Glucorein PCOS Will Be A Pill

by Becky Miller on February 27, 2014

img 6 150x150 Glucorein PCOS Will Be A Pill

Glucorein PCOS Will Be A Pill

Have you been having trouble ordering your Glucorein PCOS? Maybe you don’t even know what Glucorein PCOS is or you’ve never tried it. You can read more about Glucorein PCOS, here.

The purpose is this post is strictly informational. I have tried Glucorein PCOS and have recommended it for women with PCOS. I was baffled when the links to Napa Valley Nutritionals (NVN Therapeutics), the company that makes and markets Glucorein PCOS, suddenly stopped working. So I started to do a little research and found that NVN Therapeutics has been issued a warning letter by the FDA, seemingly for the misbranding of Glucorein PCOS as a ‘medical food’ instead of a ‘drug.’ 

The FDA offers 4 different tiered classifications of products being offered to consumers. When I spoke with NVN Therapeutics they also shared ‘common language’ for how these tiers are all regulated by the FDA.

  • Drug – Highly Regulated
  • Medical Device – Strictly Regulated
  • Medical Food – Regulated
  • Supplement – Not regulated very highly

I contacted and spoke with a representative from NVN Therapeutics and learned that they were having difficulty getting Glucorein PCOS classified as a ‘medical food.’ As it turns out, it is challenging to prove that women with PCOS are deficient in L-Cystein and Chlorogenic Acid, the two active ingredients in Glucorein PCOS. This is a key to getting Glucorein PCOS approved by the FDA as a medical food.

After speaking with a NVN Therapeutics, Glucorein PCOS representative, here is what they told me.

  • You can still order Glucorein PCOS but only by phone. They’ve been given permission by the FDA to continue to sell the product.
  • Glucorein PCOS is in the process of being remanufactured in pill form and under the new name Glucorein HOP (Healthy Ovaries Plus). It should be available around April 2014.

You can read more about the recent trend of the FDA cracking down on this issue, with other products and companies. NVN Therapeutics is the fourth warning in the last 9 months.

Also available to the public is the warning letter issued to NVN Therapeutics from the ‘Office of Compliance Center For Food Safety and Applied Nutrition.’

Remember, this post is strictly informational based upon my own personal investigation and I offer no bias to either side of the discussion. 

Have you benefited from using Glucorein PCOS? What are your thoughts about the argument that the FDA is bringing to the table? Comment below to share your thoughts and opinions.

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