New FDA E-Cigarette Rules – What Does It Mean

Yesterday (April 24, 2014) the US Food and Drug Administration (FDA) announced new regulation of e-cigarettes. The rule changes the FDA’s prior position of only regulating e-cigarettes if the aim of the product was to aide in smoking cessation. Effectively the prior regulations intended to regulate e-cigarettes only if they were intended to be marketed and sold as a medical device. Now the regulations state the FDA position is to monitor, review and exercise enforcement over e-cigarettes no matter how they are marketed and sold.

The biggest change will be a new approval process for ingredients, such as flavors and coloring. A number of changes will occur once the rule is finalized, this includes registration with the FDA and submitting applications for approval of ingredients, such as flavor and color additives. More information will be posted as the rule is finalized. Feel free to post comments or call/e-mail with any questions.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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