[Reuters and the NY Times provides the bulk of the information for the
following report.]
www.reutershealth.com/archive/2002/10/17/eline/links/20021017elin033.html
The US Food and Drug Administration said on Thursday it had ordered the seizure of hundreds of bottles of a dietary supplement that the agency said falsely claimed to treat autism. US marshals raided Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories, and took away bottles of Kirkman's HypoAllergenic Taurine Capsules, the agency said. "FDA seized these products because they violate the Federal Food, Drug and Cosmetic Act," the agency said in a statement. "In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease." The FDA did admit in their statement that "to date no illnesses have been reported in association with consumption of this product." The FDA actions are apparently not in response to consumer complaints.
FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling.
"Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug." Apparently, the offending assertion comes from a description of Taurine in Kirkman's catalogue that includes the following: "Dr. Jeff Bradstreet, a physician in Palm Bay, Florida who treats autistic patients reports good success in treating autism with Taurine."
The FDA said it tracked down the company from its Internet site. In a reprint of an article that appeared in this newsletter just last Tuesday, "Stung by Courts, F.D.A. Rethinks Its Rules", the NY Times reported on the FDA's controversial practices like the raid on Kirkman's: "After losing a series of court decisions that found it in violation of the First Amendment's guarantee of freedom of speech, the Food and Drug Administration has begun a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.
"At issue is the delicate balance between a company's right to communicate with its customers and the food and drug agency's mandate to protect the public. "But the court decisions, which included a stinging rebuke from the Supreme Court in April, have prompted the agency to ask whether it may, at times, have gone too far in its insistence that it decides when scientific truth has been established and what companies can say. At issue are regulations governing everything from what a drug company can print on a T-shirt to what a sales representative can say in the privacy of a doctor's office.
"No one is advocating that false or inaccurate claims be permitted. But agency officials are asking questions like whether they can continue to prevent food companies from making health claims for their products and whether they can continue to insist that drug advertising include a full accounting of side effects and conditions that may make the drug inadvisable.
[The full NY Times article can be read at:}
http://www.nytimes.com/2002/10/15/health/policy/15FDA.html?pagewanted=1
[Kirkman Laboratories can be found at:]
http://www.kirkmanlabs.com
[Contact the FDA at:]
FDA Deputy Commissioner Lester M. Crawford email:
deputy.commissioner@fda.gov
or 5600 Fisher Lane, Rockville, MD 20857, Phone: 301-827-2410, Fax:
301-443-3100
Mr Crawford I am a parent of two autistic children, ages 21 and 15 a boy and girl. I have researched autism for the last 17 years (after finding out this diagnosis for my son), and have come to certain conclusions of how disinterested the FDA and CDC, NIH and AAP and IOM have in regards to children sentenced to autism. I say sentenced for a reason. There has been million dollar studies done on the causations of autism. For the last fifty years however, there has been no studies on the following:
1. Take a vaccinated and unvaccinated population, and find out the percentage of those who will get autism in those two groups. Nor long term safety studies, more than 2 weeks.
2. Find out what contraindicates vaccinations by testing newborns of the biomarker propensities and immune malfunctions and toxic overloads that would exclude the vulnerable to neurological sequale.
PS...we are all in essence vulnerable, just taking away the obvious vulnerability would be a start.
3. Have uninterested third party peer reviewed data that attests the validity of studies, other than Pharma companies and the Governmental bodies that pay their politicians campagins.
4. Do a study on the efficacy of supplementation of natural substances and avoidance diets to see direct evidences of improvements in children with autism. Have it done by third party review.
5. Directly show if children have Hyper IgE responses to all adjuvents and materials in vaccines, which is a true contraindication. This includes Thimerisol, 2-pe, Glutamic Acid, Foreign Dna and Proteins, and allergenic egg or other derivatives of vaccines.
I am stating this because we at VOSI and CHILDSCREEN are attempting such of these points, and have already begun your worst nightmare, that we are proving our children are sitting ducklings.
www.voicesofsafety.com (see V50.2 and V50.3)
www.childscreen.org Although I appreciate the main focus of FDA is to have safety in supplements, I often find they wield their power based upon what pharmaceutical companies need to compete with. I also feel that you have been tipped about some studies that were going to be done and funded by Kirkman Labs in regards to the systemic multi faceted neuroimmune dysfunction in our children, which would in essence change the medical diagnosis codes and reflect a bias towards treating these children with natural substances rather than pharmaceuticals. Of course becuase FDA and Pharma companies are connected nephariously, this would not be in your best interest. I am not naive to think that this raid is not motivated by pure self interest.
I am quite familiar with DSHEA laws and how they must not state cure, alleviate. fix, etc. However, DSHEA does not state that parents cannot tell others what certain things work on their autistic children. Kirkman has given tirelessly to the cause of autism. I take great offense at the bold stances you have taken against our children with autism simply because I know your motivation, and that motivation has nothing to do with safety and efficacy.
Many of our children have poor bile systems, which require TAURINE to enable them to make adequate bile, and to also handle iron appropriately and detox appropriately. Many parents look to kirkman to give them complete and accurate information, researched and proven deficiencies in our children. If you have a deficiency, your saying, this is against DSHEA?
Many neurologist give suggestions of Taurine to epleptic patients in a way to control seizures. Natural substances do have a place in the market share, as well as our children. Most of not all of the interventions that are recovering children form autism, are in fact natural supportive therapies and diets, things that FDA and Pharma companies are writhing their hands over. How dare you stop this most valuable research and effort ! How dare FDA once again treat our children as acceptible losses in disease wars. How dare you still not look at the toxicity of mercury in vaccines and not recall them!
Kathy Blanco
Dear Mr. Crawford,
If you really want to provoke the ire of the parents of the Number One Children's disability in the United States, autism, then you will continue with your misguided efforts to raid Kirkman Labs in Lake Oswego, Oregon. Personally, I view your "raid" of taurine from Kirkman Labs as harrassment to the one company who has supported the autistic community for over 20 years, when no one else paid any attention to our injured children's health needs. I think the fact that the FDA conducted this seizure is sinister, given the fact that many parents are using supplements on their children in response to noticeable and dramatic improvements after adverse vaccine reactions, whose safety is the responsibility of the FDA. Why are you raiding supplement labs that help little autistic children regain function and immune system support? My son has personally benefited from Taurine - I've seen it with my own two eyes, as have thousands and thousands of parents with late-onset autism across the country. What you really should be doing is studying why taurine is effective with children with late-onset autism. Perhaps taurine is effective because some children have been vaccine injured and it supports their immune system? I believe so.
The FDA itself in the 90's reported that no serious side effects were seen in any of 442 research studies in which human subjects were given single amino acids such as taurine. Why deprive autistic children of a nutrient often found helpful to them, when there is no evidence whatever of possible harm?
Secondly, when there are well over 100,000 deaths per year in the US from FDA approved prescription drugs, and immense damage done to children given FDA approved vaccines, why is the FDA expending precious resources seizing safe, nutritional supplements intended to help the very children harmed by these vaccines?
The more interesting question is why there were no seizures of thimerosal-laden vaccine lots after the FDA/CDC/USPHS/AAP joint announcement in July 1999 identifying the potential mercury exposure from the product. If anything should have been yanked from shelves at doctors' offices, clinics and pharmacies, that should have been
I intend to contact every media agency in our state and nationally to have your actions discussed in a public format for scientific response. I am also going to make it my personal business to contact every Senator and/or Congressman and ask them to hold you accountable.
Are you going to believe thousands and thousands of honest parents who suffer with autistic children who see improvement with taurine, or are you completely compromised by the pharmaceutical industry - which views supplements as a threat to their profits?
Tory Mead
1386 SW Orinda Way
Portland, Or. 97225
fax:503-643-4884
email to: Tory@meadgroup.com
FDA Approves Viruses To Be Sprayed On Food
Monday, September 04, 2006 -
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced in the Federal Register on Aug. 18 that it has approved the spraying of viruses on ready-to-eat (RTE) meat and poultry products.
Approved was the use of a bacteriophage preparation made from six individually purified phages to be used on RTE meat and poultry products as an antimicrobial agent against Listeria monocytogenes, which was in response to a food additive petition submitted in 2002 from Intralytix, Inc., based in Baltimore.
This is the first time the FDA has regulated the use of a phage preparation as a food additive. However, phages are currently approved in the U.S. for pesticide applications, including uses on crops. Although not currently permitted in the U.S., phages are used in other countries in antibiotic therapy.
According to the FDA, the phage preparation will be used in meat and poultry processing plants for spray application to the surface of RTE meat and poultry products, such as lunch meats and hot dogs, to kill Listeria. The phage preparation will be applied to the surface of RTE meat and poultry products at a level not to exceed 1 ml per 500 cm2 food surface just prior to packaging. These foods can become contaminated with Listeria during production, but unlike fresh meat and poultry, these foods are consumed without additional cooking that would kill the bacteria, thereby increasing the risk to Listeriosis, an infection caused by the bacteria.
Furthermore, says the FDA, L. monocytogenes is capable of multiplying at low temperatures, so it can multiply in food over time even when the food is kept in the refrigerator. Persons with increased risk to Listeriosis are pregnant women, newborns, those with a compromised immune system, and the elderly.
To support the safety of the proposed use of the Listeria-specific phage preparation, the petitioner submitted published reports from animal studies and results from the use of phages as therapies in the treatment and prevention of infections in humans caused by bacteria. Based on this and other information, FDA says that the additive does not pose any safety concerns, providing that it complies with the identity and specifications in the regulation.
In an article on NewsWithViews.com, Byron J. Richards, CCN, takes exception to the FDA approval.
He writes, "The FDA wants you to believe it will be safe to consume these viruses every day for the rest of your life with no adverse health effects. This is a monumental announcement by the FDA, indicating they are throwing all caution to the wind regarding the safety of our food supply."
Richards asks, "Are you willing to stand in line for a virus-laden sandwich? How do you like the idea of buying virus-infested food for your family?"
Richards notes that live viruses will be sprayed on foods such as cold cuts, sausages, hot dogs, sliced turkey, and chicken, and that the FDA "plans to use one infectious organism to fight another."
"The carnage of battle will end up in your digestive tract along with victorious live viruses, which the FDA assures us will not attack human cells. However, they cannot possibly be certain the viruses will not attack the friendly bacteria that make up the lining of your digestive tract," he noted, adding that the FDA approval was based on scant human testing.
In his article, Richards contends that the FDA-approved cocktail actually contains six different viruses intended to attack one strain of bacteria, resulting in "massive viral replication inside the bacteria, until such point that the bacteria simply bursts," which causes significant production of bacterial poisons called "endotoxins," and, ultimately, "these, along with the victorious live viruses, will be on the food that will be eaten."
INFO:
http://www.newswithviews.com/Richards/byron7.htm
http://www.cfsan.fda.gov/%7Edms/opabacqa.html
following report.]
www.reutershealth.com/archive/2002/10/17/eline/links/20021017elin033.html
The US Food and Drug Administration said on Thursday it had ordered the seizure of hundreds of bottles of a dietary supplement that the agency said falsely claimed to treat autism. US marshals raided Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories, and took away bottles of Kirkman's HypoAllergenic Taurine Capsules, the agency said. "FDA seized these products because they violate the Federal Food, Drug and Cosmetic Act," the agency said in a statement. "In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease." The FDA did admit in their statement that "to date no illnesses have been reported in association with consumption of this product." The FDA actions are apparently not in response to consumer complaints.
FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling.
"Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug." Apparently, the offending assertion comes from a description of Taurine in Kirkman's catalogue that includes the following: "Dr. Jeff Bradstreet, a physician in Palm Bay, Florida who treats autistic patients reports good success in treating autism with Taurine."
The FDA said it tracked down the company from its Internet site. In a reprint of an article that appeared in this newsletter just last Tuesday, "Stung by Courts, F.D.A. Rethinks Its Rules", the NY Times reported on the FDA's controversial practices like the raid on Kirkman's: "After losing a series of court decisions that found it in violation of the First Amendment's guarantee of freedom of speech, the Food and Drug Administration has begun a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.
"At issue is the delicate balance between a company's right to communicate with its customers and the food and drug agency's mandate to protect the public. "But the court decisions, which included a stinging rebuke from the Supreme Court in April, have prompted the agency to ask whether it may, at times, have gone too far in its insistence that it decides when scientific truth has been established and what companies can say. At issue are regulations governing everything from what a drug company can print on a T-shirt to what a sales representative can say in the privacy of a doctor's office.
"No one is advocating that false or inaccurate claims be permitted. But agency officials are asking questions like whether they can continue to prevent food companies from making health claims for their products and whether they can continue to insist that drug advertising include a full accounting of side effects and conditions that may make the drug inadvisable.
[The full NY Times article can be read at:}
http://www.nytimes.com/2002/10/15/health/policy/15FDA.html?pagewanted=1
[Kirkman Laboratories can be found at:]
http://www.kirkmanlabs.com
[Contact the FDA at:]
FDA Deputy Commissioner Lester M. Crawford email:
deputy.commissioner@fda.gov
or 5600 Fisher Lane, Rockville, MD 20857, Phone: 301-827-2410, Fax:
301-443-3100
Mr Crawford I am a parent of two autistic children, ages 21 and 15 a boy and girl. I have researched autism for the last 17 years (after finding out this diagnosis for my son), and have come to certain conclusions of how disinterested the FDA and CDC, NIH and AAP and IOM have in regards to children sentenced to autism. I say sentenced for a reason. There has been million dollar studies done on the causations of autism. For the last fifty years however, there has been no studies on the following:
1. Take a vaccinated and unvaccinated population, and find out the percentage of those who will get autism in those two groups. Nor long term safety studies, more than 2 weeks.
2. Find out what contraindicates vaccinations by testing newborns of the biomarker propensities and immune malfunctions and toxic overloads that would exclude the vulnerable to neurological sequale.
PS...we are all in essence vulnerable, just taking away the obvious vulnerability would be a start.
3. Have uninterested third party peer reviewed data that attests the validity of studies, other than Pharma companies and the Governmental bodies that pay their politicians campagins.
4. Do a study on the efficacy of supplementation of natural substances and avoidance diets to see direct evidences of improvements in children with autism. Have it done by third party review.
5. Directly show if children have Hyper IgE responses to all adjuvents and materials in vaccines, which is a true contraindication. This includes Thimerisol, 2-pe, Glutamic Acid, Foreign Dna and Proteins, and allergenic egg or other derivatives of vaccines.
I am stating this because we at VOSI and CHILDSCREEN are attempting such of these points, and have already begun your worst nightmare, that we are proving our children are sitting ducklings.
www.voicesofsafety.com (see V50.2 and V50.3)
www.childscreen.org Although I appreciate the main focus of FDA is to have safety in supplements, I often find they wield their power based upon what pharmaceutical companies need to compete with. I also feel that you have been tipped about some studies that were going to be done and funded by Kirkman Labs in regards to the systemic multi faceted neuroimmune dysfunction in our children, which would in essence change the medical diagnosis codes and reflect a bias towards treating these children with natural substances rather than pharmaceuticals. Of course becuase FDA and Pharma companies are connected nephariously, this would not be in your best interest. I am not naive to think that this raid is not motivated by pure self interest.
I am quite familiar with DSHEA laws and how they must not state cure, alleviate. fix, etc. However, DSHEA does not state that parents cannot tell others what certain things work on their autistic children. Kirkman has given tirelessly to the cause of autism. I take great offense at the bold stances you have taken against our children with autism simply because I know your motivation, and that motivation has nothing to do with safety and efficacy.
Many of our children have poor bile systems, which require TAURINE to enable them to make adequate bile, and to also handle iron appropriately and detox appropriately. Many parents look to kirkman to give them complete and accurate information, researched and proven deficiencies in our children. If you have a deficiency, your saying, this is against DSHEA?
Many neurologist give suggestions of Taurine to epleptic patients in a way to control seizures. Natural substances do have a place in the market share, as well as our children. Most of not all of the interventions that are recovering children form autism, are in fact natural supportive therapies and diets, things that FDA and Pharma companies are writhing their hands over. How dare you stop this most valuable research and effort ! How dare FDA once again treat our children as acceptible losses in disease wars. How dare you still not look at the toxicity of mercury in vaccines and not recall them!
Kathy Blanco
Dear Mr. Crawford,
If you really want to provoke the ire of the parents of the Number One Children's disability in the United States, autism, then you will continue with your misguided efforts to raid Kirkman Labs in Lake Oswego, Oregon. Personally, I view your "raid" of taurine from Kirkman Labs as harrassment to the one company who has supported the autistic community for over 20 years, when no one else paid any attention to our injured children's health needs. I think the fact that the FDA conducted this seizure is sinister, given the fact that many parents are using supplements on their children in response to noticeable and dramatic improvements after adverse vaccine reactions, whose safety is the responsibility of the FDA. Why are you raiding supplement labs that help little autistic children regain function and immune system support? My son has personally benefited from Taurine - I've seen it with my own two eyes, as have thousands and thousands of parents with late-onset autism across the country. What you really should be doing is studying why taurine is effective with children with late-onset autism. Perhaps taurine is effective because some children have been vaccine injured and it supports their immune system? I believe so.
The FDA itself in the 90's reported that no serious side effects were seen in any of 442 research studies in which human subjects were given single amino acids such as taurine. Why deprive autistic children of a nutrient often found helpful to them, when there is no evidence whatever of possible harm?
Secondly, when there are well over 100,000 deaths per year in the US from FDA approved prescription drugs, and immense damage done to children given FDA approved vaccines, why is the FDA expending precious resources seizing safe, nutritional supplements intended to help the very children harmed by these vaccines?
The more interesting question is why there were no seizures of thimerosal-laden vaccine lots after the FDA/CDC/USPHS/AAP joint announcement in July 1999 identifying the potential mercury exposure from the product. If anything should have been yanked from shelves at doctors' offices, clinics and pharmacies, that should have been
I intend to contact every media agency in our state and nationally to have your actions discussed in a public format for scientific response. I am also going to make it my personal business to contact every Senator and/or Congressman and ask them to hold you accountable.
Are you going to believe thousands and thousands of honest parents who suffer with autistic children who see improvement with taurine, or are you completely compromised by the pharmaceutical industry - which views supplements as a threat to their profits?
Tory Mead
1386 SW Orinda Way
Portland, Or. 97225
fax:503-643-4884
email to: Tory@meadgroup.com
FDA Approves Viruses To Be Sprayed On Food
Monday, September 04, 2006 -
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced in the Federal Register on Aug. 18 that it has approved the spraying of viruses on ready-to-eat (RTE) meat and poultry products.
Approved was the use of a bacteriophage preparation made from six individually purified phages to be used on RTE meat and poultry products as an antimicrobial agent against Listeria monocytogenes, which was in response to a food additive petition submitted in 2002 from Intralytix, Inc., based in Baltimore.
This is the first time the FDA has regulated the use of a phage preparation as a food additive. However, phages are currently approved in the U.S. for pesticide applications, including uses on crops. Although not currently permitted in the U.S., phages are used in other countries in antibiotic therapy.
According to the FDA, the phage preparation will be used in meat and poultry processing plants for spray application to the surface of RTE meat and poultry products, such as lunch meats and hot dogs, to kill Listeria. The phage preparation will be applied to the surface of RTE meat and poultry products at a level not to exceed 1 ml per 500 cm2 food surface just prior to packaging. These foods can become contaminated with Listeria during production, but unlike fresh meat and poultry, these foods are consumed without additional cooking that would kill the bacteria, thereby increasing the risk to Listeriosis, an infection caused by the bacteria.
Furthermore, says the FDA, L. monocytogenes is capable of multiplying at low temperatures, so it can multiply in food over time even when the food is kept in the refrigerator. Persons with increased risk to Listeriosis are pregnant women, newborns, those with a compromised immune system, and the elderly.
To support the safety of the proposed use of the Listeria-specific phage preparation, the petitioner submitted published reports from animal studies and results from the use of phages as therapies in the treatment and prevention of infections in humans caused by bacteria. Based on this and other information, FDA says that the additive does not pose any safety concerns, providing that it complies with the identity and specifications in the regulation.
In an article on NewsWithViews.com, Byron J. Richards, CCN, takes exception to the FDA approval.
He writes, "The FDA wants you to believe it will be safe to consume these viruses every day for the rest of your life with no adverse health effects. This is a monumental announcement by the FDA, indicating they are throwing all caution to the wind regarding the safety of our food supply."
Richards asks, "Are you willing to stand in line for a virus-laden sandwich? How do you like the idea of buying virus-infested food for your family?"
Richards notes that live viruses will be sprayed on foods such as cold cuts, sausages, hot dogs, sliced turkey, and chicken, and that the FDA "plans to use one infectious organism to fight another."
"The carnage of battle will end up in your digestive tract along with victorious live viruses, which the FDA assures us will not attack human cells. However, they cannot possibly be certain the viruses will not attack the friendly bacteria that make up the lining of your digestive tract," he noted, adding that the FDA approval was based on scant human testing.
In his article, Richards contends that the FDA-approved cocktail actually contains six different viruses intended to attack one strain of bacteria, resulting in "massive viral replication inside the bacteria, until such point that the bacteria simply bursts," which causes significant production of bacterial poisons called "endotoxins," and, ultimately, "these, along with the victorious live viruses, will be on the food that will be eaten."
INFO:
http://www.newswithviews.com/Richards/byron7.htm
http://www.cfsan.fda.gov/%7Edms/opabacqa.html
