New FDA Rules Bring E-cigarettes Under Federal Control

In a move conversely praised by public health advocates and bemoaned by e-cigarette manufacturers, the U. S. Food and Drug Administration (FDA) issued new rules on May 5, 2016 bringing e-cigarettes, and similar products, under FDA scrutiny for the first time in their history. E-cigarettes are battery-powered electronic nicotine delivery devices that turn liquid nicotine into a vapor. The rules extend to all “electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels, among others.” The new rules require manufacturers to submit ingredient, safety and other product information normally required to initially obtain FDA approval for market sale, to ban the sale of these products to minors, and require new health warnings on product labels and in advertising.

The new FDA rules go into effect August 8, 2016, and will require manufacturers, importers, and retailers of e-cigarettes and similar products to undergo a pre-market analysis and regulatory review by the FDA, including registering manufacturers and listing all ingredients and potentially harmful substances in these products. Manufacturers will have 2-3 years to file pre-market analysis and safety data on each product, and each product must be found to be in FDA compliance in order to remain on the market. All new e-cigarette and similar products will be subject to FDA review and pre-market approval.

Before this recent FDA ruling, e-cigarettes and similar products were not subject to any federal regulation or industry-wide standardization on the manufacture, sale, marketing, or distribution. Some E-cigarettes, for example, have been touted as a safer alternative to traditional tobacco cigarettes, or as an effective way to quit smoking, yet there are no studies proving either of these. Bringing these products under the purview of the FDA will prevent manufacturers from making false health claims, and will give the FDA the power to issue warnings about health risks to consumers.

Many in Congress and consumer health advocates praised the FDA’s ruling as necessary for consumer protection recognizing the use of tobacco products “is the single largest preventable cause of disease and death in the United States”, but industry insiders and e-cigarette and other tobacco products manufacturers argue the new FDA rules are cost-prohibitive and unnecessary and will serve only to put an end to their multi-billion dollar industry. They are urging the FDA to soften the new rules for products already on the market, or grandfather them in and exempt them altogether.

FDA Director for the Center for Tobacco Products Mitch Zeller disagreed with the industry, explaining, “We need to bring these products out of the wild, wild west and into the world of regulation so we can protect the public.”

Hoping to improve public health overall and prevent future generations from using tobacco products, the new rules also forbid the sale of e-cigarettes and other tobacco products to anyone under 18 years old, either in person or online, and require photo identification to purchase these products. A handful of states have laws banning sales to minors so this new FDA rule codifies the ban nationally. The rule will also remove these products from vending machines and disallow giving away of free samples.

The rule further requires health warnings on product packaging and changes in safety labeling and in advertisements.

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