Saturday, March 31, 2007

03/31/07 - Your FDA Compliance Notebooks, Affiliate Marketing


VLUeM – 03.31.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Your SoP & Substantiation Notebooks & FDA Inspections
2. Grow Your Online Affiliation Program!
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1. Your SoP & Substantiation Notebooks & FDA Inspections


I’ve been asked what a Dietary Supplement marketer ought to have available for an FDA visit, in the event of a surprise agency inspection.

Ideally, you ought to have a couple loose leaf note books, (a) one entitled "Standard Operating Procedures Notebook" (or “SoP Notebook”) and (b) the other entitled “Substantiation Notebook.”

(A) The first Notebook should contain your:

(1) Operations Manual/SoPs and Employee Manual
(2) Formula sheets
(3) Label copies (with dates as to when they were in use)
(4) Literature copies (likewise dated)
(5) Copies of your Structure and Function Notices
(6) Insurance Policy binder page
(7) Certificate of Incorporation (or LLC Certificate of Formation)
(8) EIN and Bank Account number information

(B) The second Notebook contains information that substantiates the claims you are making. This Notebook should have a section for each product and each claim for the product, by ingredient.

(1) Abstract pages of scientific journal articles regarding the ingredients
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters

If you are ever visited by FDA, for one of their famous "surprise visits" having this stuff together so you can give them a copy would make them very happy.
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2. Grow Your Affiliate Program

The Vitamin Lawyer Consultancy does provide Affiliate Program Rules. Let me know if you want to establish an Affiliation Program.

Besides the right Rules, of course, you need the right software. One good program that I can recommend is the program used by BiomagScience.com for its online biomagnet sales program. It is a two step program, so, typically, you will see two banners from it on Affiliate web sites. One is for retail sales of biomagnets (for which you receive a sales commission), and the other is a “Become a Biomagscience Affiliate” banner, where another web site can join as an Affiliate, and your site earns an override on all retail sales through that site. If you go to the following page, you can see that banner: http://home.earthlink.net/~lifespirit23/support-lifespirit.htm .

But that’s just the start. After you have your web site and your affiliation program, you need to market it! If you do it right, you can expect very significant sales growth!

Here are excerpts from a piece through Add Me Newsletter about being an affiliate marketer.

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www.addme.com
How To Immediately Boost Your Affiliate Marketing Sa'les
By Titus Hoskins

Affiliate marketing is a very competitive field. Savvy affiliate marketers use every tactic they know to get the upper hand over their competition. It can mean the difference of whether or not they get that all important sa'le.

One of the best ways to boost your affiliate sa'les is to take full advantage of brand name recognition. … Popular brand names with popular trendy products sell the best.

If you're an affiliate marketer you must choose the products you promote with the utmost care; in many cases this is where you will determine the outcome of your marketing efforts…

As an affiliate marketer you can promote anything, why not choose the most popular brands and products. Just look for popular trends and join the bandwagon. Sure, the competition might be stiffer but the demand for these products will also be greater.

If you join affiliate networks like Commission Junction [or, for another example, eAffiliatez.com – rf] they will show you the companies with the highest sa'les volume in their system. Study this sa'les data before you pick your affiliate companies or products.

You can even use Google Trends to tell which products are popular and in which countries. Do some market research first and pick the most popular products to promote.

Many marketers keep an eye on their PPC (Pay Per Click) keywords for any surges in searches or impressions. A big jump could mean an increase in popularity for that product or company.

* Be Aware of “The Buzz” Factor …Certain brand names and products have buzz. …

* Can It Only Be Bought Online? … One of my most successful tactics has been to pick products or offers that are only available online. Dell products come quickly to mind. … Online coupons and exclusive deals also increases your affiliate sa'les. Look for these and display them along with your popular brands for they will increase your sa'les. Everybody loves a deal!

* Use Brand Names In Your Site Copy and PPC Advertising … You must always check with your affiliate company what rules they have about displaying brand names and trademarks on your site copy. Most companies will supply their affiliates with web content they can use for promotion.

Most Companies have strict rules prohibiting affiliates from using certain brand name keywords in their PPC advertising. Each company is different, so check before you proceed with any PPC campaigns.

However, one of the most effective ways for PPC advertising is to use the particular brand name and product name in your PPC ads. Savvy affiliate marketers have figured this one out long ago, it mainly has to do with finding the buyer at the right stage in their buying process. If they're looking a particular product ; they may already have their minds made up and are ready to buy…

* A Rose Is A Rose Is A Sa'le! … In conclusion… Keep your eyes peeled for popular trends and shifts in the marketplace so you can adjust your marketing to meet these new demands….

About the Author - The author is a full-time online marketer. For the latest and most effective web marketing tools try: Internet Marketing Tools - http://www.titushoskins.com/ © 2007 Titus Hoskins.

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Well, that’s all for now.

Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved

Friday, March 16, 2007

03/16/07 - Making Claims, SoP Outline, Health Freedom Site attacked


03.16.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Making Claims & New Dietary Supplements
2. Record Keeping SoP and Employee Manual – Online Outlines Available
3. Health Freedom Site Attacked
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1. MAKING CLAIMS & NEW DIETARY INGREDIENTS

Say your company needs a "DSHEA compliance" letter from The VitaminLawyer.com Consultancy about a new product. The threshold issue is whether the product is a "new dietary ingredient". We start by noting whether the product is found in the IBIDS data base. Then we check to see if similar products are found in the general FDA data base and look for references indicating whether FDA treats the product as a new dietary ingredient.

Journal abstracts showing the product being studied prior to the DSHEA "grandfathering" date of June, 1994 can be useful. Such information could show that the product was part of the food supply before the grandfathering date. This will negate the new dietary ingredient issue (which would have required prior FDA approval before marketing -- with proof of safety).

The other part of the DSHEA compliance issue has to do with the claims to be made for the product. If there are no claims being made, other than "a good source of [ingredient]" or "advanced bioavailable form of [ingredient]" (with substantiation for these claims, of course) then there would be no claim issues. Simple general “support of normal structure and function” claims are allowed. Even “immune system support” claims could be allowed:

"A “claim that a product "supports the immune system" is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function."

Here is access to the FDA guidance: http://www.fda.gov/ohrms/dockets/98fr/98n-0044_gdl0001.pdf. Once these threshold issues are resolved, it becomes possible to provide a DSHEA compliance letter for use with potential distributors, online affiliates and joint venturers.

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2. RECORD KEEPING SoP AND EMPLOYEE MANUAL

SoP – Standard Operating Procedures – are an important part of cGMPs (current Good Manufacturing (Marketing) Practices. I’ve created a new web page with outlines of the contents of the SoP and EM documents - http://tinyurl.com/2eu6yj

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at: http://tinyurl.com/2eu6yj

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3. HEALTH FREEDOM SITE ATTACKED ON 03/12:

The websites of the Natural Solutions Foundation - www.globalhealthfreedom.org and www.healthfreedomusa.org – disappeared from the Internet within hours of the site exposing the genocidal agenda “the illness industry.” The sites are online again, but with a number of images and other information still missing. You can read the original article and the Internet attack at: http://www.healthfreedomusa.org/index.php?page_id=219

Here is what Dr. Laibow had to say in an email blast while the sites were down: “…our hosting company… locked our site with no reason given, no warning and no explanation. When I called to talk to someone about this I was told that the supervisor was "on leave," the manager was "not here," probably would not call me back when he got there, and that there was no one to talk to about the fact that my site was locked for no apparent reason at all. All this after 19 minutes and 45 seconds of international phone call holding. Why is our site blocked? Because, according to the technical services person, the site was locked in the computer with no explanation and can not be unlocked until I talk with the right person. Who is that? He does not know… The War on Freedom IS a War on Health Freedom… I wrote about the genocidal intent of the illness industry called Big Pharma in my latest email to you. Funny, immediately after that our site is mysteriously locked for no reason. Hmmmmm. Could it be that the Power Beast does not want you to know about these realities? Looks like it, doesn't it…”

As of today, the two parts of the site that still do not work, curiously, are the email sign-up and the Organics 4 U Shop. So no one can join or help support NSF*. Curious and curiouser… If you’ve chosen to be in this industry, you need to acknowledge its realities.

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

* The Foundation can receive donations through PayPal, however.
You can PayPal to naturalsolution@optonline.net and the donation will go directly to the Foundation.

Also, do see Nutricide, now on YouTube at: http://video.google.com/videoplay?docid=-5266884912495233634&q=Nutricide

Friday, March 2, 2007

03/02/07 - More SoP, more attacks... Web 2.0


03.02.07 - VITAMIN LAWYER UPDATE e-MEMO
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1. Record Keeping SoP and Employee Manual – Online Outlines Available
2. New Meta-Analysis Attacks Antioxidant Vitamins: Is it flawed? What to do?
3. Web 2.0 – What the Entrepreneur Should Know
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1. RECORD KEEPING SoP AND EMP MANUAL

[I was asked to repeat this information from previous eMemos. I’ve created a new web page with outlines of the contents of the SoP and EM documents -
http://tinyurl.com/2eu6yj    Updated: www.VitaminIndustryCompliance.com]

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at: http://tinyurl.com/2eu6yj

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2. FLAWED ANALYSIS – OR NEW APPROACH NEEDED FOR PRODUCTS?

Study alleges link between antioxidants and increased mortality.

“2/28/2007 - A meta-analysis of 68 randomized trials with antioxidant supplements has reported that vitamins A and E, and beta-carotene may increase mortality risk by up to 16 per cent, but vitamin C did not have an effect on mortality and the antioxidant mineral selenium was associated with a nine per cent decrease in all-cause mortality. … The pooled analysis, published in the Journal of the American Medical Association, could have significant negative effects on the sale of antioxidant dietary supplements… The new pooled analysis has already drawn criticism from both inside and outside the dietary supplements industry concerning the methodology applied, and the conclusions drawn. … The most prevalent criticism of the study has come from the diverse nature of the studies pooled together, described by one industry expert as comparing "apples and oranges"… A wealth of epidemiological evidence has linked dietary antioxidant intake to reduced risk of a wide-range of diseases, such as cancer and cardiovascular disease, but when such
antioxidants have been extracted and purified, or synthesized and put into supplements, the antioxidants, according to randomized clinical trials (RCTs), do not always produce the same positive results. … [The meta-analysis] findings contradict the findings of observational studies… that antioxidants improve health.”

http://www.nutraingredients-usa.com/news/ng.asp?n=74582&m=1NIU228&c=jegwylrviswtnqa

The language used in the reports about the meta-analysis does appear carefully chosen to overstate the risks and understate the benefits. The bottom line for vitamin purveyors: (1) if these allegations begin to impact the market, consider substituting whole food sources of ingredients for extracts; (2) budget the funding needed for RCTs and (3) note the astoundingly positive results for Selenium: a 9% decrease in mortality. Think Whole Food Supplements!

[03/02 Update: Linus Pauling Institute blasts AMA fake meta-analysis: http://www.sciencedaily.com/releases/2007/02/070228172604.htm -- the Institute points out obvious flaws in the report and show the bias of the authors, who started with 815 trials, selected out 68 of them, ignored the most valid trials, and then manipulated the statistics to provide the preordained result. Voodoo science at its most obvious.]

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3. WEB 2.0 FOR “NEWBIES”

Excerpts from: Becoming the Spider: Next Generation SEO Tactics

"Just when you believed you had all your SEO tactics figured out, the web goes and changes on you. ... Web 2.0 changes the whole ballgame. It not only places the Internet user squarely in the middle of things, but it gives that user the means and power to create and manipulate data. Web 2.0 dramatically changes how we view and use the web. ... Just what exactly is Web 2.0? ...perhaps the simple definition can be found in the word "you"! Time magazine probably summed it up best by making reference to the "you" in user generated content. Web 2.0 is basically all the platforms that give us this brave new user-powered interactive Internet, generally referred to as 'social media'. .. Web 2.0 can be seen or manifested in such sites as YouTube, MySpace, Del.icio.us, Digg, Squidoo. ... Web 2.0 uses scripting languages such as Python, Perl PHP, RSS... to construct interactive platforms that websites can use to create all this user-generated content. ... If you have used Google Earth, you will realize how powerful and revolutionary these new applications
can be, not to mention, they are a whole lot of fun. ... all webmasters should optimize their sites for this new Web 2.0 and take full advantage of all the SEO possibilities presented by this brave new Internet. … Here are a few SEO suggestions you can try:

1. RSS/Blogging. You must place a blog and RSS feed on all your sites. This is a fairly simple procedure to do with free server-based programs... Having a blog and RSS feed will place your site into the whole tagging process. Each category you create in your blog will be seen as a tag by such sites as Technorati. RSS stands for 'Really Simple Syndication' and your RSS feeds will get your content distributed across the web. ...

2. Create some Google Juice! Join as many of these highly interactive sites as you can: MySpace, YouTube, Del.icio.us, Digg, Wikipedia ... my favorite is Squidoo, where you can create Lenses on different topics that interest you. User driven content that's utilized by all the major social media sites. Of course, link back to your sites in your posts and creations in these user-created content havens and watch your PR ratings go way up.

3. Use Interactive Scripts. Place interactive JavaScripts and platforms on your own sites. Have membership forums, polls, blogs, feedback forms, user-contributions... to build unique content driven sites. Become the spider!

4. Tagging (Folksonomy). Be constantly aware of the tags (keywords) you're creating with your blogs and sites. This can have a very beneficial effect on your traffic and rankings. Closely relate these tags to the content on your sites and build higher rankings in all the major search engines.

5. The Long Tail. Especially important for affiliate marketers, you need to cover special niches where there is less competition and content. These narrow niches make up a large portion of the whole vast web, creating content in these unique areas will get your site included in the search engines a lot quicker and keep them there a lot longer.

6. Holistic Web 2.0! Be constantly vigilant in placing your sites in the whole 'Interactive Game', building links and partnerships with the important YouHubs: MySpace, Del.icio.us, YouTube, Digg, Squidoo... the more connections you have, the more your own sites will prosper.

"... Web 2.0 will play an ever increasing role in the development and evolution of the web. Make sure your sites are optimized and in the 'You' game. Create blogs, RSS feeds, interactive forums, membership areas, user-generated content and truly make your sites interactive havens in their own right. Just remember to tag everything and your sites will reap the benefits of this new Web 2.0 generated SEO gold rush. ... The author [Titus Hoskins] is a full time Internet Marketer with numerous sites on the web, including two niche sites on Internet Marketing. His main site is www.bizwaremagic.com ...”

Well, that’s all for now. Remember to check the SoP contents tables at: http://tinyurl.com/2eu6yj



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