Breaking News: FDA withdraws PMTA ruling.

[method1]

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-27456.pdf

(very expensive) PMTAs still have to be filed so it's not really good, but some back-pedalling could be seen as encouraging, possibly an incremental step in a better direction. However this does seem to to be more geared towards letting big business interests get their products to market sooner rather than later.

"Today, the FDA withdrew a direct final rule describing when the agency could reject PMTAs for being deficient (i.e., not in English, not describing an actual tobacco product, etc.)

This is NOT a major change to the PMTA process or the FDA regulation.

This is about procedure for those who actually can afford to file PMTAs. If you are in the 99%+ that don't have millions of dollars sitting around, this doesn't impact you."

 

[RichJB]

These are the minimum requirements which have been withdrawn:

Previously, FDA stated for efficiency reasons, it would not evaluate applications under the following circumstances:

1. Does not pertain a tobacco product;
2. Is not in English (or does not include a complete translation);
3. Is submitted in an electronic format that FDA cannot process, read, review, or archive;
4. Does not include the applicant’s contact information;
5. Is from a foreign applicant and does not include the name and contact information of an authorized U.S. agent (authorized to act on behalf of the applicant for the submission);
6. Does not include a required form(s);
7. Does not identify the tobacco product;
8. Does not identify the type of submission;
9. Does not include the signature of a responsible official authorized to represent the applicant;
10. Does not include an environmental assessment or claim of a categorical exclusion, if applicable.

Honestly, any applicant who sees that as a barrier to entry and is unable to provide the requirements shouldn't be overly optimistic about making a successful application. It's like SA companies who complain that govt are excluding them unfairly from tenders because they can't provide a tax clearance certificate, company registration papers or copies of shareholder IDs, and their only contact details is a cell phone number. It's an admission that they're fly-by-nights and govt is quite correct to exclude them.

Regarding the freeze, I can't see any evidence of it. On Aug 8, YouTube reviewers lamented that the end of the world had come, they'd no longer be doing reviews and would just do vlogs from now on. Yet we still see a constant stream of reviews on new products, and Rip announced a couple of weeks ago that he is releasing some new commercial juices. Presumably these products are all on sale to the US public. Perhaps the manufacturers of the hardware have submitted PMTAs to allow their products into the market until their application is assessed. But I can't see Rip doing that somehow. So what is this "freeze" that people were so worried about?