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- Regulatory Intelligence Insights for January 6, 2025
Regulatory Intelligence Insights for January 6, 2025
Deep Dive: Age-Gating Technology Research Overview
Jon Dice
January 06, 2025
Regulatory Intelligence Recap
FDA Import Alert Updates From January 3, 2025:
-FDA revises Import Alerts 98-07 and 98-06, separating e-cigarette products from other tobacco products
-Enhanced detention authority for unauthorized products without physical examination
-Clarifies that pending applications do not create legal safe harbor for unauthorized products
- Recent additions to Import Alert 98-06 include NOIS, LYFT, and SKRUF brand pouches
FDA CTP issued final guidance for Validation and Verification of Analytical Testing Methods Used for Tobacco Products on January 6, 2025:
-Expression of the Agency’s support for the use of national and international standard analytical test methods for the analysis of finished tobacco products;
-The addition of a spike and recovery approach for determining the limit of detection in order to provide flexibility in the analytical sampling procedure recommendations
-Expression of the Agency’s support for the use of national and international standard analytical test methods for the analysis of finished tobacco products;
FDA submits proposal to limit nicotine in cigarettes to White House
Altria launches test marketing of SWIC heated tobacco device in UK
BAT reports growth and improved profitability in vape category, on track for fiscal year targets
Mexican Congress adopts constitutional ban on e-cigarettes
VPZ and Morrisons partner to open 10 vape shops in UK
Wales votes to ban disposable vapes
Dallas adds vapes to smoke-free law
PMI CEO criticizes bans on tobacco alternatives
Qnovia raises $16M for prescription nicotine inhaler development
New Kentucky vape rules to start January 1
Rhode Island vape shop owners sue over flavor ban
European Union countries push to include vaping in tobacco tax law
Study examining e-cigarettes as smoking cessation treatment via umbrella review (Drug & Alcohol Dependence)
Research on safety of e-cigarette use via systematic review of health effects (Revue des Maladies Respiratoires)
Study on physical/chemical characterization of nicotine pouch aerosols (Chemical Research Toxicology)
Research on quitline-based young adult vaping cessation (American Journal of Preventive Medicine)
Analysis of vaping dependence across days in US young adults (Nicotine & Tobacco Research)
Study on early onset e-cigarette use among US high school students (Preventive Medicine Reports)
CONNECTing to LungCare - Study on smoking cessation and lung cancer
Feasibility of Delivering VergeRx at FQHCs - Testing tobacco cessation intervention
Real-world Study of Trastuzumab Deruxtecan in breast cancer patients
Study examining smoking behavior in human laboratory model
FDA CTP Marketing Granted Order Metrics from 2021-2024
Since January 1, 2021, there have been 41 PMTA - Marketing Granted Orders. The breakdown by sub-category is as follows:
Closed E-Liquid: 17
Closed E-Cigarette: 15
Other: 4
HTP Consumable: 3
E-Cigarette Component: 2
Since January 1, 2021, a total of 1,070 EXREQ - Found Exempt Orders have been granted. The breakdown is as follows:
Categories:
Cigarette: 813
Cigar: 129
Waterpipe/Hookah: 98
Roll-Your-Own: 23
Heated Tobacco Product: 5
Smokeless: 2
Yearly Breakdown:
2021: 224
2022: 140
2023: 663
2024: 43
Since January 1, 2021, a total of 521 Substantial Equivalent Orders (SE) have been granted. The breakdown of categories is as follows:
Pipe: 244
Cigar: 129
Waterpipe/Hookah: 74
Cigarette: 29
Smokeless: 23
Roll-Your-Own: 20
The breakdown of Substantial Equivalent Orders (SE) granted by year since January 1, 2021, is as follows:
2021: 188
2022: 158
2023: 109
2024: 66
In December 2024, Representative Raja Krishnamoorthi (D-IL)has initiated a federal investigation into Chinese-made vaping products as part of his role as the ranking Democratic member of the House Select Committee on the Chinese Communist Party. He announced a probe focusing on illicit vapes imported from China and sold in the United States. To this end, Krishnamoorthi sent inquiry letters to five Chinese manufacturers and six U.S. distributors and wholesalers, requesting detailed information regarding their operations. The inquiries include requests for global revenue data for the past three years, sales figures specific to the U.S. market, shareholder information, taxes paid, subsidies received, and details about customs brokers, distributors, and retailers associated with these products. Additionally, he is seeking information on product specifications and safety research.
Krishnamoorthi's investigation aims to uncover how these products are being unlawfully marketed to both children and adults, raising concerns about potential harmful substances beyond nicotine in these vaping products. He emphasized that this investigation is part of a broader effort to combat youth vaping and ensure the safety of consumers in the marketplace.
Age-Gating Technology and Regulation in the United States with a Focus on Electronic Nicotine Delivery Systems (ENDS)
Introduction
Age-gating technology and its associated regulations are becoming increasingly critical in the United States and globally, driven by a recent surge in legislation aimed at protecting minors online1. This is particularly relevant for age-restricted products like electronic nicotine delivery systems (ENDS), where preventing underage access is a significant public health concern. This overview explores the current landscape of age-gating technology, relevant US regulations, and the specific implementations and challenges for ENDS, drawing upon recent research and government publications.
Age-Gating Technology in the US: An Overview
Age-gating technology employs various methods to prevent minors from accessing age-restricted materials online, ranging from basic self-declaration to advanced AI-powered solutions. These methods aim to ensure compliance with legal age requirements and protect young people from potentially harmful content or products. Age estimation, using AI to analyze images or online activity, has emerged as a key technology in these efforts, driven by recent legislation and regulations2.
Age Assurance Methods
Age assurance methods can be broadly categorized as follows: 3
Method | Category | Description | Example* |
|---|---|---|---|
Self-Declaration | Age Gate/Screen | A user self attests their age by checking or inputting their date of birth. | Instagram asks users to submit their date of birth upon sign-up to confirm they are 13+. |
Account-Based Assurance | Third-Party Verification | User’s account on an age verified service is used to vouch for their account on a different service. | X partners with Au10tix to verify paid users. |
Vouching | Third-Party Verification | Parent or other users vouch that the user in question is of a certain age. | Meta offers social vouching in which users can select three people to confirm their age. TikTok allows users to submit a photo with their parent, guardian, or trusted adult over the age of 25 as part of an age appeal. |
Cookie Tracking | Third-Party Verification | Browser cookies are used to determine whether or not the user has already completed a qualifying age verification check. | AgeVerify previously offered a service that used browser cookies to track individuals that had successfully completed an age-gate process to avoid users completing multiple age verification checks. |
Browser Storage | Third-Party Verification | Browsing session storage is used to identify if a user has already completed a qualifying age verification check or not. | AgeVerify, which previously used cookie tracking to implement age verification across multiple sites, now uses browser storage to identify users that have already completed an age verification process. |
AI Facial Age Estimation | Age Estimation | AI analyzes a still or live photo of the user’s face to estimate their age. | Yoti, which currently partners with Meta, offers AI facial age estimation. |
Social Graph Age Estimation | Age Estimation | This method is also called social proofing or algorithmic profiling, where AI analyzes a user’s social graph (online connections to other users) and online activity to estimate their age. | TikTok scans users’ public videos to help ensure ages are accurately reported. |
Liveness Detection | Age Estimation | Users may submit a photo or video while holding written specific information or saying a specific word or phrase. AI can also be used to analyze the age of the user shown in the video or phone. (This technique is usually used in coordination with another age verification method to prove the user is the person completing the age verification check.) | Yubo asks users to take a real-time photo in the app that is then analyzed using Yoti technology to estimate the age of the user. |
Credit Card | Third-Party Verification | Users submit their credit card information to confirm their age. | To access age-restricted content or update an account to meet age requirements, Google allows users to submit a photo and either a credit card or government-issued ID to confirm their age. |
Government- Issued Identity | ID Verification | Users submit a government-issued ID, such as a driver’s license or passport, to verify their identity. | X offers voluntary ID verification for premium users through government-issued IDs. |
Government ID and Current Photo | ID Verification | Users submit a government-issued ID, such as a driver’s license, passport, or residency card, along with a current still or live photo to verify their identity. | Roblox is testing a new age ID verification feature that asks users to submit a current photo and a valid government-issued ID. |
Mobile Phone Registration /SIM Card | Third-Party Verification | To unlock default age restrictions or parental controls on new phones and SIM cards, users must verify their age. | O2, the United Kingdom’s largest mobile network provider, filters and blocks 18+ websites, requiring users to verify their age before accessing. In Japan, LINE requires users to verify their age through their SIM card or mobile phone registration. |
Token-Based | Third-Party Verification | Users verify their identity and age with a third party in exchange for a token that can be stored in a digital wallet. The token can be used to verify age on platforms and websites without requiring users to re-enter credentials or submit identification. | Yoti offers reusable age verification checks, or age tokens, that allow users to verify their age across browsers and devices. |
Zero-Knowledge Proof (Double-Blind Systems) | Third-Party Verification | A zero-knowledge proof or double-blind system uses a third-party facilitator to connect a user’s age verification provider and website in a data minimizing capacity. The third-party facilitator confirms with the website that a user meets the age or age range requirements, but shares no other information about the user and collects no information about the site requesting the verification. | Researchers from France’s CNIL built “a possible implementation of an age verification system that allows accessing restricted websites without sharing other personally identifiable data.” |
Challenges and Considerations
The implementation of age-gating technologies presents various challenges that require careful consideration:
Accuracy: Age estimation technologies, especially those based on facial analysis, can be inaccurate. Factors such as image quality, lighting, facial expressions, gender, ethnicity, and even the age of the person in the photograph can influence the accuracy of these systems4. This can lead to both false positives (adults being denied access) and false negatives (minors gaining access), highlighting the need for robust testing and evaluation of these technologies5.
Privacy: Collecting and storing personal data for age verification raises significant privacy concerns. This is particularly true for methods involving government-issued IDs or credit card information, which can be vulnerable to data breaches or misuse. Furthermore, Americans have expressed skepticism towards online age verification due to concerns about how companies will handle their data, highlighting the need for transparency and robust data protection measures6.
Accessibility: Not all age verification methods are equally accessible to all users. Methods requiring government-issued IDs or credit cards can disproportionately impact individuals who lack these forms of identification, such as minors, undocumented immigrants, or those experiencing homelessness. This raises concerns about equity and potential exclusion from online services7.
Cost: Implementing and maintaining robust age verification systems can be expensive, particularly for smaller businesses and startups with limited resources8. The costs associated with technology acquisition, integration, user support, and ongoing compliance can pose a significant barrier to entry, potentially hindering innovation and competition in the market.
US Regulations Related to Age Verification
In the US, age verification regulations primarily focus on restricting youth access to age-restricted products like tobacco, alcohol, and firearms. While there is no single federal law mandating age verification for all online services, several states have enacted laws requiring age verification for specific types of content, particularly social media and adult content9.
Federal Regulations
Federal regulations play a crucial role in setting a baseline for age verification, particularly for age-restricted products:
Tobacco 21 law: Enforced by the FDA, this law prohibits the sale of all tobacco products, including ENDS, to individuals under 21. Retailers are required to verify the age of anyone under 30 using a photo ID10. This law reflects a growing concern about the health risks associated with youth tobacco use and aims to prevent underage access to these products.
Preventing Online Sales of E-Cigarettes to Children Act: This act aims to reduce youth access to ENDS by regulating online sales and prohibiting the USPS from shipping these products12. It recognizes the increasing prevalence of online ENDS sales and the need to prevent minors from purchasing these products through these channels.
PACT Act: This act requires all sellers, transferors, or shippers of ENDS to register with the ATF and comply with all federal, state, local, and tribal laws12. It aims to create a comprehensive regulatory framework for ENDS, ensuring compliance with age restrictions and tax requirements.
Children's Online Privacy Protection Act (COPPA): The FTC is actively working to expand guidance on complying with COPPA, which requires websites and online services to obtain verifiable parental consent before collecting personal information from children under 1314. This reflects a broader effort to protect children's privacy online and ensure that companies are taking appropriate measures to safeguard their data.
Federal Trade Commission (FTC) Enforcement: The FTC is actively involved in enforcing age verification requirements. For example, the FTC ordered the anonymous messaging app NGL to implement a "neutral" age gate, designed to prevent children from circumventing age restrictions by simply clicking "yes" when asked if they are old enough15. This demonstrates the FTC's focus on ensuring that age-gating mechanisms are effective in preventing underage access.
State Regulations
While federal regulations provide a foundation, individual states have also taken steps to address specific concerns related to online safety for minors:
State Age Verification Laws: As of December 2024, 19 states have enacted laws requiring age verification for online services, primarily targeting social media and adult content16. These laws often require platforms to implement "reasonable age verification methods" but may lack specific guidelines on implementation, leading to variations in how these requirements are enforced17.
Effectiveness of Age-Gating Technologies for ENDS
Research suggests that age-gating technologies can be effective in reducing youth access to ENDS, but challenges remain1. Simple age gates, such as requiring users to enter their date of birth, are easily bypassed by minors7. More sophisticated methods, like facial age estimation, may raise privacy concerns or have accuracy limitations, particularly for certain demographic groups5. The effectiveness of age-gating for ENDS ultimately depends on the chosen method, its implementation, and ongoing monitoring and enforcement.
ENDS Implementations of Age-Gating Technology
ENDS companies face a unique challenge in implementing age-gating technology due to the stricter regulations imposed by the PACT Act and Tobacco 21 law12. These regulations require age verification for all ENDS sales, including online and delivery sales, placing a greater burden on ENDS companies to ensure compliance. Commonly used methods include:
Age gates: Requiring users to enter their date of birth or check a box confirming they are of legal age12.
ID verification: Requesting users to upload a government-issued ID for verification15.
Third-party age verification services: Utilizing services that specialize in age verification, such as those offered by BlueCheck13.
Proposed and Upcoming Regulations
The landscape of age verification regulations is constantly evolving, with several states considering or having introduced legislation related to age verification for online services7. This reflects a growing focus on online safety for minors and the need for robust age verification solutions. However, these efforts also raise concerns about potential risks to free speech and privacy7. Finding the right balance between protecting minors and respecting user rights is a key challenge in the ongoing development of age verification regulations.
International Efforts
International efforts to regulate online age verification are also gaining momentum. The UK's Age Appropriate Design Code (AADC), adopted in 2021, has significantly impacted social media companies' safety and privacy measures19. The AADC requires online services to prioritize children's best interests and implement safeguards to protect their privacy and safety. This has led to a "flurry of improvements" by major social media companies, including changes to default settings, restrictions on targeted advertising, and increased transparency about data collection practices.
Conclusion
Age-gating technology and regulation are essential for protecting youth from accessing age-restricted products like ENDS. While significant progress has been made in developing and implementing age verification methods, challenges remain in terms of accuracy, privacy, and accessibility. ENDS companies must navigate a complex web of federal and state regulations, requiring them to implement effective age-gating solutions while ensuring compliance. The ongoing evolution of age verification technologies and regulations necessitates continued research, collaboration, and a focus on balancing youth protection with user privacy and access.
The increasing focus on online safety for minors is driving the development of more sophisticated age verification methods. However, these advancements must be carefully evaluated to ensure they do not disproportionately impact certain populations or compromise user privacy. ENDS companies, in particular, face unique challenges due to the stricter regulations imposed by the PACT Act and Tobacco 21 law. They must prioritize age verification in their online and delivery sales processes while balancing user experience and business needs.
Proposed and upcoming regulations, both in the US and internationally, highlight the dynamic nature of this landscape. The tension between protecting minors online and potential risks to free speech and privacy requires careful consideration and a nuanced approach to regulation. Ultimately, the goal is to create a safer online environment for minors while preserving user rights and fostering innovation in age verification technologies.
Works cited
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