The process:
One of the ways the U.S. Food and Drug Administration enforces the law is by monitoring companies for what sorts of claims they make about their products and, if the agency believes company is violating the law, sending out what is called a “warning letter.”
The letter outlines how the company is in violation of federal law, specifically, the Federal Food, Drug, and Cosmetic Act. Companies usually have 15 working days to tell the FDA how they are going to respond. Companies that fail to comply can face fines, seizure of products and more.
Last month, Dr. Joseph Mercola, who runs a mammoth online health empire based in Hoffman Estates, received a warning letter from the FDA
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, his third since 2005. The letter singles out the way Mercola is marketing a thermographic camera, the Med2000, an FDA-approved medical device that maps skin temperature.The postitions:
The FDA is maintaining that the device is not approved to do things like diagnose breast cancer, and that Mercola’s website is making claims along those lines with statements calling thermography “The Newest Safe Cancer Screening Tool.”
Mercola disagrees with the FDA and is vowing to fight the administration. In an email to the Tribune, he pointed to a line in the Med2000 FDA approval letter that reads:
“Use of this device is determined by the healthcare professional upon his or her assessment of the patient’s medical condition and requirements.”
How you can search for warning letters:
FDA warning letters, despite being filled with the dry legalese of regulatory language, are actually fascinating documents. In some ways, they are one way the FDA tells the public – and companies – what is okay and what is not when it comes to interpreting federal law.
The FDA makes warning letters easily accessible to the public on its website: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#moreinfo
You can search by company name, by keyword (such as “thermography”) or you can just browse by year.
And, if you are especially interested, you can even sign up to email receive updates from the FDA about new warning letters as they become public.
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