What You Should Know About Supplements (part 2)

Posted by on March 28th, 2013 | No Comments

Are Cheerios medicine?

As stated in the Part 1 of this series, senator Durbin is leaning toward labeling all supplements as drugs. Need vitamin C? Calcium? You may have to get a prescription from your doctor if his bills pass. Stay informed.

Letter from the Food and Drug Administration.
Did you know the FDA went after General Mills for saying their Cheerios were heart healthy? See the full letter here: http://www.fda.gov/iceci/enforcementactions/warningletters/ucm162943.htm

As ridiculous as this seems (no one would overdose after eating even an entire box of Cheerios), the FDA wants you to know that making claims about cholesterol reduction would classify Cheerios as medicine even though clinical studies have shown it’s possible to reduce cholesterol after eating Cheerios due to the water soluble fiber contained in them.

The same nonsense occurred with POM Wonderful 100% Pomegranate Juice.

Supplements that make any medical claims would also be considered medicines. This is why you see this statement so frequently: “XXXX is not intended to treat or cure any disease. The claims made for XXXX have not be evaluated by the Food and Drug Administration.”

As stated in the Part 1 of this series, senator Durbin is leaning toward labeling all supplements as drugs. Need vitamin C? Calcium? You may have to get a prescription from your doctor if his bills pass. Stay informed.
General Mills, Inc. 5/5/09
www.fda.gov
Promotional Claims False & Misleading/Misbranded

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What You Should Know About Supplements (part 1)

Posted by on March 25th, 2013 | No Comments

There are those who want to take them away

In a backhanded approach to ‘protect’ consumers from supplements, for years Senator Dick Durban has attempted to get their availability restricted. His bills have failed a few times due to incredible scrutiny of organizations such as the Alliance for Natural Health (http://www.anh-usa.org/). Get their free newsletter to stay informed!

Durbin’s tactics lean toward labeling supplements as drugs which would make them available by prescription only and put many of the supplement manufacturers out of business because of the harsh restrictions placed on manufacturing, clinical trials, regulation by the Food and Drug Administration, etc.

Part two later…
The Alliance for Natural Health USA
www.anh-usa.org
Alliance for Natural Health USA is dedicated to protecting access to integrative medicine and promoting the benefits of natural health.

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Suicide & ADHD Meds

Posted by on February 22nd, 2012 | No Comments

What’s the connection?

On Monday, January 30, 2012, pediatric health advisers acting as an advisory committee to the Food and Drug Administration requested that a special warning be placed on the label of a common stimulant medication used to treat attention deficit disorder.

The drug is Focalin and produced by Swiss drug maker Novartis. The FDA has approved Focalin for children aged 6 or older. However, Focalin is often prescribed off-label meaning even younger children may be prescribed the medication.

The advisory committee is responding to reports the FDA received over the past six years in which eight reports of suicidal thoughts for children or adolescents who took the drug were documented. Only four of the eight cases could be linked to Focalin. Links to Focalin in the remaining cases remain subject to further scrutiny.

The FDA monitors reports of side effects (often reported from the drug manufacturers themselves) from FDA approved drugs to discover potential side effects or health risks. To this end, the FDA holds regular advisory meetings to review drug safety for medications used by children.

The FDA typically tries to balance the vast number of Focalin users with the number of children reporting suicidal thoughts. The FDA noted that reports were miniscule compared to how many children used the drug. A staggering 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011 with only eight reported cases of suicidal thoughts. The FDA also stated the risk of suicidal thoughts did not appear in clinical trials for Focalin.

The Focalin website (http://www.focalinxr.com/info/about-focalinxr.jsp) warns patients that they may have new psychotic or manic symptoms after taking the drug, and requests the patient confer with his doctor if they have a history of suicide, bipolar disorder, or depression.

The FDA often follows the advice of its committees, although it is not required to do so.

“Novartis is committed to patient safety and will continue to work closely with the FDA as the agency completes its review,” said Brandi Robinson, spokeswoman for the company.

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