Public health groups sue FDA

Public health groups sue FDA

The Campaign for Tobacco-Free Kids and different groups behind the claim contend candy flavored cigars and e-cigarettes bid to kids, who could become dependent while the items are sold and before the surveys are finished.

Gottlieb told the Associated Press in an interview earlier this month that the FDA would soon take action against "products that are being marketed in kid-appealing ways", including e-cigarettes.

The 45-page lawsuit was filed in federal district court in Maryland by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and several individual doctors.

Public health groups are suing the Food and Drug Administration for allowing candy flavored cigars, electronic cigarettes and other products to remain on the market for years without being reviewed and approved by the FDA.

The groups also argue the FDA exceeded its authority under the Family Smoking Prevention and Tobacco Control Act and violated the Administrative Procedure Act by not giving the public an opportunity to comment on the deadline delays.

E-cigarettes are vapor-emitting devices that have grown into a $4-billion dollar industry in the USA despite little research on their long-term effects, including whether they are helpful in helping smokers quit cigarettes. "There is this enormous anxiety in the public health community about e-cigarettes leading kids to smoke - we don't know that that's true".

The groups cited the recent skyrocketing popularity of the e-cigarette brand JUUL among teens and young adults as an example of this harm.

The manufacturer says each JUUL cartridge, which delivers about 200 puffs, contains as much nicotine as a pack of cigarettes.

The lawsuit filed Tuesday in federal court argues that the FDA didn't follow proper requirements a year ago when it chose to push back the deadline for makers of e-cigarettes to submit their products for review.

The FDA extended its regulatory authority to e-cigarettes, cigars, and other previously unregulated tobacco products in August of 2016, stipulating that products already on the market must show that they pose no new health risks.

As part of a historic revision of its tobacco regulation plan, last summer the FDA announced that e-cigarette makers had until August 2022 to register their products with the agency, and submit detailed information about the health impacts of those products. The FDA would have an additional year to review the application. FDA officials also set no deadline for completing its review of the products.

Executive vice president for advocacy and health quality department of the American Heart Association, Mark Schoeberl said that, "The American Heart Association believes protecting the health of young people in this country should be one of the FDA's top priorities and that's why our organization joined this lawsuit".

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