Posts Tagged ‘Government’

Protect Your Right to Take Supplements

Tuesday, September 6th, 2011

The Food and Drug Administration (FDA) has proposed restrictions on the use of nutritional supplements that may go into effect on October 1, 2011, unless sufficient opposition is offered. The plan is to classify supplements introduced after October, 1994, as “new dietary ingredients”, subject to expensive and prolonged testing and verification.
These restrictions would apply to resveratrol, GABA, ubiquinol, curcumin, and other products introduced in recent years, and make them no longer available to consumers, except at great expense.

Only wealthy pharmaceutical companies have the assets to undertake such testing and approval processes, which would cost in the tens of millions of dollars per item. The result would be to eliminate supplement manufacturers from competition, and raise the cost of these items astronomically. A supplement now available for $50 dollars would cost $250-$500. Some items would be financially out of reach for most people.

We have already seen this strategy in action. Patients have entered the office with bottles of omega 3 fatty acids and folic acid/B12 combinations, prescribed by physicians and obtained as pharmaceutical products, costing 5-10 times more than similar items made by reputable producers of supplements. (more…)

FDA May Prosecute More Pharmaceutical Execs

Thursday, March 11th, 2010

The FDA plans to increase misdemeanor prosecutions of industry execs as it looks to refocus its Office of Criminal Investigations (see this letter to the Senate Finance committee). The move comes in response to a new report from the General Accountability Office that the OCI suffers from lax oversight, despite increased in funding and staffing over the past decade. In fact, the FDA hasn’t reviewed most OCI offices in more than three years. The OCI investigates counterfeit drugs and other bad stuff, as well as misconduct by FDA employees.
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Senator McCain Files New Bill That Attacks Your Access to Supplements

Wednesday, March 10th, 2010

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 stopdeveloped as a drug and sold for multiples of its price as a supplement.

To read more about this bill and to take action against it, CLICK HERE.