Friday, May 1, 2009

05/01/09 - Supplement Shelf Life; Device Attacks; Webinars

0.  News  -  “Pandemic” Panic…
1.  Supplement Shelf Life
2.  FDA Plans to Review Pre-’76 Devices
3.  Webinar Series Archives and Plans – May 6th and 9th

0. Blog News – Weaponized Virus; Weaponized Vaccines

Pandemic Alert: Proactive Protection Steps

[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]


1. Supplement Shelf Life

Recently several clients asked me about dietary supplement product shelf-life (and ''best used by'') requirements. The general rule regarding dietary supplements (unlike drugs) is that you do not have to specify a shelf-life unless clinical studies have been done that show a limit on the shelf-life.

If you do state a shelf-life, however, you have to be able to substantiate the claimed shelf-life. Some lawyers advise that having a specific shelf-life limits exposure to consumer claims for use beyond the specified period. I'm not aware of any cases in which that actually became an issue.

The CGMPs "Requires records associated with the manufacture, packaging, labeling, or holding of a dietary supplement to be kept for 1 year beyond the shelf life dating (when such dating is used, such as expiration dating, shelf life dating, or ''best if used by'' dating), or if shelf life dating is not used, for 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records." Final Sec. 111.605

And this comment: "Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ''best if used by'' date) should be supported by data."

Excerpts from the FDA comments on “shelf-life” are reproduced below.


“In the preamble to the 2003 CGMP Proposal (68 FR 12157 at 12203), we stated that we had considered whether to propose requirements for expiration dating, shelf life dating, or ''best if used by'' dating (referred to in this preamble as shelf life or expiration dating). We recognized that there are current and generally available methods to determine the expiration date of some dietary ingredients, such as vitamin C. However, we were uncertain whether there are current and generally available methods to determine the expiration dating of other dietary ingredients, especially botanical dietary ingredients…

The preamble to the 2003 CGMP Proposal emphasized that, if you use an expiration date on a product, you should have data to support that date (68 FR 12157 at 12204). We recommended that you have a written testing program designed to assess the stability characteristics of the dietary supplement, and that you use the results of the stability testing to determine appropriate storage conditions and expiration dates…

(Comment 200) Several comments agree with our decision not to require expiration dating on labels for dietary supplements at this time, because of the wide range of products and the need for additional data. Most of these comments state, however, that manufacturers should be allowed to include a ''best if used by'' date. One comment suggests addressing the issue in a separate rulemaking. Other comments support an expiration date because consumers and retailers expect one, and some markets require one. Some comments state that the expiration date or
statement of product shelf life will help ensure that the product meets its label claims and potency…

(Response) These comments do not provide data or information that would reduce the uncertainty about the feasibility of conducting tests to support an expiration date and, thus, do not persuade us to alter our position not to require that you establish an expiration date for your product. Indeed, the comments generally concur with that position. Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ''best if used by'' date) should be supported by data.”


2.  FDA Plans to Review Pre-’76 Devices

“FDA to Review Medical Devices Marketed Prior to 1976
“The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.

“These 25 device types… were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976... The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices are marketed after submission of premarket notifications establishing their substantial equivalence to legally marketed devices that do not require premarket approval…

“’We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency,’ said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. ‘New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.’

“… The FDA will review the submitted data and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II.”

From: www

Please note that none of the 25 devices listed at www include any of the popular Advanced Healthcare (CAM) electro-energetic devices.


3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:

Go to www. VitalConnectionUniversity .com

At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.

Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.

A. CAM Advanced Healthcare Practitioner SOPs

Date: May 6, 2009 [This Webinar is being re-taught for the new webinar platform.]
Time: 8:00 PM EDT (approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

B. Bringing New Natural Products to Market

Date: May 10, 2009
Time: 8:00 PM EDT (approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook and a private forum for additional communications.

Sign up through link at: www. healthfreedomusa. org/?page_id=2002

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources). The new webinar system will also include Vital Connection forums specific to the participants in the webinar..


Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

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