Big Pharma Tries to Crush the Natural Food Supplements Market Through John McCain
by Dr. Robin Falkov
TAKE ACTION AND TELL YOUR SENATOR NOT TO CO-SPONSOR THIS BILL
Senator McCain’s bill is called The Dietary Supplement Safety Act (DSSA). It would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.
These protections are far from perfect. They discourage companies from developing new forms of supplements. New supplements may be arbitrarily banned by the FDA or adopted by drug companies in a way that precludes their further sale as supplements.
McCain’s bill would wipe out even the minimal protections contained in DSHEA. It would give the FDA full discretion and power to compile a discreet list of supplements allowed to remain on the market while banning all others.
Everyone knows that the FDA is friendly to drug companies (which pay its bills and provide good revolving door jobs) and hostile to supplement companies. Under this bill, this same Agency could quite arbitrarily ban any supplement it wished or turn it over to drug companies to be developed as a drug and sold for multiples of its price as a supplement.
The FDA will like this because it believes that it can more easily control a few industry giants. But isn’t it more likely that the industry giants will eventually gain control over the FDA?
The FDA is already misusing the adverse event reporting process that exists. Drugs rack up thousands of adverse event reports without any action. Just recently, the FDA yanked from the market a supplement product based on just a couple of alleged adverse event reports without even allowing the company (an old and respected firm) to provide any counter-evidence or counter-argument.
The bill also allows the FDA to yank a product (at the company’s expense) if there is a “reasonable probability” that it is “adulterated” or “misbranded”. Let’s remember that “adulterated” could mean there is a minor record keeping error on the producer’s part and “misbranded” can mean that the producer simply tells the truth about the product. An “adulterated” and “misbranded” supplement in Orwellian FDA speak may actually be both completely safe and effective.
We must prevent this bill from gaining traction! Protect your access to supplements by contacting your senators today and asking them NOT to co-sponsor the Dietary Supplement Safety Act but rather to oppose it. – More here.
by Brandon Turbeville
McCain’s Dietary Supplement Bill[…]
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 legislation effectively gives the FDA carte blanche to do whatever it wishes in regards to natural supplements.
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)
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. – More here .