On May 3rd, 2017, the U.S. Food and Drug Administration (FDA) (FUFDA!) announced it will defer enforcement of all future compliance cigar regulation deadlines for all categories of newly regulated products, including cigars, for three months and plans to issue guidance describing its position in the near future.
Why in the heck would the FDA make this change? According to the FDA, “this extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in Federal court.” Perhaps, just maybe, the new FDA Director will revise or dump the regulations. Doubtful, but there is hope!
This decision concerns cigar regulation deadlines set for May 10th, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, Pre-Market Tobacco Product Applications (PMTAs), and Harmful and Potentially Harmful Constituent (HPHC) reports. This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.
The FDA issued guidance titled, “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.” This extension only applies to dates set for May 10th, 2017 or later. This extension was first communicated in legal filings in Federal court on May 1st, 2017, and was then shared with stakeholders.
For all future compliance dates related to the final deeming rule, the FDA is deferring its enforcement for an additional three months. Provisions for which this extension will apply include, but are not limited to the following:
- Submission of cigar rotational warning plans (Cigars will kill you, smoking cigars while pregnant will kill you, smoking around other people will kill them, etc.),
- Registration and listing,
- Ingredient listing (Tobacco, water, gum to hold the label on.),
- Health documents,
- Substantial Equivalence (SE) exemption requests (The 2016 version had 14 tobacco leaves and the 2017 version will have 13 tobacco leaves),
- Substantial Equivalence (SE) applications (Cigar x is made of tobacco, water, and gum and my new cigar y is made of tobacco, water, and gum, and is therefore substantially equivalent. Ugh),
- Pre-Market Tobacco Product Applications (PMTAs), and
- Harmful and Potentially Harmful Constituent (HPHC) reports (Cigar x is made of tobacco, water, and gum, and therefore has no HPHCs).
For more information, including a chart with all of the provisions and corresponding new compliance dates, please read the guidance.