Saturday, September 3rd, 2016
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As many have seen, the Utah Dept of Health has released an update to the HB0415 regulations (Rule R384-415) on September 1st. Anyone may submit public comment through 5pm MDT on October 3rd and providing no further updates are required, will have an effective date of 10/10/2016. The changes are intended to clarify the rule in light of the FDA’s Tobacco Control Act Deeming Rule.
You may review the revised rules by clicking here
The UTSFA has reviewed the updates to the regulations and the following is our assessment of the language:
- Requirements for batch numbers have been removed, any FDA requirements remain
- Requirements for specific qualities of ingredients has been removed
- Requirements for Utah specific labeling requirements have been aligned to match FDA requirements. This means,
- No requirement for tamper evident warning
- No unique Utah language for nicotine warning, any FDA requirements remain
- No requirement for manufacturing name, any FDA requirements remain
- No requirement for an ingredient list, any FDA requirements remain
- A Utah specific requirement for non-nicotine warning was added
- The maximum nicotine content rule remains
- The rule allowing for a 10% variance in nicotine content of a final mixed product has been removed
- Requirement for use of a tamper-evident feature has been removed
- Enforcement of the rules remains with the Departments of Health
- Requirements for record keeping has been removed.
- Language added that allows for only the sale of FDA approved products after August 8, 2019.
Based on a few of the items above, the UTSFA will likely be submitting feedback during the public comment period to try and correct a few items we believe are in violation of the new federal regulations and express our concern the modifications were done in isolation without input from the committee who designed the regulations. As further updates become available, the UTSFA will inform the community accordingly.by