Frequently Asked Questions 
About Medical Foods;  
Third Edition
Guidance for Industry 
Additional copies are available from:  
Office of Nutrition and Food Labeling, HFS-800 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive  
College Park, MD 20740  
(Tel) 240-402-2373 
http://www.fda.gov/FoodGuidances 
You may submit written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov. Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number FDA-2013-D-0880 listed in the notice of availability that publishes in 
the Federal Register. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
March 2023 
This is a revision to this guidance, which was originally issued in May 2007.  Contains Nonbinding Recommendations 
 
 
Table of Contents 
I.  Introduction 
II.  Questions and Answers 
III. References 
Document History 
 
2  Contains Nonbinding Recommendations 
 
Frequently Asked Questions About Medical Foods 
1
Guidance for Industry  
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or we) on this topic. It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies the requirements of 
the applicable statutes and regulations. To discuss an alternative approach, contact the FDA 
staff responsible for this guidance as listed on the title page. 
 
I.  Introduction 
This guidance is intended to provide industry with a convenient place to find answers to 
frequently asked questions (FAQs) about medical foods.  The responses to these FAQs 
address common questions about the definition of and regulations for medical foods. 
This guidance is a third edition of the May 2007 guidance titled Guidance for Industry: 
Frequently Asked Questions About Medical Foods. 
FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe our current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in agency guidances means that 
something is suggested or recommended, but not required. 
II. Questions and Answers 
1.  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 
 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
 
3  Contains Nonbinding Recommendations 
 
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 conditions specific dietary 
management. 
2.  Has FDA established by regulation any criteria that clarify the statutory definition 
of a medical food? 
Yes.  The following criteria that clarify the statutory definition of a medical food can be 
found in FDAs regulations at 21 CFR 101.9(j)(8).  A medical food is exempt from the 
nutrition labeling requirements of 21 CFR 101.9 only if: 
a.  It is a specially formulated and processed product (as opposed to a naturally 
occurring foodstuff used in its natural state) for the partial or exclusive 
feeding of a patient by means of oral intake or enteral feeding by tube, 
meaning a tube or catheter that delivers nutrients beyond the oral cavity 
directly into the stomach or small intestine;2  
b.  It is intended for the dietary management of a patient who, because of 
therapeutic or chronic medical needs, has 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; 
c.  It provides nutritional support specifically modified for the management of 
the unique nutrient needs that result from the specific disease or condition, as 
determined by medical evaluation; 
d.  It is intended to be used under medical supervision; and 
e.  It is intended only for a patient receiving active and ongoing medical 
supervision wherein the patient requires medical care on a recurring basis 
for, among other things, instructions on the use of the medical food. 
We discuss nutrition labeling requirements and medical foods in questions 4 to 6 below. 
 
 
 
2 Enteral feeding can be achieved by oral intake or by tube.  Enteral feeding by tube refers to a tube or catheter that 
delivers nutrients beyond the oral cavity directly into the stomach or small intestine.  These enteral feedings should 
not be confused with parenteral (or intravenous) nutrient formulations. 
 
4  Contains Nonbinding Recommendations 
 
3.  Does FDA regulate medical foods as drugs? 
No.  Medical foods are not drugs and, therefore, are not subject to any regulatory 
requirements that specifically apply to drugs. 
4.  Do the labeling requirements for nutrient content claims apply to medical foods? 
Medical foods are exempt from the labeling requirements for nutrient content claims 
under the Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343(r)(5)(A)). 
As with any food, a medical food that bears a false or misleading claim would be 
considered misbranded under section 403(a)(1) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). 
5.  Do the labeling requirements for health claims apply to medical foods? 
Medical foods are exempt from the labeling requirements for health claims under the 
Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343(r)(5)(A)).  As with 
any food, a medical food that bears a false or misleading claim would be considered 
misbranded under section 403(a)(1) of the FD&C Act. 
6.  What labeling requirements apply to medical foods? 
The 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 101.7); 
  The name and place of business of the manufacturer, packer, or 
distributor (21 CFR 101.5);  
  A complete list of ingredients, listed by their common or usual name and 
in descending order of predominance (21 CFR 101.4); and 
  Allergen information, if necessary (section 403(w) of the FD&C Act)  
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)). 
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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 
CFR101.2.  Further, the requirements concerning the misbranding of food (21 CFR 
101.18) apply to medical foods. 
7.  What other FDA requirements apply to medical foods? 
Manufacturers of medical foods must comply with all applicable FDA requirements for 
foods, including the following regulations: 
  Current good manufacturing practice (21 CFR part 110); 
  Registration of food facilities (21 CFR part 1 subpart H); 
  Thermally processed low-acid foods packaged in hermetically 
sealed containers (21 CFR part 113); 
  Acidified foods (21 CFR part 114); and 
  Emergency permit control (21 CFR part 108). 
8.  Do the allergen labeling requirements of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) apply to medical foods? 
Yes. The allergen labeling requirements of the FD&C Act apply to all foods other than 
raw agricultural commodities, including medical foods. 
9.  Where can I find more information on the allergen labeling requirements of the 
FD&C Act?  
You can find more information on FDAs Web site and the following links: 
https://www.fda.gov/food/food-labeling-nutrition/food-allergies 
 
https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-
supplements/food-allergensgluten-free-guidance-documents-regulatory-information   
10. What are the registration requirements for medical food facilities? 
Any facility engaged in manufacturing, processing, packing, or holding medical foods 
for consumption in the United States must register with FDA.3 You can find additional 
information regarding the registration of food facilities on FDAs Web site. 
11. Does FDA maintain a list of medical foods? 
FDA does not maintain a comprehensive list of medical food products. 
 
3 See section 415 of the FD&C Act (21 U.S.C. 350d). 
 
6  Contains Nonbinding Recommendations 
 
12. Is there a compliance program guidance manual for medical foods? 
Yes.  FDA has a compliance program guidance manual entitled Medical Foods 
Program - Import and Domestic that is available on FDAs Web site. 
13. What is the purpose of FDAs compliance program for medical foods? 
FDAs compliance program gives direction to FDA inspectors on: (1) obtaining 
information regarding the manufacturing/control processes and quality assurance 
programs employed by domestic manufacturers of medical foods through establishment 
inspections; (2) collecting domestic and import surveillance samples of medical foods 
for nutrient and microbiological analyses; and (3) recommending action when 
significant violations of the FD&C Act (or related regulations) are found. 
14. Does FDA require that medical foods be made available by written or oral 
prescription? 
No.  The requirement for a written or oral prescription in section 503(b) of the FD&C 
Act and its implementing regulations at 21 CFR 201.100 only applies to the dispensing 
of prescription drug products.  The Orphan Drug Act provides that medical foods must 
be formulated to be consumed or administered enterally under the supervision of a 
physician, but there is no requirement for a prescription. 
15. How does FDA interpret under the supervision of a physician? 
FDA considers the requirement that a medical food be formulated to be consumed or 
administered enterally under the supervision of a physician to mean that the intended 
use of a medical food is for the dietary management of a patient receiving active and 
ongoing medical supervision (e.g., in a health care facility or as an outpatient) by a 
physician who has determined that the medical food is necessary to the patients overall 
medical care.  The patient should generally see the physician on a recurring basis for, 
among other things, instructions on the use of the medical food as part of the dietary 
management of a given disease or condition. 
16. May the labeling of a medical food bear the symbol Rx only? 
The labeling of medical foods may not bear the symbol Rx only.  Section 
503(b)(4)(A) of the FD&C Act (21 U.S.C. 353(b)(4)(A)) provides that a prescription 
drug is misbranded if the label of the drug fails to bear, at a minimum, the symbol Rx 
only to indicate that the product may not lawfully be dispensed without a prescription.  
Unlike prescription drugs, medical foods are not required by federal law to be dispensed 
by prescription.  Therefore, the use of the symbol Rx only in the labeling of a medical 
food would misbrand a medical food under section 403(a)(1) of the FD&C Act because 
it would be a false and misleading statement about that product.  However, because 
medical foods are required by statute to be formulated to be consumed or administered 
7  Contains Nonbinding Recommendations 
 
enterally under the supervision of a physician, FDA would not object to the use of 
language to communicate this requirement in the labeling of a medical food product that 
is not false or misleading (e.g., must be used under the supervision of a physician). 
17. Should National Drug Code (NDC) numbers be used in the labeling of medical 
foods? 
The labeling of medical foods should not include NDC numbers.  Drug products are 
identified and reported using a unique, three-segment number, called the NDC, which is 
a universal product identifier for human drugs.4 NDC numbers are intended for 
uniquely identifying drugs and should not be used in the labeling of medical foods since 
they are not drugs.  The presence of an NDC number on a food product that is not a 
drug misbrands the product under section 403(a)(1) of the FD&C Act.  In addition, any 
representation that creates an impression of official FDA approval through the use of an 
NDC number in labeling constitutes misbranding.5  
18. What requirements apply to ingredients added to medical foods? 
An ingredient that is added to a medical food should be safe and in compliance with all 
applicable provisions of the FD&C Act and FDA regulations.  Any ingredient added to 
a medical food should be: (1) a food additive used in accordance with FDAs food 
additive regulations (see 21 CFR part 172); (2) a color additive used in accordance with 
the color additive regulations (see 21 CFR parts 73 and 74); (3) a substance that is 
generally recognized, by qualified experts, to be safe under the conditions of its 
intended use (generally recognized as safe (GRAS)) (see 21 CFR 170.30 and 21 U.S.C. 
321(s)); or (4) a substance that is authorized by a prior sanction (see 21 CFR 170.3(l), 
21 U.S.C. 321(s)(4)). 
19. Where can I find additional information on food additives and GRAS ingredients? 
Additional information on food additives and GRAS ingredients can be found under the 
food topic Food Ingredients & Packaging on FDAs Web site. 
20. Does FDA generally consider inborn errors of metabolism (IEMs) to be diseases or 
conditions that a medical food could be used to manage? 
Yes.  FDA generally considers IEMs to be diseases or conditions that a medical food 
could be used to manage.  IEMs include inherited biochemical disorders in which a 
specific enzyme defect interferes with the normal metabolism of protein, fat, or 
carbohydrate.  As a result of diminished or absent enzyme activity in these disorders, 
certain compounds accumulate in the body to toxic levels, and levels of other 
compounds that the body normally makes may become deficient (Ref. 1).  Without 
 
4 See section 510(e) of the FD&C Act (21 U.S.C. 360(e)); 21 CFR 207.35. 
5 See 21 CFR 207.39. 
8  Contains Nonbinding Recommendations 
 
appropriate and accessible management, these metabolic disturbances can lead to a host 
of medical and developmental consequences ranging from intellectual disability to 
severe cognitive impairment and even death (Ref. 1).  Management may include one or 
a combination of the following: drug therapy, modification of the normal diet, or use of 
a medical food.6  
Some of these disorders can be managed with modification of the normal diet alone 
(e.g., reduction of galactose and lactose for galactosemia).  However, others cannot be 
managed solely with diet modification.  For these IEMs, a medical food is required in 
addition to a specific dietary modification in order to obtain adequate levels of essential 
nutrients (e.g., essential amino acids, essential fatty acids) that are restricted by 
modifying the normal diet.  Medical foods become indispensable for individuals with 
these IEMs in order to meet the daily requirements of essential nutrients and to limit the 
metabolic disturbances associated with the particular IEM (e.g., see question 21). 
21. Are there any examples of specific IEMs that medical foods could be used to 
manage? 
Yes.  Some examples of specific IEMs that medical foods could be used to manage 
involve amino acid/protein, organic acid, or fatty acid metabolism.  These IEMs 
primarily require significant restriction of particular amino acids and/or total protein 
such as in phenylketonuria (phenylalanine restriction), ornithine transcarbamylase 
deficiency (nonessential amino acid restriction), methylmalonic acidemia (isoleucine, 
methionine, threonine, and valine restriction), or significant modification of fatty 
acids/total fat such as in very long-chain acyl-CoA dehydrogenase deficiency (long 
chain fatty acid restriction with an increase in medium chain fatty acid levels). 
22. Does FDA consider pregnancy to be a disease? 
FDA does not consider pregnancy to be a disease.7  
23. Are there distinctive nutritional requirements associated with pregnancy? 
No.  There are no distinctive nutritional requirements associated with pregnancy. 
Essential nutrient requirements to support pregnancy can be met by diet modification. 
The Institute of Medicine (IOM) established nutrient recommendations to meet 
essential nutrient requirements associated with pregnancy.  Pregnancy is one of the 
twelve life stage groups identified by the IOM.  For each life stage group, where data 
were available, IOM established dietary reference intakes (DRIs) to apply to the healthy 
general population.  DRIs are standards for apparently healthy people and are not meant 
 
6 Medical foods may also include infant formulas used for IEM which are regulated as exempt infant formulas under 
section 412(h)(1) of the FD&C Act; 21 CFR 107.50. 
7 See, e.g., 65 FR 999 at 1000 (Jan. 6, 2000); 63 FR 23623 at 23627 (Apr. 29, 1998). 
 
9  Contains Nonbinding Recommendations 
 
to be applied to those with acute or chronic disease or for the repletion of nutrient levels 
in previously deficient individuals (Ref. 2). 
24. Does FDA consider pregnancy to be a condition for which a medical food could be 
labeled and marketed? 
Under 21 CFR 101.9(j)(8)(ii), 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.  While some diets may not supply the full amount of nutrients 
necessary for women who are pregnant or planning to become pregnant, generally the 
levels of micronutrients necessary for pregnancy can be achieved by the modification of 
the normal diet alone.  It is generally practicable for women who are pregnant or 
planning to become pregnant to follow the IOM and FDA recommendations for nutrient 
intake within a normal diet.  Therefore, FDA generally would not consider a product 
labeled and marketed for pregnancy to meet the regulatory criteria for a medical food. 
25. Are there distinctive nutritional requirements associated with the management of 
diabetes mellitus (DM)? 
No.  There are no distinctive nutritional requirements associated with the management 
of DM.  Essential nutrient requirements for individuals affected by DM are no different 
than those for unaffected (generally healthy) persons.  Following an individualized 
healthy, well-balanced diet is crucial to managing conditions such as DM.  There are 
nutritional recommendations established for persons to manage DM (Refs. 3, 4, and 5). 
26. Does FDA consider DM to be a condition for which a medical food could be labeled 
and marketed? 
No.  Diet therapy is the mainstay of diabetes management.  A regular diet can be 
modified to meet the needs of an individual affected by DM (along with appropriate 
drug therapy if necessary).  Under 21 CFR 101.9(j)(8)(ii), 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. 
27. Does FDA consider diseases resulting from essential nutrient deficiencies (e.g., 
scurvy, pellagra) to be diseases for which a medical food could be labeled and 
marketed? 
No.  Diseases (e.g., scurvy, pellagra) that result from essential nutrient deficiencies 
(e.g., deficiencies of vitamin C, niacin) are primarily caused by inadequate intake (e.g., 
famine, significant calorie restriction, eating disorders, alcoholism, diet practices/fad 
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diets).  The deficiencies, excluding any permanent physical damage, can typically be 
corrected once foods with these essential nutrients (or dietary supplements, if 
necessary) are made available and/or consumed.  Because such diseases can typically 
be managed through consumption of a healthy, well-balanced diet, FDA generally 
would not consider a product labeled and marketed for these diseases to meet the 
statutory and regulatory criteria for a medical food (see 21 CFR 101.9(j)(8)(ii)). 
28. Does FDA consider conventional foods that, in their natural state, do not contain 
protein or are low in protein to meet the definition of a medical food? 
No.  Conventional foods such as fruits, certain vegetables, fats, and sugars generally are 
not specially formulated to be significantly low in protein or to contain no protein
instead, they are low in protein in their natural state.  Under 21 CFR 101.9(j)(8)(i), a 
medical food must be a specially formulated and processed product (as opposed to a 
naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding 
of a patient by means of oral intake or enteral feeding by tube. Therefore, conventional 
foods that do not ordinarily contain protein or are ordinarily low in protein would not 
meet the statutory and regulatory criteria for medical foods. 
III.  References 
We have placed the following references on display in the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  
You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.  
As of April 12, 2016, FDA had verified the Web site address for the references it makes 
available as hyperlinks from the Internet copy of this guidance, but FDA is not 
responsible for any subsequent changes to Non-FDA Web site references after April 12, 
2016. 
1. Camp, K., Lloyd-Puryear, M., Huntington, K. Nutritional treatment for inborn errors 
of metabolism: Indications, regulations, and availability of medical foods and dietary 
supplements using phenylketonuria as an example. Molecular Genetics and 
Metabolism, 107:3-9, 2012. Available: 
http://www.ncbi.nlm.nih.gov/pubmed/22854513. 
2. Otten, J., Hellwig, J., Meyers, L. eds. Institute of Medicine. Dietary Reference 
Intakes. The Essential Guide to Nutrient Requirements, Part 1: Development and 
Application, Introduction to the Dietary Reference Intakes and Applying the 
Dietary Reference Intakes, pp. 5-17, 2006. 
3. American Diabetes Association. Nutrition Therapy Recommendations for the 
Management of Adults With Diabetes. A Position Statement of the American 
Diabetes Association. Diabetes Care, 37(1):S120-S143, January 2014. Available: 
http://care.diabetesjournals.org/content/37/Supplement_1/S120.full.pdf+html. 
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4. Standards of Medical Care in Diabetes 2016, American Diabetes 
Association, Diabetes Care. 39 (Supplement 1): S1-S112, January 2016. 
Available: http://professional.diabetes.org/content/clinical-practice-
recommendations. 
5. Centers for Disease Control and Prevention. Eat Right! 
www.cdc.gov/diabetes/consumer/eatright.htm (accessed April 12, 
2016). 
Document History 
May 2007  First edition of guidance was issued. 
May 2016  Second edition of guidance was issued. 
March 2023  Third edition.  The guidance was updated to include updates on allergens.  
12