FDA to declassify electroshock therapy to same risk category as condoms

The Food and Drug Administration is set to allow for the dramatic expansion of electroshock therapy for patients who have been diagnosed with clinical depression, through reclassification of the devices used to deliver shock treatment, despite the fact that experts and former patients have attested to the damage such treatment causes.

As noted by mental health watchdog organization Citizens Commission on Human Rights International (CCHRI), the FDA began the reclassification process for Electroconvulsive Therapy Devices (ECT) in early January. The change would lower the devices from their current highest-risk Category III classification, “to allow electric shock machines to be utilized in the treatment of specific alleged mental illnesses with less regulatory controls,” the organization noted in an alert.

The change, detailed here at Regulations.gov, is being sought, “despite the federal agency’s admission that the ECT device has not been proven safe and effective,” CCHRI noted further, adding that to date, some 5 million Americans have been given ECT treatments without their manufacturers having been required to submit valid scientific evidence (like clinical trials), that they were safe and effective. …

http://www.naturalnews.com/053298_electroshock_therapy_FDA_risk_classification.html

Massive FDA crackdown coming on natural product companies

Following the confirmation of new FDA head Robert Califf, I have been told by people in the legal field with close ties to FDA staffers that the FDA is planning to ramp up a wave of inspections and crackdowns targeting natural product companies.

This sweeping crackdown assault, I’ve been told, will be invoked under the Food Safety and Modernization Act (FSMA), which was aggressively pushed into law following a series of highly suspicious outbreaks of E.coli and salmonella in food products in 2010. These outbreaks were widely publicized by the mainstream media which obeyed its propaganda marching orders from the government to whip up a frenzy of irrational fear over all fresh food. From that fear, the political establishment passed the FSMA and Obama signed it into law on January 4, 2011.

FSMA to bankrupt small businesses by requiring pharma-level manufacturing practices

The FSMA essentially requires all nutritional supplement, herbal formula and superfood companies to adhere to many of the same quality control procedures as multi billion-dollar pharmaceutical companies. The FDA’s GMP (Good Manufacturing Practices) guidelines describe these measures and have been the law of the land since the signing of the FSMA. Yet most small supplement and superfood companies are nowhere near GMP-compliant due to the extraordinary costs of compliance. (Our own operation is GMP compliant, which is why I am intimately familiar with the extreme costs of compliance and the mountain of paperwork that must be produced to achieve this compliance.)

It is this non-compliance with GMP and FSMA that the FDA is now planning to use as a regulatory weapon in nationwide, sweeping shut down of natural product companies, I’ve been told. …

http://www.naturalnews.com/053287_FDA_crackdown_natural_product_companies_Robert_Califf.html