FDA's E-Cigarette Authorization: Fruity Vapes Not Significantly Better than Tobacco Ones
The agency said manufacturers did not show fruity flavors provide a greater public-health benefit than tobacco-flavored products.
- The Food and Drug Administration recently authorized disposable, fruit-flavored e-cigarettes from Los Angeles-based Glas Inc., despite the agency's longstanding position that such flavors appeal to children and must show extra health benefits to warrant approval for adults.
- A brief six-page FDA memo released this week provides the agency's rationale, revealing that regulators sidestepped previous concerns about sweet flavors while acknowledging the data from Glas lacked evidence of superior quitting efficacy.
- Data in the memo indicated no "statistically significant differences" between adults using mango or blueberry flavors and those using tobacco-flavored vapes, failing to meet the bar set for previous authorizations.
- Criticism mounted as 10 Democratic senators sent a letter to the agency last month requesting information and labeling the approval a "shortsighted and reckless decision" regarding public health standards.
- Regulators justified the approval by explaining that Glas products "did not have to demonstrate added adult benefit" because young people were unlikely to use them, diverging from prior authorization standards.
36 Articles
36 Articles
Why is the FDA approving kid-friendly, fruit-flavored e-cigarettes?
Fruit-flavored e-cigarettes recently authorized by the Food and Drug Administration were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes, according to a new memo that’s likely to stir more questions about the agency’s decision. The FDA last month gave its first OK to fruit-flavored vapes — essentially endorsing them as a less-harmful alternative to traditional cigarettes. The decision came despite the agency’s…
FDA: Fruity vapes not significantly better than tobacco ones
WASHINGTON — Fruit-flavored e-cigarettes recently authorized by the Food and Drug Administration were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes, according to a new memo that’s likely to stir new questions about the agency’s decision.
The Columbian
FDA’s e-cigarette authorization: Fruity vapes not significantly better than tobacco ones
WASHINGTON — Fruit-flavored e-cigarettes recently authorized by the Food and Drug Administration were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes, according to a new memo that’s likely to stir new questions about the agency’s decision. Read more...
Associated Press News
FDA's e-cigarette authorization: Fruity vapes not significantly better than tobacco ones
A new memo from U.S. health regulators is raising questions about a recent decision to authorize the first fruit-flavored e-cigarettes for adult smokers.
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