Deans' stroke musings: United States Files Consent Decree of Permanent Injunction Against California Dietary Supplement Manufacturer to Stop Distribution of Adulterated and Misbranded Dietary Supplements

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Friday, January 20, 2017

United States Files Consent Decree of Permanent Injunction Against California Dietary Supplement Manufacturer to Stop Distribution of Adulterated and Misbranded Dietary Supplements

Be careful out there, you have no clue what is in those supplements you take. And if our fuckingly stupid federal legislators hadn't passed the Dietary Supplement Health and Education Act of 1994 (DSHEA): (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise. Caveat Emptor. This recalls the patent medicines in the 18th and 19th centuries. It took the Pure Food and Drug Act of 1906 to reign these in.
https://www.justice.gov/opa/pr/united-states-files-consent-decree-permanent-injunction-against-california-dietary-supplement

Company Failed to Follow Good Manufacturing Practices and Distributed Dietary Supplements Containing the Unsafe Food Additive “DMAA”

The Department of Justice filed a complaint in the U.S. District Court for the Central District of California seeking a permanent injunction against VivaCeuticals Inc., doing business as Regeneca Worldwide, and its CEO Matthew A. Nicosia, to prevent violations of the Federal Food, Drug and Cosmetic Act (FDCA). Defendants have agreed to cease all operations as part of a settlement with the Department.

According to the complaint, which was filed by the Department of Justice’s Consumer Protection Branch, the defendants violated the FDCA by failing to manufacture dietary supplements in accordance with the FDA’s current good manufacturing practice (CGMP) regulations. The complaint also alleges that the defendants violated the FDCA by manufacturing and distributing a product called RegeneSlim Appetite Control (RegeneSlim), which contained the unsafe food additive 1, 3 dimethylamylamine (DMAA), and failing to disclose the presence of DMAA in RegeneSlim’s labeling. The complaint further alleges that the defendants violated the FDCA by marketing RegeneSlim to be used in the cure, mitigation, treatment or prevention of disease, thereby causing RegeneSlim to be an unapproved new drug and a misbranded drug.

The government’s enforcement action resulted from a series of U.S. Food and Drug Administration (FDA) inspections of the defendants’ manufacturing facility that found recurring FDCA violations of the same nature as those alleged in the complaint, and which the defendants failed to correct despite FDA warnings.

“When dietary supplement manufacturers place unsafe and undisclosed ingredients in their products and disregard CGMP regulations, they put the public health at risk,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA to prevent dietary supplement manufacturers from jeopardizing public health.”

In conjunction with the filing of the complaint, the defendants agreed to settle the litigation through a consent decree that would permanently prohibit them from committing violations of the FDCA. The consent decree requires the defendants to cease all operations, and requires that if the defendants wish to resume manufacturing dietary supplements or drugs in the future, the FDA first must determine that the defendants’ manufacturing practices have come into compliance with the law. The proposed decree is currently awaiting judicial approval.

This matter was handled by Trial Attorneys Clint Narver and Monica Groat of the Civil Division’s Consumer Protection Branch, with assistance from Claudia Zuckerman of the FDA’s Office of the Chief Counsel.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at http://www.justice.gov/civil/consumer-protection-branch.