Safer Solutions: Goldilocks Regulation – Getting Substance Regulation ‘Just Right’
Most products we put in or on our bodies are subject to some form of regulation, although the frameworks vary significantly. For example, rigorous clinical trials are required to test whether pharmaceutical products deliver on the claims made by the manufacturer and to identify side effects, potential medication interactions, and other risk factors. But dietary supplements—many with their own extensive list of side effects and contraindications—are regulated like food products instead. This leaves claims about health benefits unconfirmed and potential health risks obscured.
The ideal substance regulation process balances scrutiny with practicality to create frameworks that protect public health without preventing beneficial innovations from entering the market. This is “Goldilocks regulation”—not too big, not too small, but just right. However, addictive products often face regulatory inconsistency and policy barriers that adversely impact public health, safety, and access to innovative and beneficial products.
Regulatory burdens don’t always align with product risk
When regulatory burdens on substances don’t align with product risk, we end up with frameworks that can erect barriers for new, lower-risk products while allowing more dangerous products to enter the market. We see this dynamic at play with tobacco and nicotine products, where traditional combustible tobacco products (e.g., cigarettes) and new, lower-risk nicotine products face different pathways to the market.
The 2009 Family Smoking Prevention and Tobacco Control Act empowered the Food and Drug Administration (FDA) to review new tobacco products before they can be sold legally in the United States. At the time, e-cigarettes and other reduced-risk products were nascent—often with limited market share—and were not defined as tobacco products. In 2016, clarifying regulation gave the FDA authority to regulate these products and outlined distinct regulatory pathways for market entry. Now, everything from combustible cigarettes to e-cigarettes to nicotine pouches must receive FDA authorization before being sold here.
Combustible cigarettes—the deadliest mechanism for tobacco and nicotine consumption—can use a less onerous, regulatory pathway than reduced-risk products. The “substantial equivalence” pathway allows manufacturers to seek approval for a new product as long as it closely mirrors a product that was already available before the new approval process went into effect. This is a lower bar than the full premarket tobacco product application (PMTA), which is the only option for reduced-risk products.
The PMTA is a more onerous regulatory approval process for completely new products containing nicotine. This long and costly process requires manufacturers to prove to the FDA that any new products—including reduced-risk products like nicotine pouches and many e-cigarettes—are “appropriate for the protection of the public health.” This designation is a high and poorly defined bar.
The result of this dual regulatory framework is stark: 491 new combustible cigarettes have entered the market via the less burdensome “substantial equivalence” pathway, while only 85 lower-risk products have cleared the bar for novel products. In short, our regulatory system smooths the path for the most dangerous products while erecting barriers for reduced-risk products that adults who smoke could use to improve their health.
Poorly crafted regulation can stifle innovation
This inefficient regulation of novel reduced-risk nicotine products also demonstrates how regulation can prevent innovative products from entering the market. Not only can the FDA authorization process to sell a new reduced-risk product legally take years and cost up to $100 million per product, but if an authorized reduced-risk product is modified or upgraded (e.g., new battery, new flavor, new technology), the manufacturer must start from square one to seek new FDA authorization. As a result, innovative changes that could improve user experience and uptake by smokers or product safety can take years to reach consumers. Those years matter for products that could help adults switch away from deadly combustible cigarettes.
Take one reduced-risk heat-not-burn product that’s been available in other countries since as early as 2014. That same product didn’t receive FDA authorization until 2019. Manufacturers have since developed upgraded versions of the device, but because of the “square one” dynamic described above, the 2018 model is still the only version authorized for sale in the United States. Regulation is vital, but it must be able to respond to innovation and should (at the very least) make it harder to get more dangerous products onto the market.
Every substance warrants ‘just right’ regulation
Regulation must be thoughtfully devised, responsive to emerging challenges, and designed with the true intention of protecting and informing consumers. Getting regulation right is especially important when it comes to products that contain substances with psychoactive properties, and thoughtful, evidence-based regulation can help improve public health when there is a spectrum of risk across a substance (e.g., reduced-risk nicotine products versus deadly combustible cigarettes).
Every substance needs that “just right” approach to regulation that considers how different products compare to one another in terms of risk and benefit and the extent to which innovation within a particular product category might benefit the public.