Allem explained that while research-based digital interventions had demonstrated efficacy in controlled settings, commercially available apps showed unreliable variability in therapeutic approach, transparency, and evidence base. He emphasized the clinical risk posed by unvalidated tools, noting that “sometimes the advice given is inappropriate or could be harm promoting” when patients use these applications. Such guidance, he observed, could delay effective treatment, undermine motivation for behavior change, or even inadvertently encourage substance use.
Many companies avoid oversight by the US Food and Drug Administration by marketing their products as general wellness tools rather than medical devices, thereby circumventing requirements for evidence, evaluation, or quality standards. Allem highlighted the need for regulatory frameworks, third-party assessments, and clearer documentation of clinical claims. He also pointed to recent Congressional scrutiny of youth interactions with companion bots, underscoring broader concerns about digital tools used for clinical purposes being delivered without guardrails.2
He recommended that clinicians guide patients toward validated, evidence-based digital programs, like those incorporating cognitive-behavioral therapy or motivational interviewing, while advocating for regulation that ensures safety, accuracy, and equitable access to effective digital therapeutics.
Dr Allem is an associate professor of social and behavioral health sciences at Rutgers School of Public Health and a core member of the Institute of Nicotine and Tobacco Studies at Rutgers. His full paper on apps for substance use disorder can be found here.
References
1. Russell AM, Colditz JB, Allem JP. The need for oversight over apps for substance use reduction. JAMA. Published online October 27, 2025.
2. O&I subcommittee: innovation with integrity: examining the risks and benefits of AI chatbots. House Committee on Energy and Commerce. November 18, 2025. Accessed November 25, 2025. https://energycommerce.house.gov/events/o-and-i-subcommittee-nnovation-with-integrity-examining-the-risks-and-benefits-of-ai-chatbots