• April 2, 2020

FDA issues new ingredient guidence

The US Food and Drug Administration has published its revised guidance on the Listing of Ingredients in Tobacco Products.

In a note issued through the FDA’s Center for Tobacco Products, the agency said the guidance was intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act.

The guidance announces that the FDA intends to enforce the ingredient listing submission requirements of section 904(a)(1) only with respect to finished tobacco products and their components or parts that are made or derived from tobacco, or containing ingredients that are burned, aerosolized or ingested during tobacco product use,’ the note said.

‘For example, ingredients of cigarette paper should be submitted to FDA as it is burned during the use of a cigarette and produces constituents that are inhaled by the smoker.’

The note added that, for example, the FDA did not intend to enforce the ingredient listing submission requirement in respect of coils, wicks and mouthpieces.

Information of what components and parts require an ingredient listing submission is at: https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm191982.htm?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=guidance&utm_campaign=CTP%20News%3A%20Listing%20Guidance%20Update%20-%2041318.

The guidance is said to streamline the requirements for manufacturers by clarifying ways in which tobacco product manufacturers or importers can satisfy the ingredient listing requirements by providing one listing that corresponds to multiple products.

‘It explains the statutory requirement to submit a list of all ingredients in tobacco products, who submits ingredient information, what information is included in the submissions, how and when to submit the information, FDA’s compliance policies, and definitions,’ the note said.

The note issued a reminder to manufacturers and importers of ‘deemed tobacco products’ that were on the market as of August 8, 2016, that the deadline to submit ingredient listings is May 8, 2018. For small-scale manufacturers, the deadline was said to be November 8, 2018.