FDA Compliance Timeline for Premium Cigars: the Major Dates

Here is an abbreviated timeline of the FDA compliance process.  If you haven’t started the planning process for this, the time is now! Many of the dates below seem rather far off, but the preparation needed to meet the deadlines is incredibly time-consuming.

 

08.08.16 – Deadline for new products without prior FDA approval. Ban on free samples. Basic health standards for manufacturing. Age requirements. Product registration.

08.20.16 – First report of User Fees. Monthly reporting hereafter.

12.31.16 – Manufacturer facility registration.

02.08.17 – Health information and ingredient lists.

05.10.17 – Cigar warning plan submission.

08.08.17 – Modified descriptor ban (“light” “mild” etc.). SE Exemption application deadline.

02.08.18 – SE Reports deadline.

08.08.18 – Health warning in labels and advertising. Pesticide level restrictions. PMTA applications due.

08.08.19 – HPHC testing due.

Jacob Delaplane

In private practice, Delaplane navigates the labyrinth of government compliance for clients in the agricultural, healthcare, and land development industries. His experience and expertise handling FDA, TTB, and USDA compliance has helped his clients thrive in some of the most heavily-regulated areas of commerce.

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