FDA Warning Letters

Tierney Salter, The Herbalist, Inc., Get FDA Warning Letter

Tierney Salter and her company, The Herbalist, Inc., have been formally warned by the U.S. Food and Drug Administration, or FDA, after Salter was found to be hawking numerous herbal remedies with medical claims that the agency says just go too far.

From the letter, which was just made public on the FDA’s website this morning, we learn that Salter’s company, The Herbalist, Inc., was the target of a multi-day inspection in October and November of last year. It was then that inspectors say that they observed “significant violations” involving Salter’s recordkeeping, labeling and marketing.

But FDA investigators also paid a visit to Salter’s website, TheHerbalist.com, where they put together a lengthy list of products marketed with unallowed claims. Some of those products and the medical issues which they promised to treat include things like:

  • Wormwood Capsules – parasitic “worms”
  • Immuno-Blast – cold and flu prevention
  • Prostate Choice – inflammation and reduced urine flow
  • Ache-Less – pain, inflammation, muscle spasms and menstrual cramps
  • Kids Be Calm – teething pain

Of course, says the agency, none of those supplements has ever been recognized as safe or effective for any of those conditions. And even if they were, many of them would still be considered “misbranded” because they are touted for medical conditions that an average person cannot accurately self-diagnose or effectively treat at home.

Bookkeeping Problems at The Herbalist, Inc.

During the October/November inspection Salter was also informed that her recordkeeping was inadequate. She had in place, for example, no system to document the strength or chemical composition of her batches.

She was also informed that the labeling for several products did not follow current FDA regulations.

Tierney Salter was given the standard 15  working days to address the inspectors’ concerns. The letter was dated May 25, 2017; as of my visit to TheHerbalist.com this morning I found the wormwood claims (“. . . powerful anti-parasitic agent that is effective at killing both mature parasites as well as their larvae.”) still clearly visible, as you can see in this screengrab:

Screenshot of Teirney Salter's TheHerbalist.com website with the wormwood claims still there.

Screengrab clearly showing FDA-cited claim about Tierney Salter’s wormwood herbal supplement still visible.


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