February 24, 2010
A bill recently introduced to the U.S. Senate, the Dietary Supplement Safety Act of 2010 (S. 3002), by Senators John McCain and Byron Dorgan is possibly the most direct assault on natural health freedom we have seen for some time. If passed into law, this bill would require all dietary supplement manufacturers, distributors, and holders all the way down to the retail store level to be comprehensively registered. It would also allow for the arbitrary banning of nutritional supplements by the FDA and the introduction of deceitful reporting of adverse events related to them.
The cover for this legislation is that it is designed to prevent both intentional and unintentional steroid adulteration of dietary supplements. The trigger, according to McCain, was six NFL players who were accused of doping with supplements tainted with steroids. Even with this being the case, however, the FDA already has the authority to regulate synthetic anabolic steroids via the Anabolic Control Act of 2004 which permits them to do just that. Nevertheless, under the guise of the behavior of six NFL players, an entire market that has been proven not only very safe but very healthy will be essentially regulated out of business. (NHF)
The Dietary Supplement Safety Act of 2010 would require registration of any “business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing a dietary supplement for consumption in the United States,” definitions which could possibly include even retail stores that sell herbal and nutritional products. (DSSA p.2) Currently, under the Dietary Supplements and Non-Prescription Consumer Protection Act, small retailers are not required to register. This, however, will change with the passage of McCain-Dorgan’s bill. (NHF)
The switch from the current practices of Serious Adverse Event Reporting to that of simply Adverse Event Reporting is of concern as well. Existing law requires the reporting of serious adverse events related to the supplement in question to be reported for regulatory and recall purposes. The McCain-Dorgan bill, however, removes the language “Serious Adverse Event” and replaces it with the term “adverse event,” opening up the floodgates for the most ridiculous possible claims of adverse events such as bad taste or even dislike of packaging. This “report everything possible” stance is will vastly increase the numbers of complaints that will hence be used to add credence to the arguments for banning supplements in the future. Not only that, but more government bureaucracies will have to be created in order to organize and sort through all of the incoming “adverse event reports.” (NHF)
Yet the most frightening aspect of this bill is the immediate effects it would have on natural supplements. Currently, due to the Dietary Supplements Health and Education Act of 1994 (DSHEA), all supplements on the market prior to October 15, 1994 can lawfully be sold in the United States. However, the legislation being proposed completely reverses this and defines a “new dietary supplement” as one that “is not included on the list of ‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary” (DSSA p.5-6). This seemingly slight change in language actually removes the grandfathering in of supplements on the market prior to 1994. These new dietary supplements will also be considered “adulterated” unless “there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement….” (DSSA p.5) The registrants are then required to create and maintain a “scientifically reasonable substantiation file” which is to be made available for the Secretary of Health and Human Services to inspect at his/her whim. These products are to be registered at least 75 days prior to market. (NSF)
- A d v e r t i s e m e n t
As quoted above, the bill also mandates that an “Accepted Dietary Ingredients” list should be created by the Secretary of HHS which will replace the current guidelines. Such a list effectively gives the FDA carte blanche to do whatever it wishes in regards to natural supplements. The FDA is given absolute authority to determine what supplements are allowed on the “Accepted Dietary Ingredients” list, thereby granting it the authority to ban any supplement without due process, scientific merit, or even a hearing simply by refusing to place it on the ADI list. (NSF) The FDA will also be able to remove supplements from market even after it has allowed it to be included on its’ list. As the bill states,
“If the Secretary finds there is a reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse, health consequences or death, or is adulterated or misbranded, the Secretary shall issue a cease distribution and notification order requiring the person named in the order to immediately – cease distribution of such dietary supplement or a product marketed or sold as a dietary supplement; notify distributors, importers, retailers, and consumers of the order; and instruct those distributors, importers, retailers, and consumers to cease distributing, importing, selling, and using the dietary supplement.”(DSSA p.9)
The cost of the recall, of course, will be absorbed by the retailer. (DSSA p.11)
While the Dietary Supplement Safety Act of 2010 is an egregious attack on Americans’ freedom of choice, it is also a symptom of an even larger problem. The McCain-Dorgan bill is not just another silly attempt by corrupt politicians to demonstrate that they still have some value to their constituents, but an attempt to implement Codex Alimentarius at the national level and move the United States away from our Common Law heritage. The European Union has already passed similar legislation in the European Union Food Supplements Directive which has decimated open access to natural dietary supplements. Canada has passed laws to the same effect in recent weeks as well.
“Dietary Supplement Safety Act of 2010.” February 2, 2010. http://mccain.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=2fe2fa5d-636b-4705-97df-8318a24f718f
“Bullet Points on McCain’s Anti-Supplement Bill S.3002.” National Health Federation. http://www.thenhf.com/press_releases/pr_19_feb_2010.html
“McCain Anti-DSHEA Bill a Clear and Present Threat to Health Freedom.” http://www.healthfreedomusa.org/?p=4608