The U.S. Food and Drug Administration (FDA) recently extended its regulatory authority to cover e-cigarettes in regulations that went into effect in August. The new regulations make it illegal to sell e-cigarette products to anyone younger than 18, either in person or online. Following compliance checks at retail chains, specialty shops, and online retailers, the FDA sent 55 separate warning letters to retailers across the country for selling newly regulated e-cigarette products to minors.
In several instances, the investigators found that minors were still able to buy e-cigarette products in a variety of flavors that were clearly marketed toward underage customers. The FDA gave the retailers 15 days to respond to the warning letters with a plan for taking corrective action to prevent further sales to minors. A list of the offenders that received the warning letter can be found on the FDA’s website.
The new regulations also 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. While the rule went into effect on Aug. 8, 2016, retailers, manufacturers, importers and distributors will have until May 10, 2018, to come into full compliance with the new advertising health warnings and packaging requirements.
Before these new rules went into effect, 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.
If you would like more information on this subject, you can contact Will Sutton, a lawyer in our Toxic Torts Section. He can be reached at 800-898-2034 or by email at William.Sutton@beasleyallen.com.
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