Wednesday, August 29, 2007

Educating Congressional Staffers

While the rest of us are enjoying the hazy days of late summer, my intrepid co-trustees at Natural Solutions Foundation, Gen. Bert Stubblebine and Dr. Rima Laibow are in Washington DC, educating congressional staffers who are already back in town about pressing health freedom and FDA reform issues -- as Congress gets ready to reconvene.

Here is the message they are delivering this week:

Natural Solutions Foundation Media
Protecting Health Freedom for Consumer and Entrepreneur

1. While manufacturers and retailers seek to meet consumer demand for high potency, high quality Dietary Supplements and advanced Natural Therapies, abusive FDA regulatory initiatives restrict continued access to them. FDA enforcement includes unwarranted raids against “mom-and-pop” shops, including a current invasion diabetes therapy providers. FDA enthusiastically endorses this “aggressive enforcement policy” (

2. Access to wholesome nutrition is threatened by regulatory initiatives:

* FDA CAM (“Complimentary and Alternative Medicine) Guidance) – final – would criminalize natural health services not provided by licensed physicians, create new regulatory category of “Complementary and Alternative Products” which would be regulated as unlicensed drugs and devices if used with an intent to bring about a beneficial health result. Ex: FDA threatened to turn cherries into an untested (forbidden) drug when Michigan Cherry Growers Ass’n mounted 6 independent scientific papers on benefits of cherry juice for arthritis on its website.

* FDA Health Claims Guidance – draft – would prevent disclosure of food-related health benefits to consumers by requiring impossible significant scientific agreement instead of more reasonable common law standard – “more than a scintilla of evidence”. This policy is consistent with Codex prohibition on “advertising” which reveal health benefits that would change consumer’s food beliefs, behaviors or purchases.

* FDA Dietary Supplement GMPs (Good Manufacturing Practices) – final – would, by FDA’s own admission, close down significant numbers of small businesses.

FDA Economic Impact: “significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... very small [less than 20 employees] and … small dietary supplement manufacturers [less than500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry…”

Supplements, because they are treated as food, are generally regarded as safe under the Dietary Supplements Health and Education Act (DSHEA, 1994).

* AER (Adverse Event Reporting) Regulations for dietary supplements, despite little to no history of dangers associated with supplements, are about to be issued. These could easily lead to questionable reporting and misuse of data, further threatening dietary supplements with additional draconian and unnecessary regulation

3. “Harmonization” with Codex Alimentarius is the basis for the regulatory initiatives. FDA has announced preference for International Standards (i.e., Codex) in preference to U.S. regulation and law. (Fed. Reg., October 11, 1995). Consistent with the definition of advertising adopted by the Codex Committee on Food Labeling (2007) with FDA leadership, these regulations will create a stranglehold on truth and choice. FDA head of Office of Dietary Supplements, who also acts as the US Codex Delegate, is pushing to eliminate health claims and information re: health benefits for foods both domestically and through Codex.

4. The FDA Revitalization Act, pending congressional conference committee, is a bad law which rewards FDA abuse of power with more power to abuse and more money to do it with. Sect 608 of the Senate version would protect DSHEA (the 1994 Dietary Supplement Health Education Act) products from additional regulation and should remain in the law.

5. Conflicts of interest in favor of drugs and against foods (a major economic competitor to drugs) currently leads FDA to preside over the active degradation of the food supply, including the subclass of food known as "Dietary Supplements”, at the same time the FDA fails to protect the public from dangerous drugs. Properly used drugs are a leading cause of death in the developing world. Supplements do not pose a significant morbidity/mortality threat.


1. Reverse the decision Congress made in 1938 to put drug and food regulation under the auspices of the same organization. Experience since that time has shown this to be a serious administrative and regulatory error. To protect the integrity of the food supply and the health of Americans, it is essential to separate food regulatory authority from the same regulatory agency which regulates drugs.

2. Support HR 2117, The Health Freedom Protection Act, which protects Health Claims for Dietary Supplements from FDA restrictions unless the claim cannot be made truthful by revision.

The Natural Solutions Foundation is a 501 ( c )3 nonprofit with 230,000 members, founded in 2004, with the goal of protecting the majority of humans in their preference for healthy, natural therapies, goods and services, from threatening overregulation by national and international Government Entities. Its Medical Directed is Rima Laibow, MD. For more information or to sign up for our e Newsletter, please check out our website,

The reports I am receiving indicate that Congress may be ready to listen to the call for real reform of the FDA and for the adoption of Dr. Ron Paul's health freedom bill.

My thanks, as always, to Charlie Frohman, our equally intrepid DC consultant, for sheparding Rima and Bert through the House and Senate office buildings maze! As always, the messanger and the message...

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