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.
Cannabadiol (CBD) containing products have seen a rapid increase in consumer demand over the past number of years. Since January 2019, CBD products have been regulated as Novel Food Products in the European Union following the decision by the European Commission.
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy. Inter Regulatory brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burdon.
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