Friday, November 2, 2007

11/02/07 - FDA Commissioner Warns Industry


Lots of ground to cover in this memo… important information…

1. Health Freedom Blog Update, Factoid & Client GMP Warning
2. Raising the RDA
3. Taking vitamins is good for you
4. Organic is better…
5. Warning from new FDA Commissioner to DS industry
6. SEO for small businesses

1. Vitamin Lawyer Health Freedom Blog –
New Posting -

“In the past, over-conservative government-sponsored [maximum level] standards have encouraged dietary complacency…” - Vitamin Safety Review Panel

Client GMP Warning: This just in: one of the Vitamin Lawyer clients reports receiving a request from his production people: “In the very near future we are going to need a copy of your stability study which substantiates your Exp [expiration] date. FDA requires that this be on file and available for review.” This particular client is wisely having his contract manufacturer laboratory retain samples to test every six months so he will have the data.

Please note that the FDA does not currently require the use of “expiration” or “best if used by” dates.

The new GMP Rule comments state: “if you use an expiration date on a product, you should have data to support that date... 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… 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.”

To get on to the Global Health Freedom eblast list, please go to:

2. Raising the RDA

“The US Recommended Daily Allowance/Daily Reference Intakes are too low and most should be raised immediately, says an independent panel of physicians, academics and researchers. In a statement this week, the Independent Vitamin Safety Review Panel said: “Government-sponsored nutrient recommendations, such as the US RDA/DRIs, are not keeping pace with recent progress in nutrition research… In the past, over-conservative government-sponsored standards have encouraged dietary complacency. People have been led to believe that they can get all the nutrients they need from a 'balanced diet' of processed foods. That is not true. For adequate vitamin and mineral intake, a diet of unprocessed, whole foods, along with the intelligent use of nutritional supplements, is more than just a good idea: it is essential.”

3. Taking vitamins is good for you…

Knowledge of Heath, Inc. -
Special Report: Dietary Supplement Fanatics Healthiest Of All - By Bill Sardi © 2007

“They may not be laughing at vitamin supplement fanatics much longer. According to an authoritative study just published in The Nutrition Journal, avid dietary supplement users who, on average, take 17 different supplements daily, were judged to be far healthier than adults who just take a single supplement such as a common multivitamin, or who don't take dietary supplements at all.…While more than half of U.S. adults take dietary supplements, nearly
half of these supplement consumers take only one type of supplement, most commonly an inexpensive multivitamin…Risk for disease was far lower among the multi-supplement users compared to non-users. Risk for diabetes was 73% less, coronary heart disease 52% less, and self-determined health status (report health status was rated as "good or excellent") 74% more often, compared to non-supplement users.

This study may dispel a common belief that a low-dose multivitamin may be sufficient to address essential nutrient shortages. Source: Gladys Block, et al, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study. The Nutrition Journal, 6: 30, 2007

4. Organic is better…

“The biggest study into organic food has found that it is more nutritious than ordinary produce and may help to lengthen people's lives. The evidence from the £12m four-year project will end years of debate and is likely to overturn government advice that eating organic food is no more than a lifestyle choice. The study found that organic fruit and vegetables contained as much as 40% more antioxidants, which scientists believe can cut the risk of cancer and heart disease, Britain’s biggest killers. They also had higher levels of beneficial minerals such as iron and zinc.”

5. Warning from new FDA Commissioner to DS industry

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), outlined what the agency claims is its science-based approach to regulating dietary supplements

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr. Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have
seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

The article continues: When DSHEA was passed a decade ago, there were about 4,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, which cannot be put on the market unless a high threshold of evidence about their safety and efficacy is met, and that, like foods, such dietary supplements should in general be given the benefit of the doubt as to safety. A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements and that there are about 29,000 such products on the market, with another 1,000 new products introduced each year.

Are your papers in order?

6. Search Engine Optimization for Small Business Owners

Entireweb Newsletter * November 1, 2007 * ISSUE #384

Small business owners are often limited by small marketing budgets and manpower. But that doesn't mean they can't compete against larger businesses or websites when focused on search engine optimization. SEO is a basic marketing tool that everyone should use regardless of size...

What makes a keyword competitive? One way to determine the competitiveness of a search term is to simply type that search term into Google and notice the number of web pages that contain that search term. This number appears in the upper right-hand corner of the search results page and appears as, "Results 1 - 10 of about 228,000,000 for [your search term here]." ...From my perspective, when this number is less than 3 or 4 million, the particular search term would not be all that competitive in and of itself.

Determining just how competitive the search term is. There are a variety of methods to determine true keyword effectiveness (KEI, etc.)... In addition to the number of sites that contain your keyword, how well optimized are the top 3 sites that appear on the search result. You can determine this by:

1. Visiting the site and determining the Google PR of the page. This information is available by downloading the Google toolbar and looking in your browser. You will see a green bar and ranking (ex: PR5), which tells you how Google ranks this page/website with regard to popularity. Any site with a Google PR6 or better is well established and will be difficult to outrank in the near term.

2. Visit Google and type , "". Be sure to replace 'competitorwebsite' with the website name you are researching... This will tell you how many sites are linking to this particular website. The larger the number the more difficult it will be to outrank.

3. Look at the website code. Simply visit the competitor's website and go to "View", "View Source". Look for the meta tags of "Title", "Description", and "Keywords"...

Using the above will give you a good sense of whether of not you can compete for given keywords...

About the Author: Michael Fleischner is an Internet marketing expert with more than 12 years of marketing experience...

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