GDPR changes rules on data protection: You might be forgiven for a little fatigue when it comes to new regulation. The TPD in Europe, Deeming in the United States…it’s been tough to keep up with. But a new horizontal regulation in the EU will affect the way everyone does business, and that includes the vaping industry: the General Data Protection Regulation (GDPR).
GDPR will come into force next year, and it’s particularly important that companies who sell online take note, as they way that they process customer data likely needs a radical overhaul. Many are examining their procedures now in anticipation.
Key changes include:
- International scope – for the first time, non-EU companies are within the scope of GDPR when they process the personal data of EU residents. That means US companies selling to European consumers need to pay attention too.
- Consent for processing – Consent for data processing must be freely given by the subject, specific, informed and unambiguous. Requests for consent should be separate from other terms, and be in clear and plain language. A data subject’s consent to processing of their personal data must be as easy to withdraw as to give. Consent must be “explicit” for sensitive data such as addresses and credit card details.
- Parental consent – parents must give consent for minors to receive information society services – a minor is considered to be anyone under 16 but Member States can lower that to 13 if they wish.
- Information provided to data subjects – Data controllers must continue to provide transparent information to data subjects. This must be done at the time the personal data is obtained. However, existing forms of fair processing notice will have to be re-examined as the requirements in the GDPR are much more detailed than those in the current Directive. For example, the information to be provided is more comprehensive and must inform the data subject of certain of their rights (such as the ability to withdraw consent) and the period for which the data will be stored.
- International data transfer – US companies selling on the web should take note: exporting personal data from the EU to third countries is strictly controlled. An outright ban on transfers to foreign regulators without approval did not survive the adopted text. That said, most routine transfers are prohibited and they can only take place when sufficient information is given to data subjects informing them of the specific risks of the transfer.
The deadline to get all of this implemented in May 2018, so if you’ve never heard of GDPR, now might be the time to take a look.,
In an email sent to the FDA’s mailing list yesterday, the Angency announced that FDA ingredients listing deadlines would be moved for those companies struggling to cope with the effects of natural disasters.
In a statement on its website, the Angecy said:
“The FDA is aware that tobacco manufacturers and importers in the affected areas are dealing with extraordinary circumstances and may need additional time to meet certain requirements. As a result, the FDA is extending the compliance deadlines for the ingredient listing and health document submission requirements by an additional six months for manufacturers and importers of deemed products in the areas affected by these recent natural disasters.”
FDA has listed the areas where manufacturers will be given extra time to complete FDA ingredients listing. This includes Caribbean Islands and large parts of Texas and Florida that were hit by tropical storms; along with parts of California that were hit by wildfires. We have reproduced this list below for reference (last updated 19th October 2017). Should FEMA decide that other areas have been significantly affected by these disasters, FDA will do likewise.
It’s not yet known whether those companies not in these areas but who have significant suppliers who were affected will also be granted exemptions. The Agency have provided a telephone number (1.877.287.1373) and email address (SmallBiz.Tobacco@fda.hhs.gov) for those who would like further clarity. If you’re not in one of the areas listed, you should assume that the original deadline still applies to you unless you are told otherwise.
For those who will receive an extension for their FDA ingredients listing, the new deadlines are:
Large scale manufacturers: May 8 2018
Small scale manufacturers: November 8 2018
Areas Affected by Recent Natural Disasters
- Caribbean Islands — This extension will apply to manufacturers and importers of deemed products in all areas of:
U.S. Virgin Islands
Antigua and Barbuda
Sint Eustatius and Saba
British Virgin Islands
Saint Kitts and Nevis
Saint Vincent and the Grenadines
Saint Martin/Sint Maarten
Turks and Caicos Islands
In the continental United States, this extension will apply to manufacturers and importers of deemed products in the following counties designated by the Federal Emergency Management Agency (FEMA) as disaster areas:
- California —
- Florida —
- Texas —
PolicyMatters – one of the longest standing consulting firms in the field of vape regulation – has rebranded to Beckett Associates.
The firm, which was founded by Peter Beckett in 2014 and has been working on vaping and regulation since its inception, provides client-focused regulatory services to companies operating in and around vaping. Its core offerings include:
- TPD notifications and ongoing compliance: helping clients with liquid and emissions testing, toxicological data and notifications for vaping products that are to be sold in the European Union and regulated under the Tobacco Products Directive.
- FDA submissions: helping clients active in the United States prepare their Premarket Tobacco Application, which will require
- Toxicological data: providing a cost efficient solution to clients that require toxicological literature searches using software to compile publicly available data on any known chemical substance.
The Beckett Associates team is made up of three best in class advisors on the science, regulation and politics of vaping; and includes a globally recognised pharmaceutical development scientist and a Brussels-based former diplomat. It’s founded on key principles of transparency, simplicity, professionalism and value for money.
Peter Beckett, Beckett Associates Managing Director, said:
“While our name and our brand has changed, our core values and customer-focused approach to regulatory consulting will remain the same. We’re proud to work with some of the best companies in vaping, both large and small, and we look forward to continuing to serve this transformational industry as it matures and grows”.