September 11th, 2013

The FDA has sent a warning letter to health supplement company Metagenics for selling “medical foods” in violation of the Food, Drug, and Cosmetic Act. Metagenics sold several foods and food supplements advertised to help with conditions such as chronic fatigue syndrome, fibromyalgia, asthma, and cardiovascular disease.

According to the FDA, “medical food” has a very strict definition, and Metagenics products do not comply.

[A] medical food must be intended for the dietary management of a disease or condition for which there are distinctive nutritional requirements. Further […], a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.

Not only are Metagenics products not medical food, they are not generally recognized as safe or effective for the treatment of any medical conditions, despite their claims to the contrary.

Metagenics has 15 days to respond to the FDA with specific steps it has taken to correct these violations.

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