By Patricia I. Kovacevic
Where do we stand at federal level with vaping products regulation? As of the end of February, the proposed Food and Drug Administration (FDA) deeming vaping products (and other products) tobacco products appears to still be with the Office of Management and Budget of the White House. In fact, as late as mid-February, the Office of Management and Budget took additional meetings with interested parties, specifically with senators, on the so-called deeming rule.
However, in response to general concerns regarding accessibility of nicotine-containing liquids by unintended individuals, on Jan. 13, Congress passed the Child Nicotine Poisoning Prevention Act of 2015, which was then sent to the President of the United States and was signed into law on January 28, 2016.
The Child Nicotine Poisoning Prevention Act gives the Consumer Product Safety Commission (CPSC) jurisdiction over anyone selling a “liquid nicotine container” in or into the U.S. and controls the packaging of such containers under the Poison Prevention Packaging Act. The act requires any nicotine, which is offered for sale in liquid nicotine containers, to be packaged in accordance with the CPSC’s standards and to pass testing in accordance with the method described below.
Liquid nicotine container is defined as “a package […] (i) from which nicotine in a solution or other form is accessible through normal and foreseeable use by a consumer; and (ii) that is used to hold soluble nicotine in any concentration, but it does not include a sealed, pre-filled, and disposable container of nicotine in a solution or other form in which such container is inserted directly into an electronic cigarette, electronic nicotine
delivery system, or other similar product, if the nicotine in the container is inaccessible through customary or reasonably foreseeable
handling or use, including reasonably foreseeable ingestion or other contact by children.“ In lay terms, cigalikes and sealed refill cartridges need not meet the child-safe packaging requirement.
The Child Nicotine Poisoning Prevention Act does not preempt the Food and Drug Administration’s future authority over vaping products or other nicotine containing products packaging. The act, however, mandates that the Food and Drug Administration consult with the CPSC if the FDA “adopts, maintains, enforces, or imposes or continues in effect any packaging requirement for liquid nicotine containers, including a child-resistant packaging requirement […] taking into consideration the expertise of the Commission in implementing and enforcing this Act and the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.).” One could wonder – is this recent law
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in fact contemplating an erosion of the Food and Drug Administration’s authority over the packaging of vaping products?
An important consequence of this lawpre-empting requirements in place by state and local authorities. The Child Nicotine Poisoning Prevention Act does not specifically address the preemption issue, however it is well established that CPSC regulation will preempt state and local requirements applicable to the same product. Thus, the Poison Prevention Packaging Act specifically preempts state and local standards on child resistant packaging that are not identical to the Consumer Product Safety Commission standard. The broader issue of state and local preemption with respect to vaping products is addressed in the Family Smoking Prevention and Tobacco Control Act of 2009. Certain state laws adopted to date with respect to vaping products manufacturing or specifications will become inapplicable if vaping products are deemed tobacco products. One could argue that states had affirmative knowledge of such future FDA regulation since the 2010 Sottera decision and should not have gone through the trouble of regulating the manufacture or labeling of vaping products, among other things, as this will fall under the FDA’s jurisdiction.
In conclusion, the Child Nicotine Poisoning Prevention Act is now the governing federal statute with respect to child resistant packaging for vaping products as defined and limited in the act itself. Manufacturers have 180 days to comply with the act, meaning until July 25, 2016. Since compliance may require the replacement of some existing containers that do not meet the CPSC’s standards, manufacturers should take steps to meet these requirements soon.
Child Nicotine Poisoning Prevention Act of 2015 full text: https://www.govtrack.us/congress/bills/114/s142/text
Consumer Product Safety Commission’s standards: https://www.gpo.gov/fdsys/pkg/CFR-2012-title16-vol2/pdf/CFR-2012-title16-vol2-sec1700-20.pdf