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
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0. Blog News – Weaponized Virus; Weaponized Vaccines
Pandemic Alert: Proactive Protection Steps
www .healthfreedomusa.org/?p=2581
[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.]
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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."
http://www.cfsan.fda.gov/~lrd/fr07625a.html
Excerpts from the FDA comments on “shelf-life” are reproduced below.
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“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.”
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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 .fda.gov/bbs/topics/NEWS/2009/NEW01990.html
Please
note that none of the 25 devices listed at www
.fda.gov/OHRMS/DOCKETS/98fr/E9-8022.htm include any of the popular
Advanced Healthcare (CAM) electro-energetic devices.
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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..
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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