Notification requirements identified
Submission of product samples, ingredients and manufacturer information
Lab analysis (nicotine dose consistency, carbonyls and metals)
TPD Notification to European Commission
Product noticed and placed on the market
In May 2016, the Food and Drug Administration finalised its “deeming” rule, subjecting nicotine products to scrutiny under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. Products marketed after February 2007 must submit a Premarket Tobacco Product Application (PMTA) before the product can be sold in the US.
Since January 2019, CBD products have been regulated as Novel Food Products in the European Union following the decision by the European Commission. CBD manufacturers, trade bodies and suppliers are required to apply for authorisation with a deadline of March 31, 2021 set for all applications for products on the market.
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy. Inter Science brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burden.
Inter Regulatory has worked with us in our understanding of some of the complexities of the TPD and have simplified the regulatory requirements for us. Their knowledge and speed have made it a pleasure to work with them.
Founder – ENDS product brand