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 and capricious in violation of the Administrative Procedures Act (APA), insofar as the agency failed to provide a reasoned explanation for this action.”
The FDA’s deeming regulation required that all premium cigar product packages must display one of the following six health warnings statements:
• WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
• WARNING: Cigar smoking can cause lung cancer and heart disease.
• WARNING: Cigars are not a safe alternative to cigarettes.
• WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
• WARNING: Cigar use while pregnant can harm you and your baby.
• WARNING: This product contains nicotine. Nicotine is an addictive chemical.
Each of these warning statements would appear directly on the two “principal display panels of the package,” comprising “at least 30% of each of the principal display panels.”
For cigars that are sold individually and not in a product package, the health warnings statement would need to be posted at the retailer’s point-of-sale on an 8.5 x 11-inch “clear, legible, and conspicuous” sign.
As for print and other advertisements, the warnings statement would need to be located in the “upper portion of the area of the advertisement” and occupy “at least 20% of the area of the advertisement.”
In its ruling, the court states that one of the basic procedural requirements for new regulation is that an agency provides adequate reasons for proposing the regulation, including a rational connection between the facts and the proposed regulation.
The court found that “the (FDA) failed to supply a reasoned explanation to substantiate applying health warnings to premium cigar products because the warnings themselves are factually unfounded for such products [and] the agency did not adequately justify the need for health warnings for premium cigars because premium cigar consumers already appreciate the risks of regular use.”
That is, the FDA did not adequately justify why the health warning statements were appropriate for a dis- tinct category of the cigar market — namely, the premium cigar.
The court not only vacated the premium cigar health warning state- ment regulation but sent the matter back to the FDA for further review and proceedings.
Reminder: FDA to Enforce Ban on Certain Flavored Electronic Cartridge and Pod-Based Nicotine Products
As a reminder, as of February 6, the FDA has begun enforcement of a Final Guidance policy that pro- hibits the manufacture, distribution, and sale of flavored cartridge-based and pod-based electronic nicotine delivery products (other than
tobacco-flavored and menthol- flavored), unless a specific product has already received a Premarket Tobacco Authorization (PMTA) approval order from the FDA.
The FDA defines a “cartridge-based” electronic nicotine delivery product as consisting of “a cartridge or pod that holds liquid that is to be aerosolized through product use” and “a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.”
This means that a cartridge or pod is separated from the actual electronic cigarette device and must be fit into or be attached to the device.
Under the Final Guidance policy, a self-contained, sealed, disposable electronic cigarette product can continue to be sold on and after February 6, whether flavored or not by any retailer.
However, a manufacturer will need to file a PMTA application for the disposable electronic cigarette product with the FDA on or before May 12 to allow the product to continue to be sold during the FDA PMTA application review period, which runs for up to twelve months from the date that the PMTA is filed with the FDA.
In addition, all retailers can continue to sell any non-cartridge-based or “open system” electronic nicotine delivery products and bottles of nicotine e-liquids on and after February 6. However, a manufacturer will need to file a PMTA application for the non-cartridge-based or “open system” electronic nicotine delivery product or bottle of e-liquid product
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