Take Action, Protect Dietary Supplements

Take Action to Protect Your Access to Dietary Supplements!

Protect your freedom to dietary supplements

Health Freedom Alert!
Senator Durbin & the FDA Viciously Attack Dietary Supplements Under the cover of the July 4th holiday, Senator Richard Durbin (D-Illinois) and the FDA launched an unprecedented and coordinated assault on the dietary supplement industry - a direct attack on consumers. Without a massive consumer protest of this abhorrent abuse of regulatory power consumers will be denied access to many dietary supplements they currently take. Read more...

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1. Contact the FDA
Write the FDA and tell them you want all nutrients currently on the market grandfathered in so that none of them need to comply retroactively to new NDI guidelines. Tell them it is vital you have access to all of the nutrients currently on the market and that their regulatory actions will drive up prices, cause nutrients to needlessly disappear from the market, and result in health harm to the American public – not improved safety.

Instructions:
1) Copy and personalize this sample letter ►
2) Click here to contact the FDA
3) Fill out the form on that page and paste your message. Then submit!

Sample Letter:
Dear Sir or Madam,
Please personalize your message:

I am writing to express my grave concerns about your Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient (NDI) Notifications and Related Issues. Your Agency sprung this on both industry and consumers without seeking any prior input from us and your draft Guidance is badly flawed as a result. Please withdraw this document at once, consult with industry, and propose a new Guidance that reflects the realities of the marketplace and the safe track record of supplements. The draft Guidance is badly flawed because it:

1. Requires NDIs to meet drug-like safety tests 
2. Requires NDIs to be proven through unnecessary, expensive tests 
3. Elevates NDI submissions to food-additive or GRAS levels 
4. Ignores the proven safety record of supplements, both new and old 
5. Ignores the intent of Congress when passing DSHEA that "the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers" 
6. Through its imposition of unnecessary high costs, arbitrarily discriminates against small- and medium-sized businesses 
7. Will put thousands of people out of work by destroying jobs in a time of economic decline 
8. Turns a basic notification system for new supplements into an arbitrary approval system. 
9. Is overly burdensome and destructive of Congress’ express intent in DSHEA that "the right of access of consumers to safe dietary supplements is necessary in order to promote wellness" 
10. Reveals the true agenda of your Agency to ignore the intent of Congress and suppress consumer access to safe dietary supplements while promoting dangerous drugs.

You are put on notice this draft Guidance must be withdrawn for all of the above reasons, and more. Your proposed document is unauthorized under Law and will guarantee you a backlash of legislative action the likes of which have not been seen in this legislative arena since the passage of DSHEA in 1994.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]

2. Contact Your Senators
Write your Senators, tell them to be aware of S.1310 and to Vote NO on it.

Find elected officials in your area.
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Sample Letter:
Dear [Senator Name],
Please personalize your message:

I am greatly concerned about the FDA's draft guidance on New Dietary Ingredient notifications for dietary supplements. It turns what was meant to be a simple notification system into a scheme where FDA can approve -- or deny -- any supplement created in the past seventeen years, making the FDA the ultimate arbiter of what dietary supplements will and will not be available.

The FDA already refuses to "file" (turns down) most notifications of new supplements. If the new guidance is accepted, new supplements will be a rarity. It is all completely arbitrary.

The agency's interpretation of "new dietary ingredient" is far too broad. Under the new rules, all ingredients in the food supply before 1994 that have been chemically altered in any way are considered NDIs and therefore subject to NDI notification. Moreover, the definition of "chemically altered" includes certain types of fermentation and exposure of ingredients to high temperature baking and cooking, and using a botanical ingredient at a different life stage than previously used -- for example, an extract of unripe apples instead of ripe apples. How absurd!

The guidance states that a synthetic copy of a constituent or extract of an herb or other botanical is not considered a dietary ingredient. This arbitrary distinction will make many dietary ingredients on the market illegal -- particularly as this standard does not apply to non-botanicals.

Most importantly, the guidance makes the NDI notification process burdensome and repetitive. It requires a different notification for the same ingredient for every different version of the supplement it is in -- for example, the same ingredient at a higher concentration needs a separate notification/approval. Or the same ingredient in a different combination of ingredients requires yet another notification/approval.

The Dietary Supplement Health and Education Act of 1994 states that "the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers." It says that Congress finds that "dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare." And it says that "legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness."

The guidance may also have far-reaching consequences. For example, if Sen. Durbin's dangerous Dietary Supplement Labeling Act goes forward, with the list of "safe" supplements and doses which FDA and IOM would draw up under the bill -- such as vitamin D in amounts greater than 4000 IU -- it would mean that more therapeutic doses or supplement preparations could never meet the new NDI hurdle. This could have a profoundly negative impact on this nation's health.

This draft guidance does the exact opposite of what Congress intended. It imposes unreasonable barriers that limit and slow the flow of safe products and accurate information to consumers. I call upon Congress to uphold the landmark legislation it passed seventeen years ago, and to direct the FDA to revise its NDI draft guidelines to reflect DSHEA's (and Congress's) stated values and goals.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]

3. Spread the Word!
Share this page and these related articles with anyone who values their access to dietary supplements.

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Senator Durbin & the FDA Viciously Attack Dietary Supplements Under the cover of the July 4th holiday, Senator Richard Durbin (D-Illinois) and the FDA launched an unprecedented and coordinated assault on the dietary supplement industry - a direct attack on consumers. Without a massive consumer protest of this abhorrent abuse of regulatory power consumers will be denied access to many dietary supplements they currently take. Read more...

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The FDA's Scheme to Reclassify Nutrients as Drugs The current attack on the dietary supplement industry will target some of the most popular and effective dietary supplements, removing them from the free market and placing them under control of large pharmaceutical companies. This move will drastically drive up the price of dietary supplements while severely limiting access to extremely safe and effective nutrients. Read more...

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4. Stay Informed!

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Additional Resources

To read Senate bill S.1310, click here.
To see a list of Senators on the HELP committee, which you could also write about S.1310, click here.

To read the FDA draft guidance on NDI, click here.
To read legal analysis of the FDA draft guidance on new dietary ingredients, click here and here.

To better understand why the FDA is such a corrupt and morally bankrupt organization, read my 2006 book,
Fight for Your Health, Exposing the FDA’s Betrayal of America.