0. News - Continuing Regulatory Threats…
1. 2008 FDA Warning Letters - Analysis
2. Identifying Target Markets for Your Brand
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0. VL Blog News
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
vitaminlawyerhealthfreedom.blogspot .com/2009/01/so-is-codex-threat-to-dietary.html
Yes, Codex continues like a dark cloud on the horizon… and, even closer to home:
BREAKING NEWS! This message from the Natural Products Association (NPA)
FDA
responding “…to a citizen petition filed on behalf of a pharmaceutical
company… has determined that products containing pyridoxamine, a form
of vitamin B6… are not dietary supplements within… DSHEA… 201(ff) and
"may not be marketed as such." In a confusing twist, the agency goes on
to clarify that although pyridoxamine is a dietary ingredient… FDA has
determined by the petition that pyridoxamine is excluded under §
201(ff)(3) because: pyridoxamine is authorized for investigation as a
new drug for which substantial clinical investigations have been
conducted and their existence made public; and there is no "independent,
verifiable evidence" of prior marketing of pyridoxamine as a food or
dietary supplement; this includes the… NNFA list of grandfathered
ingredients. …this development presents a number of problems, including
the agency's interpretation of §301 (ll) of the FFDC Act (which
prohibits the interstate shipment of certain foods to which an approved
drug or a licensed biological product has been added)…”
This past November, I warned the industry about the “sleeper” danger in section 301(11); see:
vitaminlawyerhealthfreedom.blogspot .com/2008/11/emergency-fda-usda-attacking-foods.html
And this very important piece by Dr Laibow: "The Psychology and Physiology of Change" - healthfreedomusa .org/?p=1940
Please
note: all URL links are “broken” so AOL and other providers will not
treat this eMemo as “spam,” so please remove any spaces and add the www.
prefix.”
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1. Analysis of FDA Warning Letters in 2008nutraingredients-usa .com/content/view/print/234091
FDA supplement warning letters: 2008 year in review
By Ivan Wasserman and Svetlana Walker, 27-Jan-2009
“The
US Food and Drug Administration (FDA) issued over 40 warning letters to
supplement marketers last year. An analysis by FDA legal specialists
Ivan Wasserman and Svetlana Walker reveals that the agency’s focus was
on cancer claims made on internet web sites. The oftentimes ‘fuzzy’ line
between permissible and unlawful claims for dietary supplements makes
it essential to stay apprised of FDA’s enforcement actions in order to
successfully navigate the dietary supplement marketing waters without
triggering regulatory scrutiny. … The agency sends Warning Letters to
manufacturers or marketers to inform them of violations of FDA laws and
regulations. FDA may observe violations during an inspection of
manufacturing or other facilities. The agency can also review product
labeling and, importantly, claims made on websites.
One
area of focus for dietary supplements is the distinction between
permissible ‘structure/function’ claims and unlawful ‘disease’ or ‘drug’
claims (i.e., claims that the product will treat, cure, or prevent a
disease. …Unless the recipient is able to convince the agency that it
was wrong about any of the alleged violations, failing to correct
violations may lead to product seizures, injunctions, or other
enforcement actions.
Our
review identified 44 Warning Letters concerning dietary supplements
issued by FDA in 2008. Some of the findings of our review are set out in
the following chart, and discussed in more detail below.
‘Disease’ claims 44
Cancer claims 36
Heart disease/cardiovascular claims 10
Diabetes claims 6
…
Claims made on websites - 41
Claims made in metatags - 21
Claims made on labels - 6
Claims made in ‘third party literature’ - 11
Claims concerning ‘FDA approval’ - 4…
Out
of 44 warning letters issued to dietary supplement firms, 41 of them
were issued as a result of FDA’s review of the firms’ websites. Only
three letters were sent following facility inspections.
The
amount of letters triggered by website reviews highlights the
importance of diligence when it comes to creating website content. As a
general rule, FDA can consider any statement or claim that appears on
dietary supplement web pages to be a labeling claim for the product.
This can include claims made in consumer testimonials and in third party
literature excerpts that describe the health benefits of their dietary
supplements.
In
terms of product categories, in 2008 FDA overwhelmingly targeted
dietary supplements that made any type of cancer claim. Out of the 44
Warning Letters, 36 addressed cancer claims, making cancer by far the
number one ‘disease’ targeted by FDA. …
In
addition, our review revealed that the agency is concerned with the use
of metatags with ‘disease’ terms. Metatags are used by companies to
cause search engines to identify their websites when certain search
terms are used by consumers. …
Finally,
approximately 25 percent of the 2008 Warning Letters addressed third
party literature violations, albeit as a secondary focus. In the
letters, FDA noted that the use of excerpts from scientific
publications, or citations to scientific publications in the same
context as the marketing of a dietary supplement, was problematic if the
excerpt or citation involved disease treatment or prevention….”
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2. Identifying Target Markets for Your Brand
Entireweb .com/newsletter/archive/2009/PRINT513.html
“Identifying
target markets for your brand is critical because your customers are
the future success and growth of your business. But who are your
customers and how can you find more like them? …
Your
target audience is made up of the people who love of your business and
what it offers. They are not everyone who will come in contact with your
business.
In order to find your target market, start by refining your target audiences…
- Who are your best customers?
- Which target segment makes up the bulk of your customers, supporters, or members?
- What do all these segments or individuals have in common?
- Can you find others like them?
Recognizing
what your customers have in common can help you craft a marketing
strategy to draw in more of the same people, thus building your target
audience into a successful business. …
- What is their typical age?
- Are they primarily male or female?
- What level of education have they received?
- Do they have any special interests or hobbies?
- How much is their household income?
By
combining demographic and psychographic information… you can begin
building a mental profile of your core market. … The only way to develop
marketing communications that resonate with your target audience is to
become knowledgeable about their wants, needs, and motivations. So ask
them. Set up a continuous feedback and communication loops between your
customers and the company. Make two-way communications a part of your
corporate culture. You might also consider designing a short survey and
sending it to your current and prospective customers and see what kinds
of offerings, messages, and services your business should be providing. …
While most businesses have multiple target audiences, they should only
have one core market in order to provide as much focus as possible.”
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Your
papers must be in order. Do you have your SOPs (Standard Operating
Procedures)? Is your web site Site Use Statement up-to-date? Learn more
at my web site, www. SiteUseStatement .com or on my SOP page, http://
tinyurl .com/2eu6yj – Is your Substantiation Notebook ready? Your papers
need to be in order before the FDA inspection!
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
