The U.S. Food and Drug Administration (FDA) recently issued a guidance that extends the compliance dates for tobacco ingredient submissions for newly deemed tobacco products introduced into interstate commerce on or before August 8, 2016. FDA plans to enforce the ingredient list submission requirement on August 8, 2017 for businesses that are not small-scale manufacturers, and on February 8, 2018 for small-scale manufacturers. The original date for compliance was February 8, 2017.
The compliance deadlines have been extended to allow manufacturers and importers additional time to prepare quality submissions. The extension also allows some manufacturers to submit multiple lists for multiple tobacco products.
Ingredient submissions should include the following information:
- Manufacturer/Importer Identification
- Product Identification
- Ingredient Identification
- Ingredient Quality
Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements. For more information on FDA regulations for tobacco manufacturers, including the recently finalized refuse to accept tobacco rule, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.