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DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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 

Regulation by the Food and Drug Administration1

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 FDA’s 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 product’s 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 

product’s classification under the Act, probiotics may also be subject to 

the PHS Act’s 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 product’s 

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 patient’s 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 mindbody 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 mindbody 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 Act’s 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 Act’s 

requirements for premarket review and approval by FDA.18 

 A detailed discussion of the Act’s 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 Act’s 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 Act’s 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 

Act’s 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 Act’s 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 Act’s 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 Secretary’s 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 Act’s 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 Act’s 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 moisturizer’s 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 product’s proper name, the name, address, and applicable license 

number of the biological product’s manufacturer, and the product’s 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 FDA’s 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 (HFS200), 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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