FDA hits firm with thermography warning letter

2016 09 02 09 36 05 93 Fda Logo V2 400

A California provider of natural health products has been hit with a warning letter from the U.S. Food and Drug Administration (FDA) for a variety of alleged infractions, including using marketing claims for a breast thermography system that the FDA said have not been approved by the agency.

In an April 17 letter, the FDA detailed claims made by Nature's Treasures of Glendale, CA, for products ranging from anti-inflammatory agents (which the firm claimed can help people with cancer) to a green tea blend that the company said could be used to "fight cancer." The FDA noted in its letter that the company was making claims for products intended to treat illnesses "that are not amendable to self-diagnosis or treatment without the supervision of a licensed practitioner."

With respect to thermography, the FDA letter stated that Nature's Treasures has been marketing a telethermographic system by making claims that are not supported with a premarket approval (PMA) application. The letter noted that the FDA regulates thermography systems as class I devices when they are used as an adjunct to mammography screening, which would require a 510(k) application, and as class III devices with a PMA if intended to be used alone for diagnostic screening.

The FDA believes that the firm's promotion of its telethermographic system positions the device as being intended for diagnostic screening to detect breast cancer, including as a sole screening device. The system should be classified as an "adulterated" product because the company has neither a PMA nor a 510(k) for the uses it is claiming.

The FDA cited a number of claims made on the company's website, specifically the following:

  • Thermography is suitable for all women 25 and older.
  • Thermography can detect cancer "much earlier" and is "far more sensitive than mammography."
  • Breast thermography has 99% sensitivity, 90% specificity, and 90% accuracy.

What's more, the company's website claims that many women are choosing to undergo thermography instead of mammography.

The FDA requested that Nature's Treasures immediately stop activities that result in the "misbranding" of its thermography system, and that the company respond to the FDA letter within 15 working days.

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