FDA Deeming Regulation Update

The FDA released a Revised Guidance: New Compliance Period for Registration and Product Listing.

The Revised Guidance extends the registration deadline to June 30, 2017 for manufacturers that were on the market prior to August 8, 2016. Manufacturers on the market after August 8, 2016 must still meet the new deadline.

(They are) still recommending registration as soon as possible. The new year will be busy with pre-PMTA meetings, health documentation, and ingredient submissions. The complexity and time involved in these submissions will  make juggling registration difficult.

The extended deadline will enable revisions or changes until June. That said no new products can be introduced in the new year.

Leave a Reply