The Food and Drug Administration (FDA) recently announced a ruling that extends its authority through the Family Smoking Prevention and Tobacco Control Act to all tobacco products, including e-cigarettes, e-juices, cigars, hookah tobacco, and pipe tobacco. While the use of traditional cigarettes has declined, “vape” products like e-cigarettes and e-juices have skyrocketed with little federal oversight – that is, until now. States have their own laws regarding tobacco related products (e.g. legal smoking age to purchase and use) but this is the first time that a federal agency has the power to regulate all tobacco products. Let’s review what the new FDA ruling entails so you can better understand the FDA’s role in e-cigarette and e-juice regulation.
Helping to Prevent Youth Access
Before the FDA’s latest ruling, there was no federal law prohibiting retailers from selling e-cigarettes and e-juices to people under the age of 18. The push for a federal law was partly born from the growing concern that e-cigarettes are attracting youths and non-tobacco users with their appealing flavors, and “creating a new generation of Americans who are at risk of addiction.” According to the FDA, the purpose of the new ruling is to restrict youth access in the following ways:
- 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 covered tobacco products in vending machines (unless in an adult-only facility); and
- Not allowing the distribution of free samples.
The FDA isn’t only concerned about youth access to e-cigarettes and other tobacco products, but also on what’s in those products and how they’re made.
Requiring Products to Be Reviewed
Along with new age and selling requirements, the FDA will require manufacturers to show that the products meet the applicable public health standard set by the law and receive marketing authorization from the FDA (unless the product was on the market as of Feb. 15, 2007). The review process gives the FDA the ability to evaluate ingredients, product design and health risks, as well as their appeal to youth and non-users. Manufacturer requirements for product reviews include:
- 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.
The review process will be done under staggered timeless and “the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application.” After the FDA reviews the product, it will then issue an order granting marketing authorization, and if authorization isn’t granted, the product will face FDA enforcement.
For Labeling Tips:
The latest FDA ruling will certainly have an impact on the e-cig and e-juice industry, however, it’s too early to tell in which ways. One very likely outcome is that the new labeling requirements and product reviews will require manufacturers to update their packaging labels. In our previous report on FDA regulations, we offer a variety of tips to help manufacturers develop a labeling strategy that will make updating or getting new labels an easier process.
FDA Resources:
