Interesting FDA Newsletter



J

Jim Dumas

Guest
Just about all the news in this FDA News Digest has some impact for us.

FDA News Digest February 2, 2004
______________________________________________________________

Expanded 'Mad Cow' Measures Designed to Boost U.S. Safeguards

FDA has put in place several new public health measures designed to bolster existing "firewalls"
against bovine spongiform encephalopathy (BSE or mad cow disease). Included is a ban on a wide range
of bovine-derived material from human food, dietary supplements and cosmetics. FDA also is
prohibiting certain previously allowed practices involving feed for cattle and other ruminant
animals. http://www.hhs.gov/news/press/2004pres/20040126.html
______________________________________________________________

2nd FDA/Customs 'Blitz' Underscores Risks of Illegal Medicine Imports

A second "blitz," conducted in late 2003 by FDA and the U.S. Customs and Border Protection agency to
examine imported medicine shipments, has uncovered 1,728 unapproved drugs. These included foreign
versions of FDA-approved drugs, along with drugs that have been recalled, require special storage,
require close physician monitoring, and contain addictive controlled substances. FDA points to these
findings as additional evidence of the serious risks posed by illegal importation of prescription
drugs. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html
______________________________________________________________

Administration Proposes Budget Increase for Medical Devices in FY '05

As part of its fiscal year 2005 budget, the Bush administration has requested a $25.6 million
increase over the previous fiscal year's funding for FDA's medical device program. The increase will
help FDA reach performance goals for the prompt review of medical devices so those products can be
marketed quickly. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01012.html
______________________________________________________________

Guidance Aims to Improve Information on Use of Investigational Drugs

FDA has issued a draft guidance designed to make further information about the use of
investigational drugs more readily available to patients. The document is intended to help patients
with serious or life-threatening diseases who cannot be treated with existing therapy and who don't
meet the eligibility criteria or are otherwise unable to participate in a clinical trial.
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01010.html
______________________________________________________________

New Web Site Explains Required Labeling of Trans Fats in Foods

A 2003 FDA rule requires food manufacturers to list on labels the amount of trans fats found in
their foods. To help consumers understand the new labeling, which must be in place no later than
January 2006, the FDA Center for Food Safety and Applied Nutrition has created a Web site with
helpful background on trans fats and how to minimize them in the diet. Though found in many food
products, trans fats have been shown to raise levels of LDL ("bad") cholesterol and increase the
risk of heart disease. The site includes sample "Nutrition Facts" labels showing where trans fat
information will be located. http://www.cfsan.fda.gov/~dms/transfat.html
______________________________________________________________

Consumers Warned Not to Feed Infants 'Better than Formula Ultra Infant Immune Booster 117'

FDA is warning consumers that Better Than Formula Ultra Infant Immune Booster 117, sold over the
Internet as a dietary supplement, should not be fed to infants. Even though the manufacturer, NSP
Research Nutrition of Mt. Clemens, Mich., labeled the product as "a dietary supplement," FDA is
concerned that the product may be used as an infant formula as a result of its labeling. If the
product is used as formula, there are no assurances that it would support growth of infants, that it
contains nutrients essential for infants, or that is has been manufactured using good practices.
Also, the label lists a number of ingredients that have not been evaluated for safe use in infant
formula. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01009.html
______________________________________________________________
 
B

bistoury

Guest
This is why you must buy supplements that a vegetarian based and not animal based.

Jim Dumas wrote:

> Just about all the news in this FDA News Digest has some impact for us.
>

>
>
> FDA News Digest February 2, 2004
> ______________________________________________________________
>
> Expanded 'Mad Cow' Measures Designed to Boost U.S. Safeguards
>
> FDA has put in place several new public health measures designed to bolster existing "firewalls"
> against bovine spongiform encephalopathy (BSE or mad cow disease). Included is a ban on a wide
> range of bovine-derived material from human food, dietary supplements and cosmetics. FDA also is
> prohibiting certain previously allowed practices involving feed for cattle and other ruminant
> animals. http://www.hhs.gov/news/press/2004pres/20040126.html
> ______________________________________________________________
>
> 2nd FDA/Customs 'Blitz' Underscores Risks of Illegal Medicine Imports
>
> A second "blitz," conducted in late 2003 by FDA and the U.S. Customs and Border Protection agency
> to examine imported medicine shipments, has uncovered 1,728 unapproved drugs. These included
> foreign versions of FDA-approved drugs, along with drugs that have been recalled, require special
> storage, require close physician monitoring, and contain addictive controlled substances. FDA
> points to these findings as additional evidence of the serious risks posed by illegal importation
> of prescription drugs. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html
> ______________________________________________________________
>
> Administration Proposes Budget Increase for Medical Devices in FY '05
>
> As part of its fiscal year 2005 budget, the Bush administration has requested a $25.6 million
> increase over the previous fiscal year's funding for FDA's medical device program. The increase
> will help FDA reach performance goals for the prompt review of medical devices so those products
> can be marketed quickly. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01012.html
> ______________________________________________________________
>
> Guidance Aims to Improve Information on Use of Investigational Drugs
>
> FDA has issued a draft guidance designed to make further information about the use of
> investigational drugs more readily available to patients. The document is intended to help
> patients with serious or life-threatening diseases who cannot be treated with existing therapy and
> who don't meet the eligibility criteria or are otherwise unable to participate in a clinical
> trial. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01010.html
> ______________________________________________________________
>
> New Web Site Explains Required Labeling of Trans Fats in Foods
>
> A 2003 FDA rule requires food manufacturers to list on labels the amount of trans fats found in
> their foods. To help consumers understand the new labeling, which must be in place no later than
> January 2006, the FDA Center for Food Safety and Applied Nutrition has created a Web site with
> helpful background on trans fats and how to minimize them in the diet. Though found in many food
> products, trans fats have been shown to raise levels of LDL ("bad") cholesterol and increase the
> risk of heart disease. The site includes sample "Nutrition Facts" labels showing where trans fat
> information will be located. http://www.cfsan.fda.gov/~dms/transfat.html
> ______________________________________________________________
>
> Consumers Warned Not to Feed Infants 'Better than Formula Ultra Infant Immune Booster 117'
>
> FDA is warning consumers that Better Than Formula Ultra Infant Immune Booster 117, sold over the
> Internet as a dietary supplement, should not be fed to infants. Even though the manufacturer, NSP
> Research Nutrition of Mt. Clemens, Mich., labeled the product as "a dietary supplement," FDA is
> concerned that the product may be used as an infant formula as a result of its labeling. If the
> product is used as formula, there are no assurances that it would support growth of infants, that
> it contains nutrients essential for infants, or that is has been manufactured using good
> practices. Also, the label lists a number of ingredients that have not been evaluated for safe use
> in infant formula. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01009.html
> ______________________________________________________________
 
S

Sleepyman

Guest
On Mon, 02 Feb 2004 17:22:59 GMT, Jim Dumas
<[email protected]!mindspring.com> wrote:

>Just about all the news in this FDA News Digest has some impact for us.
>

Well I shall do my best to carry on, but it will be *hard*............

Sleepy

----------------------------------------------------
If you don't dissagree with me, how will I know I'm right?
----------------------------------------------------