Thursday, July 7, 2011

DSHEA & Nutrients Under Increasing FDA Attack!


Updated Foundation Counsel's Blog Report:

Last week Natural Solutions Foundation's Health and Food Freedom Action eAlert reported on the Nutraingredients USA article that warned us about a new threat to Health and Food Freedom in Congress: the Durbin Dietary Supplement Labeling Bill -

According to the article: "The bill would... require manufacturers to register dietary supplement products [with] the FDA, require labels to disclose the known risks of ingredients and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events. The bill also calls for labels to display the batch number, something already adopted as standard"

The article quotes leading dietary supplement lawyer Jonathan Emord, calling the bill a “classic example of regulatory overkill.... The FDA has full regulatory power to prevent the sale of adulterated and misbranded foods and dietary supplements... By introducing new powers when old ones are more than sufficient, [Durbin] invites abuses, including more burden and cost on an industry that is already overwhelmed by the burden and cost of the GMPs and, now, the [sic] Food Safety Modernization Act...”

POWER IS THE GOAL: "Sen Durbin said that his goal “is to take the decision about how a product will be regulated out of the hands of the manufacturer and put it in the hands of the FDA where it belongs."

For More About Our Analysis of the Attacks on Nutrients please see Foundation President, Gen. Bert Stubblebine's First Risk Assessment, updated: Threats to Health and Food Freedom -

Subsequent to this disturbing report, we learned of a new FDA dietary supplement regulation under the new Food Control Law, the infamous S.510 of the 111th Congress.

As Natural News reports: "...nearly all vitamin and supplement ingredients could soon be banned under the FDA's new NDI [New Dietary Ingredient] rules because very few supplement ingredients can be conclusively shown to have been widely used BEFORE [the "grandfathering" date of] 1994... Through this clever trick with NDI rules, the FDA can now position itself as the gatekeeper for all supplement approvals. Far from merely being a requirement to "notify" the FDA of the use of new ingredients, NDI rules essentially subject supplements to approval from the FDA.

Learn more:

Similarly, the Natural Products Association has this to say:
We believe the draft guidance does not match Congress’s clear intent that products made from ingredients on the market prior to DSHEA should remain on the market. The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce. That was not the intent of DSHEA. These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.
Our Action Item has been updated to help educate decision makers about the new NDI rule as well as Sen. Durbin's bill: please contact your congress-critters daily about this the other health and food freedom issues that matter!

Updated Action item:

Here is Dr. Ron Paul about Push Back:

And while you are at it... Please support Dr. Ron Paul's Raw Milk Interstate Commerce Freedom Bill, HR.1830: - hear him about that here:

* The draft of the "Educate Decision Makers" email reads as follows (you can modify it):
To the White House, Speaker Boehner, Chairman Kingston & Congress:


DO NOT SUPPORT Sen Durbin's "Dietary Supplement Labeling Act" which would require pre-market registration of these nutrient food products.

I am a concerned organic gardener, family farmer, rancher and/or consumer... I am concerned about food safety and I am concerned about protecting my access to local and natural food production and distribution; that is, Food Freedom.

I am very concerned that the FDA will implement the 2010 Food Safety Modernization Act in ways that will harm these important interests. This is not a "food safety" law; it is a Federal power-grab food control law!

The new Congress ought to re-consider its controversial provisions, such as section 104 that may allow secret regulations, in violation of the pledge of transparency.

Further concerns include the convoluted procedure for local food production exemptions and the "road map" the new law provides for rapid "HARMonization" of our food freedoms with international Codex Alimentarius restrictions.

I urge the White House to be very closely involved in the writing of the regulations under the new law, to ensure the protection of these interests and to make sure all interest groups are heard and considered by the regulators.

To my Congressperson and to Chairman Kingston & Speaker Boehner - please help the White House avoid the worst aspects of the food control bill.

DO NOT FUND ITS PROVISIONS. We are especially concerned with the provision for thousands of new FDA food control inspections. No provision of this bill should be funded by the new Congress. DE-FUND FOOD CONTROL!

I also oppose what Health Freedom USA has called Sen. Leahy's "Criminalization of Food and Speech" bill, which claims to "increase criminal penalties for certain knowing and intentional violations relating to food..." but applies only to SPEECH -- this bill has reared its ugly head again, as S.216.

Do not increase FDA authority; oppose the Durbin Dietary Supplement Labeling Act.

I agree with Rep Jack Kingston:

"I think we will [not fund the food control law]. We have a lot of concerns about the necessity of putting 18,000 food police on the streets and the kitchens of America. The trend in food safety has been very, very favorable. I'm not sure that this kind of investment is going to give any returns that justify it."

Food Freedom is an important issue to me and I will pay attention to what the White House and FDA do with any new power granted by Congress. But what would be best would be for Congress to REDUCE the Power of the FDA!
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