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New bill to overhaul DSHEA regulation of herbal supplements
11/4/2003-
Legislation that would significantly increase the costs of marketing herbal dietary supplements was introduced in the House of Representatives last week, designed to better prevent adverse events caused by herbal ingredients.
The bill, called the Dietary Supplement Access and Awareness Act (HR 3377), is sponsored by Susan Davis (D-CA), Henry Waxman (D-CA) and John Dingell (D-MI). It excludes dietary supplements that consist only of vitamin and/or mineral ingredients but applies to other ingredients defined by the Dietary Supplement Health and Education Act (DSHEA), including herbs, amino acids, and the ingredients described in DSHEA as 'dietary substance(s) used by man to supplement the diet by increasing the total dietary intake'.
The legislation would require all manufacturers and processors of thementioned supplements to provide a list of all their products and all active ingredients used, and the labeling of each product to the FDA, to be updated every six months.
It also demands that manufacturers and distributors of these products, unless specifically waived by FDA, report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records.
Finally the FDA would be given new authority to react to safety risks. It would be able to order a manufacturer to conduct postmarket surveillance of supplements for which there is "a reasonable possibility...[of] serious adverse health consequences'. FDA could also require a manufacturer to demonstrate safety of a supplement if the agency has 'reasonable grounds for believing' that the supplement presents a significant or unreasonable risk of illness or injury or is an imminent hazard to public health or safety.
New authority for FDA to establish criteria for determining that a supplement may pose a significant risk to minors and for deeming the act of selling such product to minors as misbranding has also been tabled.
"AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements but it appears as if this bill fails to provide the protections to industry that are established by law for adverse event submissions by drug companies," said Michael McGuffin, president of the American Herbal Products Association (AHPA).
"Also, the idea of a product registration is one that may deserve discussion and cost evaluation, but Representative Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs. In addition, the subjective nature of FDA decision making for each of their proposed new authorities must be challenged," he added.
In addition, the bill would provide funding to educate health professionals on the importance of reporting adverse health experiences associated with dietary supplements to FDA, and to educate consumers about the importance of informing their health professionals of the dietary supplements and drugs they are taking.
It would also strike language from the current law, as amended by DSHEA, which states that the burden of proof is on the federal government for showing that a supplement is adulterated.
The bill has been referred to the House Committee on Energy andCommerce.
Sunday, May 11, 2008
Herbal remedy industry wary of bill!!!
Monday » May 12 » 2008
Herbal remedy industry wary of bill
Sonja Puzic
Canwest News Service
Sunday, May 11, 2008
WINDSOR, Ont. - Some producers and vendors of natural health products are concerned their livelihoods may be at risk if recently introduced amendments to the federal Food and Drugs Act become law.
Bill C-51, tabled by the Conservative government in early April, focuses on the safety and monitoring of drugs, food and health products, from clinical testing to the way they are marketed to Canadians. If passed, it would give the federal government more power to order recalls of unsafe products and impose harsher fines for safety violations.
Bill C-51 has been touted as a much-needed overhaul of Canada's weak consumer-protection legislation.
But critics say it would also over-regulate the sale and use of natural health products, which include vitamins, minerals, homeopathic medicines and herbal remedies. By replacing the word "drug" with "therapeutic product" throughout the act, Health Canada would have broader power over the natural health product industry.
Some say the proposed legislation will limit consumers' choices, crack down on private growers of herbs and medicinal plants and eventually outlaw products that have been used by many for decades.
Health Canada says Bill C-51 is not going after the natural health product industry, but Windsor herbalist Anthony Pantalleresco says the legislation would have a drastic impact on millions of Canadians.
"This affects anybody who uses herbs or spices or vitamins in any way shape or form," he said. "Your right to choice is gone. Your right to make your own decisions, based on your own research and whatever you learned, is gone out the door."
According to an e-mail from a Health Canada spokesman, "Bill C-51 is not focused on natural health products and will not affect the manner in which these products are regulated in Canada.
"The standards of evidence for safety and efficacy that are in place for natural health products will not be affected by the new legislation," Stephane Shank wrote. "The risks and benefits associated with natural health products will continue to encompass factors that are unique to natural health products; including history of use, traditional uses and cultural practices."
Shank said the proposed legislation will not limit access to natural health products or require prescriptions for their use. He said such products will continue to be regulated under the same framework introduced in 2004, which includes provisions on licensing, labelling, clinical trials and reporting of adverse reactions.
Penelope Marrett, president of the Toronto-based Canadian Health Food Association, said there are misconceptions about Bill C-51. "People need to remember that we're an already regulated industry," she said. "Because these regulations are much newer than others, their variations (under Bill C-51) may not be as great."
Marrett said the bill does not suggest the removal of natural health products from store shelves.
"Herbalists and naturopaths will still be able to provide the products and the compounds that they do under the current situation," she said.
Windsor Star
© Windsor Star 2008
Herbal remedy industry wary of bill
Sonja Puzic
Canwest News Service
Sunday, May 11, 2008
WINDSOR, Ont. - Some producers and vendors of natural health products are concerned their livelihoods may be at risk if recently introduced amendments to the federal Food and Drugs Act become law.
Bill C-51, tabled by the Conservative government in early April, focuses on the safety and monitoring of drugs, food and health products, from clinical testing to the way they are marketed to Canadians. If passed, it would give the federal government more power to order recalls of unsafe products and impose harsher fines for safety violations.
Bill C-51 has been touted as a much-needed overhaul of Canada's weak consumer-protection legislation.
But critics say it would also over-regulate the sale and use of natural health products, which include vitamins, minerals, homeopathic medicines and herbal remedies. By replacing the word "drug" with "therapeutic product" throughout the act, Health Canada would have broader power over the natural health product industry.
Some say the proposed legislation will limit consumers' choices, crack down on private growers of herbs and medicinal plants and eventually outlaw products that have been used by many for decades.
Health Canada says Bill C-51 is not going after the natural health product industry, but Windsor herbalist Anthony Pantalleresco says the legislation would have a drastic impact on millions of Canadians.
"This affects anybody who uses herbs or spices or vitamins in any way shape or form," he said. "Your right to choice is gone. Your right to make your own decisions, based on your own research and whatever you learned, is gone out the door."
According to an e-mail from a Health Canada spokesman, "Bill C-51 is not focused on natural health products and will not affect the manner in which these products are regulated in Canada.
"The standards of evidence for safety and efficacy that are in place for natural health products will not be affected by the new legislation," Stephane Shank wrote. "The risks and benefits associated with natural health products will continue to encompass factors that are unique to natural health products; including history of use, traditional uses and cultural practices."
Shank said the proposed legislation will not limit access to natural health products or require prescriptions for their use. He said such products will continue to be regulated under the same framework introduced in 2004, which includes provisions on licensing, labelling, clinical trials and reporting of adverse reactions.
Penelope Marrett, president of the Toronto-based Canadian Health Food Association, said there are misconceptions about Bill C-51. "People need to remember that we're an already regulated industry," she said. "Because these regulations are much newer than others, their variations (under Bill C-51) may not be as great."
Marrett said the bill does not suggest the removal of natural health products from store shelves.
"Herbalists and naturopaths will still be able to provide the products and the compounds that they do under the current situation," she said.
Windsor Star
© Windsor Star 2008
Wednesday, November 21, 2007
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Preferred Customer
No cost to enroll
Order products at full wholesale discount
Cannot participate in the business plan
You can phone in and register a preferred customer. Choose the last 6 numbers of then* phone
number as their ID number.
Distributor
No cost to enroll
Order products at full whole discount
Can enroll distributors and preferred customers
Free Starter kit
Free product with first order in first month.
Free DVD 'Business is Booming'
Free Primetime Magazine
Can set up a retail customer account by calling customer service, whereby customers can
order online or phone hi and you are paid the retail profit.
Business Builder
Enroll in Gold DS 150PV to qualify for the solid start Manager or Supervisor program.
HYBRID COMPENSATION PLAN
Two Separate plans. One for quick cheque and one for business builders.
Multiplex
First 100PV Paid on 10th ofMonth. Canqualify for 5...8...10% withminimum
qualifications of 50PV
Affinity
over 100PV Paid on 25* of month. Must be on 150PV gold direct ship to qualify
150PV Gold DS qualifies you to be paid on both the Multiplex and Affinity plans.
You may register your new distributor over the phone and place then- order at the same time.
At this time they will receive their ID number to place further orders. They will receive a free
kit and a welcome letter with their password to access newaysonline which is the distributors
website. If they want it sooner, they can phone in and ask for it.
To enroll in the DS program which can be done verbally, however they must complete the
fax purchase form. It is important that you tick and initial the 'enroll me hi DS program' tick
and initial 'payment information' If credit card, tick and initial which card and sigh under the
credit card number.
If bank draft, the bank draft application must be completed with a void cheque.
If the order is placed over the phone they will be given the order number which you will
place hi the order description part of the fax order form and again initial that also. The
paperwork must be mailed or faxed in within 30 days.
It would be a good idea to have them fill out the ICN form and send that hi with your other paperwork.
Monday, November 19, 2007
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I do thank you for taking the time and the opportunity to look at this blog and I do hope you were able to enjoy it and since there is nothing there for you at this time.
I encourage you to share this block with your family, friends and acquaintances, people that you work with because there just might be something they may see that you were unable to see at this time and who knows it could be something they were looking for to give them the opportunity of
"TIME, FREEDOM, FINANCIAL SECURITY and a RESIDUAL INCOME"
Sincerely,
Garry Cuthbert
INDEPENDENT DISTRIBUTOR-SUPERVISOR
E-mail:natures_natural_way@yahoo.ca
WebSite:http://www.ineways.com/garrycuthbert
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