FDA provides warnings guidance

| September 1, 2016

The US Food and Drug Administration has published a draft guidance to assist in the submission of health warning plans for cigar packages and advertisements, and is asking for comments on the guidance by September 29.

‘The draft guidance discusses the required warning statements for cigars and how each must be randomly distributed, randomly displayed on packages, and rotated quarterly in advertisements in accordance with an approved warning plan submitted to FDA for review and approval,’ the FDA said.

‘Cigars will be required to carry warning statements on all packaging and advertisements beginning May 10, 2018.’

The draft guidance includes information about who must comply with this requirement, and about what needs to be submitted as part of a warning plan.

The draft guidance is at: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm517680.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Meanwhile, the FDA has revised its guidance defining the phrase ‘harmful and potentially harmful constituent’.

‘The revised guidance represents FDA’s current thinking on the matter, and it better reflects the current range of tobacco products subject to the agency’s authority,’ it said.

‘For the purpose of establishing a list of tobacco product constituents that are harmful or potentially harmful to human health, as required under section 904(e) of the FD&C Act, FDA believes the phrase ‘harmful and potentially harmful constituent’ includes any chemical or chemical compound in a tobacco product or in tobacco smoke that is, or potentially is, inhaled, ingested, or absorbed into the body, including as an aerosol (vapor) or any other emission.

The guidance is at: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm241339.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

Category: Breaking News

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