Wednesday, January 28, 2009

01/28/09 - FDA Revving Up Regulatory Actions

0.  News  -  Continuing Regulatory Threats…
1.  2008 FDA Warning Letters - Analysis
2.  Identifying Target Markets for Your Brand

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.”

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….”


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.”

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!

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

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