ME/CFS South Australia 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. Disclaimer ME/CFS South Australia Inc aims to keep members informed of various research projects, diets, medications, therapies, news items, etc. All communication, both verbal and written, is merely to disseminate information and not to make recommendations or directives. Unless otherwise stated, the views expressed on this Web site are not necessarily the official views of the Society or its Committee and are not simply an endorsement of products or services. |
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Bioenergy receives warning over medical foodsMonday 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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Registered Charity 3104
Email:
sacfs@sacfs.asn.au
Mailing address:
PO Box 322,
Modbury North,
South Australia 5092
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1300 128 339
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