Wednesday, September 12, 2007

09/12/07 - FDA focus on saftety?


1. Health Freedom Blog Update
2. News bits… Vit. C shortage?
3. Reminder: Update Archives are at:

1. Vitamin Lawyer Health Freedom Blog New Postings

Divesting the FDA and A Little History of Regulations

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."

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."

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.”

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..”
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.”

3. Reminder: Update Archives at:

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

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