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v1 - Medical Foods

What exactly IS a Medical Food?

Medical Foods

What is a medical food?

A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

FDA considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food (21 CFR 101.9(j)(8)). Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition. Not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.   Read more....

DA required SSA testing criteria.

An evidence-based review system is a systematic science-based evaluation of the strength of the evidence to support a statement. In the case of health claims, it evaluates the strength of the scientific evidence to support a proposed claim about a substance/disease relationship. The evaluation process involves a series of steps to assess scientific studies and other data, eliminate those from which no conclusions about the substance/disease relationship can be drawn, rate the remaining studies for methodological quality and evaluate the strength of the totality of scientific evidence by considering study types, methodological quality, quantity of evidence for and against the claim (taking into account the numbers of various types of studies and study sample sizes), relevance to the U.S. population or target subgroup, replication of study results supporting the proposed claim, and overall consistency of the evidence. After assessing the totality of the scientific evidence, FDA determines whether there is SSA to support an authorized health claim, or credible evidence to support a qualified health claim.  Read More....

DA labeling requirements for medical food.

he labeling for medical foods must comply with all applicable food labeling requirements except for those specific requirements from which medical foods are exempt.

Specifically, the labeling of medical foods must contain:

  •   A statement of identity (21 CFR 101.3);
  •   An accurate statement of the net quantity of contents (21 CFR 101.105);
  •   The name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5); and
  •   A complete list of ingredients, listed by their common or usual name and in descending order of predominance (21 CFR 101.4).

In addition, all words, statements, and other information required by or under authority of the FD&C Act to appear on a label or labeling of a medical food must appear with prominence and conspicuousness (21 CFR 101.15) and be in English except that, for medical foods distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English (21 CFR 101.15(c)(1)). Further, if a label bears any representation in a foreign language, then all mandatory label information must be repeated in each foreign language used on the label (21 CFR 101.15(c)(2)).

Medical food labels must also conform with the principal display panel requirements under 21 CFR 101.1 and the applicable information panel requirements under 21 CFR 101.2. Further, the requirements concerning the misbranding of food (21 CFR 101.18) apply to medical foods. Read more...

Medical Foods Program: Import and Domestic

ecause of the susceptible population for which medical foods are intended, the agency is committed to assuring their continued safety and integrity through annual inspections of all medical foods manufacturers in the U.S. and foreign countries. Prior to the start of each fiscal year, CFSAN/Office of Compliance/Division of Field Programs (DFP) (HFS-636) will provide the Office of Regulatory Affairs, Division of Field Investigations (ORA/DFI) a list of all foreign firms known to manufacture medical foods. ORA/DFI will work with individual districts to schedule an inspection at each of these firms.   Read more...