Tuesday, November 4, 2014
Salina, Kansas - Fluoride on the Nov. 4th ballot - TV Commercials + More
Fluoride Debate - October 20, 2014, Newsradio 1150 KSAL
The Truth About Fluoride with Dr. Charles Hinshaw and Dr. Ron Hunninghake
Ed Asner: "Fluoride Should Be a Choice, Not a Mandate"
Truth about Fluoride hits Mainstream TV in Australia 2010-8-5 its a poison Solution $10 Billion Lien
Friday, September 5, 2014
Newest info on the battle to keep DSHEA
Negotiating the New Dietary Ingredient Notification Process
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires that manufacturers and distributors who wish to market dietary supplements that contain new dietary ingredients (NDI) notify FDA about these ingredients. These are ingredients that were not marketed in the United States prior to Oct. 15, 1994—the date that DSHEA became law. There is, however, no official list of “old dietary ingredients" not requiring notification, and it is up to ingredient suppliers to ensure that any notification requirements are met. Whether an ingredient is actually new can be a difficult question.
When an ingredient supplier determines that notification is necessary, DSHEA requires the material submitted to FDA demonstrates that there is a “reasonable expectation of safety" for its intended use. To date, the only real guidance provided by FDA on how this standard can be satisfied was found in a July 2011 guidance document, which was subsequently withdrawn for revision following nearly unanimous objection by the trade and members of Congress.
Even if the ingredient is new, no notification is required if that specific ingredient has been “present in the food supply as an article used for food in a form in which the food has not been chemically altered." Again, exactly what constitutes “chemically altered" can be a difficult question, though some insight can be gleaned from a review of FDA’s June 2014 guidance discussing changes in manufacturing processes for food and the need for additional regulatory notifications.
Each of these issues has contributed to a situation where FDA finds approximately 75 percent of the NDI notifications it receives fail to satisfy the “reasonable expectation of safety" standard. While this is an alarming failure rate, companies that take the time to understand why others have failed and what those who have succeeded have in common stand a good chance of having their NDI notification filed by FDA without substantive objection.
It is important to remember that the NDI Notification process is just that: a premarket notification of intent to sell. Seventy-five days after a notification is submitted, the statutory requirement has been satisfied, even if FDA has substantive questions concerning safety. Whether it is wise to go to market when FDA has such questions is another question.
Is an Ingredient Really “New?"
While there is no official list of “old dietary ingredients, industry trade associations such as the United Natural Products Alliance (UNPA) and Council for Responsible Nutrition (CRN) have submitted lists of “grandfathered" ingredients to FDA. While these lists have limitations such as not identifying extraction methods and solvents, they can provide a substantive starting point for building a case that an ingredient was marketed prior to the passage of DSHEA and not subject to the NDI notification process. The American Herbal Products Association’s (AHPA) “Herbs of Commerce" was published in 1992 and provides a list of all common and scientific names of botanicals that were sold in the United States at that time. This publication, while not accepted as authoritative by FDA, is generally recognized as strong evidence that a botanical was marketed in the United States prior to Oct. 15, 1994.
How to Show “Reasonably Expected to Be Safe?"
Satisfying this standard can be a daunting challenge. FDA has never provided a clear, concise statement describing the data set that will meet this standard. What we do know, however, is that a significant toxicological profile along with a coherent explanation of why the ingredient is safe for use in dietary supplements must be provided. While the standard of certainty required for a “reasonable expectation of safety" is somewhat less that needed to satisfy the GRAS (generally recognized as safe) standard for food ingredients, companies that attempt to negotiate the NDI notification process on their own are almost certainly doomed to failure. Companies that assemble a team that includes qualified toxicologists and counsel have a far greater chance of success than those that try and go it on their own.
The best way to understand what FDA is looking for to satisfy this standard is to review both successful and unsuccessful NDI notifications. FDA’s efforts to maintain a public docket allows public access to this information (the most recent entry is for NDI notification number 744 from May 2012). The AHPA NDI database has full reports through NDI notification number 779 and reports of results through notification number 820. The AHPA database also has a much more user friendly search function and a table of contents that provides easily accessible information on whether FDA stated any substantive objection to the notification.
Present in the Food Supply?
Often, when NDI notification requirement is discussed, the question is generally framed as “Was the substance present in the food supply in a form not chemically altered?" By pushing the discussion in this direction, companies that do not want to deal with the notification process have been able to bypass the “as an article used for food" clause in the law. However, the inclusion of this clause in the law means the answer to the question of whether a NDI notification is required hinges on whether the particular ingredient has been intentionally consumed as food—=and not merely been consumed because it happens to be a constituent of a food item.
Successful NDI Notification
Aside from assembling a qualified team of experts to support a company’s work, it is vitally important to understand why some NDI notifications succeed and nearly three-fourths of the others fail. According to Corey Hilmas, M.D., senior vice president of scientific and regulatory affairs for the Natural Products Association (NPA), and the person who oversaw the NDI program at FDA until June 2014, key factors are repeatedly seen in both successful and unsuccessful Notifications.
For unsuccessful submissions, these include:
· Use of data from another company’s product rather than data on the specific ingredient that is the subject of the submission;
· Failing to ensure that a company has met all regulatory requirements for a notification including translating foreign language scientific articles submitted in support of the notification;
· Providing evidence of “history of use" that is not relevant to the ingredient submitted, including considerations relating to the serving size of the ingredient that users are expected to consume; and
· Not including information on the fermentation media for microbial ingredients.
For successful submissions:
· The company has had met with the FDA NDI review team prior to submitting a notification;
· Understanding FDA’s comments following an unsuccessful notification and resubmitting after those concerns are fully addressed; and
· Testing a high enough dose to determine the no-observed-adverse-effect level to show that the serving level or dose on the label has sufficient safety margin in humans.
Companies that submit poor, rushed and/or incomplete data packages in support of their NDI notifications are certain to receive a letter from FDA stating that the agency disagrees with the company’s belief that their ingredient is safe. However, with the proper resources, commitment to thorough science, the right team of expert consultants and a thorough understanding to the process, a company should be able to successfully negotiate the NDI notification process.
For more tips to help understand laws regulating the supplement and functional foods market, visit INSIDER’s Regulatory Content Library. Also, hear more from Ullman during the panel discussion, "Current Issues Regarding New Dietary Ingredient (NDI) Notifications," on Thursday, Oct. 8, at 9 a.m., during SupplySide West, Las Vegas.
Marc Ullman is a partner at the New York-based law firm Ullman, Shapiro & Ullman LLP.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires that manufacturers and distributors who wish to market dietary supplements that contain new dietary ingredients (NDI) notify FDA about these ingredients. These are ingredients that were not marketed in the United States prior to Oct. 15, 1994—the date that DSHEA became law. There is, however, no official list of “old dietary ingredients" not requiring notification, and it is up to ingredient suppliers to ensure that any notification requirements are met. Whether an ingredient is actually new can be a difficult question.
When an ingredient supplier determines that notification is necessary, DSHEA requires the material submitted to FDA demonstrates that there is a “reasonable expectation of safety" for its intended use. To date, the only real guidance provided by FDA on how this standard can be satisfied was found in a July 2011 guidance document, which was subsequently withdrawn for revision following nearly unanimous objection by the trade and members of Congress.
Even if the ingredient is new, no notification is required if that specific ingredient has been “present in the food supply as an article used for food in a form in which the food has not been chemically altered." Again, exactly what constitutes “chemically altered" can be a difficult question, though some insight can be gleaned from a review of FDA’s June 2014 guidance discussing changes in manufacturing processes for food and the need for additional regulatory notifications.
Each of these issues has contributed to a situation where FDA finds approximately 75 percent of the NDI notifications it receives fail to satisfy the “reasonable expectation of safety" standard. While this is an alarming failure rate, companies that take the time to understand why others have failed and what those who have succeeded have in common stand a good chance of having their NDI notification filed by FDA without substantive objection.
It is important to remember that the NDI Notification process is just that: a premarket notification of intent to sell. Seventy-five days after a notification is submitted, the statutory requirement has been satisfied, even if FDA has substantive questions concerning safety. Whether it is wise to go to market when FDA has such questions is another question.
Is an Ingredient Really “New?"
While there is no official list of “old dietary ingredients, industry trade associations such as the United Natural Products Alliance (UNPA) and Council for Responsible Nutrition (CRN) have submitted lists of “grandfathered" ingredients to FDA. While these lists have limitations such as not identifying extraction methods and solvents, they can provide a substantive starting point for building a case that an ingredient was marketed prior to the passage of DSHEA and not subject to the NDI notification process. The American Herbal Products Association’s (AHPA) “Herbs of Commerce" was published in 1992 and provides a list of all common and scientific names of botanicals that were sold in the United States at that time. This publication, while not accepted as authoritative by FDA, is generally recognized as strong evidence that a botanical was marketed in the United States prior to Oct. 15, 1994.
How to Show “Reasonably Expected to Be Safe?"
Satisfying this standard can be a daunting challenge. FDA has never provided a clear, concise statement describing the data set that will meet this standard. What we do know, however, is that a significant toxicological profile along with a coherent explanation of why the ingredient is safe for use in dietary supplements must be provided. While the standard of certainty required for a “reasonable expectation of safety" is somewhat less that needed to satisfy the GRAS (generally recognized as safe) standard for food ingredients, companies that attempt to negotiate the NDI notification process on their own are almost certainly doomed to failure. Companies that assemble a team that includes qualified toxicologists and counsel have a far greater chance of success than those that try and go it on their own.
The best way to understand what FDA is looking for to satisfy this standard is to review both successful and unsuccessful NDI notifications. FDA’s efforts to maintain a public docket allows public access to this information (the most recent entry is for NDI notification number 744 from May 2012). The AHPA NDI database has full reports through NDI notification number 779 and reports of results through notification number 820. The AHPA database also has a much more user friendly search function and a table of contents that provides easily accessible information on whether FDA stated any substantive objection to the notification.
Present in the Food Supply?
Often, when NDI notification requirement is discussed, the question is generally framed as “Was the substance present in the food supply in a form not chemically altered?" By pushing the discussion in this direction, companies that do not want to deal with the notification process have been able to bypass the “as an article used for food" clause in the law. However, the inclusion of this clause in the law means the answer to the question of whether a NDI notification is required hinges on whether the particular ingredient has been intentionally consumed as food—=and not merely been consumed because it happens to be a constituent of a food item.
Successful NDI Notification
Aside from assembling a qualified team of experts to support a company’s work, it is vitally important to understand why some NDI notifications succeed and nearly three-fourths of the others fail. According to Corey Hilmas, M.D., senior vice president of scientific and regulatory affairs for the Natural Products Association (NPA), and the person who oversaw the NDI program at FDA until June 2014, key factors are repeatedly seen in both successful and unsuccessful Notifications.
For unsuccessful submissions, these include:
· Use of data from another company’s product rather than data on the specific ingredient that is the subject of the submission;
· Failing to ensure that a company has met all regulatory requirements for a notification including translating foreign language scientific articles submitted in support of the notification;
· Providing evidence of “history of use" that is not relevant to the ingredient submitted, including considerations relating to the serving size of the ingredient that users are expected to consume; and
· Not including information on the fermentation media for microbial ingredients.
For successful submissions:
· The company has had met with the FDA NDI review team prior to submitting a notification;
· Understanding FDA’s comments following an unsuccessful notification and resubmitting after those concerns are fully addressed; and
· Testing a high enough dose to determine the no-observed-adverse-effect level to show that the serving level or dose on the label has sufficient safety margin in humans.
Companies that submit poor, rushed and/or incomplete data packages in support of their NDI notifications are certain to receive a letter from FDA stating that the agency disagrees with the company’s belief that their ingredient is safe. However, with the proper resources, commitment to thorough science, the right team of expert consultants and a thorough understanding to the process, a company should be able to successfully negotiate the NDI notification process.
For more tips to help understand laws regulating the supplement and functional foods market, visit INSIDER’s Regulatory Content Library. Also, hear more from Ullman during the panel discussion, "Current Issues Regarding New Dietary Ingredient (NDI) Notifications," on Thursday, Oct. 8, at 9 a.m., during SupplySide West, Las Vegas.
Marc Ullman is a partner at the New York-based law firm Ullman, Shapiro & Ullman LLP.
Thursday, July 17, 2014
Sunday, June 15, 2014
Wednesday, May 28, 2014
Friday, March 7, 2014
New Zealand Court Verdict on Fluoride Is In.....and it came from Illinois over in the USA???
Fluoridation court ruling in New Zealand
http://doubtfulnews.com/2014/03/fluoridation-court-ruling-in-new-zealand/?utm_source=rss&utm_medium=rss&utm_campaign=fluoridation-court-ruling-in-new-zealand
by Sharon Hill • March 7, 2014 • 2 Comments
Fluoridation is a reasonable activity for the common good. It is not medication, says a new ruling.
Fluoridation a local government issue: court.
The High Court has affirmed the right of local government to fluoridate drinking water.
In a decision released today, Justice Rodney Hansen threw out claims from anti-fluoride campaigners who disputed the South Taranaki District Council’s decision add fluoride to drinking water in Waverley and Patea.
The campaign group, New Health New Zealand, applied to review the council’s decision.
The court rejected the application on all grounds.
Justice Hansen quoted a decision from a case in the Illinois Supreme Court: “Fluoridation programmes, even if considered to be medication in the true sense of the word, are so necessarily and reasonably related to the common good that the rights of the individual must give way.”
He drew analogies between fluoridation and the use of chlorine, which is an accepted public health treatment of drinking water.
David Sloan, Chairman of New Health New Zealand Inc, said in a statement that New Health “respectfully disagrees” with the High Court’s decision and will appeal.
Opponents say that fluoridation is a medical treatment and should not be imposed on citizens since there are problems with dosage and individual needs as well as consent. However, this process is widespread and demonstrable SAFE and EFFECTIVE. Yes there are issues but the comparison to chlorine and iodine addition makes some sense. You can always buy bottled water without fluoride. Many people have chosen that route for various reasons. Is this controversy settled? Nope. Not by any means. It’s not a simple one.
The High Court has affirmed the right of local government to fluoridate drinking water.
In a decision released today, Justice Rodney Hansen threw out claims from anti-fluoride campaigners who disputed the South Taranaki District Council's decision add fluoride to drinking water in Waverley and Patea.
The campaign group, New Health New Zealand, applied to review the council's decision.
The court rejected the application on all grounds.
Justice Hansen said the purpose of local government was to enable democratic local decision-making and action by and on behalf of communities.
It was within the council's legal power, and right mind, to add fluoride to drinking water, he said.
Murray Thomson, professor of dental epidemiology and public health at the University of Otago, said the judgment was "sensible" and "affirmed the important role of community water fluoridation in keeping New Zealanders healthy".
Justice Hansen quoted a decision from a case in the Illinois Supreme Court: "Fluoridation programmes, even if considered to be medication in the true sense of the word, are so necessarily and reasonably related to the common good that the rights of the individual must give way."
He drew analogies between fluoridation and the use of chlorine, which is an accepted public health treatment of drinking water.
"The addition of iodine to salt, folic acid to bread and the pasteurisation of milk are, in my view, equivalent intervention made to achieve public health benefits by means which could not be achieved nearly as effectively by medicating the populace individually."
A person who did not want to consume fluoride could choose to supply their own drinking water or filter out fluoride.
David Sloan, Chairman of New Health New Zealand Inc, said in a statement that New Health "respectfully disagrees" with the High Court’s decision and will appeal.
In particular, New Health disagrees with the view that fluoridation is not a medical treatment for the purposes of the Bill of Rights.
"In today’s consumer-enlightened era, people should have the choice whether or not to ingest something that has a claimed therapeutic purpose," Sloan said.
"Delivering medication this way is contrary to medical ethics as it fails to control for dose, individual need and sensitivities, and overrides individual consent."
Fluoride was first added to New Zealand drinking water in Hastings in 1954. Forty-eight per cent of the New Zealand population now live in communities with water fluoridation programmes.
Jonathan Broadbent, a public health dentistry specialist at the University of Otago, said: "The decision reaffirms the legal basis of the scientifically sound practice of community water fluoridation.
"The people of New Zealand have the right to benefit from this effective public health practice. Community water fluoridation benefits everyone, especially those New Zealanders who are disadvantaged."
The naturally occurring fluoride level in New Zealand water supplies is usually between 0.1 parts per million and 0.3ppm. Fluoride content for drinking water in New Zealand is in the range of 0.7 - 1.0ppm. The maximum acceptable value for fluoride is 1.5ppm (parts per million).
- © Fairfax NZ News
http://doubtfulnews.com/2014/03/fluoridation-court-ruling-in-new-zealand/?utm_source=rss&utm_medium=rss&utm_campaign=fluoridation-court-ruling-in-new-zealand
by Sharon Hill • March 7, 2014 • 2 Comments
Fluoridation is a reasonable activity for the common good. It is not medication, says a new ruling.
Fluoridation a local government issue: court.
The High Court has affirmed the right of local government to fluoridate drinking water.
In a decision released today, Justice Rodney Hansen threw out claims from anti-fluoride campaigners who disputed the South Taranaki District Council’s decision add fluoride to drinking water in Waverley and Patea.
The campaign group, New Health New Zealand, applied to review the council’s decision.
The court rejected the application on all grounds.
Justice Hansen quoted a decision from a case in the Illinois Supreme Court: “Fluoridation programmes, even if considered to be medication in the true sense of the word, are so necessarily and reasonably related to the common good that the rights of the individual must give way.”
He drew analogies between fluoridation and the use of chlorine, which is an accepted public health treatment of drinking water.
David Sloan, Chairman of New Health New Zealand Inc, said in a statement that New Health “respectfully disagrees” with the High Court’s decision and will appeal.
Opponents say that fluoridation is a medical treatment and should not be imposed on citizens since there are problems with dosage and individual needs as well as consent. However, this process is widespread and demonstrable SAFE and EFFECTIVE. Yes there are issues but the comparison to chlorine and iodine addition makes some sense. You can always buy bottled water without fluoride. Many people have chosen that route for various reasons. Is this controversy settled? Nope. Not by any means. It’s not a simple one.
Fluoridation a local government issue: court
KATIE KENNY
Last updated 17:53 07/03/2014
The High Court has affirmed the right of local government to fluoridate drinking water.
In a decision released today, Justice Rodney Hansen threw out claims from anti-fluoride campaigners who disputed the South Taranaki District Council's decision add fluoride to drinking water in Waverley and Patea.
The campaign group, New Health New Zealand, applied to review the council's decision.
The court rejected the application on all grounds.
Justice Hansen said the purpose of local government was to enable democratic local decision-making and action by and on behalf of communities.
It was within the council's legal power, and right mind, to add fluoride to drinking water, he said.
Murray Thomson, professor of dental epidemiology and public health at the University of Otago, said the judgment was "sensible" and "affirmed the important role of community water fluoridation in keeping New Zealanders healthy".
Justice Hansen quoted a decision from a case in the Illinois Supreme Court: "Fluoridation programmes, even if considered to be medication in the true sense of the word, are so necessarily and reasonably related to the common good that the rights of the individual must give way."
He drew analogies between fluoridation and the use of chlorine, which is an accepted public health treatment of drinking water.
"The addition of iodine to salt, folic acid to bread and the pasteurisation of milk are, in my view, equivalent intervention made to achieve public health benefits by means which could not be achieved nearly as effectively by medicating the populace individually."
A person who did not want to consume fluoride could choose to supply their own drinking water or filter out fluoride.
David Sloan, Chairman of New Health New Zealand Inc, said in a statement that New Health "respectfully disagrees" with the High Court’s decision and will appeal.
In particular, New Health disagrees with the view that fluoridation is not a medical treatment for the purposes of the Bill of Rights.
"In today’s consumer-enlightened era, people should have the choice whether or not to ingest something that has a claimed therapeutic purpose," Sloan said.
"Delivering medication this way is contrary to medical ethics as it fails to control for dose, individual need and sensitivities, and overrides individual consent."
Fluoride was first added to New Zealand drinking water in Hastings in 1954. Forty-eight per cent of the New Zealand population now live in communities with water fluoridation programmes.
Jonathan Broadbent, a public health dentistry specialist at the University of Otago, said: "The decision reaffirms the legal basis of the scientifically sound practice of community water fluoridation.
"The people of New Zealand have the right to benefit from this effective public health practice. Community water fluoridation benefits everyone, especially those New Zealanders who are disadvantaged."
The naturally occurring fluoride level in New Zealand water supplies is usually between 0.1 parts per million and 0.3ppm. Fluoride content for drinking water in New Zealand is in the range of 0.7 - 1.0ppm. The maximum acceptable value for fluoride is 1.5ppm (parts per million).
- © Fairfax NZ News
Friday, February 21, 2014
Voters in 1859 proposed to divide California in half - now 2014 voters are proposing to divide California into 6 different states - What do you think about it?
Plan to split California into six states gains ground
http://news.yahoo.com/plan-split-california-six-states-gains-ground-222139687.html
In 2012, California was tied with Russia and Italy -- all with a GDP of approximately $2.0 trillion -- for eighth place in world GDP rankings, according to the Center for Continuing Study of the California Economy.
The proposal would create a state out of Silicon Valley, home to tech giants Google, Facebook and Apple. It would also create South California, which would include Hollywood and the US entertainment industry.
http://news.yahoo.com/plan-split-california-six-states-gains-ground-222139687.html
Los Angeles (United States) (AFP) - A plan to divide California into six separate US states is closer to making it on to a November ballot, with organizers gaining approval to collect signatures.
The seemingly far-fetched initiative, sponsored by Silicon Valley venture capitalist Tim Draper, claims "political representation of California's diverse population and economies has rendered the state nearly ungovernable."
And on Tuesday, the California Secretary of State's office gave the movement a boost, saying that proponents "may begin collecting petition signatures."
At least 807,615 voters -- representing eight percent of the total ballots cast for governor in the 2010 election -- will need to sign the petition by July 18 to make it on to the ballot.
The proposal aims to split the state -- America's most populous with around 38 million inhabitants -- into "six smaller state governments, while preserving the historical boundaries of the various counties, cities and towns."
In 2012, California was tied with Russia and Italy -- all with a GDP of approximately $2.0 trillion -- for eighth place in world GDP rankings, according to the Center for Continuing Study of the California Economy.
The proposal would create a state out of Silicon Valley, home to tech giants Google, Facebook and Apple. It would also create South California, which would include Hollywood and the US entertainment industry.
West California, Central California, North California, and Jefferson in the most northern part of the state, would also go it alone.
According to the proposal, voters overwhelming approved dividing California in two in 1859, but Congress did not act due to the Civil War.
Draper, who has funded more than 400 companies including Skype and Baidu, is founder of venture capital firm Draper Fisher Jurvetson in Menlo Park, California.
- Politics & Government
- California
- California Secretary of State
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