The FDA has just intensified its war on America’s and your personal health and wellness by abruptly deciding to strictly enforce a little-known section of the 1994 DSHEA, which has thusfar protected supplement manufacturers from harsh, discriminatory and unreasonable regulations. The NDI (New Dietary Rules) clause in the DSHEA mandates that dietary supplement manufacturers notify the FDA whenever a new ingredient is added to their formulations. Since 1994 this bureaucratic formality has been only loosely enforced. Now the FDA will begin enforcing NDI, in order to intentionally deny all ingredients introduced since 1994 and to amplify their blatant, unethical alliance with the pharmaceutical international monopoly. This NDI enforcement is now mandated under Senate Bill 510, which passed in 2010. Supplement companies will now need to seek FDA approval for all their formulations, which will put many of them out of business and make supplements significantly unavailable to the public.
Hypocritically, synthetic pharmaceutical drugs need no notification approval. Clearly the FDA has become a functional subsidiary of the international pharmaceutical establishment. It has the pharmaceutical companies’ best commercial interests at heart, as they continue to attempt to increase an allopathic monopoly on medicine by trying to eliminate the growing and increasingly popular and effective natural health industry. It is an old approach - if one cannot beat the competition, then try to destroy it. The “danger” contrast between the natural supplement world and allopathic drugs is dramatic. Approximately 150,000 people die per year from properly prescribed drugs while very rarely does anyone die from misused natural supplements.
This is a major showdown and attack on our access to supplements. You need your support! This denial of access to supplements will all take place through a bureaucratic nightmare of red tape, which will cripple or destroy the supplement companies. This is a very personal attack on our individual, God-given right and liberty to pursue health and happiness. As it is a personal attack, we need to respond personally and directly in a collective way
I also recommend that you speak to your senators and congress people and forward this message to as many people as possible as this is an overt attack on your right to health, happiness, and wellbeing In blessing to your health,
Rabbi Gabriel Cousens MD, MD(H)
The following is a sample letter for you to send to your senators and congress(wo)men:
The Honorable _________________________ Washington, DC
In direct violation of the law, the FDA is threatening to ban my access to new dietary
The FDA defines dietary supplements as being "new" if they were introduced after October 15, 1994. That means that nutrients that I have been safely using over the course of three decades will be subject to FDA's oppressive policies that mandate costly animal testing, which translates into forced withdrawal from the market, and higher prices for me if the supplement is ever allowed to be sold again.
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."
This new 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 New Dietary Ingredient draft guidelines to reflect DSHEA's (and Congress's) stated values and goals.
- Vote against the newly introduced Dietary Supplement Labeling Act as this would give the FDA even greater arbitrary powers to remove safe dietary supplements from the market, and will profoundly impact this nations' health in a negative way.
All of these proposals result in wasteful federal spending, while at the same time impose a massive new "regulatory tax" on consumers and the vitamin industry. Kindly let me know what actions you are taking in response to the urgent issues raised in this letter.