Subcommittee Urges FDA to Evaluate JUUL Labs’ False Medical Claims about E-Cigarettes
Washington, D.C. (September 5, 2019)—Today, Rep. Raja Krishnamoorthi, the Chairman of the Oversight Subcommittee on Economic and Consumer Policy, sent a letter to the Food and Drug Administration (FDA) urging the Acting Commissioner to evaluate admissions and statements made by JUUL representatives under oath, and expeditiously take all appropriate enforcement action to protect the American public from the fraudulent and unapproved medical claims made by JUUL Labs.
“Your predecessor, Scott Gottlieb, when he was Food and Drug Administration (FDA) Commissioner, pointed to JUUL as a primary cause of the epidemic,” wrote Chairman Krishnamoorthi. “Testimony from our hearing supports that conclusion. It demonstrates that JUUL appears to be violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes.”
Testimony given by JUUL Co-Founder James Monsees and Chief Administrative Officer Ashley Gould directly relate to matters within FDA’s jurisdiction and ability to act regarding JUUL’s marketing of its product as a smoking cessation device and JUUL’s unapproved modified risk claims. During the two-part hearing examining JUUL’s role in the youth e-cigarette vaping epidemic JUUL representatives:
- Made various admissions that JUUL presents its product as a smoking cessation device, which means that it should be subject to FDA regulation as a drug, device, or combination drug/device; and
- Made numerous unfounded and unapproved claims that its product is safer and healthier than cigarettes.
In considering whether a product is being marketed as a smoking cessation device, the FDA is required to look past overt claims and determine the product’s intended use, which it may do by considering “labeling claims, advertising matter, or oral or written statements” by the company and its representatives. It also may be shown by how the company knows that a product is actually being “offered and used for a purpose for which it is neither labeled nor advertised.”
JUUL representatives’ testimony revealed that the company:
- Pitched its product as a smoking cessation device to a Native American health committee;
- Told children in high school to use JUUL as a smoking cessation device;
- Marketed its product to community-based smoking cessation groups;
- Presented its product as a smoking cessation device in “switching” ads;
- Told the U.S. Trade Representative that its product is a smoking cessation device;
- Markets its product to kids in schools as “totally safe” and to Native American Tribes as “healthful;”
- Markets its product to employers and insurers as a way to “save people’s lives;” and
- Asked the U.S. Trade Representative not to tariff JUUL consumer products because they are healthier than cigarettes.
Claims that a product helps users quit smoking are “therapeutic claims,” subject to FDA jurisdiction under the drug/device provisions of the Food, Drug, and Cosmetic Act (FD&C Act). Such drugs or devices must be approved by FDA, and if they are not, they are unapproved drugs or devices being marketed illegally under the FD&C Act. FDA must consider the full picture in order to determine if therapeutic claims are being made.
Click here to read today’s letter.