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Medical Food Case Studies
Metagenics is a medical foods company with over 30 years of experience, while Axona is a brand of Cerecin, a company with over 20 years of experience. Complete case studies for each medical food brand are presented below.

Metagenics
Who the Brand Is
  •  Metagenics has operated for more than 30 years as a functional nutrition company with the dedication to do scientific discovery and practitioner partnerships with unparalleled quality. The company has made more than 300 solutions for scientifically formulated foods and 87 research publications in PubMed.
  • More than $7 million has been spent in research and development with more than 100,000 partnerships all around the world.

What They Provide in the Medical Food Space

Process for Approval for Medical Foods
  •  Metagenics medical foods are highly regulated by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
  • The company's products must meet the regulations and rules set by the FDA by testing the products before appearing on the market with product claims.
  • Then, manufacturers are inspected, and if they do not meet current good manufacturing practices (cGMPs), they receive warnings and potentially can be shut down.
  • The FDA inspected the company on some aspects such as appropriate testing, purchasing quality ingredients, and following sanitary procedures in its facility. The inspectors requested to review any adverse event reports received by Metagenics over the last six years. They also reviewed product labels, and even took and tested the product. These inspections sometimes take weeks.


Axona
Who the Brand Is
  •  Axona is a medical food brand that has a mission to offer clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease.
  • Axona is produced by Cerecin (formerly known by Accera), a healthcare company with about 20 years of experience in brain health.
  • Cerecin has headquarters in Singapore and the United States; Axona is their first product. This company also made therapies that address metabolic deficiencies and provide alternative energy sources for brain cells. 

What They Provide in the Medical Food Space
  • Axona is a medical food designed for Alzheimer's disease but it may be used, with caution, for ketoacidosis, alcohol abuse, diabetes, inflammation, metabolic syndrome, and renal dysfunction.
  • It should be taken with a doctor's prescription; it contains whey (dairy) and lecithin (soy).
  • Axona offers medical food for Alzheimer's because the brain becomes less able to use glucose to make energy, so the lack of glucose in metabolism can be fulfilled by Axona. 

Process for Approval for Medical Foods
  • It is stated on the Axona website that medical food does not go through the same approval process as a traditional drug, although it was under FDA regulation.
  • The company stated that the process conducted by the parent company included all the necessary and safety studies required to produce Axona under the FDA's regulatory definition of medical food.
  • After the company produced Axona, then it became subject to manufacturing facility inspections, including product and label reviews by the FDA.


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