FDA warns vaping manufacturers of illegal marketing

On October 7, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to nearly 30 vaping product manufacturers for continuing to illegally market their products, which had been subject to a marketing ban.[1].

The FDA is responsible for ensuring that new tobacco and nicotine products are subject to prior approval to meet certain health standards before they are marketed. If a product does not meet a particular standard, the agency issues an order denying the marketing application. It is therefore illegal to market a new tobacco product in the United States without this prior FDA marketing approval.

The warning letter is the FDA's first step before applying sanctions that could be financial against the manufacturer, or administrative through a temporary closure of the stores that sell these products.

More than 50,000 products affected by marketing refusal orders

The FDA received applications from more than 500 companies covering more than 6.5 million tobacco and nicotine products. In late August, the FDA issued the first marketing refusal orders for vaping products after it failed to establish that the products offered a benefit to adults (including helping smokers quit) that outweighed the risks to younger people.

Around 55,000 flavoured vaping products, particularly popular with teenagers, which included flavours such as apple crumble, Coca-Cola and cinnamon cereal, were not given marketing authorisation.[2]. So companies could not introduce these products to the market and the marketed products had to be withdrawn from sale.

FDA's Efforts to Protect Youth from Nicotine Addiction

Since January 2021, the FDA has issued a total of 170 warning letters to companies that collectively listed more than 17 million vaping products with the FDA and had not submitted premarket applications for those products. These actions by the FDA are part of a policy effort to reduce the appeal of new nicotine products to youth.

At the beginning of October, the agency also strengthened its system for the pre-market examination of new tobacco and nicotine products.[3]. Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports are the two most common ways a manufacturer seeks FDA approval to market a product. The new rules allow for additional data collection and requirements on ingredients, additives, components, toxicological profiles, and how the product is manufactured, packaged, and labeled before it is marketed. The FDA's purpose is to determine the potential public health implications of a product's introduction and to review the company's marketing plan before it is marketed.

Keywords: FDA, United States, vaping, regulations, flavors, youth, health

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