Overview of New FDA E Cig/E Liquid Regulations
Overview of New FDA E Cig/E Liquid Regulations
Tobacco Products deeming Rule
On May 10, 2016, the US Food and Drug Administration (FDA) published its final rule to deem all “tobacco products” as within its authority and subject to the Tobacco Control Act (TCA). These are the new FDA e cig / e liquid regulations.
Legal Background: The TCA gives the FDA the power to regulate cigarettes, cigarette tobacco, roll your own tobacco and smokeless tobacco. The Federal Food, Drug and Cosmetic Act (FDCA) permits the FDA to issue rules “deeming” other tobacco products not named in the TCA to be subject to the FDCA. (21 USC § 387, et seq.) Once a product is “deemed” subject to the FDA authority, the FDA can propose restrictions on sale and distribution, including restrictions on access and advertising when it determines that the regulation would protect public health.
What Products are Covered?: The products on the market that are now deemed to be under the
FDA’s authority for new e cig / e liquid regulations include: dissolvables; gels; waterpipe tobacco; electronic nicotine delivery systems (ENDS); components or parts of tobacco products (atomizers, batteries, cartomizers, tank systems, flavors, e-liquid); cigars; and pipe tobacco.
The FDA acknowledges that there are several types of ENDS, e.g. e-cigarettes, e-hookah, e-cigars, vape pens, refillable personal vaporizers, and electronic pipes. The FDA has deemed all ENDS subject to the TCA, regardless of the name.
“Accessories,” such as ashtrays, spittoons, hookah tongs, cigar clips, and pipe pouches are not covered.
Overview of Important Dates:
- August 8, 2016 – Deeming provisions, minimum age and identification requirements and vending machine restrictions were effective.
- December 31, 2016 – Annual registration and deadline for product listing for all Tobacco Products
- August 8, 2017 – Deadline to submit substantial equivalence (SE) exemption requests
- February 8, 2018 – Deadline to submit SE Applications
- August 8, 2018 – Deadline to submit PMTAs
- February 8, 2019 – End of compliance period for SE products
- August 8, 2019 – End of compliance period for PMTA products
Age Restriction: The new FDA regulations are aimed at restricting youth access to tobacco products, including: prohibiting the sale of e-cigarettes to people under 18 (both in person and online) (Age 21 in California andHawaii); requiring age verification by photo ID; prohibiting the sale of tobacco products in vending machines (unless in an adult-only facility); and prohibiting the distribution of free samples.
Health Warning: All covered tobacco products must contain certain health warnings on product packages and advertisements. Specifically, they must contain a nicotine addictiveness warning, as follows: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
Premarket Authorization: The new FDA e cig / e liquid regulations also requires manufacturers, importers, and retailers of newly deemed products that were on the market after February 15, 2007 to obtain FDA marketing authorization by showing that the products meet applicable public health standards.
The authorization may be obtained through one of three pathways: substantial equivalence (SE); exemption from substantial equivalence; or premarket tobacco product applications (PMTA).
Notable provisions include: registering manufacturing establishments and providing product listings to the FDA; reporting ingredients and harmful and potentially harmful constituents to the FDA; requiring premarket review and authorization of new tobacco products by the FDA; placing health warnings on product packages and advertisements; and prohibiting the sale of modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
The rules allow manufacturers to continue selling their products for up to two years while they navigate the FDA’s new approval process. Sales can continue for an additional year while the FDA reviews manufacturer submissions.
LEARN MORE
If you would like more details about compliance with the new FDA e cig / e liquid regulations, please contact Brown & Charbonneau, LLP at 714 406-4434 or email Paula Reno at inquiries@bc-llp.com.