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FDA may postpone enforcement of all future Deeming Regulation compliance deadlines

FDA compliance deadlines delay

A letter from FDA indicated a delay on future Deeming Regulation compliance deadlines by 3 months, the reason for the extension stated in the letter is that;

” This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court. ”

 

We are not sure whether the Trump administration will repeal the current Deeming rule or not, but it is good to see changes are moving in the right direction. Not only does that three months give the vaping industry a breather, it also gives the administration the necessary time to amend the unfair regulations on vapor products. Aspire has been working closely with U.S. law firms to ensure we could be the first group to get the latest information.

Link: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

Good evening,

 

The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

 

In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.

 

This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.

 

This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.

 

This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.

 

Please contact me with any questions.

 

Lindsay R. Tobias

Center for Tobacco Products

Office of the Center Director

U.S. Food and Drug Administration

 

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Aspire on track to Fully Comply with FDA/TPD Regulations

Dear Valued Aspire Customers,

For those of you who are affected by FDA/TPD regulation guidelines, Aspire is working hard and making progress on both fronts.

Aspire is working to meet the FDA guidelines. We have retained a lawyer are working to register products and company. We will also be completing the ingredients listings which are due February 17, 2017.

As most of us know, in the USA, we will have at least two years to continue selling products that were already on the market before August 8, 2016.

Regarding the FDA’s PMTA process which will be due at the end of this two year period, Aspire will apply for as many products as we can. We do not have any specific number of products we will submit. We also do not have a specific time line.

The TPD November 20 deadline is approaching soon. Aspire is completing required TPD emissions and toxicology testing. The test results will confirm and ensure that Aspire vaping hardware is safe to use with E-liquids. TPD material submissions will only be provided to European governments via the submission portal. Some test results will also be required by the FDA and we will share the reports with the FDA when necessary.

Customers will not need to register to sell Aspire products for either TPD or FDA. Aspire will take all necessary steps to ensure you can continue reselling Aspire products as you have in the past. For this reason, we will not be releasing any files to the public.

We will have product registrations complete TPD by Mid-November. Please stay tuned to this blog as we will be releasing more FDA and TPD news.

Thanks,

Aspire Team

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