What Has FDA Done to Stop Industry Lawbreakers in the Last Year?


Acting FDA Commissioner Stephen Ostroff, MD, shares FDA’s accomplishments from the last year in protecting supplement consumers, as well as challenges that remain.

Photo © iStockphoto.com/Zardinax

Photo © iStockphoto.com/Zardinax

Arriving a little more than a month since FDA’s Division of Dietary Supplement Programs was elevated to its own Office within the agency, Acting FDA Commissioner Stephen Ostroff, MD, recently shared a laundry list of actions FDA has taken in the last year to enforce against lawbreakers in the dietary supplement industry.

In a post on FDA’s official blog, FDAVoice, dated January 20, Ostroff outlined some of the agency’s recent enforcement accomplishments, as well as challenges that remain.

Most recently, U.S. Marshals seized nearly 90,000 bottles of dietary supplements labeled as containing kratom, an ingredient associated with narcotic and stimulant-like effects, said Ostroff. The action took place earlier this month at the request of FDA.

In 2015, FDA took action against other harmful ingredients, such as powdered caffeine, BMPEA, and DMBA, by sending warning letters to distributors and marketers of products containing these ingredients.

The agency worked with the Department of Justice (DOJ), the Federal Trade Commission (FTC), and the U.S. Postal Inspection Service in 2015 to identify “potentially unsafe products and/or products containing undeclared ingredients.” As a result of the sweep, FDA issue civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products in November, said Ostroff.

Also in the last year, FDA issued more than 100 consumer alerts warning of products containing active pharmaceutical ingredients that were falsely marketed as dietary supplements. Additionally, FDA conducted more than 600 inspections of dietary supplement firms in the United States and abroad.

Ostroff also touched on the new Office of Dietary Supplement Programs, and FDA’s intentions to increase “the visibility, capacity, and staffing for that new office.”

“This will include hiring permanent leadership to sharpen our focus on potential safety problems and to support regulatory actions,” said Ostroff.


FDA’s Challenges

At the beginning of his post, Ostroff spoke to the challenges FDA faces in protecting consumers from unsafe supplements, such as the sprawling and unwieldly volume of the supplements industry.

“The significant growth in the dietary supplements industry, and the various ways supplements reach consumers, outpace FDA’s resources to regulate this industry,” said Ostroff.

He also touched on the difficulty of tracing products because of fragmented supply chains, with a single product often passing through numerous suppliers, manufacturers, and distributors that may not always reside in the United States.

Ostroff concluded with a note on the importance of FDA’s cooperation with other regulatory agencies, including the FTC, DOJ, state health departments, and state attorneys general.


Nutritional Outlook thanks the Council for Responsible Nutrition (CRN; Washington, DC) for the story tip.


Read more:

Industry Welcomes New FDA Office of Dietary Supplements

FDA Requesting Comments on Use of the Term "Natural"


Michael Crane
Associate Editor
Nutritional Outlook Magazine

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