New FDA Rules for eLiquid Producers
On May 10, 2016 the Food and Drug Administration issued "Final Rules" which for the first time regulate the eliquid product market.
Tobacco products, including eliquids, will now be treated the same as other tobacco products and effective August 08, 2016 will be subject to the
Food, Drug, and Cosmetic Act (FD&C Act). The FDA also added new restrictions and requirements under this ruling:
"Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act… Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products"
We have compiled below highlights of the regulations in an attempt to simplify a confusing set of new and comprehensive requirements.
Requirements effective August 8, 2016 with a 90 day compliance period (November 6, 2016) include:1. Prohibition on the sale of eliquid to anyone under the age of 18 (and identification requirements).
2. Vending machine restrictions.
3. Free samples prohibited.
4. Premarket submission to the FDA for approval prior to the introduction of any new product.
Requirements effective August 8, 2018, 24 months from the date of publication of the final rules (August 8, 2016) include:Health warning statements for packages and advertisements to read:
"WARNING: This product contains nicotine. Nicotine is an addictive chemical."The rules require the warnings to cover at least 30 percent of the two principal display panels of the package, and at least 20 percent of the area of advertisements.
The FDA recognizes that the warning size requirement (minimum 12 point font size) may present special difficulties for products in small packages. The FDA has added: "A product that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning, printed in the required font size, may instead carry the warning on the carton or other outer container or wrapper. In cases where there is no carton or other outer container or wrapper that is large enough to carry the warning, the product may carry the warning on a tag firmly and permanently affixed to the package."
(Compliance period: 24 months plus and additional 30 days to sell inventory manufactured before the effective date)
Manufacturers must receive "Premarket Authorization" from the FDA to market their product if the product was introduced after February 15, 2007 (the grandfather date).
There are 3 approaches with different required submission dates:
1 - "SE" (Substantially Equivalent) Exemption - 12 months to submit.
2 - "SE" (Substantially Equivalent) Application - 18 months to submit.
3 - "PMTA" (Premarket Authorization) - 24 months to submit.
A PMTA is an application that requires the manufacturer to provide information about the product including ingredients, additives, properties, manufacture, processing, labeling, and health risks, among other things. The FDA will grant permission to market the new product if the PMTA shows that the new product would be appropriate for the protection of the public health. The FDA is required to consider the risks and benefits to both users and non-users, and the FDA is explicitly required to consider the effect of marketing the product on the likelihood that existing users of tobacco products will stop using them, and the likelihood that non-users of tobacco products will start.
The FDA is announcing the availability of a draft guidance, which (when final) will provide the Agency's current thinking regarding some appropriate means of addressing the premarket authorization requirements for newly deemed products. The guidance will include specific recommendations on how to support a showing that the marketing of a new tobacco product is appropriate for the protection of the public health.
*If the FDA has received an application within the required time, the FDA will continue to allow the product(s) to be marketed for an additional 12 months.
State and local governmental authority over tobacco products is limited by the FD&C Act.
The act expressly gives the Federal government precedence over any State or local requirement that is different from, or in addition to the act.
Manufacturing establishments will be required to register with the FDA and submit product and ingredient listings (under Section 905). The compliance period of this requirement is not yet set. The FDA expects to issue the final rules concerning the registration requirement within six months from August 08, 2016.
Vape establishments (retail stores) that mix or prepare eliquids are considered product manufacturers and are subject to the same rules as other product manufacturers.
"Small-scale tobacco product manufacturers"- companies that employ 150 or fewer full-time employees and have annual total revenues of $5,000,000 or less will receive special assistance from the FDA's Center for Tobacco Products (CTP's) Office of Science (OS).
The CTP's Office of Compliance and Enforcement (OCE), will assist small-scale tobacco product manufacturers in their submission of plans for FDA approval and will provide a system to assist businesses in navigating the regulatory requirements of the FDA.
The FDA recognizes that compliance with many of the automatic provisions may be challenging at first for entities that are new to Federal public health regulation. Section 915 requires the testing and reporting of the constituents, ingredients, and additives that the FDA determines should be tested to protect the public health. The section 915 testing and reporting requirements apply only after the FDA issues a regulation implementing that section, which it has not yet done. Until these testing and reporting requirements have been established, newly deemed tobacco products (and currently regulated tobacco products) ARE NOT subject to the testing and reporting provisions found under section 915. The FDA does not intend to enforce the reporting requirements under section 904(a)(3) for newly deemed products before the close of the 3-year compliance period.
Published in the Federal Registry
81 FR 28973
28973 -29106 (134 pages)
21 CFR 1100
21 CFR 1140
21 CFR 1143