FDA warning letter to Darlene Doble and Sanapac.
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Sanapac Warned – Multiple Products

Darlene Doble and Sanapac are warned by FDA
FDA Warning Letter to Sanapac and Darlene Doble

The US Food and Drug Administration, or FDA, has made public is warning letter to Sanapac and its president, Darlene Doble.

From the letter, which is dated March 24th, we learn that Sanapac Company, Inc. was targeted in a multi-day inspection last winter. Agents with FDA also visited Sanapac’s website, where they allege they found additional violations of the agency’s Current Good Manufacturing Practice, or CGMP, rules.

The letter alleges multiple “serious violations”, including incomplete recordkeeping, but most of the alleged violations involved unallowed medical claims made about these products, in particular:

  • Inner Man
  • Inner Man Gold
  • Inner Woman
  • Rooster Kings

Inner Man and Inner Man Gold

Sanapac’s Inner Man Gold and Inner Man products contain ingredients which the company said can address issues like:

  • Cystitis
  • Kidney stones
  • Various skin conditions
  • Cough
  • High blood pressure

Inner Woman

The company’s Inner Woman supplement is made with ingredients that Sanapac claimed can aid conditions like:

  • Menstrual paid
  • High blood pressure

Rooster Kings

The Rooster Kings supplement was promoted with ingredients able to address medical conditions like:

  • Cough
  • Urinary issues

Of course, the FDA says that none of the mentioned supplements has ever been officially recognized as safe or effective for any of those conditions. But even if they were, the products would be further “misbranded” because they are promoted for medical issues that the average consumer cannot accurately self-diagnose or safely self-treat.

As of my visit to sanapac.com this morning, it appeared that the site’s About Our Ingredients page, where many of the troublesome claims were originally found, had been removed.

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Screenshots of Sanapac products and webpages captured 04-07-2017 by Lisa Barger and used under Fair Use doctrine.