FDA Moves Against Alternative Diabetes Treatments# ChineseMed - 中医
l*z
1 楼
By THOMAS M. BURTON
WASHINGTON—The Food and Drug Administration is acting to stop U.S. sales of
nearly two dozen products marketed as diabetes treatments that the agency
said are illegal and can be ineffective, counterfeit or dangerous.
The federal agency sent warning letters to the companies involved and said
it can follow up by seizing the products, enjoining their sale and even
criminally prosecuting companies whose officials fail to take corrective
action.
The products include dietary supplements, self-styled "natural treatments"
as alternatives to prescription drugs, over-the-counter drugs and ayurvedic
medicines, part of an alternative health system that evolved in India and
includes herbs and special diets.
They also include unapproved versions of prescription diabetes medicines
such as metformin and Januvia. The products can both be found on the
Internet and at retail outlets, and make claims such as being a "natural
diabetes cure."
"If you have diabetes, you should be getting treatment from a doctor," said
Howard Sklamberg, director of compliance at the FDA's center for drug
evaluation and research. He said the FDA is taking actions to "protect
consumers" and that the agency recommends people not use the products in
question.
One of the products involved, Anti-diabetic Pancreatic Capsule (known in the
original Chinese as Jiang Tang Yi Huo Su Jiao Nang), included phenformin.
It was removed from the U.S. market in 1978 because it was linked to lactic
acidosis, a serious condition requiring immediate medical attention caused
by an accumulation of lactic acid in the bloodstream. The FDA didn't
identify the company that makes this current diabetes product.
The FDA said the range of products covered in warning letters could not only
be ineffective but could be contaminated or could cause people "to delay
seeking proper timely treatment leading to an increased risk for developing
serious health complications."
Another significant issue is the lack of labels. Many prescription-drug
labels disclose side effects, including some serious ones, and without them
consumers can't fully understand the risk-benefit balance of the drugs
involved.
Diabetes, which afflicts nearly 26 million Americans, can cause heart
disease, blindness and kidney failure, and may lead to lower-extremity
amputations if the malady isn't kept under control. The products at issue
include some aimed at treating those complications.
Many of them, the FDA said, are sold with such claims as "prevents and
treats diabetes" and "can replace medicine in the treatment of diabetes."
They also include ayurvedic medicines and prescription drugs for diabetes
sold by online pharmacies without a prescription.
Among the products and companies about which warning letters were sent were
Sugar Balancer from Health King Enterprise & Balanceuticals Group Inc.,
Diabetes Daily Care from Nature's Health Supply Inc., and Diabetic
Neuropathy Foot Cream from MagniLife.
Lindsay Rohnke, general manager of the Magni Co., said the company is "
looking into any potential marketing violations, and we will make any
necessary changes to keep MagniLife Diabetic Neuropathy Foot Cream available
to our customers."
Health King didn't respond to a request for comment. The Health King website
on Monday said Sugar Balancer is formulated "in an effort to maintain
healthy blood and urine sugar levels" but that such statements haven't been
evaluated by the FDA and that "this product is not intended to diagnose,
treat, cure or prevent any disease."
Diabetes Daily Care was being sold Monday on Amazon.com as AMZN -0.80% a "
natural diabetes cure." A man who answered the phone at Nature's Health
Supply, and who declined to identify himself, said he didn't "see how
anything good could come out of" discussing the matter.
WASHINGTON—The Food and Drug Administration is acting to stop U.S. sales of
nearly two dozen products marketed as diabetes treatments that the agency
said are illegal and can be ineffective, counterfeit or dangerous.
The federal agency sent warning letters to the companies involved and said
it can follow up by seizing the products, enjoining their sale and even
criminally prosecuting companies whose officials fail to take corrective
action.
The products include dietary supplements, self-styled "natural treatments"
as alternatives to prescription drugs, over-the-counter drugs and ayurvedic
medicines, part of an alternative health system that evolved in India and
includes herbs and special diets.
They also include unapproved versions of prescription diabetes medicines
such as metformin and Januvia. The products can both be found on the
Internet and at retail outlets, and make claims such as being a "natural
diabetes cure."
"If you have diabetes, you should be getting treatment from a doctor," said
Howard Sklamberg, director of compliance at the FDA's center for drug
evaluation and research. He said the FDA is taking actions to "protect
consumers" and that the agency recommends people not use the products in
question.
One of the products involved, Anti-diabetic Pancreatic Capsule (known in the
original Chinese as Jiang Tang Yi Huo Su Jiao Nang), included phenformin.
It was removed from the U.S. market in 1978 because it was linked to lactic
acidosis, a serious condition requiring immediate medical attention caused
by an accumulation of lactic acid in the bloodstream. The FDA didn't
identify the company that makes this current diabetes product.
The FDA said the range of products covered in warning letters could not only
be ineffective but could be contaminated or could cause people "to delay
seeking proper timely treatment leading to an increased risk for developing
serious health complications."
Another significant issue is the lack of labels. Many prescription-drug
labels disclose side effects, including some serious ones, and without them
consumers can't fully understand the risk-benefit balance of the drugs
involved.
Diabetes, which afflicts nearly 26 million Americans, can cause heart
disease, blindness and kidney failure, and may lead to lower-extremity
amputations if the malady isn't kept under control. The products at issue
include some aimed at treating those complications.
Many of them, the FDA said, are sold with such claims as "prevents and
treats diabetes" and "can replace medicine in the treatment of diabetes."
They also include ayurvedic medicines and prescription drugs for diabetes
sold by online pharmacies without a prescription.
Among the products and companies about which warning letters were sent were
Sugar Balancer from Health King Enterprise & Balanceuticals Group Inc.,
Diabetes Daily Care from Nature's Health Supply Inc., and Diabetic
Neuropathy Foot Cream from MagniLife.
Lindsay Rohnke, general manager of the Magni Co., said the company is "
looking into any potential marketing violations, and we will make any
necessary changes to keep MagniLife Diabetic Neuropathy Foot Cream available
to our customers."
Health King didn't respond to a request for comment. The Health King website
on Monday said Sugar Balancer is formulated "in an effort to maintain
healthy blood and urine sugar levels" but that such statements haven't been
evaluated by the FDA and that "this product is not intended to diagnose,
treat, cure or prevent any disease."
Diabetes Daily Care was being sold Monday on Amazon.com as AMZN -0.80% a "
natural diabetes cure." A man who answered the phone at Nature's Health
Supply, and who declined to identify himself, said he didn't "see how
anything good could come out of" discussing the matter.
