February 5, 2010

New Health Alert: The Dietary Supplement Safety Act of 2010, S. 3002 is Restricting Your Rights to Health

The agents of Big Pharma are at it again. Under the guise of “supplement safety,” Senator John McCain (R-AZ) has introduced a bill that, if passed, would effectively undermine the very foundation of vitamin freedom DSHEA established in 1994.

The most outspoken leader in the field of vitamin research and activism, Dr. Matthias Rath, has been warning of such an attack for many years. Unfortunately, the voices of appeasement have been more popular in the natural health industry. Since the passage of DSHEA, the Pharmaceutical lobby has been repeatedly attempting to erode consumers’ rights and access to vital nutrients in order to further their deadly business with disease.

This latest bill is a key component to their diabolical strategy, and must be confronted and stopped.

What is S. 3002?

The Dietary Supplement and Safety Act of 2010, S. 3002, is a bill that was introduced in the Senate on February 4, 2010 by Senator John McCain (R-AZ). It is co-sponsored by Senator Byron Dorgan (D-ND). Currently, the bill has been referred to the Committee on Health, Education, Labor, and Pensions – chaired by Senator Tom Harkin (D-IA). To view the text of the bill, click here.

In short, this bill serves to amend the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services, Kathleen Sebelius, to “prepare, publish, and maintain” a list of “Accepted Dietary Ingredients.” Anything not on this list will be deemed “adulterated,” and therefore inaccessible to consumers.

S. 3002 goes on to then mandate a bloated bureaucracy of reporting requirements and substantiation files for anyone who “manufacturers, packages, holds, distributes, labels, or licenses a dietary supplement.” In practice, this will only serve to harass and increase the cost of operations for these companies, thus increasing the cost of the basic supplements you take every day to maintain your health.

Also added to this new reporting standard is a basic rewrite of the Adverse Event Reporting Bill, changing the reporting requirements from “serious adverse” events to “adverse” events and “non-serious adverse” events. So, any event, serious or not, proven or not, that is reported to a company will by law have to be reported to the Secretary of Health and Human Services, and can form the foundation for banning and / or recalling any dietary supplement. This isn’t even required for the most deadly pharmaceutical drugs, but Senator John McCain (R-AZ) wants to make it mandatory for an industry whose safety record is close to immaculate due to excellent standards of self-regulation high standards of quality and the use of natural non-toxic vitamins, minerals and other food components.

Lastly, The Dietary Supplement and Safety Act of 2010, S. 3002, gives the Secretary of Health and Human Services the power to cease distribution and initiate a recall of any dietary supplement if there is a “reasonable probability” that the supplement may cause adverse effects, is adulterated, or misbranded. Given the broad and vague requirements for these determinations, the Secretary essentially has the power to cease distribution and initiate a recall for any product at any time.

Why does it matter?

First of all, the reporting requirements put forth in this bill are unprecedented, and cause concern because they will place a tremendous burden on all manufacturers and distributors of dietary supplements. Larger companies may be able to set the policies and procedures to deal with the new bureaucracy, but this will likely mean passing the cost of these procedures on to the customer. Smaller companies, however, will most likely collapse under the weight of this burden. For an industry with a tremendously clean safety record, this is unnecessary and only means that consumers will have a diminishing access to unique products they enjoy. The ultimate goal is to curtail the growth of nutritional supplement industry and eliminate any competition to toxic pharmaceutical products.

Further, the manner by which this list of “Accepted Dietary Ingredients” is to be created is especially disturbing, as it is a direct attack on a key part of DSHEA. DSHEA established that any ingredient marketed in the United States before October 15, 1994 is unadulterated, and therefore can be considered to fall under the category “Generally Recognized as Safe (GRAS).” The Dietary Supplement and Safety Act of 2010, S. 3002, however, changes this integral part of DSHEA to allow the Secretary of Health and Human Services to determine what is allowed on the list based on such ambiguous terms as “scientifically reasonable substantiation” and “reasonably expected to be safe.” Essentially, this changes the basic position of dietary supplements from “food” to “drugs” opening the gate for further regulations and limiting access to these life-saving safe components.

These attacks on nutritional supplements are not new to Europe and were expected to be enacted in the US. European Union regulations introduced in the recent years have dramatically restricted people’s access to dietary supplements. The “Accepted Dietary Ingredients” list eliminating many vital nutrients already exists there. For instance, this year, all chelated forms of minerals have been restricted in the dietary supplement products. The results are seen already: the assortment of supplement products is very limited and the potency so restricted, they pale in comparison to what we have available here in the United States. This is something that Dr. Rath, as an international leader in the natural health science, has been fighting for decades and repeatedly warning the American public of the global implications of the influence of the pharma multinationals on health. Now it is up to us here in the U.S. to fight for our right to health.

What you can do!

Join the fight for your free access to healthy dietary supplements! Click on the red button to the right to find your congressional representatives and then take a few minutes to voice your concerns about this bill. It is only by voicing our concerns publicly that we can hope to defeat this bill, and ensure our access to the supplements we rely upon to help keep us in good health.