E-Cigarette Smoker

Heart Health: Regulator blocks sale of 55,000 flavoured e-cigarettes from market

*US Food and Drug Administration insists the burden is on product manufacturers to provide evidence to demonstrate that marketing of their products meets the statutory standard of ‘appropriate for the protection of the public health’

Isola Moses | ConsumerConnect

Sequel to the manufacturers’ alleged failure to produce evidence that the products could help adults quit smoking and also protect young consumers, the United States (US) Food and Drug Administration (FDA) has issued marketing denial orders to block the sale and distribution of 55,000 e-cigarette products in the country.

ConsumerConnect reports e-cigarettes are electronic devices that use a battery to create vapour from a nicotine-containing liquid, which is then inhaled like cigarette smoke.

It was learnt the regulatory agency’s action marks the first time it has ever used that authority against manufacturers in the country.

The FDA said the products, from three different companies, lacked evidence that they could help adults quit smoking but would not be appealing to young people, agency report stated.

It disclosed that the affected products were all produced by JD Nova Group LLC, Great American Vapes, and Vapor Salon.

According to FDA, the products are not tobacco flavoured, which young people do not seem to like, but include youth-appealing flavours, such as Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.

Acting FDA Commissioner Dr. Janet Woodcock said: “We know that flavoured tobacco products are very appealing to young people; therefore, assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”

Products already for sale must be removed

The regulator meanwhile said that the products not yet on the market would be blocked from distribution, and those already available to consumers must be withdrawn from the market.

The FDA, therefore, has threatened that if the affected cigarette products are not removed, the concerned companies could face enforcement action in the US.

E-cigarettes were introduced more than a decade ago as a tool to help smokers quit. However, millions of teenage non-smokers began using them, causing alarm among health officials, according to report.

Health experts at Johns Hopkins University, in the United States, say “vaping” is generally less harmful than smoking cigarettes, but they note that it carries its own health risks.

Research suggests that it can be harmful to the heart and lungs and can create an addiction to nicotine.

Meanwhile, the Centers for Disease Control and Prevention (CDC) has estimated that e-cigarette sales in the US alone rose by nearly 300 percent between November 2016 and August 2019.

Several of these devices ended up being used by kids in high school and middle school in the country, report said.

Mitch Zeller, Director of the FDA’s Center for Tobacco Products, also noted that flavoured e-cigarettes are extremely popular among young people, and companies that make and sell these products must demonstrate that their benefits to adult smokers outweigh their risk to young people.

Zeller added: “The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.

“If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”

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