Comments filed with FDA on AERs

Filed 7:15 PM - Comment Number: 215742

Natural Solutions Foundation
www.healthfreedomusa.org

December 14, 2007

To: Food and Drug Administration
Docket No. 2007D-0388

“Draft Guidance for Industry: Questions
and Answers Regarding Adverse Event
Reporting…”

We recommend that all [dietary supplement] AERs include clear indications of any and all prescription and over the counter drugs being used by the person involved. We believe that often supposed “adverse reactions” to nutrients are actually drug – nutrient interactions or nutrient depletions caused by drugs, wherein normal structure and function are changed to the detriment of the person.

The Foundation joins in Maury Silverman’s comments below, including urging that all drugs be labeled to indicate the nutrient depletions they cause, so that truthful AERs can be filed.

For the Natural Solutions Foundation
Ralph Fucetola JD, Trustee
http://vitaminlawyerhealthfreedom.blogspot.com

Mr. Silverman’s Comments

http://www.healthfreedomusa.org/index.php/?p=475

THANK YOU MAURY!

NGO Strives to Help Companies Meet Standard for FDA AER Regulation

Copy of Press Release of 10/13/07 on PR Web:

Nongovernmental Institute Sponsored Framework for Supplement Adverse Event Reporting
More information: http://www.aer-consulting.com/

The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the AER Guide.

Summit, NJ (PRWEB) October 13, 2007 -- The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the IHR AER Guide. The draft guide for vitamin industry companies can be found at the Guide website, AER-Consulting.com. It is intended to meet the standards suggested by the draft AER guidance announced by the FDA yesterday.

The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, known as the Adverse Event Reporting (or AER) Law, goes into effect on December 22, 2007, having been signed into law one year before. To date the FDA has not issued any regulation or guidance enabling the industry to comply with the law. After indications that the agency was going to issue the new regulation in September, to allow the industry sufficient time to react, the lack of action until yesterday has been criticized. 1

Supporting natural products' compliance with the new law, while gathering important research information, the Institute has created a community outreach, Adverse Event Reporting Consultants (AERC) with the web address: aer-consultants.com. It has developed a collaborative structure, under its general sponsorship, in cooperation with credentialed healthcare professionals and advocacy groups, acting as a neutral third party, to evaluate adverse reaction claims, on behalf of consumers and purveyors.

The History of the FDA Bill:

Congress adopted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. The new AER law requires manufacturers and distributors to report all "serious" adverse events to the FDA. The bill was introduced June 21, 2006 by a group of Senators that included both critics and supporters of the industry. It was supported by major supplement industry groups. Others, including supplement consumer groups and health freedom advocates, vigorously opposed the bill. The bill was adopted on December 9, 2006 and signed into law on December 22, 2006. It becomes effective December 22, 2007 and the FDA had been expected to issue draft Regulations under the statute during September 2007. Issuing them on October 12, 2007 leaves the industry little time to prepare for the new reporting requirement.

With the FDA just specifying how these events are to be recorded and reported, most organizations are concerned how to address these events responsibly. AER Consultants has, as its Counsel Ralph Fucetola JD states, "…stepped up to the plate and developed a framework that in addition to complying with the FDA mandate will allow the collection of data that will be invaluable in the future to determine drug and non-pharmaceutical interactions..." The Institute invites public comment on the implementation of this consumer and industry initiative.

Notes:
1. vitaminlawyerhealthfreedom.blogspot.com/2007/10/fda-faulted-for-failure-to-issue-aer.html

Also, see the FDA comment site for its draft AER guidance:fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf

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The Institute for Health Research is a non profit, nongovernmental, exempt organization. P.O. Box 642 Summit, NJ 07901 - Inhere.org . Its trustees are Karen Horbatt, MBA, President of The Green Turtle Bay Vitamin Company, energywave.com, Ralph Fucetola JD, vitaminlawyer.com and Dr. Richard Podell, MD, drpodell.org.
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FOLLOW-UP:

The release has been picked up by Medical News -
http://medical.presslib.com/alternative-medicine/560637.htm

Today, 10/16/07, the release has a top Google position on "AER FDA guide" and the fourth position on "AER FDA."

FDA faulted for failure to issue AER regulations

Industry criticizes FDA for failure to act - where are the FDA regulations?
Private groups stepping in to prepare industry for AER reporting.

10/09/07 - FDA must commit to AER guidance
Functional Ingredients Staff
http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1467&strSite=FFNSite

"The detailed data required under new adverse event reports (AERs) laws, need to be made transparent sooner rather than later, a major trade group has told the United States Food and Drug Administration. The Maryland-based American Herbal Products Association (AHPA) has requested what it considers an overdue guidance document to give the supplements industry a clearer idea of what is expected of them when the law kicks in on December 22. FDA guidance was expected on September 19 but has yet to see the light of day.

"AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS). The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."

"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."

Without implimenting regulations, the industry is truning to private experts for guidance. More at: http://www.aer-consultants.com/ - preparing for the new law.

Adverse Event Reporting...

See: http://www.aer-consultants.com/ for background on the AER Act of 2006.

Act as signed into law:
http://www.fda.gov/cder/regulatory/public_law_109462.pdf

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.

www.nutraingredients-usa.com/news/ng.asp?n=78773&m=1NIU803&c=jegwylrviswtnqa

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, NewsTarget.com, 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."

http://www.newstarget.com/021952.html

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.