Safer Solutions: What does the FDA approve?

The Food and Drug Administration (FDA) regulates a range of products well beyond food and drugs. Tobacco products, cosmetics, veterinary products, medical devices, electronic products that give off radiation, dietary supplements, and biologics used in medicine all fall under the FDA’s purview. In fact, about 20 cents of every dollar Americans spend goes toward purchasing an FDA-regulated product.

Because the FDA’s role has evolved over time, the agency uses different regulatory processes and terminology for each product class. The term “FDA-approved” has a specific meaning but is often used loosely, which can be confusing.

Today’s edition of Safer Solutions gives a general overview of FDA approval terminology and nuances within that language, with the caveat that explaining all the different exemptions and pathways that may apply in some circumstances is beyond the scope of this newsletter.

But first, a brief history lesson to help explain why FDA regulatory actions are so varied.

Regulatory authority varies by product type

Although the FDA’s regulatory authority covers a wide range of products, it did not acquire this authority in one fell swoop. The FDA was established in 1906 to address misbranded and adulterated food and drugs. Since then, various public health crises have prompted legislation to expand the agency’s regulatory authority. Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 following a mass-poisoning event related to an antimicrobial medicine. This law required all drugs to receive approval before being sold and brought cosmetics and medical devices under FDA authority.

The Food, Drug, and Cosmetic Act has been amended multiple times since then. For example, a consequential 1962 amendment required manufacturers to prove a drug’s efficacy in addition to its safety and quality. Another amendment in 1976 built a tiered classification system for medical device regulation based on risk of harm.

Separate legislation has also shaped the FDA’s regulatory authority:

• A 1994 law reaffirmed that dietary supplements should be regulated as food products.
• A 2009 law formally brought the manufacturing, distribution, and marketing of tobacco products under FDA regulatory authority.
• A 2011 law shifted regulation of the food supply to a more proactive model and expanded the FDA’s authority to issue mandatory recalls.
• Other legislation has dealt with marketing of prescription drugs, regulation of infant formula, and nutritional labels.

This ad hoc approach has generally been used to address to major lapses in regulatory action, consequently creating the multiple regulatory pathways and structures we see today. The following examples highlight key regulatory terminology and explain the difference between FDA approval and authorization.

New drugs and biologics

Manufacturers of drugs and biologics cannot sell a product in the United States before seeking FDA approval. FDA approval is a rigorous process that involves reviewing a new product’s safety, quality, and effectiveness. The FDA does not test new products itself; instead, manufacturers must submit specific data that the agency then evaluates. If the FDA determines that the benefits of the drug, biologic, or medical device outweigh the known risks, then the product is approved for sale.

Medical devices

Medical devices like exam gloves, catheters, mechanical heart valves, and dialysis equipment are either “FDA-approved” or “FDA-cleared” based on the risk they pose to consumers. Medical devices that present the highest risks of harm (e.g., mechanical heart valves, ventilators) are considered “Class III” medical devices and must be FDA approved (like drugs and biologics) before being made available to the public. “Class II” medical devices (e.g., sutures, dialysis equipment) present a lower risk to consumers, and manufacturers can pursue “510(k) clearance” instead of FDA approval. This requires the manufacturer to demonstrate that a medical device is “substantially equivalent” to a device already on the market. Finally, medical devices that present little risk to the public (e.g., exam gloves, tongue depressors) are considered “Class I” medical devices. These do not typically require FDA approval or clearance, though they are subject to other regulation.  

New tobacco products

While the FDA assesses drugs, biologics, and medical devices for safety and efficacy, this standard does not apply to tobacco products because they are not intended to treat illness. Instead, the FDA assesses new tobacco products through several different pathways. There is no such thing as an “FDA-approved” tobacco product. Instead of approvals, the FDA issues marketing orders through these pathways, thus authorizing a product to be legally marketed and sold in the United States.

The least onerous pathway is only open to new products that are “substantially equivalent” to a product that was on the market before 2007—in other words, products like traditional combustible cigarettes. New reduced-risk products like e-cigarettes and nicotine pouches use a different pathway that requires submitting mountains of data on risks and health effects to prove they are “appropriate for the protection of public health.” The third and most challenging type of marketing order authorizes manufacturers to market their product as less harmful or less risky than other tobacco products. This authorization structure has the unfortunate effect of subjecting combustible cigarettes (the deadliest way to consume nicotine) to less rigorous review than reduced-risk products that could help people quit or minimize the harms of smoking.

Why does this matter?

Although regulatory policy is extremely wonky, it is important for consumers and policymakers to understand that the FDA regulates products differently by class and know what different regulatory terms mean. These distinctions matter—particularly in tobacco harm reduction, because while only drugs, biologics, and Class III medical devices are “FDA approved” for safety and efficacy, tobacco products are evaluated against their own criteria (entirely different from other products). We are starting to see movement from the FDA in authorizing more reduced-risk products for sale in the United States. Those marketing orders matter to public health because they can put more legal, regulated harm reduction tools on the shelves; cut down on the unregulated illicit market for nicotine products; and give healthcare providers more confidence in recommending harm reduction tools to patients who are struggling to quit via traditional methods.