Friday, January 18, 2008
01/18/08 - SOPs and FDA Regulations
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 from costly new FDA regulations…
1. Health Freedom Blog update
2. News Target targets FDA attacks on supplements… are your SOPs ready?
3. Food niche with potential
4. VL Memo Archives Blog - improved format for this Update eMemo!
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite
The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”
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 is still blocking my usa.net emails; however, please email me at firstname.lastname@example.org 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.
2. News Target targets FDA attacks on supplements – see SOP Alert! below.
“FDA Announces Plan to Eliminate Vitamin Companies by Byron Richards
“(January 15 - NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... very small …and …small dietary supplement manufacturers … will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)
”This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.
”Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.”
To read more: http://www.newstarget.com/022499.html
SOP ALERT FOR COMPANIES: Now more than ever, “your papers must be in order…” – The Vitamin Lawyer Consultancy has prepared formats for Standard Operating Procedures to allow small companies to comply with the new rules, including the new AER law, by maintaining the necessary records. Our SOP format is relatively short (about 20 pages) but does cover all the areas needed:
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
You can find out more at: http://tinyurl.com/2eu6yj
If you need the format, please email me at email@example.com and put “SOP” in the subject line. Typically, it takes an hour or two of my time to fine tune the format for you.
3. Food niche with potential
Report pinpoints functional food niche with most potential - By Lorraine Heller
January 16, 2008 - Foods and drinks developed to address the specific health needs of consumers are expected to exceed category growth in the US functional food segment, according to a new report. Published by TSG, the study estimates that 'targeted foods', which currently make up 12 percent of the $60bn functional food segment, could grow to take a massive 25-35 percent share in 2012. This could bring up the total value of the sub-segment to between $55bn and $77bn over the next 13 years. Functional foods as a whole are projected to have a market value of $219bn by 2012.
TSG defines targeted foods are those functional foods that are designed to address specific health or disease conditions; specific physical or mental states; or specific age or gender needs. These, says the study, will grow "exponentially" as the functional foods markets continues its ascent into the mainstream.
"They will be the evolution of functional foods," TSG CEO Panna Sharma told NutraIngredients-USA.com.
Foods and beverages in this category include products that address: Digestive health, Celiac disease, Arthritis, Cancer prevention, Heart health
[Note from Vitamin Lawyer: some of these claims would not be allowed as Dietary Supplement claims.]
…[Other of these] products address: * Sports performance, * Beauty, * Skin care, * Libido, * Brain function
…TSG states: "Beverages will continue to drive innovation and early consumer adoption which will drive tighter alignment between functional ingredients and nutraceutical companies and the beverage community."
…"Global food and beverage giants will aggressively enter the market through acquisitions, alliances and select investments," said TSG.
For more –
4. Upgrading the VL Update eMemo!
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, 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!
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 donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – firstname.lastname@example.org
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