Confusing news about FDA and restrictions on supplements

Dear Reader,

Being a person who is constantly learning about nutrition, supplements and working toward improving your health, you may have been alarmed by some recent reports that the FDA (Federal Drug Administration) is cracking down on what constitutes a dietary ingredient.  Some people are getting their nickers in a twist over government interference in our precious right to buy and take whatever supplements we want.

I was very pleased when my colleague Bob Ferguson took the trouble to contact Shaklee's legal council, Marjorie Fine, for clarification.  Here's what he and she have to say:

As is most often the case, the sky-is-falling emails we all get don't tell the whole story, or get facts confused. Here's an explanation of what is happening at the FDA from Marjorie Fine, and under what condition she will ask us in the field to contact our representatives. When we have done that in the past in a coordinated way, it has been highly effective. Sure glad we have someone of Marjorie's stature representing us and other responsible companies.

Best wishes,

Bob

Hi Bob - What FDA published in July was not the Codex Alimentarius, as this article states, but, rather, a draft guidance respecting New Dietary Ingredients.  FDA was required to publish this guidance pursuant to the FDA Modernization Act.  A guidance document does not have the force of law and can be challenged only if enforced. 

 

The Dietary Supplement Health and Education Act of 1994 distinguished between grandfathered dietary ingredients (ie, those on the market prior to October 15, 1994) and new dietary ingredients ("NDI").  The law required that prior to marketing a NDI a company must submit a notification to FDA along with proof of safety.  There has long been confusion as to just which dietary ingredients are grandfathered and which are new as well as to what evidence is required to be submitted to FDA.  That's why Congress required FDA to publish a guidance explaining these issues.

 

The draft guidance defines NDI much too broadly and also goes beyond the bounds of reason in the safety documentation required.  I am working on comments with our trade association.  We hope to influence FDA to write a more reasonable final guidance document.  If we are unable to obtain that, I will ask the field for help with our Congressional representatives, but it is too early to go to them now.

 

I hope this helps.  Let me know if you have any questions.  Marjorie

 

 

Marjorie L. Fine
Executive Vice President & General Counsel
Shaklee Corporation
4747 Willow Road
Pleasanton, CA  94588
T  925-924-2586
F  925-924-2155
E  mfine@shaklee.com

Thanks for reading,  In good health,

Betsy

BetsyBell'sHealth4U

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