Monday, August 6, 2007

Adverse Event Reporting...

See: for background on the AER Act of 2006.

Act as signed into law:

AER Regulations Immanent

This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.

CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud

"08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…""

Like many people involved in the Vitamin Industry, I am a bit conflicted regarding the AER Act. I believe mandatory reporting of serious adverse events will prove Dietary Supplements to be very safe indeed; on the other hand, I can see how the system could be used to falsely paint all nutrients with the problems of a few examples of abuse or misuse. Since foods are generally recognized as safe, I doubt there will be many AE Reports... time will tell.

One thing we want to make sure, as Maury Silverman suggested in an email earlier today, "PLEASE TELL FDA NOT TO SCAPEGOAT DIETARY SUPPLEMENTS WHEN IT IS A CONCURRENT DRUG-DRUG INTERACTION. DRUGS DEPLETE NUTRITION."

This is true; drugs act by changing normal structure and function and must deplete nutrients to carry-on that effect. Thus, Mike Adams,, in expressing the 26 myths that rule the minds of what we might call the pharmaphiliacs (lovers of pharmaceuticals) satirically suggests:

"4. Most diseases are caused by pharmaceutical deficiencies and can only be treated with pharmaceutical supplementation.

5. Botanicals interfere with pharmaceuticals, not the other way around. There is no such thing as a pharmaceutical that interferes with an herb."

The truth is quite the contrary: dis-ease is predicated on nutritional deficiencies and the body needs good nutrition to return to normal structure and function.

We need to assure that the AER system takes into account dangerous drug-drug interactions and the harmful impact drugs have on nutrients before blaming the nutrients. When the AER Regulations are issued, these will matters will have to be taken up with the FDA.

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