FDA backs down on supplement ban

June 25, 2012
Volume 3    |   Issue 48

You did it! Last year, the FDA tried to stomp out supplements with new guidelines that would significantly alter the type of supplements you can buy. So I asked you to call your Senators and Representatives to pressure the FDA to change the guidelines. Well, you responded and so did the FDA.

After tremendous pressure from people like you, Sen. Orrin Hatch (R-UT) and Tom Harkin (D-IA), and the supplement industry, the FDA finally gave in. Making a major concession thanks to the outcry, the FDA agreed to revise its New Dietary Ingredients (NDI) draft guidance.

If you remember, in the original draft guidance the FDA would have to put its stamp of approval on almost every supplement on the market. Supplement companies would have had to spend millions of dollars to submit applications to the FDA for approval. And there was no guarantee the FDA would ever approve any of the applications.

But last Tuesday, the top three FDA officials (Commissioner Margaret Hamburg, Assistant Commissioner for Legislation Jeanne Ireland, and Deputy Commissioner for Foods Michael Taylor) met with Harkin and Hatch and finally agreed to reissue their guidance.

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Harkin and Hatch were the authors of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law required the FDA to draft regulatory guidance in accordance with the law. But the FDA went way outside its bounds. Harkin and Hatch both pushed the FDA to bring the guidance more in-line with the intent of the law. At this point, they have agreed to do so.

While this is a great start, it’s still too early to celebrate. Sources say the FDA agreed to modify, clarify, and compromise on all of the issues raised by Harkin, Hatch, and industry professionals. But that doesn’t mean they will behave.

If anything, we know the FDA loves to overstep its bounds, and doesn’t hesitate to do so. We must remain vigilant and keep the pressure on the FDA to draft guidelines that are reasonable. I will keep you up-to-date on any news coming from the FDA or the supplement industry regarding the revisions.

Again, congratulations on this fantastic victory. It could protect your access to supplements and your health for years to come. Please take a moment to contact Sen. Harkin (202-224-3254 or http://www.harkin.senate.gov/contact.cfm) and Sen. Hatch (202-224-5251 or http://www.hatch.senate.gov/public/index.cfm/contact?p=Email-Orrin) to express your gratitude for their hard work in this matter.

Your insider for better health,

Steve Kroening

Steve Kroening is the editor of Nutrient Insider, a twice-a-week email newsletter that brings you the latest healing breakthroughs from the world of nutrition and dietary supplements. For over 20 years, Steve has worked hand-in-hand with some of the nation's top doctors, including Drs. Robert Rowen, Frank Shallenberger, Nan Fuchs, William Campbell Douglass, and best-selling author James Balch. Steve is the author of the book Practical Guide to Home Remedies. As a health journalist, Steve's articles have appeared in countless magazines, blogs, and websites.

Source:

http://newhope360.com/regulation-and-legislation/fda-agrees-issue-revised-ndi-draft-guidance?cid=nl_nbj_weekly.

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