Industry AnalysisIndustry Case Study

Understanding the Medical Foods Market (the Process to Get Approval for Medical Foods, and Case Studies of Companies that Have Created Medical Food Products)


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.

1. 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.

2. 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.

Medical Food Labeling and Ingredient Requirements

Even though the commercialization of medical foods does not require FDA approval, the agency has published a guidance document for the industry (last updated in May 2016). Barring specific exemptions, medical foods are required to comply with all applicable food labeling requirements. The ingredients added to these products should be “safe and in compliance with all applicable provisions of the FD&C Act and FDA regulations.”

Overview of FDA’s Regulations for the Medical Foods Industry

  • Medical food manufacturers are not required to seek the approval of FDA to commercialize their products.
  • As medical foods are not drugs, they are “not subject to any regulatory requirements that specifically apply to drugs.”
  • FDA’s Office of Nutrition and Food Labeling has published a guidance document for the medical foods industry.
  • FDA’s guidance documents “do not establish legally enforceable responsibilities” as they only provide the agency’s “current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

FDA’s Guidance for Labeling Requirements of Medical Foods

FDA’s Guidance for Ingredient Added to Medical Foods

  • The ingredients added to medical foods should be “safe and in compliance with all applicable provisions of the FD&C Act and FDA regulations.”
  • Any ingredient added should be a “food additive used in accordance with FDA’s food additive regulations,” a “color additive used in accordance with the color additive regulations,” a “substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use,” and a “substance that is authorized by a prior sanction.”
  • As mentioned above, the list of ingredients added to the medical foods must be published on the labels of the products.
Glenn is the Lead Operations Research Analyst at Simple Manifestation with experience in research, statistical data analysis and interview techniques. A holder of degree in Economics. A true specialist in quantitative and qualitative research.

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