potentially harmful to health (HPHC).
The guidelines for researching and quantifying HPHCs in ENDS are currently being defined by FDA.

Deadlines:

MARKETING DATE BIG SCALE COMPANY SMALL SCALE COMPANY
ENDS already on the market on August 8, 2016 November 8, 2019
ENDS placed on the market after August 8, 2016 These deadlines are currently being defined by FDA.

The indications relating to the HPHC dossier are not defined in detail, and the deadlines for the delivery of this document are not imminent. However, gathering information on the toxicity of the substances present in every product on the market is a long and highly responsible process.

If you are looking for someone who has the tools to help you proceed in this aspect, contact us.

6. Premarket tobacco application (PMTA)

To be placed legally on the market, a vaping product must obtain an authorization from FDA, which will be issued on the basis of the evaluation of a dossier in which the product and each component is described in terms of quality and safety.

Deadlines:

MARKETING DATE BIG SCALE COMPANY SMALL SCALE COMPANY
ENDS already on the market on August 8, 2016 August  8, 2022
ENDS placed on the market after August 8, 2016 The evaluation of the PMTA could take about 180 days, as indicated by FDA itself.

The deadlines for the submission of the PMTA are not imminent and the related guidelines are currently being defined by FDA.

PMTA is a document of fundamental importance, the preparation of which is very demanding. It is therefore important to begin to know the information requested, and to check if they are available or not in relation to your products.

Contact us for more information.