Safer Solutions: Natural vs. Synthetic Substances Part II—Regulation Improves Safety
Our previous installment looked at how the distinction between “natural” and “synthetic” substances has little to do with their relative safety or potential benefits and harms. Disparate regulatory treatment often stems from assumptions that synthetic substances are automatically more dangerous than natural ones. Here, we’ll discuss smart regulation as a key to consumer safety and argue for a regulatory focus on safety and relative risk rather than substance type.
The Tale of Two Nicotines
In Part I, we used nicotine as an example of a substance that can either be derived naturally from the tobacco plant or synthesized in a lab. Regardless of its origin, it’s the same chemical.
Despite this, synthetic and tobacco-derived nicotine were regulated differently for a time. The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) defined tobacco products as “…any product made or derived from tobacco that is intended for human consumption…” Because synthetic nicotine is not derived from tobacco, it technically did not qualify as a tobacco product. The Tobacco Control Act also made introducing new tobacco products to market more difficult, leading manufacturers to begin using synthetic nicotine in non-combustible products like nicotine pouches and e-cigarettes. Seeking to close this loophole, Congress passed legislation in 2022 clarifying that the regulatory authority of the Food and Drug Administration (FDA) also includes synthetic nicotine.
Today’s legal definition of a tobacco product is “… any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption…” This makes sense, as synthetic and naturally derived nicotine are the same chemical with the same health and dependence risks. Leaving synthetic nicotine unregulated would have allowed the proliferation of such products on the market; conversely, regulating synthetic nicotine differently from tobacco-derived nicotine would create two separate classes of products with different standards. Closing the synthetic nicotine loophole mitigated the need for a different regulatory system and ensured that all tobacco and nicotine product manufacturers disclosed their product’s ingredients and components and where they were sourced. This unified regulation is important because it increases manufacturer accountability and helps the FDA protect consumers.
Prohibited Substances Are Inherently Unregulated
Regulation plays an important part in keeping consumers safe, but whether a substance is natural or synthetic has little to do with its safety profile and should not impact how it is regulated. Regulatory frameworks can set product and labeling standards for legal substances, ensure consistency, and educate consumers on what a particular substance is and how much of it they are consuming.
As we’ve discussed before, the “Iron Law of Prohibition” states that prohibited substances tend to become more potent and easier to smuggle. In the 2010s, suppliers began mixing potent synthetic opioids like fentanyl into heroin and counterfeit prescription pills—a shift that exacerbated the overdose epidemic. Because there are no quality and purity controls for manufacturing these drugs, they frequently contain contaminants, and the concentration of substances in each dose can be uneven. The high potency of fentanyl and other synthetic opioids means even the smallest dose miscalculation can be deadly. A batch of counterfeit pills might contain one pill that’s relatively safe to consume and another that causes a fatal overdose. But it’s the unregulated nature of these products—not their designation as natural or synthetic—that increases these risks.
Another example of how prohibition prevents regulation and causes harm is the 2019 “e-cigarette or vaping product use-associated lung injury” (EVALI) outbreak. Despite the name, regulated nicotine e-cigarettes did not cause EVALI; rather, illicit cannabis vapes contaminated with vitamin E acetate were to blame. Generally recognized as safe in food products, this chemical is unsafe to inhale and isn’t used in regulated nicotine or cannabis vapes. A lack of regulatory oversight around prohibited products or substances allowed those manufacturing the illicit vapes to add the chemical to them. Researchers found that states where cannabis was legal had significantly fewer EVALI cases than states that prohibited cannabis. The availability of legal, regulated cannabis products “may have crowded out use of riskier, informally sourced e-liquids” from the illicit market, thereby saving lives.
Getting Regulation Right
Chemicals interact with our bodies in complex ways. Thoughtful regulation that reflects product characteristics is key to ensuring the safety of any product. This is a challenging balance to strike, so policymakers and regulators should be prepared to adapt existing regulations to changing circumstances, new products, and consumer behaviors. They should also consider relative risks and benefits of regulation or prohibition regardless of a substance’s status as natural or synthetic.