Guidance for Industry on  
 
Complementary and Alternative 
Medicine Products and Their 
Regulation by the Food and 
Drug Administration 
 
 
 
DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit comments to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments 
should be identified with the docket number listed in the notice of availability that publishes in 
the Federal Register. 
 
For questions regarding this draft document, contact (CBER) Sheryl Lard-Whiteford at 301-827-
0379, (CDER) Daniel Nguyen at 301-827-8971, (CDRH) Ted Stevens at 301-594-1184, or 
(CFSAN) Wayne Amchin at 301-827-6739. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
December 2006 
 
   
Guidance for Industry: 
 
Complementary and 
Alternative Medicine 
Products and Their 
Regulation by the Food and 
Drug Administration
 
 
Additional copies are available from: 
 
Office of Communication, Training, and Manufacturers Assistance (HFM-40) 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
1401 Rockville Pike, Suite 200N 
Rockville, MD 20852-1448 
Phone: 800-835-4709 or 301-827-1800 
Internet: http://www.fda.gov/cber/guidelines.htm 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research (CBER) 
Center for Drug Evaluation and Research (CDER) 
Center for Devices and Radiological Health (CDRH) 
Center for Food Safety and Applied Nutrition (CFSAN) 
 
 
December 2006 
  2  
Table of Contents 
 
I.       Why Are We Issuing This Guidance?................................ 1 
   
II.      What Is Complementary and Alternative Medicine (CAM)?..... 2 
A. What Are Biologically Based Practices?..................... 3 
B. What Is Energy Medicine?...................................... 4 
C. What Are Manipulative and Body-Based Practices?........ 5 
D. What Is Mind-Body Medicine?................................. 5 
E. What Are Whole Medical Systems?........................... 6 
 
III.     How Do CAM Domains Relate to Products That We Regulate?. 7 
 
IV.    What FDA Authority Might Apply to CAM Products?............ 7 
  A.  What Statutory Definitions Might Apply?.............................. 7 
    1.  Drug and New Drug.................................... 7 
    2.  Device...................................................... 8 
    3.  Food........................................................ 9 
    4.  Food Additive............................................. 10 
    5.  Dietary Supplement..................................... . 10 
    6.  Cosmetic................................................... 12 
    7.  Biological Product?....................................... 13 
 
V.    Whom Do You Contact for More Information?........................... 13 
  3  
Complementary and Alternative Medicine Products and Their 
1
Regulation by the Food and Drug Administration
 
 
 
This draft guidance, when finalized, will represent the Food and Drug Administration's 
(FDA's) current thinking on this topic.  It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public.  You can use an alternative 
approach if it satisfies the requirements of the applicable statutes and regulations.  If you 
want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance. 
 
 
 
I.  Why Are We Issuing This Guidance? 
 
The term complementary and alternative medicine (CAM) encompasses a wide 
array of health care practices, products, and therapies that are distinct from practices, 
products, and therapies used in conventional or allopathic medicine.  Some forms of 
CAM, such as traditional Chinese medicine and Ayurvedic medicine, have been practiced 
for centuries, whereas others, such as electrotherapy, are more recent in origin.   
 
  In the United States, the practice of CAM has risen dramatically in recent years.  
In 1992, Congress established the Office of Unconventional Therapies, which later 
became the Office of Alternative Medicine (OAM), to explore unconventional medical 
practices.  In 1998, OAM became the National Center for Complementary and 
Alternative Medicine (NCCAM).  NCCAM is a center within the National Institutes of 
Health.  The Institute of Medicine, in its book entitled, Complementary and Alternative 
Medicine in the United States, stated that more than one-third of American adults 
reported using some form of CAM and that visits to CAM providers each year exceed 
those to primary care physicians.2
 
As the practice of CAM has increased in the United States, the Food and Drug 
Administration (FDA, we) has seen increased confusion as to whether certain 
products used in CAM (which, for convenience, we will refer to as CAM products) are 
subject to regulation under the Federal Food, Drug, and Cosmetic Act (the Act) or 
Public Health Service Act (PHS Act).  We have also seen an increase in the number of 
CAM products imported into the United States.  Therefore, we are providing guidance as 
                                                           
1   This guidance was prepared by the Office of Policy and Planning, Office of the Commissioner, Food and 
Drug Administration, with assistance from the Center for Biologics Evaluation and Research, the Center 
for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for 
Food Safety and Applied Nutrition. 
2   See Institute of Medicine, Complementary and Alternative Medicine in the United States, pages 34-35 
(2005). 
  1  
to when a CAM product is subject to the Act or the PHS Act.3  This guidance makes two 
fundamental points: 
!  First, depending on the CAM therapy or practice, a product used in a 
CAM therapy or practice may be subject to regulation as a biological 
product, cosmetic, drug, device, or food (including food additives and 
dietary supplements) under the Act or the PHS Act.  For example, the PHS 
Act defines biological product, and the Act defines (among other 
things): 
o  Cosmetic; 
o  Device; 
o  Dietary supplement; 
o  Drug, as well as new drug and new animal drug; 
o  Food; and 
o  Food additive. 
These statutory definitions cover some CAM products. 
!  Second, neither the Act nor the PHS Act exempts CAM products from 
regulation.  This means, for example, if a person decides to produce and 
sell raw vegetable juice for use in juice therapy to promote optimal health, 
that product is a food subject to the requirements for  foods in the Act and 
FDA regulations, including the hazard analysis and critical control point 
(HACCP) system requirements for juices in 21 CFR part 120.  If the juice 
therapy is intended for use as part of a disease treatment regimen instead 
of for the general wellness, the vegetable juice would also be subject to 
regulation as a drug under the Act.  
We explain these two points in greater detail later in this document.   
 
 
II.  What Is Complementary and Alternative Medicine (CAM)? 
 
NCCAM defines CAM as a group of diverse medical and health care systems, 
practices, and products that are not presently considered to be part of conventional 
medicine.4  It interprets complementary medicine as being used together with 
conventional medicine, whereas alternative medicine is used in place of conventional 
medicine. 
 
  NCCAM classifies CAM therapies into four categories or domains.  These are: 
!  Biologically-based practices;  
!  Energy therapies; 
                                                           
3 When this guidance mentions a particular CAM therapy, practice, or product, it does so 
in order to provide background information or to serve as an example or illustration; any 
mention of a particular CAM therapy, practice, or product should not be construed as 
expressing FDAs support for or endorsement of that particular CAM therapy, practice, 
or product or, unless specified otherwise, as an agency determination that a particular 
product is safe and effective for its intended uses or is safe for use.   
4   See NCCAM, Get the FACTS  What Is Complementary and Alternative Medicine (CAM)? available 
at http://nccam.nih.gov/health/whatiscam (accessed on November 22, 2005). 
  2  
!  Manipulative and body-based methods; and 
!  Mind-body medicine. 
NCCAM once had a fifth domain, Alternative medical systems, but now considers 
alternative medical systems (now known as whole medical systems) to be a separate 
category rather than another domain because alternative medical systems use practices 
from the four domains listed above.  For purposes of this guidance, we adopt the same 
domains and whole medical systems category that NCCAM uses.   
 
 
A.  What Are Biologically Based Practices? 
 
According to NCCAM, the domain called biologically based practices includes, 
but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, 
amino acids, proteins, prebiotics5 and probiotics,6 whole diets, and functional foods.7
 
  Many biologically-based products within this domain are subject to statutory and 
regulatory requirements under the Act or the PHS Act.  The intended use of a product 
plays a central role in how it is regulated.  For example: 
 
!  Botanical products, depending on the circumstances, may be regulated as 
drugs, cosmetics, dietary supplements, or foods.8  All four types of 
                                                           
5   Prebiotics have been defined as nondigestible food ingredients that beneficially affect the host by 
selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon (see 
Gibson, G.R. and Roberfroid, M.B., Dietary Modulation of the Human Colonic Microbiota: Introducing 
the Concept of Prebiotics, Journal of Nutrition, 125: 1401-1412 (1995)).  Oligosaccharides are commonly 
used as prebiotics.     
6   Probiotics have been defined as live microbial food supplements which beneficially affect the host 
animal by improving its intestinal microbial balance (see Fuller, R., Probiotics in Man and Animals, 
Journal of Applied Bacteriology, 66: 365-378 (1989)) and as live microorganisms which, when consumed 
in adequate amounts of food, confer a health benefit on the host (see Food and Agriculture Organization 
and World Health Organization, Health and Nutritional Properties of Probiotics in Food including Powder 
Milk with Live Lactic Acid Bacteria (1-4 October 2001)).  For purposes of this document, we will 
consider probiotics to refer to whole, live microorganisms that are ingested with the intention of providing 
a health benefit (such as supporting digestion and nutrient adsorption in the intestine).  Our Center for Food 
Safety and Applied Nutrition, simply refers to such bacteria as live microorganisms.   
  Probiotics are not defined as a regulatory product category under the Act or the PHS Act, and 
products that may be considered to be probiotics may be foods or drugs under the Act, depending on the 
intended use of the product. 
7   See NCCAM, BACKGROUNDER: Biologically Based Practices: An Overview (October 2004), at 
page 1 (available at http://nccam.nih.gov/health/backgrounds/biobasedprac.pdf) (accessed on November 
22, 2005)).  NCCAM interprets functional foods as components of the usual diet that may have 
biologically active components (e.g., polyphenols, phytoestrogens, fish oils, carotenoids) that may provide 
health benefits beyond basic nutrition (id. at page 3).  However, functional foods are not defined as a 
regulatory product category, and products that NCCAM would interpret to be functional foods would 
either be foods or drugs to FDA, depending on the claims associated with the product. 
8   Although dietary supplements are a type of food (see section 201(ff) of the Act (last sentence)), for ease 
of reference, we will use the term food to refer to foods other than dietary supplements (e.g., 
conventional foods, food additives, or GRAS substances intended for use in food)  throughout the 
remainder of this guidance.  We may discuss specific types of foods, such as food additives, separately 
  3  
products are subject to the Act.  For example, a botanical product intended 
for use in treating a disease would generally be regulated as a drug; a 
botanical product taken by mouth, labeled as a dietary supplement, and 
intended for use to affect the structure or function of the body would 
generally be regulated as a dietary supplement; a raw or dried botanical 
intended for use as an ingredient to flavor food would generally be 
regulated as a food or as a food additive, depending on whether the 
botanical was generally recognized as safe for its intended use in food; and 
a lotion containing botanical ingredients and intended for use in 
moisturizing the skin would generally be regulated as a cosmetic. 
!  Probiotics may be regulated as dietary supplements, foods, or drugs under 
the Act, depending on the products intended use.  Other factors may also 
affect the classification of the product, e.g., whether the product contains a 
dietary ingredient as defined in section 201(ff)(1) of the Act (21 U.S.C. 
321(ff)(1)), whether it is represented as a conventional food or as a meal 
replacement (see section 201(ff)(2)(B) of the Act), and, for probiotics used 
as  ingredients in a conventional food, whether the ingredient is generally 
recognized as safe for its intended use (see section 201(s) of the Act (21 
U.S.C. 321(s)).   In addition to any requirements that apply based on the 
products classification under the Act, probiotics may also be subject to 
the PHS Acts provisions concerning the prevention of communicable 
disease, due to potential disease-causing microorganisms that might be 
contained in such products.  Finally, if a probiotic is a drug under the Act, 
it may be subject to regulation as a biological product under the PHS Act 
as well.   
!  Products that NCCAM would consider to be functional foods may be 
subject to FDA regulation as foods, dietary supplements, or drugs under 
the Act.  As with botanicals and probiotics, the classification of a 
functional food under the Act is based primarily on the products 
intended use and may also involve other factors, depending on the 
elements of the statutory definition of a particular product category.   
 
 
 
B.  What Is Energy Medicine? 
 
NCCAM considers energy medicine to involve energy fields of two types: 
!  Veritable energy fields, which can be measured and use either mechanical 
vibrations (such as sound) or electromagnetic forces, including visible 
light, magnetism, monochromatic radiation (such as laser light), and other 
light rays; and 
!  Putative energy fields (or biofields) that have defied measurement to date 
by reproducible methods.  According to NCCAM, therapies involving 
putative energy fields are based on the concept that human beings are 
                                                                                                                                                                             
to explain additional statutory or regulatory requirements or concepts, but those products are still foods 
under the Act. 
  4  
infused with a subtle form of energy and therapists claim that they work 
with this subtle energy, see it with their own eyes, and use it to effect 
changes in the physical body and influence health.9  
 
In a sense, conventional medicine already uses various forms of energy 
medicine.   For example, a magnetic resonance imaging (MRI) device uses 
electromagnetic waves to create images of internal body organs and tissues.  As another 
example, an ultrasound machine uses sound waves to create images of body organs, 
tissues, and fetuses.  Given their intended uses, we regulate these products as medical 
devices under the Act. 
 
CAM products that use veritable energy fields in the diagnosis of disease or other 
conditions or in the cure, mitigation, treatment, or prevention of disease in man or 
animals or to affect the structure or any function of the body of man or animals may be 
medical devices under the Act.10  Additionally, if the product is electronic and emits 
radiation, it may be subject to additional requirements to ensure that there is no 
unnecessary exposure of people to radiation.   
 
CAM products that use putative energy fields in the diagnosis of disease or other 
conditions, or in the cure, mitigation, treatment, or prevention of disease in man or 
animals may be medical devices under the Act.  For example, we regulate acupuncture 
needles as class II medical devices.11   
 
 
C.  What Are Manipulative and Body-Based Practices? 
 
According to NCCAM:  
 
Under the umbrella of manipulative and body-based practices is a heterogeneous 
group of CAM interventions and therapies.  These include chiropractic and 
osteopathic manipulation, massage therapy, Tui Na, reflexology, rolfing, Brown 
technique, Trager bodywork, Alexander technique, Feldenkrais method, and a 
host of others.... 
 
Manipulative and body-based practices focus primarily on the structures and 
systems of the body, including the bones and joints, the soft tissues, and the 
circulatory and lymphatic systems....12
 
  To the extent that manipulative and body-based practices involve practitioners 
physically manipulating a patients body, without using tools or machines, we do not 
                                                           
9   See NCCAM, BACKGROUNDER  Energy Medicine: An Overview (August 2005), at page 1 
(available at http://nccam.nih.gov/health/backgrounds/energymed.pdf) (accessed on November 22, 2005). 
10   See section 201(h)(2) and (h)(3) of the Act (21 U.S.C. 321(h)(2) and (h)(3)) (definition of device). 
11   See 21 CFR 880.5580. 
12   See NCCAM, BACKGROUNDER: Manipulative and Body-Based Practices: An Overview 
(December 2004), at page 1 (available at http://nccam.nih.gov/health/backgrounds/manipulative.pdf) 
(accessed on November 22, 2005). 
  5  
believe that such practices are subject to regulation under the Act or the PHS Act.  If, 
however, the manipulative and body-based practices involve the use of equipment (such 
as massage devices) or the application of a product (such as a lotion, cream, or oil) to the 
skin or other parts of the body, those products may be subject to regulation under the Act, 
depending on the nature of the product and its intended use..   
 
 
D.  What Is Mind-Body Medicine? 
 
  NCCAM describes mind-body medicine as focusing on the interactions among 
the brain, mind, body, and behavior, and the powerful ways in which emotional, mental, 
social, spiritual, and behavioral factors can directly affect health.13  It states that mind-
body medicine typically focuses on intervention strategies that are thought to promote 
health, such as relaxation, hypnosis, visual imagery, meditation, yoga, biofeedback, tai 
chi, qi gong, cognitive-behavioral therapies, group support, autogenic training, and 
spirituality.14   
 
  In general, CAM practices in this domain would not be subject to our jurisdiction 
under the Act or the PHS Act.  As with the manipulative and body-based practices 
domain, however, any equipment or other products used as part of the practice of mind-
body medicine may be subject to FDA regulation, depending on the nature of the product 
and its intended use.  For example, biofeedback machines intended to help a patient learn 
to affect body functions, such as muscle activity, are regulated as class II devices.15
 
 
E.  What Are Whole Medical Systems? 
 
NCCAM describes whole medical systems as involving complete systems of 
theory and practice that have evolved independently from or parallel to allopathic 
(conventional) medicine.16  These may reflect individual cultural systems, such as 
traditional Chinese medicine and Ayurvedic medicine.  Some elements common to whole 
medical systems are a belief that the body has the power to heal itself, and that healing 
may involve techniques that use the mind, body, and spirit.   
 
  Although it is unlikely that a whole medical system itself would be subject to 
regulation under the Act or the PHS Act, products used as components of whole medical 
systems may be subject to FDA regulation for the reasons described above. 
 
 
                                                           
13   See NCCAM, BACKGROUNDER: Mind-Body Medicine: An Overview (August 2005), at page 1 
(available at http://nccam.nih.gov/health/backgrounds/mindbody.pdf) (accessed on November 22, 2005). 
14   Id.   
15   See 21 CFR 882.5050. 
16   See NCCAM, BACKGROUNDER: Whole Medical Systems: An Overview (October 2004), at page 
1 (available at http://nccam.nih.gov/health/backgrounds/wholemed.pdf) (accessed on November 22, 2005). 
  6  
III.    How Do CAM Domains Relate to Products That We Regulate? 
 
  Given the vast array of CAM products, practices, and therapies, it is impractical 
for us to describe in detail how each one might be subject to regulation under the Act or 
the PHS Act.  Our intent, in part IV of this document, is two-fold: 
!  To indicate which CAM domains might be subject to regulation under the 
Act or the PHS Act; and  
!  To show that neither the Act nor the PHS Act contains any exemption for 
CAM products.  In other words, if a product meets the statutory definition 
of drug, device, biological product, food, etc., it will be subject to 
regulation under the Act and/or the PHS Act.  
 
 
IV.    What FDA Authority Might Apply to CAM Products? 
 
A.  What Statutory Definitions Might Apply? 
 
To understand how the Act or the PHS Act might apply to CAM products, we 
begin by understanding the Acts statutory definitions or, in the case of the PHS Act, our 
authority regarding biological products. 
 
1.  Drug and New Drug 
 
Section 201(g)(1) of the Act (21 U.S.C. 321(g)(1)) defines the term drug, in 
relevant part, to mean: 
 
(A) articles recognized in the official United States Pharmacopeia, official 
Homeopathic Pharmacopeia of the United States, or official National Formulary, 
or any supplement to any of them; and (B) articles intended for use in the 
diagnosis, cure, mitigation, treatment, or prevention of disease in man or other 
animals; and (C) articles (other than food) intended to affect the structure or any 
function of the body of man or other animals; and (D) articles intended for use as 
a component of any articles specified in clause (A), (B), or (C). 
 
Section 201(p) of the Act (21 U.S.C. 321(p)) defines the term new drug to 
mean: 
 
(1) Any drug (except a new animal drug or an animal feed bearing or 
containing a new animal drug) the composition of which is such that the drug is 
not generally recognized, among experts qualified by scientific training and 
experience to evaluate the safety and effectiveness of drugs, as safe and 
effective17 for use under the conditions prescribed, recommended, or suggested in 
                                                           
17   In Weinberger v. Hynson, Westcott and Dunning, 93 S.Ct. 2469, 2483 (1973), the Supreme Court stated 
that general recognition of effectiveness requires at least substantial evidence of effectiveness for 
approval of a new drug application (NDA).  (An NDA is the marketing application for a new drug.)  
  7  
the labeling thereof, except that such a drug not so recognized shall not be 
deemed to be a new drug if at any time prior to the enactment of this Act, it was 
subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such 
time its labeling contained the same representations concerning the conditions of 
use; or 
(2) Any drug (except a new animal drug or an animal feed bearing or 
containing a new animal drug) the composition of which is such that such drug, as 
a result of investigations to determine its safety and effectiveness for use under 
such conditions, has become so recognized, but which has not, otherwise than in 
such investigations, been used to a material extent or for a material time under 
such conditions. 
 
  To illustrate how these definitions might apply, consider an herbal product that is 
intended to treat arthritis in humans.  The herbal product, which would be a biologically 
based practice insofar as CAM domains are concerned, would be a drug under section 
201(g)(1)(B) of the Act because it is intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of disease (arthritis) in man.  The same herbal product would 
also be a new drug under section 201(p)(1) of the Act unless it is generally recognized, 
among experts qualified by scientific training and experience to evaluate the safety and 
effectiveness of drugs, as safe and effective for use under the conditions prescribed, 
recommended, or suggested in the labeling.  New drug status triggers the Acts 
requirements for premarket review and approval by FDA.18  
 
  A detailed discussion of the Acts drug provisions is beyond the scope of this 
guidance document.  Note, however, that the Act imposes certain requirements (including 
requirements pertaining to establishment registration and product listing, pre-market 
approval, labeling, postmarket reporting, and good manufacturing practices) on those 
who manufacture and distribute drugs.  The Act and our drug regulations can be found at 
our website at http://www.fda.gov/opacom/laws.   
 
2.  Device 
 
  In general, section 201(h) of the Act (21 U.S.C. 321(h)) defines the term device 
as: 
 
an instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent, or other similar or related article, including any component, part, or 
accessory  which is   
                                                                                                                                                                             
Section 505(d) of the Act (21 U.S.C. 355(d)) defines substantial evidence as evidence consisting of 
adequate and well-controlled investigations, including clinical investigations conducted by experts 
qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the 
basis of which it could fairly and responsibly be concluded by such experts that the drug will have the 
effect it purports or is represented to have under the conditions of use prescribed, recommended, or 
suggested in the labeling or proposed labeling thereof.  Thus, general recognition is a high standard.   
18   Under section 505(a) of the Act (21 U.S.C. 355(a)), No person shall introduce or deliver for 
introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to 
[section 505(b) or 505(j) of the Act] is effective with respect to such drug. 
  8  
(1)  recognized in the official National Formulary, or the United States 
Pharmacopeia, or any supplement to them,  
(2) intended for use in the diagnosis of disease or other conditions, or in 
the cure, mitigation, treatment, or prevention of disease in man or other animals, 
or  
(3) intended to affect the structure or any function of the body of man or 
other animals, and  
which does not achieve its primary intended purposes through chemical action 
within or on the body of man or other animals, and which is not dependent upon 
being metabolized for the achievement of its primary intended purposes. 
 
To illustrate how a CAM product might be a device under the Act, acupuncture 
is a CAM therapy that seeks to stimulate energy pathways (meridians) by puncturing, 
pressing, heating, using electrical current, or using herbal medicines.  Fine needles are 
often used, and these acupuncture needles are devices under section 201(h) of the Act 
because they are intended for use in the cure, mitigation, treatment, or prevention of 
disease in man or are intended to affect the structure or function of the body of man.  We 
regulate acupuncture needles (see 21 CFR 880.5580), but not the practice of acupuncture 
itself. 
 
  A detailed discussion of the Acts device provisions is beyond the scope of this 
guidance document.  Note, however, that the Act establishes classifications for devices 
(class I, II, or III) that affect how they are regulated.  The Act also imposes certain 
requirements on those who manufacture devices (including requirements pertaining to 
establishment registration and product listing, pre-market review, labeling, postmarket 
reporting, and good manufacturing practices). Certain requirements also apply to device 
distributors.  The Act and our device regulations can be found at our website at 
www.fda.gov/opacom/laws.     
 
3.  Food 
 
  Section 201(f) of the Act (21 U.S.C. 321(f)) defines the term food to mean 
articles used for food or drink for man or other animals, chewing gum, and articles 
used for components of any such article.   
 
  To illustrate how a CAM practice might involve foods, juice therapy uses juice 
made from vegetables and fruits.  Absent any claims that would make the juice subject to 
the drug definition, the juice would be a food under section 201(f) of the Act because it 
is an article used for food or drink for man. 
 
  A detailed discussion of the Acts food provisions is beyond the scope of this 
guidance document.  However, anyone who intends to market CAM products that might 
be subject to regulation under these provisions should familiarize himself/herself with the 
Acts requirements for foods, particularly with respect to safety and labeling.  The Act 
and our food regulations can be found at our website at www.fda.gov/opacom/laws.     
 
  9  
4.  Food Additive 
 
  Section 201(s) of the Act (21 U.S.C. 321(s)) defines the term food additive to 
mean, in part, any substance the intended use of which results or may reasonably be 
expected to result, directly or indirectly, in its becoming a component or otherwise 
affecting the characteristics of any food....if such substance is not generally recognized, 
among experts qualified by scientific training and experience to evaluate its safety, as 
having been adequately shown through scientific procedures (or, in the case of a 
substance used in food prior to January 1, 1958, through either scientific procedures or 
experience based on common use in food) to be safe under the conditions of its intended 
use....19   
 
To illustrate how a CAM product might involve food additives under section 
201(s) of the Act, some CAM practices involve dietary modifications where substances 
such as botanicals or enzymes are added to foods in the diet.  If a manufacturer adds such 
a substance to a food, the substance may fall within the food additive definition at 
section 201(s) of the Act.  A food additive is subject to premarket approval by FDA 
under section 409 of the Act (21 U.S.C. 348).  Food additives that we have not approved 
or that do not comply with applicable FDA regulations prescribing safe conditions of use 
are deemed to be unsafe under section 409(a) of the Act, and foods that contain such 
additives are adulterated under section 402(a)(2)(C) of the Act (21 U.S.C. 342(a)(2)(C)).  
The Act provides that a substance is exempt from the definition of a food additive and 
thus, from pre-market approval, if, among other reasons, it is generally recognized as safe 
(GRAS) by qualified experts under the conditions of intended use.  Whether a substance 
added to a food is considered to be a food additive or is GRAS, any claims associating 
the substance with the reduction of a disease risk are health claims (defined in 21 CFR 
101.14(a)(1)) that require premarket review by FDA.20
 
  A detailed discussion of the Acts food additive provisions is beyond the scope of 
this guidance document.  However, anyone intending to market CAM products that are or 
contain substances that might be subject to regulation as food additives should familiarize 
himself/herself with the Acts food additive requirements.  The Act and our food additive 
regulations can be found at our website at www.fda.gov/opacom/laws. 
 
5.  Dietary Supplement 
 
Section 201(ff) of the Act (21 U.S.C. 321(ff)) defines the term dietary 
supplement as follows:  
 
The term dietary supplement -  
                                                           
19   The statutory definition of food additive exempts certain substances, such as pesticide chemical 
residues in or on a raw agricultural commodity or processed food, pesticide chemicals, color additives, 
dietary ingredients in or intended for use in a dietary supplement (as defined in section 201(ff) of the Act), 
and new animal drugs.   
20  See 21 CFR 101.70. 
  10  
(1)  means a product (other than tobacco) intended to supplement the diet that 
bears or contains one or more of the following dietary ingredients: 
(A) a vitamin; 
(B) a mineral; 
(C) an herb or other botanical; 
(D) an amino acid; 
(E) a dietary substance for use by man to supplement the diet by 
increasing the total dietary intake; or 
(F) a concentrate, metabolite, constituent, extract, or combination of any 
ingredient described in clause (A), (B), (C), (D), or (E); 
(2)  means a product that 
(A) (i)  is intended for ingestion in a form described in section 
411(c)(1)(B)(i); or 
(ii)  complies with section 411(c)(1)(B)(ii); 
(B)  is not represented for use as a conventional food or as a sole item of a 
meal or the diet; and 
(C)  is labeled as a dietary supplement; and 
(3)  does-- 
(A) include an article that is approved as a new drug under section 505 or 
licensed as a biologic under section 351 of the Public Health Service 
Act (42 U.S.C. 262) and was, prior to such approval, certification, or 
license, marketed as a dietary supplement or as a food unless the 
Secretary has issued a regulation, after notice and comment, finding 
that the article, when used as or in a dietary supplement under the 
conditions of use and dosages set forth in the labeling for such dietary 
supplement, is unlawful under section 402(f); and 
(B)  does not include 
(i)  an article that is approved as a new drug under section 505, 
certified as an antibiotic under section 507, or licensed as a biologic 
under section 351 of the Public Health Service Act (42 U.S.C. 262), 
or     
   (ii)  an article authorized for investigation as a new drug, antibiotic, or 
biological for which substantial clinical investigations have been 
instituted and for which the existence of such investigations has been 
made public, 
    which was not before such approval, certification, licensing, or 
authorization marketed as a dietary supplement or as a food unless the 
Secretary, in the Secretarys discretion, has issued a regulation, under 
notice and comment, finding that the article would be lawful under this 
Act. 
  Except for purposes of section 201(g) [of the Act], a dietary supplement shall be 
deemed to be a food within the meaning of this Act. 
 
  To illustrate how a CAM product might be a dietary supplement under section 
201(ff) of the Act, consider botanical products used in naturopathy.  (Naturopathy is a 
CAM whole medical system that views disease as a manifestation of alterations in the 
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processes by which the body heals itself.21)  For example, naturopathic cranberry tablets 
might be labeled for use to maintain the health of the urinary tract.  In this example, the 
cranberry tablets generally would be regulated as dietary supplements under section 
201(ff)(1) of the Act if they were labeled for use to maintain the health of the urinary 
tract rather than prevent urinary tract infections.  The cranberry tablets would be 
regulated as drugs under section 201(g) of the Act if they were labeled for use to treat 
urinary tract infections even if they were labeled as dietary supplements.     
 
  A detailed discussion of the Acts dietary supplement provisions is beyond the 
scope of this guidance document.  However, anyone intending to market CAM products 
that might be subject to regulation as a dietary supplement should familiarize 
himself/herself with the Acts dietary supplement requirements, particularly with respect 
to safety and labeling.  The Act and our dietary supplement regulations can be found at 
our website at www.fda.gov/opacom/laws. 
 
6.  Cosmetic 
 
  Section 201(i) of the Act defines the term cosmetic to mean (1) articles 
intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise 
applied to the human body or any part thereof for cleansing, beautifying, promoting 
attractiveness, or altering the appearance, and (2) articles intended for use as a component 
of any such articles; except that such term shall not include soap. 
 
  It is possible that certain products used in conjunction with CAM practices may 
be cosmetics under the Act.  For example, if a CAM practice involves massage with a 
moisturizer, the moisturizer could be a cosmetic to the extent that it is rubbed, poured, 
sprinkled, or sprayed on the body for beautification or appearance-altering purposes.  
However, if the moisturizers intended use is also for the diagnosis, cure, mitigation, 
treatment, or prevention of disease, or to affect the structure or any function of the body, 
then it may also be subject to regulation as a drug.  Other examples of drug/cosmetic 
combinations are deodorants that are also antiperspirants, moisturizers and makeup 
marketed with sun-protection claims, and shampoos that also treat dandruff.  
 
  The Act does not require premarket approval for cosmetics, but it does prohibit 
the marketing of adulterated or misbranded cosmetics in interstate commerce.  Anyone 
intending to market CAM products that might be subject to regulation as cosmetics 
should familiarize himself/herself with the safety and labeling requirements for these 
products in the Act and our regulations.  The Act and our cosmetic regulations can be 
found at our website at www.fda.gov/opacom/laws.   
 
 
                                                           
21   See NCCAM, BACKGROUNDER: Whole Medical Systems: An Overview (October 2004) at pages 
3-4. 
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    7.  Biological Product 
   
  Section 351(a)(1) of the PHS Act (42 U.S.C. 262(a)(1)) states, in part, that no 
person shall introduce or deliver for introduction into interstate commerce any 
biological product unless that product has an effective license and its package is plainly 
marked with the products proper name, the name, address, and applicable license 
number of the biological products manufacturer, and the products expiration date.  
Section 351(a)(2) of the PHS Act gives us the authority to establish requirements for the 
approval, suspension, and revocation of biological product licenses. 
 
  Section 351(i) of the PHS Act defines biological product as a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, 
allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine 
(or any other trivalent organic arsenic compound), applicable to the prevention, 
treatment, or cure of a disease or condition in human beings.  The term virus captures 
a broad spectrum of microorganisms that cause an infectious disease and includes, but is 
not limited to, filterable viruses, bacteria, rickettsia, fungi, and protozoa (see 21 CFR 
600.3(h)(1)). 
 
  It is conceivable that some biologically based practices (as defined by 
NCCAM) could involve the use of biological products as defined by section 351(i) of 
the PHS Act.  For example, the bacteria used in a probiotic product could make the 
product a biological product subject to the PHS Act.   
 
  A detailed discussion of biological product regulation under the PHS Act is 
beyond the scope of this guidance document.  Note, however, that in addition to our 
authority under section 351 of the PHS Act, section 361 of the PHS Act (42 U.S.C. 264) 
authorizes us to make and enforce regulations to prevent the introduction, transmission, 
or spread of communicable diseases from foreign countries into the States or possessions, 
or from one State or possession into any other State or possession.  If a CAM product 
manufacturer attempted to use a live, disease-causing virus as a component of a CAM 
product, we could exercise our authority under section 361 of the PHS Act and 21 CFR 
1240.30 to take action against the product, in addition to consider the applicability of 
section 351 of the PHS Act.  The PHS Act and FDAs regulations for biological products 
can be found at our website at www.fda.gov/opacom/laws.   
 
 
V.   Whom Do You Contact For More Information?    
 
  For more information about how we regulate drugs, devices, cosmetics, foods 
(including food additives and dietary supplements), and biological products, visit our 
website at www.fda.gov.  We also have many other guidance documents that present our 
current thinking on a particular topic. 
 
  For more information about products that we regulate, and how they might relate 
to CAM, please contact: 
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!  For biological products, the Manufacturers Assistance and Technical 
Training Branch, Office of Communication, Training & Manufacturers 
Assistance (HFM-40),  Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 1-800-835-4709 or 301-827-1800. 
 
!  For cosmetics, the Office of Cosmetics and Colors, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Parkway, College Park, MD 20740, 301-436-1130. 
 
!  For devices, the Office of Communication, Education, and Radiation 
Programs (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, 1-
800-638-2041 or 301-827-3990. 
 
!  For dietary supplements, the Division of Dietary Supplement Programs 
(HFS-810), Office of Nutritional Products, Labeling, and Dietary 
Supplements, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5100 Paint Branch Parkway, College Park, MD  
20740, 301-436-2375. 
 
!  For foods and food additives, the Office of Food Additive Safety (HFS-
200), Center for Food Safety and Applied Nutrition, Food And Drug 
Administration, 5100 Paint Branch Parkway, College Park, MD 20740-
3835, 301-436-1200 
 
!  For human drugs, the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4570 or 1-888-463-6332.  
You can also send electronic mail inquiries to druginfo@cder.fda.gov. 
 
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