FDA E-Cigarette Rule Finalized

FDA E-Cigarette Rule Finalized

The FDA e-cigaratte rule finalized. That is the breaking update from the FDA on Thursday May, 5 2016. The new rule known as the “deeming” regulation will go into effect August 8,2016.

Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Now in the new e-cigarette rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.

This action is a milestone in consumer protection – going forward, the FDA will be able to:

  • Review new tobacco products not yet on the market;
  • Help prevent misleading claims by tobacco product manufacturers;
  • Evaluate the ingredients of tobacco products and how they are made; and
  • Communicate the potential risks of tobacco products.

The following are key provisions of the now finalized e-cigaratte rule:

FDA E-Cigarette Rule’s Provisions and Requirements

The final rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions related to tobacco products in the Federal Food, Drug, and Cosmetic Act and FDA regulations, including:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

In addition, there are several provisions aimed at restricting youth access to tobacco products, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in-person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.
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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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