Helping you build your brand into the America market with Food and Drug Administration (FDA) PMTA approval
On 10 May 2016, the American Food and Drug Administration (FDA) formalised its authority to regulate electronic cigarettes and vape pens under the Federal Food, Drug and Cosmetic Act, as amended under the Family Smoking Prevention and Tobacco Control Act.
Following the PMTA deadline of 9 September 2020, we announced ADACT had completed over 1,000 submissions on behalf of 20 major brands. Read more by pressing here…
Pre-Market Tobacco Product Application Marketing Order (or PMTA for short) was introduced to ensure vaping products are safe to consume and to raise standards in the American vaping industry to protect consumers. The new rules apply to companies wishing to sell existing or new electronic cigarettes and vaping products in the US and came into force on 9 September 2020.
PMTA’s are issued by the FDA and permit tobacco products to be legally marketed in the US. To issue a PMTA, the FDA first evaluates a product based on a public health standard that considers the risks and benefits of the product to the population as a whole, for users and non-users.
So, what’s next once we’ve submitted your PMTA filing? The FDA have three types of common review procedure your filing must go through:
This is the most basic, administrative review and ensures that the product falls under the Centre for Tobacco Products jurisdiction. This review confirms that all the submission’s statutory and regulatory requirements are met.
The second procedure is the filing review in which a preliminary scientific review takes place. In this, the FDA will ensure the application contains all the items set out under Section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act.
In the final review procedure, the FDA evaluates the scientific information and data in your application, as well as any recommendations from the Tobacco Product Scientific Advisory Committee (TPSAC) if your application was referred.
Thanks to the thousands of hours background work ADACT completed prior to our first filing and our excellent working relationship with submission leads within the FDA, you can be assured of a thorough submission. In the unlikely scenario that your submission does not get accepted, we have thorough internal systems in place to ensure any issues are corrected at the earliest opportunity for re-submission.
The final step on the PMTA journey is postmarket reporting in which your company is required to maintain records and report on factors the FDA will use to determine whether there are any grounds to withdraw or temporarily suspend your marketing order. The two types of reporting are:
This covers the most serious adverse experiences such as; death, life-threatening events, inpatient hospitalisation, incapacitation of user, birth defect or any other adverse or serious condition affecting quality of life. These reports must be filed within fifteen days of identification.
These are less urgent reports which are filed annually and cover; changes to manufacturing, facilities, or controls that do not modify the finished product along with inventory of ongoing and completed studies, summary of sales and distribution data, current product purchasers, labelling changes and marketing and advertising plans. This also covers certain manufacturing deviations which could cause serious health consequences or death which are required to be reported within fifteen days of identification.
PMTA is one of the most challenging areas of regulatory compliance within the electronic cigarette and vaping industry. It is vital that you work with experienced scientists who have a proven track record, and who are globally respected and trusted in the industry such as ourselves. ADACT do not directly undertake PMTA work. We engage our US partner, Adact Medical US LLC who offer the same level of expertise and excellence for the US market.
Companies around the world have trusted ADACT with their regulatory compliance.
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