Friday, September 28, 2007

09/28/07 - Vitamin Label Warnings; Functional Beverages


VLUeM – 09.28.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. How to Avoid Alienating Search Engines
3. Vitamin Label Warnings
4. Functional Beverages… the future of supplementation?
5. Are your papers in order?
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1. Vitamin Lawyer Health Freedom Blog - New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

Does the FDA really want public comments?
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2. SE Tactics: How to Avoid Alienating the Major Search Engines
http://www.entireweb.com/newsletter/archive/2007/ISSUE373.html

Some more good advice from EntireWeb.com:

Each of the major search engines… have quality webmaster guidelines … prevent … manipulation of search engine rankings …. These webmaster guidelines change frequently … and those websites found engaging in these illicit practices are consequently dropped from the search engine rankings....

Being banned or dropped from the search engine rankings can have dire effects on your website traffic, online sales generation and site popularity…

If you wish to avoid alienating the major search engines then do not engage in the following SE tactics:

1. 'Cloaking' or sneaky redirects - displaying different content to the search engines than shown to your normal website visitors including hidden text and hidden links. …
2. 'Doorway' pages created specifically for the search engines that are aimed at spamming the index of a search engine…
3. Don't create pages that install viruses, Trojans or badware. 'Badware' is spyware, malware or deceptive adware…
4. Avoid using software that sends automatic programming queries to the search engines to submit pages or check rankings... you will be penalized for using it.
5. Don't load web pages with irrelevant words.
6. Don't link to 'bad neighborhood' sites who have: Free for all links pages, Link farms - automated linking schemes with lots of unrelated links, Known web spammers or the site has been dropped or banned by the search engines.
7. Avoid 'broken links' or '404 errors,' your site will be penalized for them.
8. Don't display pages with minimal content that is of little value to your site visitors.
9. Do not duplicate content unnecessarily.
10. Do not use pop-ups, pop-unders or exit consoles.
11. Do not use pages that rely significantly on links to content created for another website.
12. Do not use 'cross linking' to artificially inflate a site's popularity... multiple sites cross linking … together, if all sites are hosted on the same servers the search engines will pick this up and the sites will be penalized.
13. Do not misuse a competitors name or brand names in site content.
14. Sites with numerous, unnecessary virtual host names will be penalized.
15. Do not use techniques that artificially increase the number of links to your web pages ie. Link farms.
16. Display web pages with deceptive, fraudulent content or pages that provide users with irrelevant page content.
17. Using content, domain titles, meta tags and descriptions that violate any laws, regulations, infringe on copyrights & trademarks, trade secrets or intellectual property rights of an individual or entity….

About the Author: Rosemary Donald is an SEO Consultant with www.rank1websitemarketing.com - & author of the SEO ebook 'Insider Secrets of Rank 1 Websites'
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3. Vitamin Label Warnings…

In addition to the statutory FDA “…not evaluated…not intended…” disclaimer, here are some warnings for you to consider for your labels; please note that the AER warning may have to be modified when the final AER regulations are issued in the next couple weeks.

Product Warnings:

- Keep out of reach of children.
- Do not exceed recommended dose.
- Do not use if outer or inner seal is broken or damaged.
- If you have a serious adverse reaction to product, discontinue use
immediately, seek medical attention if necessary, and contact us.
- If you are undergoing treatment for a medical condition or if you are pregnant
or lactating, consult your physician when taking this product.

In addition to the above, you may need a Food Allergy Warning:

“The term “major food allergen” means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.”

That warning should read: ALLERGY WARNING: contains [list allergens].

Finally, there is a special warning for iron containing pills or capsules: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”
http://www.cfsan.fda.gov/~dms/secgiro2.html
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4. Functional Beverages… the future of supplementation?

Nutraingredients.com reports: “As part of its newsletter on equity research - Healthy Living Monthly … highlighted an increased consumer focus on health and wellness as a key driver of new trends… growth and innovation will stem from more alternative segments. There will as such be opportunities for functional beverage and ingredients manufacturers alike as these categories grow. But it depends on how they align their resources and efforts.

"The beverage industry has become a leading delivery vehicle for functional nutritional ingredients, is a major beneficiary of the convenience movement in the US, and is desperate, in our opinion, for any new ideas to offset the stagnant market for carbonated soft drinks," write the report's authors.

Canaccord Adams valued the US nonalcoholic beverage market at $100bn in 2005. Carbonated soft drinks (CSDs) take up the majority of this market, with a reported $64.7bn in sales. However, the analyst says growth in the nonalcoholic segment is coming from categories other than soft drinks as consumers move towards healthier options or, at least, options that are perceived as healthier.

The firm conjectures this interest in healthier beverages is in part due to the fact US consumers are increasingly overweight. An estimated 66 percent of adults in the US are either overweight or obese, based on results from the 2003-2004 National Health and Nutrition Examination Survey (NHANES). The rate of obesity more than doubled from the previous NHANES survey - increasing from 15.0 percent (1976-1980) to 32.9 percent (2003-2004).

In terms of recommending how manufacturers large and small ought to innovate in this market, the report repeatedly highlights the example of the rise of energy drink.

"The history of the energy drink category in the United States illustrates both the opportunities and the risks that exist as change occurs within the beverage industry," write the analysts.

While Canaccord Adams has identified emerging trends in the beverage market as being fortification, functionality, and a shift towards premium, "green" and organic products… For instance, instead of water, beverage manufacturers should now look out for 'enhanced' water.

"Don't buy commodity bottled water today, despite its enormous profitability," states the report. "It is late in the trend, and the early adopters are telling us that."

Waters fortified with healthy ingredients hold the biggest potential and are being cashed in on by the beverage giants. Coca-Cola this year forked out $4.1bn to acquire vitamin water company Energy Brands for the manufacture and marketing of new nutritionally enhanced vitamin water lines.

These fortified categories are the way of the future, according to Canaccord Adams… The analyst states that though dairy was once the bastion for beverage fortification, it has given way to alternative drink sources that come with perhaps less calories or fat.

http://www.nutraingredients-usa.com/news/ng.asp?n=80162&m=1NIU927&c=jegwylrviswtnqa
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5. Are your papers in order?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and let me know how if can help your company organize for future success!

Wednesday, September 19, 2007

09/19/07 - Eco Friendly Packaging; SOPs up to date?


VLUeM – 09.19.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. More EU machinations
3. Eco-friendly packaging
4. Boomers and Dietary Supplements…
5. Are your SOPs up to date?
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SEPTEMBER 19: Fairfield, New Jersey, 7pm. Dr. Laibow, Gen. Stubblebine III, Ralph Fucetola (the Vitamin Lawyer), Prof. Murray Sabrin (spokesperson for Presidential candidate and US Congressman Ron Paul) and a spokesperson for Presidential candidate Dennis Kucinich are guest speakers at the Health Freedom vs. Health Tyranny Rally.

VFW Post 7925, 45 Plymouth Road, Fairfield, NJ. 937-227-9600.
Your Rights to Natural Health Care are in Jeopardy!

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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

Asking Congress to demand FDA reporting on AERs
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2. Does the situation in Europe portend developments here?

The FDA’s public policy of “harmonizing” with international regulations suggests so. Here is a report on what is happening in Europe, a potential market for many US dietary supplements and model for US regulators.

“…the harmonization process for EU food laws, including maximum mineral and vitamin levels, has "a long way to go" before completion. European Advisory Services (EAS) said the "vastly different national approaches" currently in place will continue to impact on companies launching onto the European marketplace. Manager of scientific and regulatory affairs Efi Leontopoulou also stressed the strategic importance of the evolving regulatory climate in non-EU countries such as Russia and Turkey, which she described as being "two complex but very promising markets for the food industry." She added that: "Bulgaria and Romania have recently joined the EU and this creates new market opportunities but also more challenges in terms of the harmonization process."

A lengthy wait is predicted due to the number or rules and complexity of the current situation, but EAS was unable to say how long this might take prior to publication. The warning means that uncertainty about what may or may not be imposed for minerals and vitamins will continue to spread through the industry. Some countries could suffer a blow if EU legislation were to proscribe the sale of high dose products or vice versa. In the UK, for example, high dose products account for 12 to 15 per cent of the £220m vitamin and mineral market and could experience trouble... Member states at the moment vary dramatically on maximum and minimum levels, which would come to an end once Europe-wide unification is imposed.

Yesterday NutraIngredients.com reported how lobbyists from Consumers for Health Choice have pleaded with the commission president José Manuel Barroso to not stay away from a heavy-handed approach to maximum levels. The setting of maximum levels forms part of the 2002 Food Supplements Directive, and the new with fortified foods regulation...

"Working with all of these different national legislations in Europe can be quite a minefield for companies, from issues such as the addition of nutrients to foods and the types of ingredients permitted in countries, to details on new product notification requirements and national approaches towards derogations for vitamins and minerals."

…A working party of Member States is expected to sit down and discuss maximum health claims next week, and the Commission is expected to propose a directive with actual figures in 2009.”

www.nutraingredients.com/news/ng.asp?n=79835&m=1NIE918&c=jegwylrviswtnqa
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3. Eco-friendly packaging

A recent issue of a nutrition industry magazine carried an interesting article on eco-friendly packaging. The two newest offerings are Polyactide (PLA) plastic bottles (made from corn and readily biodegradable) and Tetra Paks. The PLA is colorful, costs less than petroleum-based plastic and uses less energy to produce. The Tetra Paks, vaguely rectangular in shape, are mostly recyclable paper, but with a special aseptic process that allows liquids long shelf life without degrading the ingredients high temperatures, irradiation, etc.

Tetra Pak is at: www.tetrapak.com and you can Google “Polyactide bottles” for a number of links.

From “Design of the Times” September 2007 Nutrition Industry Executive – www.niemagazine.com

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4. Vitamins, minerals and boomers…

“Men and women over the age of 51 who regularly take dietary supplements are more likely to get adequate amounts of several vitamins and minerals than those who do not, a study suggests. Researchers writing in the Journal of the American Dietetic Association also found that a substantial portion of people in this age range do not get enough vitamins and minerals from their diet alone and the use of supplements is necessary. Not only do these results give the supplements industry a boost, but they could also help supplement providers in deciding which age group to target with marketing, as well as giving a clear indicator of what nutrients should be included… They concluded that a large "proportion of older adults do not consume sufficient amounts of many nutrients from foods alone. Supplements compensate to some extent, but only an estimated half of this population uses them daily…”

www.nutraingredients.com/news/ng.asp?n=79836&m=1NIE918&c=jegwylrviswtnqa

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5. Are your SOPs up to date?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and let me know how if can help your company organize for future success!

Wednesday, September 12, 2007

09/12/07 - FDA focus on saftety?


VLUeM – 09.12.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. News bits… Vit. C shortage?
3. Reminder: Update Archives are at: http://tinyurl.com/rkneb
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1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/

Divesting the FDA and A Little History of Regulations

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From an FDA warning letter issued last week: "...FDA's focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions."
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2. News Bits…

From New Hope Media: Dietary ingredient shortage!

“Retailers may have to start charging their customers more for dietary supplements containing vitamin C by the end of the year as manufacturers are forced to pass on higher prices from suppliers. Prices for vitamin C are ballooning because of supply shortages out of China, the world's primary supplier, and the use of corn, a source of vitamin C for mass production, as a biofuel, said Ed Keenan, vice president of marketing at New York-based supplements manufacturer, FutureBiotics. Keenan said Chinese suppliers claim they are shutting down plants to remodel them to meet Western standards of production. China supplies about three quarters of the global vitamin C market. "What they've done is squeeze production. They're holding back in their production," Kennan said of the Chinese production companies. "The whole industry is going to be hit by a severe shortage."
http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1436&strSite=FFNSite

AHPA Speaks Out:

The American Herbal Products Association has submitted comments to the US Food and Drug Administration, urging it to assist the dietary supplement industry in complying with good manufacturing practices, adverse event reporting, and new dietary ingredient safety regulations. The Maryland-based association was responding to calls for input from the FDA's Center for Food Safety and Applied Nutrition.

 "The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice for manufacturing, packaging, labeling, and holding dietary supplements, which were released this past June, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports associated with dietary supplements and over-the counter drugs be submitted to the FDA, which goes into effect this December," AHPA stated.

NAC & Gambling:

“A common amino acid sold as a dietary supplement could help diminish pathological gambling addictions, according to a new study. Researchers at the University of Minnesota uncovered the link following an eight-week trial involving 27 people who were given increasing doses of N-acetyl cysteine. By the end of the pilot study, published in the September 15th issue of Biological Psychiatry, 60 percent of the participants reported having less urges to gamble. The potential significance of these findings is huge - given the widespread damage caused by addictive gambling.”

http://www.nutraingredients-usa.com/news/ng.asp?n=79705&m=1NIU912&c=jegwylrviswtnqa

Symbols of Harmonization?

“The US government yesterday concluded a hearing examining the implementation of a nation-wide food labeling system to provide consistent nutrition information on product labels. .. FDA this week held a two-day meeting to gather comments from industry, health groups, advocacy organizations and medical experts on the use of a labeling program similar to the UK's traffic light system. Indeed, a number of countries around the world have already instituted voluntary labeling systems for government-designed nutrition symbols. These symbol systems vary in their format. Some systems have detailed graphic illustrations that indicate the content of a number of selected nutrients, while others simply present a single icon indicating that a food is healthful, with further information available elsewhere, such as in booklets and web sites. In the US, the food and beverage industry has identified the need to spell things out simply for consumers..”

http://www.nutraingredients-usa.com/news/ng.asp?n=79708&m=1NIU912&c=jegwylrviswtnqa
And this, from Nutrition 21, indicating that the middlemen are moving into marketing as the new GMPs become effective.

“Nutrition 21, the developer of chromium-based Chromax, announced it has entered into definitive agreements to privately place shares and warrants to fund $17.75mn for marketing and retailing of its condition-specific products. The New York state-based company previously used its science portfolio to support branded ingredient Chromax's use in supplements. However, the company has opted for a change in direction and invested heavily in promoting Chromax directly as a finished supplement product through food, drug and mass retail outlets. The company is going to attempt to take the market by storm, because it says its products have the potential to be attractive to a wide variety of consumers.”

http://www.nutraingredients-usa.com/news/ng.asp?n=79678&m=1NIU912&c=jegwylrviswtnqa

3. Reminder: Update Archives at: http://tinyurl.com/rkneb

Here are some of the topics of recent Updates.

08.31.07 - More on cGMPs impact
08.17.07 - Web Site Mistakes - Speaking in NJ 09/19
08.17.07 - Superfooods Market to Double by 2011
08.03.07 - AER Regulations about to be issued.
07.21.07 - FDA Warning; current issues bulletpoints
07.17.07 - Another FDA guidance and a DC Road Trip
07.10.07 - cGMPs, TX AG, Codex degrades standards
06.28.07 - Randomized Clinical Trials; cGMPs posted
06.23.07 - cGMP Rule issued; ingredient testing...
06.07.07 - Summer of Decisions; Define your Market
05.31.07 - Ron Paul's Bill is the Answer to FDA Failings
05.16.07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs
05.11.07 - OMB approves cGMPs- S.1082 amend confirmed
05.03.07 - Responding to Net Attacks; Victory in Congress!
04.26.07 - SUS Page Updates