FDA To Target Products That Claim To Cure Serious Disease As It Beefs Up Oversight Of Sprawling Supplement Industry
The FDA announced that it sent 12 warning letters and five advisory letters to companies the agency says are selling products that contain unapproved drugs or making illegal claims for treating Alzheimer’s or other serious conditions. “I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” said FDA Commissioner Scott Gottlieb.
The New York Times:
F.D.A. Warns Supplement Makers To Stop Touting Cures For Diseases Like Alzheimer’s
The Food and Drug Administration on Monday warned 12 sellers of dietary supplements to stop claiming their products can cure Alzheimer’s disease. At the same time, Dr. Scott Gottlieb, the agency’s commissioner, suggested that Congress strengthen the F.D.A.’s authority over an estimated $40 billion industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny. (Kaplan, 2/11)
The Washington Post:
FDA Launches Tougher Oversight Of Supplements
FDA Commissioner Scott Gottlieb said the agency is planning policy changes that could lead to the most important regulatory modernization since enactment of the 1994 Dietary Supplement Health and Education Act, which set up the regulatory regime. Under the law, dietary supplements are regulated as food and, therefore, are not subject to premarket approval or the kind of safety and effectiveness testing required for drugs. Since the law was enacted, the industry has grown from 4,000 products and $4 billion a year in sales to as many as 80,000 products and $50 billion in sales, according to the FDA. (McGinley, 2/11)
The Wall Street Journal:
FDA Challenges Supplement Makers’ Marketing Claims
“Legitimate industry benefits from a framework that inspires the confidence of consumers and providers,” Mr. Gottlieb said. “Patients benefit from products that meet high standards for quality.” Dietary supplements are a booming industry, with some 80,000 kinds of supplements sold in 2016, according to a recent government report. U.S. supplement sales reached nearly $133 billion in 2016, according to the most recent data from Zion Market Research. (Hopkins, 2/11)
The Hill:
FDA To Crack Down On Dietary Supplements
Three out of four Americans take dietary supplements on a regular basis, Gottlieb said. “That’s why today we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” he said.(Sullivan, 2/11)
The Associated Press:
What The FDA's Actions Mean For Dietary Supplements
The agency warned 17 companies for illegally making claims about their products' ability to treat diseases. Here's a look at what the FDA's announcement means. (Choi, 2/11)
