FDA Approval
Tobacco Health Certificate (NCTTP)
The tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). These certificates must be…
Walmart VTA Supplier Requirements
Selling with a major retailer is a dream for many companies. When selling with any major retailer it is important to understand the retailer’s regulatory…
Amazon FDA Registration Proof
Amazon FDA registration proof can be a moving target. Is it a certificate, a screenshot, or something else!? The answer varies from week to week…
FDA New Tobacco Deadlines
As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various…
FDA New Tobacco
FDA new tobacco regulation also known as the Deeming Regulation takes effect in 30-days (August 8, 2016). The regulations are broad, complex and impact every…
Tobacco Products Required Warnings
Among the key requirements of the FDA’s new Deeming Tobacco rule are that tobacco products bear the required warnings. This rule states advertising and packaging warnings…
FDA Device Meetings
FDA Device Meetings Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market…
E-Cig Rule Practical Guide
FDA E-Cig Rule Practical Guide Now that the shock of the new FDA E-Cig rule (Deeming Rule) is settling in it is time to get…
FDA Comments Deeming Regulation
FDA Comments Deeming Regulation This afternoon I attended a meeting with CTP Director Mitch Zeller regarding the deeming regulation (“FDA Comments on Deeming Regulation”). CTP Director…