MLMIA: Structure / Function Regulation
THE FDA GIVES UP GRACEFULLY!
YOU ARE THE HEROES AND HEROINES!
THANKS FOR THE SUPPORT!
By Rod Cook Legislative Chairman MLMIA
Finally at last! The FDA issued their new Structure/Function regulation. It is great! Not perfect by any means and there are some jagged edges that will have to be smoothed out. It is a vast improvement over what we have been going through since the Dietary Supplement Health Education Act (DSHEA) was passed in 1994 which the MLMIA supported.
The FDA is giving up trying to classify such things as aging, menopause and pregnancy as diseases! The FDA indicates it will permit structure/function claims for "non-serious conditions associated with natural states. Examples given: "acne in adolescence, hot flashes and leg edema during pregnancy. Permissible statements that may be allowed are for minor pain, stamina, stop smoking alternatives, upset stomachs, relaxation and others. What a turn about for the FDA. We thank them for their responsiveness to the American people!
Now for the story inside the story. As you know the MLMIA (and it's members) worked with a coalition of other concerned groups and citizens. All of us were concerned that the FDA always pushed for nutritional such as herbals to meet the same standard as drugs! When the FDA asked for comments on the their new structure and function guidelines, we literally buried them! Hundreds of faxes turned into thousands! Plus many good folks sent faxes not only to the FDA but to their Congressmen expressing concern about what the FDA might do! Your chairman sent out 22,000 email to a list of conearned supporters and 9,600 faxes!
We not only have the coalition to thank but also some other great folks. Dirk Pearson and Sandy Shaw, two long Nutritionists beat up the FDA in Federal court and won a case against the FDA for restricting claims they made for natural foods. Pharmanex, now a Nuskin subsidiary also drove the FDA to their knees in Federal court. Our friends Senator Hatch and his senatorial crew kept the heat on the FDA from the Senate side!
Then from the House side, Congressman Dan Burton from Indiana Introduced H.R. 3305. This bill (if passed) would keep the FDA from deviating from the intent of DSHEA. The FDA also got sideswiped by the Congressional Small Business Committees when the FDA tried to issue it's Ephedra guidelines without doing an impact study how their edict would affect small business. Who say's that fighting the bureaucracy doesn't work! What a team and our thanks to each and every one of you that fired off a fax or letter to Washington! Thanks to the Congressional staffers that helped us along our path!
Like a mule being gently prodded along it's path with a 2x4 the FDA finally came around. "This is not a free-for-all," said Peggy Dotzel, the associated acting commissioner for policy at the FDA. "What the agency is doing is faithfully carrying out the intent of Congress in passing the law" (meaning DSHEA). The new ruling made several so called 'consumer advocates' mad. Dr. Sidney Wolf, director of the Public Citizen's health Research Group in Washington said, "this is a snake-oil exemption, it's a complete cave-in to the nutritional industry." So stay alert! The heat isn't off yet, we have plenty of critics left, to help the FDA come up with reasons to reverse their action. Keep those fax machines warm! Meantime pat yourself on the back if you are one of the thousands that worked on curbing the FDA and helping them see reason!
Rod Cook is the President of America's MLM Consultants (http://www.mlmconsultant.com), one of the Premier Network Marketing consulting companies worldwide. Rod is also chairperson of the MLMIA Legislative Council since 1997.
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