Insights

Understanding the Age Verification Requirements of the FDA Deeming Rule

EVS has been working with many clients in the Vapor industry recently as they work to get in compliance with the regulations newly applicable to them under the FDA’s Deeming Rule. There is a significant amount of confusion (and misinformation) within the industry, particularly for online retailers of newly deemed products.

For their part, the FDA itself does not seem to be inclined to provide clear guidance for online retailers. The majority of guidance for retailers published on the FDA’s site is geared towards traditional “Brick and Mortar” retailers. The one bit of guidance specifically geared towards online retailers provided by the FDA states the following:

“FDA does not intend for section 1140.14(b)(3) to prohibit the sale of tobacco products via the Internet, but the sale of covered tobacco products via any medium, including the Internet, must only be to persons 18 years of age or older. Therefore, any sale of covered tobacco products over the Internet must comply with the minimum age and identification requirements in this rule.”

For online retailers struggling to understand the “minimum age and identification requirements in this rule”, this statement does little to assist.

At this point I must make the standard disclosures: EVS is not a law firm, and cannot provide legal advice. Nothing contained within this post should be considered legal advice, and businesses should consult an attorney for clarification on any matters of law.

To help our clients and other businesses currently struggling to understand the compliance requirements, we have summarized our reading of the applicable regulations below with references so you can review the regulations directly.

The rule referenced in the FDA’s statement is CFR 1140.14. In the full text for 1140.14 (link below) there are two exceptions noted for the picture ID requirement – the first exemption is for consumers over the age of 26, and the other is mail order sales, referenced as §1140.16(c)(2)(i) (second link listed below)

Based on this reading mail order sales would be explicitly exempt from the photo ID requirement, but would still be applicable to the restriction against sales to individuals under the age of 18. This still leaves the question of what the appropriate age verification method is for online sales. 15 U.S. Code § 376a 4 A (iii) provides the federal requirements for online sales (the definition of “delivery sale within the regulation specifically includes sales by means of the Internet) of cigarettes or smokeless tobacco as defined by the PACT act modifications to the Jenkins act, which reads in part:

“obtaining the full name, birth date, and residential address of that person; and verifying the information provided through the use of a commercially available database or aggregate of databases, consisting primarily of data from government sources, that are regularly used by government and businesses for the purpose of age and identity verification and authentication, to ensure that the purchaser is at least the minimum age required for the legal sale or purchase of tobacco products, as determined by the applicable law at the place of delivery.”

Language nearly identical to the PACT act language noted above has also been utilized for the recent state legislation in TX, MA, CA, and WA.

These combined regulations provide a clear direction for online retailers of the newly deemed tobacco products, and the age verification solutions provided by EVS are designed to meet these requirements as defined above.