01/04/08 - FDA on AER Labeling

 

… VLUeM – 01.04.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...

This issue: saving your company money…
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1. Health Freedom Blog update
2. Web site titles and descriptions
3. The Electric Tree – savings and more
4. Guidance from FDA on AER labeling
5. Cost of foods… calorie
6. Coming next year: improved format for the VL Update eMemo!
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1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/

Factoid: Nutrition Business Journal (nutritionbusiness.com) announced recently that the global nutrition industry has reached $226-billion annually. Other sources suggest the US share is about 50% -- so what portion of that $113 billion a year does your company earn?

eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join

If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .

This eMemo is being sent through my “back-up” Earthlink email address since AOL seems to be blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
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2. Web site advice from Entireweb Newsletter * January 1, 2008 * ISSUE #401 – entireweb.com

“How to Create Compelling Site Titles and Descriptions - There are many places in your HTML you can include keywords, but the Titles and descriptions are arguably the most important elements of your Web site… These places are …most important in terms of their ability to compel someone to visit your Web site. That is, after all, the ultimate goal of search engine positioning, isn't it? Not a lot of point in attaining a top ranking in a search engine if you are just going to call you site "Shop Here." …the Title tag has special relevance, because so many search engines use the title exactly as it appears on your page. …the title of the site is more important than the site description.

“Longer Titles are More Effective - Longer titles build a more compelling reason to visit a Web site. Because it takes a certain number of words to persuade someone to take action, logic dictates that longer sentences have more opportunity to create that compelling argument… People often scan headlines in brochures and magazines, even when they don't read all the information…

“People Don't Read Text, They Recognize Words - …Educators know that people glance at words and recognize the words by the shapes defined by the tops of the letters. …Since people recognize words because the tops of words vary in height and appearance, then sentences that start with just one capital letter and then lowercase letters are easier to recognize and get read faster… Words in all caps are hard to read…

Every little advantage helps you.” - Pamela Upshur - upshurcreative.com
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3. The Electric Tree = savings and corporate responsibility

Natural Solutions Foundation has been chosen as one of The Electric Tree’s 2008 Corporate Responsibility Designees. What does this mean to your business? If you are located in one of the currently covered states (NY, CT, MA. IL, MD, DE ) and choose to participate, with NO cost to you, The Electric Tree can save between 8 and 14% of your electric power bill… if you spend at least $2,000 per month or more on electricity and are willing to donate half your savings to the Foundation. This can be a “win – win” situation. It is very simple to do. If you have interest, please email me with Electric Tree in the subject line.

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4. FDA Guidance & AER Labeling
You can find a listing of FDA guidance documents for the vitamin industry at: http://www.cfsan.fda.gov/guidance.html

Among the new guidances published is a draft labeling guidance for the AER (adverse event reporting) system, with frequently asked questions. This document was finalized on January 2, 2008, as “Guidance for Industry: Questions and Answers Regarding, the Labeling of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act” - Docket No. 2007D-0491. It can be found at: http://www.cfsan.fda.gov/~dms/dsaergu2.html

Here is the summary of the label requirement: “the act requires the label of a dietary supplement being marketed in the United States to include a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. If the label does not include the required domestic address or telephone number, the dietary supplement is misbranded.” FDA also “recommends that the label bear a clear, prominent statement informing consumers that the domestic address or telephone number is for reporting serious adverse events associated with use of the product.”

http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/07-6266.htm

Please note the distinction between “the act requires…” and FDA “recommends.” If a company voluntarily chooses to add language that the phone number or address on the label is there to report AERs, FDA does say “dual purpose” language such as “"To report a serious adverse event or obtain product information, contact..." would be acceptable.

And the FDA’s overall FAQs for AERs cam be found at: http://www.cfsan.fda.gov/~dms/dsaergui.html

That document also states: “Your submission will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported. Any serious adverse event report submitted to FDA, including any new medical information submitted as a follow-up to the initial report, is considered a safety report under section 756 of the FD&C Act (21 U.S.C. 379v) and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the serious adverse event.”

If you have any occasion to report an adverse event, you ought to have the report reviewed by The Vitamin Lawyer before submitting it.
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5. Cost of food, per calorie
Reuters reported on 01/02/08, “the average price of the lowest-calorie foods -- including green vegetables, tomatoes and berries -- increased by almost 20 percent over 2 years. In contrast, in the same time period there was a 2-percent dip in the cost of the most calorie-laden fare, such as butter, potato chips, cookies and candy bars… findings, published in the Journal of the American Dietetic Association, highlight a key obstacle to healthy eating. … They found that snack foods, sweets and fatty foods offered the most bang for a shopper's buck. Whereas the price of the lowest-calorie fruits and vegetables was more than $18.16 per 1,000 calories, the most calorie-rich foods cost $1.76 per 1,000 calories.”
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6. Upgrading the VL Update eMemo!

Coming early this year: this email update system will be replaced by a second, private blog, the Vitamin Lawyer Update Blog, to allow me to keep you up-to-date better than ever! You’ll receive a shorter weekly update email with links to blog articles that will be posted as the information becomes available… more timely information better indexed!
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You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… 

And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com

For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider making an end-of-the-year donation to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...

Wishing you and yours a joyous, prosperous, peaceful and free new year!

Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .