Medical Societies Challenge FDA E-Cigarette Guidance Amid Congressional Authority
What happened
The American Thoracic Society and American College of Chest Physicians filed a joint amicus brief supporting a lawsuit by the American Academy of Pediatrics and other public health organizations. This action challenges the FDA’s recent guidance policy, which permits unauthorized e-cigarettes and nicotine pouches to be distributed and sold in the U.S. The guidance allows thousands of unregulated flavored products to remain on the market without required FDA review and authorization.
From newswise.com
Why it matters
The Tobacco Control Act of 2009 requires all new tobacco products to undergo FDA premarket review. Critics argue that the FDA has failed to use its authority to remove unauthorized products, leaving youth vulnerable to addiction and disease.
The FDA is responsible for setting standards for e-cigarette product approval.
From newswise.com
Who's involved
- FDARegulatory agency whose authority is established by Congress
- CongressPassed legislation that grants the FDA authority to regulate tobacco
- Philip Morris InternationalA global tobacco company potentially affected by regulatory changes
- JuulAn electronic cigarette manufacturer targeted by the challenged FDA guidance
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- JuulSpeculative
Juul may see changes in market access and compliance costs due to the challenged FDA guidance.
- Federal Trade CommissionSpeculative
The Federal Trade Commission could see changes in the scope of enforcement regarding unauthorized distribution.
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The entities involved
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