The Food and Drug Administration (FDA) is looking to clamp down on claims made by e-cigarette and tobacco firms that cannot be backed up by evidence, and could even use patent filings as evidence of unsupportable assertions such as e-cigs being effective for smoking cessation, the report says.
The federal agency has already cautioned tobacco companies over the use of terms such as “natural” and “additive-free” in the marketing of conventional tobacco products, because the language could be misconstrued as indicating that the products are classed as modified-risk, according to the FDA.
E-cig companies have also started to have their collars felt, with four companies being issued warning letters for claiming their products had received FDA approval, laboratory certification, or inspection.
“Importantly, this type of FDA enforcement action is not related to the agency’s attempt to regulate e-cigs under the deeming regulations,” said the ECigIntelligence legal team. “An FDA enforcement action is more likely to be based on false statements and representations that trick the consumer into believing the products are FDA-approved, safe, or less harmful.”
And the FDA is looking to move further beyond this, the report observes, seeking creative methods of ensuring that e-cigarette companies do not make unsubstantiated claims.
For example, it could argue that an e-cigarette product falls under its jurisdiction as a drug and/or medical device if the manufacturer seems to be making claims in a patent filing that it can play a medical role.
What This Means: E-cigarette companies are currently vulnerable to creative enforcement from agencies looking to protect consumers by prohibiting any statements that cannot fully be backed by scientific research.
To find out more about potential vulnerabilities, the ECigIntelligence report is available immediately to Silver, Gold and Platinum subscribers, and can also be purchased separately.
– Freddie Dawson ECigIntelligence staff