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regulation of healthcare products in the united states

Improving Natural Product Research Translation:  From Source to Clinical Trial 
Federation of American Societies for Experimental Biology - The FASEB Journal: 2019.
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"​While great interest in health effects of natural product (NP) foods and dietary supplements persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. "

Botanicals as "New" drugs: US development
Epilepsy & Behavior: 2015, pp. 338-343
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"Botanicals are ingredients that can be marketed as goods, drugs, cosmetics, and medical devices in the United States. When a botanical is intended to diagnose, treat, prevent, mitigate, or cure a disease, it is considered to be a "drug." This article is reviews the US regulatory requirements for botanicals as "new" drugs."

Botanical New Drug Applications - The Final Frontier 
HerbalEGram: Volume 10, Number 6, June 2013
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"Marketing botanical ingredients as foods and dietary ingredients in the United States is commonplace. Getting them approved as prescription drugs is a somewhat new frontier, and so far only two botanicals have achieved this goal..."

The State of Botanical Drugs: A new route to market may hold promise for botanicals and other complex natural products. 
Nutraceuticals World 2006
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"With the passage of the Dietary Supplement Health & Education Act (DSHEA) in October 1994, U.S. sales of dietary supplements skyrocketed. Growing at breakneck speed, markets far outstripped expectations. Within a five-year period, however, major downward trends appeared. Since 2000, sales have continued to stumble, particularly for herbals and other naturally derived products."

Regulation of Dietary Supplements in the United States:  Understanding DSHEA
Clinical Obstetrics and Gynecology: Volume 41, Number 4, December 2001
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"One of the most perplexing pieces of legislation to impact the practice of the healing arts in the United States is the Dietary Supplement Health and Education Act (DSHEA). The act, passed by Congress on October 15, 1994 and signed into law October 25, 1995 by President Bill Clinton, would change the practice of medicine in the US."

REGULATION OF HEALTHCARE PRODUCTS IN CANADA

Botanical Regulation: Comparison of the United States and Canada
Pharmaceutical Regulatory Affairs: Open Access: Volume 6, Issue 1, May 2017
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"Botanicals are defined as ingredients or finished products “of or relating to plants” or “a substance obtained from a plant.” Botanicals have been used by humans since the beginning of civilization. Archaeological excavation documents the medicinal use of plants by humans dating back as far as 60,000 years. Today about 80% of the world still uses plants and plant-based products to treat medical conditions."

Canada's Natural Health Products: A Regulatory Overview
Pharmaceutical Regulatory Affairs: Open Access: Volume 5, Issue 2, October 2016
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"Canada’s regulatory approach to natural ingredients, such as botanicals, probiotics, and other complex products, is somewhat unique. This ingredient class has defied global regulatory harmonization, although certain regions have commonalities in their approach. Canadian law allows such ingredients to be sold not only as foods, cosmetics, and drugs, but also in a novel category: “Natural Health Products” (NHPs)."

probiotics - as foods and as drugs

Executive Summary: Scientific and Regulatory Challenges of Development of Probiotics as Foods and Drugs
Science and Regulation of Probiotics,  CID 2008:46 (Suppl 2) • S53 - 2008
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"Probiotics have a long global history of traditional use. Although they are currently sold mostly as ingredients in foods or nutritional supplements, recent research has explored the potential of probiotics to treat or prevent disease conditions, to maintain health, and to reduce the risk of future disease​"

Business Considerations in the Development of Probiotics
Developing Probiotics: Business Considerations ,  CID 2008:46 (Suppl 2) • S141 - 2008
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"Industry stakeholders for probiotics include businesses involved in conventional and specialty foods, dietary supplements, consumer health care, biopharmaceuticals, veterinary health care, and agriculture. Although the workshop was focused mainly on the use of probiotics in humans, agricultural and veterinary uses should not be overlooked​"

Development of Probiotics as Biologic Drugs
Probiotics as Biologic Drugs,  CID 2008:46 (Suppl 2) • S125 - 2008
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"In the United States, probiotics that are intended to be used to diagnose, cure, mitigate, treat, or prevent disease in humans or other animals and that affect the structure or the function of the body are considered to be drugs. This article provides a brief overview of the historical basis of US regulation of drugs and biologics and explores the legal, regulatory, and policy considerations for probiotics as biologic drugs for humans.​"

Clinical Research on Probiotics: The Interface between Science and Regulation
Science and Regulation of Probiotics,  CID 2008:46 (Suppl 2) • S101 - 2008
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"Although there exists some evidence of the safety and efficacy of probiotics for treatment of disease, many of the clinical trials have lacked methodological quality. The regulatory route will determine the types of trial needed to determine safety and efficacy of these products.  This article discusses how the regulations for probiotics affect clinical research."

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