The Food and Drug Administration (FDA) recently announced that a final rule will extend its authority to all products that meet the statutory definition of “tobacco product,” which includes all forms of electronic cigarettes (e-cigarettes). 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 Aug. 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 two to three 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 their 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.
Intending 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 younger than 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.
If you would like more information, you can contact William Sutton, a lawyer in our Toxic Torts Section. He can be reached at 800-898-2034 or by email at William.Sutton@beasleyallen.com.
Source: Food and Drug Administration
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