1. What are "natural health products" (NHPs)?
Natural Health Products (NHPs) generally refers to ingredients and products that are derived from natural sources and are used to impact health. Examples include products from plants (botanicals, herbals, phytomedicines), and animals (fish oils, certain hormones, tissues, blood). Most dietary ingredients and traditional medicines are from natural sources.
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In the United States NHPs do not fall under a specific regulatory category as they may in other countries. In the United States, NHPs can be regulated as foods (including dietary supplements), drugs, cosmetics, and as medical devices. In the US, NHPs can be prescription or nonprescription drugs. Which regulatory category(ies) may be available to a particular product depends on: route of administration, formulation, safety, and intended use.
Intended use is established from the claims made about the product. This is based on the product label, which includes the bottle or package itself, but more importantly, any other information and materials about the product, including the package insert (for a drug), advertising and promotional materials, including written, video, audio, verbal, etc.
In contrast, Canadian law and regulation define NHPs and regulates them as direct-to-consumer products, which includes: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as Traditional Chinese Medicines (TCM), probiotics, other products like amino acids and essential fatty acids.
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Intended use is established from the claims made about the product. This is based on the product label, which includes the bottle or package itself, but more importantly, any other information and materials about the product, including the package insert (for a drug), advertising and promotional materials, including written, video, audio, verbal, etc.
In contrast, Canadian law and regulation define NHPs and regulates them as direct-to-consumer products, which includes: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as Traditional Chinese Medicines (TCM), probiotics, other products like amino acids and essential fatty acids.
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3. What is a "botanical"?
There are scientific and regulatory definitions of botanicals. In the United States the Food and Drug Administration (FDA) defines "botanical" as: any product that contains ingredients of vegetable matter or its constituents as a finished product. Botanicals are comprised of plant materials--- either juices, gums, fatty oils, scent oils, etc., also algae or macroscopic fungi and similar products as the finished product.
The US FDA DOES NOT INCLUDE the following as "botanicals": yeast or bacteria, products of fermentation, highly purified or chemically modified substances derived from botanical sources (paclitaxel); homeopathic drugs or elixirs.
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The US FDA DOES NOT INCLUDE the following as "botanicals": yeast or bacteria, products of fermentation, highly purified or chemically modified substances derived from botanical sources (paclitaxel); homeopathic drugs or elixirs.
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4. what is a "dietary supplement"?
In the United States dietary supplements are a category of Foods. The US Dietary Supplement Health & Education Act of 1994, defines dietary supplements as: products (other than tobacco) that are intended to supplement the diet. Dietary supplements cannot be represented as intended to diagnose, prevent, treat, mitigate or cure any condition.
Dietary supplements may contain ingredients that are: vitamins, minerals, herbs or other botanicals, amino acids, dietary substance or concentrates, metabolites, constituents, extracts, or combinations of these ingredients. (Homeopathic ingredients are “drugs” in the US.)
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Dietary supplements may contain ingredients that are: vitamins, minerals, herbs or other botanicals, amino acids, dietary substance or concentrates, metabolites, constituents, extracts, or combinations of these ingredients. (Homeopathic ingredients are “drugs” in the US.)
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5. What is a probiotic?
Probiotics are considered to be live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. It is a term of art used by industry, and does not convey a specific regulatory pathway in the United States or Canada. Therefore, such products are regulated according to the route of administration, formulations, safety and intended use, i.e., the claims that are made by the product sponsor. In general, probiotics are regulated as conventional Foods and Dietary Supplements in the United States, and as Foods and Natural Health Products in Canada.
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6. when is a probiotic considered to be a "live biotherapeutic product"?
The US Food and Drug administration has defined a LBP as a biological product that: 1) contains live organisms, such as bacteria or fungi; 2) is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and 3) is NOT a vaccine.
FDA does not consider LBPs to be filterable viruses, oncolytic bacteria, or products intended as gene therapy agents and, as a general matter, are not administered by injection.
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FDA does not consider LBPs to be filterable viruses, oncolytic bacteria, or products intended as gene therapy agents and, as a general matter, are not administered by injection.
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7. when is an investigational new drug required to be filed with fda?
An IND is required to conduct a clinical study that will test a drug or biologic that is intended to support the use of marketing of the product in the United States, when the product will study:
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- An unapproved ("new") clinical indication (use) for that product
- A change in the approved route of administration or dose level
- A change in the approved population, or one at greater risk (e.g., pediatric, geriatric, immunocompromised, etc.)
- A significant change in labeling or promotion.
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