Last fall, the Food and Drug Administration (FDA) recategorized vapor products to be “tobacco” products as a result of the Family Smoking Prevention and Tobacco Control Act (TCA). The changes went into effect on August 8, 2016 and follow a two-year pursuit by the federal agency to prohibit nearly all vapor products on the market.
What is Covered Under the Rule
The FDA’s rule is broad, noting that items related to vaping are considered tobacco products or a part or component of tobacco products and therefore, are subject to regulation. The agency has taken the position that nicotine-free and synthetic nicotine products may fall under the rule. Below are some important aspects of the changes:
- No new products: In order for a vapor product to be sold after August 8, it must have been commercially marketed as of that date. In other words, manufacturers are prohibited from releasing new devices, flavors, and coils (among other products) and no modifications may be made to already existing products without prior approval;
- Age restrictions: While a majority of the states prohibit sales of vapor products to those under 18, the FDA now mandates anyone appearing under age 27 show identification;
- Age verification for online sales: The FDA announced the intention to conduct youth access checks for online retailers in addition to brick-and-mortar retailers;
- No free samples: Another new aspect of the rule is the FDA’s prohibition of free sampling of even zero-nicotine products; and
- Accuracy in labeling and access to products: Vapor products can no longer be available by vending machine in establishments where anyone under the age of 18 is allowed. Moreover, product labels are prohibited from stating consumers have a “modified risk” when using vapor products.
Vaping products, commonly referred to as e-cigarettes, have come under fire in the past, specifically for causing serious injuries to consumers. Last fall The Guardian reported multiple injuries to vapor product users which have ranged from superficial burns to the need for surgery and skin grafts. The high number of smokers injured has prompted class action lawsuits across the nation and some state agencies have banned the products all together, according to the Wall Street Journal. Between 2008 and 2010, the FDA determined certain vapor products were unapproved drug or device combination products and withheld or refused admission to those offered for import into the United States.
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