14 Feb 2019
FDA Steps Up Enforcement of Dietary Supplements and Electronic Cigarettes
Food and Drug Administration Commissioner Scott Gottlieb on 11 February released separate statements detailing efforts by his agency to more effectively regulate dietary supplements and electronic cigarettes. On dietary supplements, Gottlieb announced “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years” since passage in 1994 of the Dietary Supplement Health and Education Act, the law that governs the FDA’s authority to regulate dietary supplements. Gottlieb noted that the US$4 billion dietary supplements industry comprised of about 4,000 products in 1994 is now a US$40 billion behemoth with more than 50,000 different products available to consumers. Three out of every four American consumers take a dietary supplement on a regular basis, including four in five older Americans and one in three children.
Gottlieb announced the establishment of a new Dietary Supplement Working Group at the FDA to be led out of his office. The group will study FDA organisational structures, processes, procedures and practices in order to modernise oversight of dietary supplements. Gottlieb also announced a new Botanical Safety Consortium, a public-private partnership to evaluate the safety of botanical ingredients and mixtures in dietary supplements. He also noted that the Office of Dietary Supplement Programs was created three years ago to ensure product safety, labelling accuracy and quality manufacturing standards.
On 11 February, the FDA also sent 12 warning letters to companies whose products are marketed as dietary supplements and falsely claim to prevent, treat or cure Alzheimer’s disease as well as a number of other serious diseases and health conditions, including diabetes and cancer. The agency is now developing a rapid-response tool to alert the public when an ingredient is found to be illegal or potentially dangerous and will notify firms so that they can avoid making or selling products containing such ingredients. Additionally, the FDA is planning to update its compliance policy on new dietary ingredient notifications, since the notification currently represents the FDA’s only opportunity to evaluate the safety of an ingredient before it becomes available to consumers.
In a separate statement, Gottlieb announced the need for greater enforcement of e-cigarette marketing regulations while threatening to limit all sales of e-cigarettes in the United States. E-cigarettes were developed in mainland China in 2003 to help smokers avoid the health risks of traditional cigarettes, although e-cigarette “vaping” is now coming under some regulation in the mainland as well as in the United States.
The FDA is particularly concerned that vaping now is leading to tobacco addiction among U.S. teens. A joint FDA/Centers for Disease Control study reported that 4.9 million middle and high school students used some type of tobacco product in 2018, up from 3.6 million in 2017, with the surge being led by e-cigarette use. More than 3.6 million middle and high school students were e-cigarette users in 2018, an increase of more than 1.5 million students in one year. A National Institutes of Health study found comparable trends – from 2017 to 2018 e-cigarette use increased from 6.6 percent to 10.4 percent among eighth grade students, 13.1 percent to 21.7 percent among tenth grade students, and 16.6 percent to 26.7 percent among twelfth grade students.
Gottlieb noted that the FDA has taken enforcement actions at both brick-and-mortar and internet storefronts and is addressing “kid-friendly marketing” and flavouring of these products. On 11 February, he sent letters to the chief executive officers of two major producers requesting a meeting to discuss his concerns that “they don’t seem fully committed to their written promises about the steps they’d take to stop youth use of their products.” Gottlieb also warned that if these trends continue the FDA will be forced to “make some tough decisions about the regulatory status of e-cigarettes.”