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. It now comes into force on 9 September 2020; previously 9 May 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.
To give the worldwide electronic cigarette and vaping industry some time to breathe during the COVID-19 pandemic, the FDA requested US law makers extend the deadline. PMTA applications must now be completed no later than 9 September 2020.
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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