URGENT CALL TO ACTION
I have previously let you know that in recent months, the FDA has launched an aggressive new campaign to put in place a series of onerous regulations for the supplement industry that in effect would drive most legitimate manufacturers out of business and potentially eliminate most supplements from the marketplace. I am writing now because you need to take action on this issue again.
The FDA rules as proposed seem innocent enough, requiring a stringent approval process for all supplements in the marketplace since 1994, when Congress passed the Dietary Supplement Health and Education Act (DSHEA). DSHEA was actually intended to protect nutritional and herbal manufacturers from unwarranted FDA harassment, and allow Americans access to legitimate supplements.
The FDA has a long history going back to the 1970s of outright hostility to the free availability of supplements. For decades the FDA has tried to eliminate their over-the-counter status, hoping that supplements would then come under the control of the pharmaceutical industry as prescription items, a situation which is currently underway in Europe where hundreds of valuable nutritional and herbal products have been removed from the shelves.
The sponsors of DSHEA intended that this law would reduce
the regulatory burden on supplement manufacturers, and provide a streamlined
process of bringing new products to market. Instead of honoring the purpose of
DSHEA, the FDA in its newly proposed regulations seems determined to institute
a complicated, burdensome, and financially prohibitive approval process for
each and every new supplement on the market since 1994, akin to the drug
No supplement company has the resources to finance such a procedure, which can run into the tens of millions of dollars for every new product. Furthermore, from what the experts who have reviewed the proposed regulations have said, the FDA could insist that even previously available supplements, like our own line, would also be subjected to such requirements and be classified as "synthetic food additives" - and our manufacturer frankly would have to close down.
Why is More FDA Supervision of the Supplement Industry
Under normal circumstances, where the government worked for the benefit of its citizens, this might be true, but the proposed regulations are a problem for many reasons. First, the FDA has a long history of antagonism to over the counter sales of supplements and has repeatedly sought to remove many from the marketplace and turn them into prescription items.
Furthermore the FDA already has the power and authority to prohibit the sale of mislabeled, harmful, or dangerous supplements. Through its Good Manufacturing Practices regulations already in place, supplement manufacturers must meet stringent requirements for safety and potency. The FDA also has the authority to punish manufacturers who make inappropriate unsubstantiated claims. Therefore, the FDA already has all the power it needs to effectively regulate nutritional supplements.
In all the years I have been fighting for freedom of choice in health care, the currently proposed regulations are the most troubling, most far-reaching, and with potentially the most catastrophic effects, not only for our own customers, but for those tens of millions of Americans who rightfully and intelligently use nutritional products for their health-supporting benefits.
The Life Extension Foundation is spearheading the opposition to the FDA, along with the Alliance for Natural Health (ANH) and Natural News, all with active websites with links to each below. Natural News links to sites with suggested letters that can be e-mailed to your elected officials, by following the listed steps. The Alliance has called for a massive protest on September 8, urging all those who want their supplements to remain available to contact their elected representatives in the Senate and House of Representatives, as well as the FDA itself. In the past, public outcry has stopped similar efforts by the FDA in its tracks and we need yet another mass protest against these regulations. If you go to the ANH website through the link provided, you will find information about how to participate in this important event.
Included below are links to Natural News, Life Extension, and the Alliance for Natural Health. Also enclosed is a link to a site that provides a proposed letter that makes contacting your Senators and Representatives easy. I would suggest you get your family members, relatives, and friends to e-mail and call, today and again on September 8. We need to keep the pressure up until the FDA appropriately backs down.
If you want Logos Nutritionals products and your other supplements to remain available, you must get involved and become active. Even if you have contacted your elected officials previously, do so again. It does make a difference.
John M. Burgstiner