MEDICAL NUTRITION IN DIETETICS Nutrition Vol. 15, No. 3, 1999

GUEST EDITOR:

EVA POLITZER SHRONTS, MMSC, RD, CNSD

Minneapolis, Minnesota, USA

The Regulatory Status of Medical Foods andDietary Supplements in the United States

CHARLES MUELLER, MS, RD, CNSD

From the General Clinical Research Center, Cornell University Medical Center, New York, New York, USA

INTRODUCTION

In the United States, the Food and DrugAdministration (FDA) has the authority toregulate all foods and drugs as mandatedby the Food Drug and Cosmetics Act of1938. Nutritional products that are subjectto regulations are conventional foods,foods for special dietary use, (which in-clude medical foods and infant formulas),dietary supplements, and parenteral solu-tions (which are regulated as drugs by vir-tue of their administration intravenously).1

Currently, medical foods, equivalent toadult enteral formulas, and dietary supple-ments are the least regulated of these prod-ucts. This article will define medical foodsand dietary supplements, provide the his-torical perspective that has influenced theirregulation, and describe their current reg-ulatory status.

DEFINITIONS

The legal definitions for medical foodsand dietary supplements are important be-cause they are designed to distinguishthem from drugs and conventional foods.This distinction is often difficult to dis-cern. For example, a product that is sold asa conventional food as a meal replacementis very similar to a standard medical foodoral supplement or meal replacement prod-uct. How do consumers distinguish be-tween meal replacement products they can

buy in an American supermarket and amedical food? The term,nutraceutical, hasbecome synonymous with dietary supple-ments. It was defined in 1989 by StephenDeFelice2 as:

. . . any substance that may be con-sidered a food or part of a food andprovides medical or health benefits, in-cluding the prevention and treatment ofdisease.

Clearly, nutraceuticals are not drugs,but drug-like claims are included in theirdefinition. In fact, nutraceuticals were de-fined as part of an effort by The Founda-tion for Innovative Medicine to encouragethe establishment of new regulations forproduct development outside those thatexisted in 1991 for conventional foods anddrugs, and to provide exclusive market-ing rights based on proprietary research.3

The FDA does not recognize the termnutraceutical.

Medical Foods

The current legal definition for medicalfoods, as set forth by a 1988 amendment tothe Orphan Drug Act is as follows:

The term ‘medical food’ means afood which is formulated to be con-sumed or administered enterally underthe supervision of a physician andwhich is intended for the specific dietary

management of a disease or conditionfor which distinctive nutritional require-ments on the basis of recognized scien-tific principles are established by medi-cal evaluation.4

The amendment applied this definitionto introduce a subcategory of medicalfoods, called orphan medical foods, whichwere described as products to be used inthe management of:

. . . any disease or condition that oc-curs so infrequently in the United Statesthat there is no reasonable expectationthat a medical food for such disease orcondition will be developed withoutassistance.5

However, there are no product devel-opment regulations for medical foods asthere are for drugs, excluding orphandrugs. Thus, there was no need for thisprovision. Additionally, the former defini-tion states that medical foods are to beused under the supervision of a physician,which is often not the case in practice.Many medical foods are available inAmerican pharmacies and grocery storesfor direct purchase by patients andconsumers.

Dietary Supplements

Currently, the FDA recognizes the fol-lowing criteria for qualification of a product

This article was originally part of a presentation on medical foods and nutraceuticals at the 22nd Clinical Congress of the American Society for Parenteraland Enteral Nutrition, Lake Buena Vista, Florida.

Correspondence to: Charles Mueller, MS, RD, CNSD, General Clinical Research Center, Cornell University Medical Center, 525 East 68th Street, NewYork, NY 10021, USA. E-mail: cmmuelle@mail.med.cornell.edu

Nutrition 15:249–251, 1999©Elsevier Science Inc. 1999 0899-9007/99/$20.00Printed in the USA. All rights reserved. PII S0899-9007(98)00186-5

as a dietary supplement as set forth by theDietary Supplement Health and EducationAct (DSHEA) of 1994:6

. . . is aproduct (other than tobacco)that is intended to supplement the dietthat bears or contains one or more of thefollowing dietary ingredients: a vitamin,a mineral, an herb or other botanical, anamino acid, a dietary substance for useby man to supplement the diet by in-creasing the total daily intake, or con-centrate, metabolite, constituent, ex-tract, or combinations of theseingredients.

. . . is intended for ingestion in pill,capsule, tablet, or liquid form.

. . . is not represented for use as aconventional food or as a sole item of ameal or diet.

. . . is labeled as a dietarysupplement.

. . . includes products such as ap-proved new drug, certified antibiotic, oflicensed biologic that was marketed as adietary supplement or food before ap-proval, certification, of license (unlessthe Secretary of Health and Human Ser-vices waives this provision)

A host of terms, including nutraceuti-cal, have been applied to products that fallunder the umbrella of dietary supplementsin the United States such as therapeuticfood, phytochemical, chemopreventiveagent, pharmafood, and functional food.The American Dietetic Association recog-nizes the termsphytochemicaland func-tional food presumably because theseterms are used in the scientific literature.7

The international scientific communityhas made efforts to sort out the distinctionsbetween functional foods and drugs, al-though no consensus has been reached onhealth claims for functional foods. Easternmedicine has long believed in the use offood as medicine, whereas in Westernmedicine, only drugs have been viewed aspotential treatment for disease. In theWestern view, nutrients are considered es-sential for biological well-being and theprevention of deficiency syndromes. Manyfunctional foods are not considered essen-tial nutrients, but may have a beneficialeffect on health or the treatment of a dis-ease or condition.8

HISTORY AND REGULATION

Medical Foods

The first commercial enteral formula inthe United States was introduced in 1942.It was a nutritionally complete formulautilizing partially hydrolyzed casein as aprotein source and was intended to be usedin pediatric patients with gastrointestinal

disorders and allergies. In the late 1950s,the first completely hydrolyzed formulawas developed for astronauts for the pur-pose of minimizing in-flight waste. Com-mercial enteral formulas continued to bedeveloped, particularly as the limitationsof parenteral nutrition were understoodand gastrointestinal access technology ad-vanced.9 The market for enteral productswas forecasted in 1991 to exceed $1 bil-lion in 1996.10

In 1941, the FDA11 established the reg-ulatory category, “foods for special dietaryuses.” In 1972, the FDA12 distinguishedsuch foods from drugs by classifying aformula for infants with phenylketonuriaas a food for special dietary use. In 1973,these foods were exempted from labelingrequirements applicable to conventionalfoods.13 The FDA went on to propose thatlabeling regulations for foods to be usedunder medical supervision should be la-beled similar to foods for special dietaryuses.14 Foods to be used under medicalsupervision were not named among thefive distinct categories of foods for specialdietary uses and therefore eluded regula-tion. However, the concept of medicalfoods was established based on their useunder medical supervision.15

Subsequent attempts to regulate medi-cal foods were rejected because of the pre-vailing climate of government deregula-tion at the time.11,13 One exception wasinfant formulas (not considered medicalfoods), which became subject to regula-tions mandated by the Infant Formula Actof 1980 passed in response to cases offailure-to-thrive associated with metabolicalkalosis caused by formulas low in chlo-ride.1 The Orphan Drug Act Amendmentof 1988,4 previously discussed, introducedthe category of orphan medical foods andprovided the current legal definition ofmedical foods. The FDA exempted medi-cal foods from the 1990 Nutrition Labelingand Education Act (NLEA) regulations forconventional foods that govern nutritionlabeling, ingredient labeling, and nutrientcontent claims, because medical foodswere intended to be used under the super-vision of a physician. Good manufactur-ing practices that apply to sanitary manu-facture of processed conventional foodshave applied in the past, and continue toapply, for medical foods as well. The FDAdid recognize that these products need reg-ulations that require higher level informa-tion than that provided for conventionalfoods.16

In 1997, the FDA solicited advancenotice of proposed rulemaking for the reg-ulation of medical foods. The AmericanSociety for Parenteral and Enteral Nutri-tion published their response to the Dock-

ets Management Branch of the FDA.17 Asof the preparation of this manuscript, theFDA has not proposed any regulations formedical foods.

Dietary Supplements

The FDA regulated dietary supple-ments as conventional foods up until1992.6 However, the rapid growth of thedietary supplement industry in the UnitedStates led to advocacy for special consid-erations for supplements as illustrated bythe nutraceutical initiative discussed pre-viously. These considerations were partic-ularly sensitive because with passage ofthe NLEA in 1990, subsequent FDA reg-ulations permitted health claims for foodand supplement labeling in seven catego-ries: calcium and osteoporosis; sodium andhypertension; saturated fat and cholesteroland the risk of heart disease; dietary fatand cancer; fiber-containing grain prod-ucts; fruits and vegetables and cancer;fiber-containing grain, vegetable, and fruitproducts and heart disease; and fruits andvegetables and cancer.18 These allowedclaims were felt by some to limit supple-ment product development in a climate ofincreased public demand for products.2,19

Consequently, dietary supplementswere exempted from the provisions of theNLEA in 1992 by the Dietary SupplementAct so that the FDA could consider alter-native regulations that would suit bothconsumers and manufacturers.20 In 1994,Congress passed the DSHEA to addressthese issues and also help ensure that prod-ucts are safe and appropriately labeled.The DSHEA redefine dietary supplements;contain provisions for ensuring safety;provide guidelines for literature displayedwhere supplements are sold; provide forthe use of claims and nutritional supportstatements; mandate ingredient and nutri-tion labeling; and grant the FDA authorityto establish good manufacturing practices.6

At first glance, these provisions wouldseem to impose significant restrictions ondietary supplements. However, examina-tion of the actual provisions indicate thatdietary supplements have more flexibleregulations than conventional foods ordrugs. Various types of statements may bemade on the labels of supplements, al-though claims may not be made that asupplement can “diagnose, prevent, miti-gate, or treat a specific disease (unlessapproved under the new drug provision ofthe Food Drug and Cosmetics Act).”6 Lan-guage such aswell-beingor functionmaybe used provided manufacturers can sub-stantiate that statements are truthful andlabels bear the avowal “this statement hasnot been evaluated by the FDA.”6 Becausedietary supplements are defined as supple-

REGULATORY STATUS OF MEDICAL FOODS AND DIETARY SUPPLEMENTS250

mentary to a diet, they are considered afood and therefore do not require premar-keting approval. They are also not regu-lated as food additives, which thereforeexempts them from premarketing approvalthat applies for food additives.21 Thus, thecontent of the DSHEA regulations provideflexibility for manufacturers to developproducts and give more responsibility toconsumers for product selection.

CONCLUSION

Medical foods and dietary supplementshave presented a significant challenge toUnited States legislators and the FDA toboth define and regulate. This challengederives from the difficulty in distinguish-ing between their purposes as food ordrug, and doing so in such a fashion as tosatisfy consumers, manufacturers, scien-

tists, and health care professionals. Medi-cal foods continue to be exempt fromproduct claim and labeling regulations,presumably because their primary role asphysician-prescribed treatment versusfood is not yet clear. Dietary supplementsare under enormous demand by the Amer-ican consumer and presently have rela-tively flexible product development andhealth claim regulations.

REFERENCES

1. Mueller C, Nestle M. Regulation of medicalfood: toward a rational policy. Nutr ClinPrac 1995;10:8

2. The nutraceuticals initiative: a proposal foreconomic and regulatory reform.TheFoundation for Innovative Medicine, 1991

3. Pszczola DE. The nutraceutical initiative: aproposal for regulatory reform. Food Tech1992;46:77

4. U. S. Congress, 1988. 100th Congress Or-phan Drug Act Amendment of 1988. P.L.100-290. Amendments of Section 525(a)(1)of the Federal Food Drug and CosmeticsAct

5. 21 U. S. Code 360 ee(b)6. U. S. Food and Drug Administration Cen-

ter for Food Safety and Applied Nutri-tion. December 1, 1995. Dietary Supple-ment Health and Education Act of 1994.www.fda.com

7. Position of The American Dietetic Associ-ation: phytochemicals and functional foods.J Am Diet Assoc 1995;95;493

8. Clydesdale FM. A proposal for the estab-lishment of scientific criteria for healthclaims for functional foods. Nutr Rev 1997;55:413

9. McCamish MA, Bounous G, Geraghty ME.History of enteral feeding: past and presentperspectives. In: Rombeau JL, RolandelliRH, eds.Enteral and tube feeding,3rd ed.Philadelphia: WB Saunders, 1997:1

10. Infant and adult enteral nutrition market:executive survey.New York: Frost and Sul-livan Inc., 1991

11. Talbot JM. Guidelines for the scientificreview of enteral products for medical pur-poses. Life Sciences Research Office, Fed-eration of American Societies for Experi-mental Biology. JPEN 1991;14(suppl):99S

12. Federal Register 1972;37(Sept 8):1822913. Scientific Status Summary. Medical foods:

a scientific status summary by the Instituteof Food Technologists’ Expert Panel onFood Safety and Nutrition. Food Tech1992;46:87

14. Federal Register 1973;38(Jan 19):212515. Scarbrough FE. Medical foods: an intro-

duction. Food Drug and Cosmet Law J1989;44:463

16. Federal Register 1993;58(Jan 6):215117. Kudsk KA. A.S.P.E.N.’s response to FDA

advance notice of proposed rulemaking.Nutr Clin Prac 1997;12:131

18. The FDA’s final regulations on healthclaims for foods. Nutr Rev 1993;51

19. Rice J. Nutraceutical initiative gatheringmomentum. Food Processing 1991;52:8

20. FDA Regulation. Compliance by dietarysupplement and conventional food estab-lishments. United States General Account-ing Office. June 1994

21. Bartels CL, Miller SJ. Herbal and relatedremedies. Nutr Clin Prac 1998;13:5

REGULATORY STATUS OF MEDICAL FOODS AND DIETARY SUPPLEMENTS 251