FDA Warning Letters

WholeFood Farmacy Is FDA Warned

Linda Schoenrock and her company, Rock Farm, have been formally warned by the U.S. Food and Drug Administration, or FDA, about nonallowed medical claims used to hawk her “natural” remedies through WholeFood Farmacy.

From the FDA’s warning letter to WholeFood Farmacy we learn that FDA inspectors spent several days at Schoenrock’s facility back in March. While there, they reportedly collected product labels and took a look at the company’s website wholefoodfarmacy.com. Ultimately, a few different products caught their attention:

  • Joule
  • Joule Micro-Electric Current
  • Stardust2Hydr8
  • Hydrating Stardust
  • Farmacy Pro Power

All of these products are “misbranded drugs” and “new drugs”, says the agency because they are marketed for medical conditions that cannot be accurately self-diagnosed or safely or accurately self-treated with over-the-counter supplements.

Joule tonic from WholeFood Farmacy

Photo of WholeFood Farmacy’s Joule supplement, which FDA says is marketed with unallowed medical promises.

A few of those non-allowed marketing claims involved medical issues like:

  • Inflammation
  • Pain
  • Tumors
  • Liver damage
  • Bacterial infection
  • Depression
  • High cholesterol

Of course, none of those products has ever been proven safe or effective for any of those conditions.

Linda Schoenrock’s Joule tonics are in further trouble because they contain flecks of gold that are intended as a colorant. Gold flecks are not an approved food colorant.

And if that wasn’t enough, inspectors found numerous examples of mistakes when it came to the was Schoenrock listed her ingredients. On one product, for example, she even misspells the name of a common food thickener. In another example, she claims to use raw Aloe vera in a product but actually uses powdered aloe instead.

The FDA’s letter to┬áLinda Schoenrock and WholeFood Farmacy was one of the longest warning letters we’ve seen in a while but was still not, says the agency, intended to serve as a full listing of all potential violations.

Schoenrock was given the normal 15 working days to answer the allegations. The letter was dated┬áSeptember 18, 2018; as of my last check this morning, I found the FDA-cited claims I looked up to be still visible on the company’s website:

FDA-cited claims about the Joule prouct that earned Linda Schoenrock a warning letter.

Screengrab of WholeFood Farmacy’s Joule tonic sales page with FDA-warned health claims still clearly visible as of September 26, 2018.