Dew How does FDA regulated " medical food " differ from FDA regulated dietary supplements ?
Hepaxa looks like a version of the approved O3 drug Lovaza .....and the DS version Omega Via
Hepaxa 's EPA/DHA ratio looks fairly close to Lovaza's. No mention of the risk of the DHA raising LDL cholesterol levels ( one of the reasons that Lovaza was never approved for the mixed dyslipidemia market )
So now we have ...FDA approved drugs ....FDA regulated Dietary supplements ...and now FDA regulated medical foods ...?
As a side note ...as you may be aware ..Amarin currently has a case before the ITC charging some dietary supplements are being used / sold as unapproved drugs ... Poster North can explain if necessary
Kiwi
PS. from Medscape
Question
What is the difference between a medical food, a dietary supplement, and a functional food?
Response from Gayle Nicholas Scott, PharmD
Assistant Professor, Eastern Virginia Medical School, Norfolk, Virginia; Clinical Pharmacist, Chesapeake Regional Medical Center, Chesapeake, Virginia
Prior to 1972, medical foods were primarily formulas designed for the unique nutritional needs of patients with inherited metabolic disorders. These products were regulated as drugs, usually as orphan products. In 1972, the US Food and Drug Administration (FDA) created the classification "medical food" to enhance product development and availability. In the nearly 4 decades since this classification change, products marketed as medical foods have strayed widely from the original narrow use in rare metabolic conditions.[1]
The FDA specifies that medical foods are foods specifically formulated for dietary management of diseases or conditions with distinctive nutritional needs that cannot be met by diet alone. Generally, a product must meet the following criteria to be labeled a "medical food"[1,2]:
A specific formulation (as opposed to a naturally occurring foodstuff in its natural state) for oral or tube feeding;
Labeled for the dietary management of a specific medical disorder, disease, or condition with distinctive nutritional requirements;
Intended for use under medical supervision; and
Intended only for a patient receiving active and ongoing medical supervision for a condition requiring medical care on a recurring basis so that instructions on the use of the medical food can be provided.
Think of medical foods as hybrids of prescription drugs and dietary supplements, more closely resembling dietary supplements in terms of regulation. Packaging for medical foods is similar to prescription products with package inserts, National Drug Code (NDC) numbers, and usually "Rx only" on the labels. However, like dietary supplements, medical foods have not been evaluated for safety or efficacy, and the FDA does not require approval before marketing. "Caution: Federal law prohibits dispensing without prescription" is not required on product labeling. The FDA specifies only that these products are for use with medical supervision[1]; however, a medical food manufacturer may market a product to be dispensed only on physician request.[3]
Unlike dietary supplements, medical foods can be labeled for medical conditions such as Alzheimer disease. Dietary supplements must be labeled for so-called "structure and function claims" and cannot make claims to treat or prevent disease.[4] For example, ginkgo may be labeled "supports memory function" but not "for treatment of dementia." A drug or medical food could be labeled "for treatment of dementia associated with Alzheimer disease."
