Today the FDA posted new potential guidance for the industry and it is now open for commenting beginning tomorrow. This new potential guidance gives a strong outline for Perception and Intention Studies. Per the FDA’s definition “TPPI studies are studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding […]
Due to the global pandemic caused by COVID-19, manufacturers had written letters to the FDA urging them to push back the PMTA submission date. Especially considering that many manufacturers have locations in South America and China that have been severely affected by COVID-19. On March 30th the FDA had put in to have the PMTA […]
FDA Accepting Research via Forum The FDA is opening a comment forum for CBD in correlation to their May 2019 forum. This decision is made to help the FDA gather more information on CBD and its users. In addition to gaining a better understanding of the products on the market and their uses. The […]
Trump Administration Supports a Ban on Flavored Vape Products On September 11th, 2019, the Trump Administration announced that, after six deaths and 450 vape related illnesses, it intends to issue a finalized guidance in the coming weeks which will amend the FDA’s enforcement policies regarding flavored vape products. The guidance would remove unauthorized flavored vape […]
In a sweeping new decision Vermont has passed legislation to ban the online sale of tobacco products. The exact legislation as it reads “Sec. 2. 7 V.S.A. § 1010(b) is amended to read: (b) No person shall cause cigarettes, roll-your-own tobacco, little cigars, or snuff, tobacco substitutes, substances containing nicotine or otherwise intended for use […]
There is a difference between managing a business and being an entrepreneur. Truth be told, many entrepreneurs despise the minutiae of managing their business…
We have all been known to bend a few rules, put off a task due to other priorities, or take the risk with that 3-day old to go box in the refrigerator.
Hey guys, a lot of my clients are ramping up for PMTA. In this vector it really does take a village, and it is important that we know who is on our side.
With so much talk about the FDA today, I see people forgetting about another crucial regulatory body that may be more likely to visit your facility (and report a problem).
One thing I have noticed going over registration and product listing files is the large amount of misleading information.