A dietary supplement (as defined in the Dietary Supplement Health and Education Act
(DSHEA) of 1994) is a product taken by mouth that contains a "dietary
ingredient" intended to supplement the diet. - The "dietary
ingredients" in these products may include: vitamins, minerals, herbs or
other botanicals, amino acids, and
substances such as enzymes, organ tissues, glandulars, and metabolites. - Dietary supplements
can also be extracts or concentrates, and may be found in many forms such as
tablets, capsules,
softgels, gelcaps, liquids, or powders. They can also be in other forms, such
as a bar, but if they are, information on
their label must not represent the product as a conventional food or a sole
item of a meal or diet. A biological product, as defined in section 351(i) of the Public Health Service Act, is a virus, therapeutic serum, toxin,
antitoxin, vaccine, blood, blood component or derivative, allergenic product,
protein (except any chemically synthesized polypeptide), 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 of human beings. Determining Whether a
Product is a Drug Intended Use of a product affects how it will be regulated
and whether it will be classified as a drug. “Intended use” is defined in 21 CFR 201.128 as the “objective intent” of the persons legally responsible for
the labeling of drugs. The intent is determined by such persons' expressions
or may be shown by the circumstances surrounding the distribution of the
article. This “objective intent”
can be determined by such things as labeling claims, advertising matter, or
oral or written statements by such persons or their representatives. It may
be shown by the circumstances that the article is, with the knowledge of such
persons or their representatives, offered and used for a purpose for which it
is neither labeled nor advertised. Note that even representations and claims
on a product’s or a firm’s website can and are used by FDA in determining an
article’s “intended use.” Intended use may also
be established by consumer perception of a product’s reputation. In other words, why
is the consumer is buying the product and what does the consumer expect it to
do? Similarly, ingredients can cause a product to be considered a drug because they have a
well-known therapeutic use. For example, fluoride in toothpaste is considered
a drug. Determining Whether a
Product is More than a Drug (Combination Products) In some cases, the
product may be a combination product. In other words, it may be composed of
any combination of a drug and a device; a biological product and a device; a
drug and a biological product; or a drug, device, and a biological product.
Under 21 CFR 3.2(e), a combination product includes: 1. A product comprised
of two or more regulated components (i.e., drug/device, biologic/device,
drug/biologic, or drug/device/biologic) that are physically, chemically, or
otherwise combined or mixed and produced as a single entity Ex: Device coated or
impregnated with a drug or biologic. 2. Two or more
separate products packaged together in a single package or as a unit and
comprised of drug and device products, device and biological products, or
biological and drug products Ex: Drug or biological
product packaged with a delivery device. 3. A drug, device, or
biological product packaged separately that, according to its investigational
plan or proposed labeling, is intended for use only with an approved
individually specified drug, device, or biological product where both are
required to achieve the intended use, indication, or effect and where, upon
approval of the proposed product, the labeling of the approved product would
need to be changed Ex: Photosensitizing
drug and activating laser/light source. 4. Any investigational
drug, device, or biological product packaged separately that according to its
proposed labeling is for use only with another individually specified
investigational drug, device, or biological product where both are required
to achieve the intended use, indication, or effect Ex: Photosensitizing
drug and activating laser/light source, if the drug and the activating light
source are being investigated for a new indication and both components are
required to achieve the investigational use, indication, or effect. Note that drug-drug
combinations and drug-cosmetic combinations are NOT combination products as
defined by 21 CFR 3.2(e). Such products may have to meet the requirements of
both CDER and the Center for Food Safety and Applied Nutrition (CFSAN). Center Lead: A combination product is assigned to an Agency
Center that will have primary jurisdiction for its premarket review and
regulation. This assignment is based on a determination of the primary mode
of action of the combination product. Because combination products are comprised
of more than one type of regulated article (biological product, device, or
drug), and each constituent part contributes a biological product, device, or
drug mode of action, combination products will have more than one
identifiable mode of action Mode of Action is the means by which a product achieves an
intended therapeutic effect or action and is defined in 21 CFR 3.2(k). For purposes of this definition, "therapeutic"
action or effect includes any effect or action of the product intended to
diagnose, cure, mitigate, treat, or prevent disease, or affect the structure
or any function of the body. A constituent part of a combination product is
said to have a drug, device, or biological product mode of action if that
constituent part meets the definition of a drug, device, or biological
product. The final rule in the August 25, 2005 Federal Register defines primary mode of action as “the single mode of action of
a combination product that provides the most important therapeutic action of
the combination product.” The formal
jurisdiction process for both combination and non-combination products is
accomplished through the Request for Designation (RFD) process, described in 21 CFR Part 3. When the classification of a product as a drug, device or
biological product is unclear or in dispute, or when the jurisdiction of a
combination or non-combination product is unclear or in dispute, the sponsor
should submit a formal request for designation to the Office of Combination
Products as soon as they have sufficient information for FDA to make a
decision regarding assignment of a product. Check out the Combination Products webpage for additional information. Determining the
regulatory status of an article can be a complex process. We hope that we
were able to shed some light on this issue Cheers, Renu
Lal, Pharm.D. CDER
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