For dietary supplement companies moving into wearables, smart packaging and other wellness technologies, familiarity with U.S. Food and Drug Administration (FDA) requirements may only go so far.
Some of these products can fall under the U.S. Consumer Product Safety Commission (CPSC), depending on their intended use, functionality and claims. That can introduce a different set of requirements around safety standards, product testing and reporting.
Regulators are also changing how they monitor the market. The FDA, for example, has begun using artificial intelligence (AI) like the Elsa LLM across a range of internal functions, including reviewing adverse event reports and identifying inspection targets.
NutraIngredients spoke with Claudia Lewis, partner and co-chair of the FDA Group at Venable, and Erin Maus, partner and co-chair of the firm’s Consumer Products team, about what supplement companies need to know as they move into these categories, from determining which agency has jurisdiction to spotting safety problems after a product reaches consumers.
NI: During a recent episode of Venable’s newly launched Beauty Law Glow-Up podcast, it was noted that the FDA is “ahead of the curve” in its use of AI for regulatory purposes. How is the agency currently using AI, and what practical implications could that have for dietary supplement manufacturers and wellness brands?
CL: FDA has rapidly integrated AI into its internal systems and workflows, and the pace of that effort is noteworthy. In June 2025, FDA launched Elsa, a generative-AI tool available to personnel ranging from scientific reviewers to investigators.
FDA has reported using it to accelerate clinical-protocol reviews and scientific evaluations, identify high-priority inspection targets, summarize adverse-event reports to support safety-profile assessments, compare labels, and generate code for nonclinical databases, and FDA has continued to expand Elsa since its initial launch.
At the same time, FDA has consolidated more than 40 application and submission data sources, systems, and portals into HALO (Harmonized AI & Lifecycle Operations for Data) and began integrating HALO with Elsa so that personnel can query agency data and build workflows without manually uploading documents into each chat.
AI is also being incorporated into FDA’s postmarket-surveillance infrastructure. FDA’s Adverse Event Monitoring System (AEMS) consolidates reporting systems across FDA-regulated product categories and includes AI-based redaction and digitization tools, enhanced analytics, and cross-product surveillance.
AEMS is also intended to centralize consumer complaints, regulatory-misconduct reports, and whistleblower submissions, which may make it easier for FDA to identify patterns across products and categories.
These developments could allow FDA personnel to review and compare more information in less time and identify potential compliance issues more quickly, although it remains to be seen whether they will produce a greater volume of enforcement actions. For dietary supplement manufacturers and wellness brands, the primary practical implication is the prospect of faster and more targeted regulatory scrutiny.
As FDA connects additional datasets and expands its analytical capacity, inconsistencies among product labels, consumer-facing claims, facility-registration information, import records, inspection history, complaints, and adverse-event reports may become easier to identify and compare. FDA already frequently relies on reviews of product labels, company websites, and other online promotional materials to identify dietary supplements marketed with disease claims or other potential violations.
It is therefore reasonable to expect that Elsa, HALO, or similar tools could reduce the effort required to search and compare those materials and help personnel focus on particular claims, ingredients, products, or firms.
NI: As nutrition companies increasingly expand into technology-enabled wellness products, where do you see the biggest areas of regulatory overlap between FDA and the CPSC, and what should companies understand before bringing these products to market?
CL: CPSC has jurisdiction over the safety of “consumer products.” Technology-enabled wellness products intended to diagnose, treat, or prevent disease, or to affect the body’s structure or function are generally regulated by FDA as medical devices, and so are carved out from CPSC’s jurisdiction. However, many wellness products are not medical devices and so are regulated by CPSC.
Before bringing a CPSC-regulated product to market, companies must ensure that they comply with all applicable CPSC mandatory standards. For example, products containing button- or coin-cell batteries are subject to specific design and labeling requirements, and children’s products are subject to lead and phthalate content restrictions.
Additionally, companies must ensure that they understand and are prepared to comply with CPSC’s onerous reporting obligations.
The Consumer Product Safety Act requires companies that manufacture, import, distribute, or sell consumer products to file a report with CPSC “immediately” after obtaining information—or after a reasonable company would have obtained information—that “reasonably supports the conclusion” that their product (a) has a defect that “could create a substantial risk of injury” to consumers; (b) creates an unreasonable risk of serious injury or death; or (c) violates a mandatory standard. Failure to immediately and fully report can result in millions of dollars in civil penalties or even criminal penalties.
For example, just last year, Fitbit agreed to pay CPSC over $12 million for allegedly failing to immediately report a serious burn hazard associated with certain of its smartwatches. To avoid penalties, it is crucial for companies to have a compliance and safety monitoring program in place that will promptly identify potentially reportable information and escalate it for evaluation by an attorney with experience in this area.
NI: As dietary supplement companies diversify into wearables, smart packaging and other consumer wellness products, what are the most significant product safety risks they should be evaluating during product development?
EM: Offering new products always presents risk. But transitioning into new product regulatory territory must be approached with both care and intention.
Dietary supplement companies diversifying into wearables or other consumer wellness products outside of FDA jurisdiction can find themselves for the first time subject to the U.S. Consumer Product Safety Commission’s mandatory safety standards, product testing, labeling and certification expectations, and reporting obligations. The CPSC enforces a number of different laws that could be applicable, including among other laws the overarching Consumer Product Safety Act, the Flammable Fabrics Act, and the Federal Hazardous Substances Act.
The obligations can also change significantly if the product is intended for children. It is advisable that any company entering this space ensure during the product development stage that a qualified body assess and test whether the product is subject to and compliant with any applicable safety standards.
Wearables and wellness products that come into contact with the skin will need to be assessed to ensure they aren’t toxic, and specific warnings and labeling may be required if they could potentially irritate or inflame the skin. If the products contain button cell batteries, they are subject to strict safety design and labeling requirements.
These products should also be assessed for thermal, burn or electrical shock risks. But even if no such mandatory standards apply, the product will still need to be put through product safety testing under both foreseeable use and foreseeable misuse scenarios. To do so, the company needs to understand how the product will or could be used by the intended consumer base, and the ways and conditions in which those consumers will interact with or come into contact with the product.
This process allows companies to both identify and assess the seriousness of any physical safety risks and consider whether it can address them through design or ingredient changes during product development. If not, the risks might still need to be addressed through product instructions, disclosures and warnings.
NI: During the podcast episode, it was emphasized that companies should manage products throughout their lifecycle, not just at launch. What practical systems should manufacturers have in place to identify and address potential safety issues before they escalate into recalls or other regulatory actions?
EM: Product lifecycle safety management is important because risk can emerge, change, or adapt over time. Consumers may use the product in ways unforeseen during product development.
The products may be stored or sold in unexpected ways. Changes in the supply of ingredients or how the product is manufactured or packaged can introduce new risks, even with strict supplier and manufacturing controls in place.
Companies should have robust incident management systems in place that not only track consumer reports to the company of quality or safety issues, but that also collect information from additional sources about the consumer product experience. Social media is becoming one of the most important sources of that information, particularly since many products are sold at least in part online.
Some companies have begun using AI tools to quickly and comprehensively analyze social media for information about their products. But collecting this information is not sufficient alone. The company must then act by looking for flags or trends in the collected information that might reveal a hidden quality or safety issue and then reacting to what is found.
Involving the right internal teams in this product lifecycle management process is critical to ensuring it is both robust and effective.
NI: Consumer demand for technology-enabled health and wellness products continues to grow. Do you expect greater regulatory scrutiny of these products in the coming years, and where do you anticipate regulators will focus their attention?
EM: Yes. The U.S. Consumer Product Safety Commission has already focused on the growing wearables market. It has dedicated agency time and energy into assessing wearables-related risks and considering the need for additional mandatory safety standards has been made.
This focus followed a number of highly publicized recalls involving wearable products, but is also a reflection of the growing US market for connected health and wellness devices.
CL: Yes. As these products account for a growing share of the health and wellness market, regulators will necessarily devote greater attention to them.
Their analysis, however, will continue to focus on familiar questions: What is the product’s intended use, and how does that affect its regulatory classification? What claims does the product make, and are those claims substantiated? Is the product safe?
Whereas regulators have traditionally considered product labeling, advertising, and supply chains in their analyses, we may see greater scrutiny of algorithms, code, and personalization as indicators of a product’s intended use, claims, and safety.
NI: For dietary supplement manufacturers and suppliers looking to expand into broader wellness categories, what is the single most important step they can take today to strengthen both regulatory compliance and product safety as innovation accelerates?
EM: Innovation is a good thing, but can lead companies into unknown regulatory territory. This is particularly true for companies that are comfortable in the regulatory regime of another agency.
Engaging early in the product development process with technical and legal experts is a critical step to take toward ensuring that product regulatory compliance does not become a barrier down the line to a product’s development and launch. It is also important for protecting against avoidable regulatory missteps that could negatively impact the company’s brand in the market.
CL: The single most important step is to determine the product’s regulatory classification and the agency or agencies with jurisdiction over it. Everything else follows from that threshold determination.
Understanding where a product fits within FDA’s regulatory framework is the first step toward identifying the applicable requirements relating to safety, permissible claims, substantiation, manufacturing, labeling, testing, and postmarket reporting.
That analysis becomes especially important as companies expand into wearables, connected devices, apps, and other wellness products. Changes to a product’s design, functionality, intended use, or claims may cause it to fall outside FDA’s primary jurisdiction and within CPSC’s jurisdiction or potentially implicate both agencies.
Companies should therefore assess classification and jurisdiction at the outset of product development and revisit that assessment as the product and its marketing evolve.
