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ME/CFS AUSTRALIA (SA) INC
Registered Charity 698
Mailing address:
GPO Box 383,
Adelaide,
South Australia 5001
Office:
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Hindmarsh,
South Australia 5007
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FIBROMYALGIA HELP: Contact Fibromyalgia SA at the Arthritis Foundation of SA 118 Richmond Road, Marleston 5033 Ph: (08) 8379 5711 |
ME/CFS Australia (SA) Inc supports the needs of sufferers of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome and related illnesses. We do this by providing services and information to members.
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ME/CFS Australia (SA) Inc aims to keep members informed of the various research projects, diets, medications, therapies etc. All communication, both verbal and written, is merely to disseminate information and not to make recommendations or directives.
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Bioenergy receives warning over medical foods
Monday 15 November 2010
Natural Products Insider reports:
Bioenergy Receives Warning Over Medical Foods
MINNEAPOLIS—FDA issued a warning letter to Bioenergy Inc. regarding the marketing of its Corvalen® products as medical foods, informing the company it does not believe the products meet the statutory definition of a medical food per federal regulations. Instead, the agency considers the Corvalen and Corvalen M® to be misbranded foods and/or new drugs.
With regard to the medical food marketing, the Corvalen products are positioned to address fibromyalgia, chronic fatigue syndrome and cardiovascular disease (CVD). However, FDA stated the statutory definition of a “medical food" per federal regulations to “narrowly constrain the types of products that fit within this category." Specifically, it noted the medical foods must address conditions for which there are distinctive nutritional requirements that cannot be managed by modification of the normal diet.
As the products are currently marketed with therapeutic claims addressing how Corvalen ribose may help address fatigue associated with CVD, chronic fatigue syndrome and fibromyalgia, FDA therefore considers them to be drugs. However, the Corvalen products have not been approved by FDA as new drugs, making them out of regulatory compliance.
The above originally appeared here.
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