Natural, Complementary, and Alternative Medicine versus the FDA
The modern healthcare environment has seen a significant and sustained expansion of medical and healthcare practices that exist outside the framework of conventional Western medicine. These approaches, often sought by consumers who perceive them as safer or more aligned with a holistic philosophy, represent a diverse and economically significant sector of the health industry. Understanding this landscape requires defining some terms, as the terminology used can be misleading.
Differentiating Complementary, Alternative, and Integrative Approaches
The National Center for Complementary and Integrative Health (NCCIH), a division of the U.S. National Institutes of Health (NIH), provides some working definitions of the terms "complementary" and "alternative." Often they are used interchangeably, but they can describe distinct concepts. These are not the only definitions in use, but they are a helpful place to start.
Complementary Medicine: This refers to the use of a non-mainstream practice together with conventional medical treatments. For example, a patient undergoing chemotherapy for cancer might use acupuncture to manage nausea, or massage therapy to reduce anxiety. The complementary therapy is an adjunct to, not a replacement for, standard medical care.
Alternative Medicine: This term describes the use of a non-mainstream practice in place of conventional medicine. An example would be treating cancer with a special diet instead of undergoing surgery, radiation, or chemotherapy. The NCCIH explicitly advises against using any product or practice that has not been proven safe and effective as a substitute for conventional medical treatment, as this can lead to postponing necessary care and pose significant health risks.
Integrative Health: Integrative health brings conventional and complementary approaches together. It often involves multimodal interventions that combine conventional treatments with evidence-based complementary therapies. The term "integrative medicine" began to replace "complementary and alternative medicine" (CAM) in the 1990s, signaling a strategic shift away from an oppositional or fringe status toward a cooperative role within the broader healthcare system.
Modalities of CAM treatments
The NCCIH classifies the vast array of complementary health approaches into two primary subgroups, which provides a useful framework for understanding their scope.
Natural Products: This category includes a wide range of ingestible substances that are widely marketed and readily available to consumers, most often sold as dietary supplements. Key examples include:
Herbs (aka botanicals): Plant-based products, such as St. John's wort, echinacea, ashwagandha or turmeric.
“Naturally-derived” products: these products include only part of a plant (tinctures, extracts, purified substances) or a bacterial or fungal product (nutritional yeast) that are taken for purported health reasons.
Vitamins and Minerals: Essential nutrients consumed to supplement dietary intake.
Probiotics: These are live microorganisms, often called "good" bacteria, intended to maintain or improve the body's microbial balance.
Mind and Body Practices: This diverse group encompasses procedures and techniques that are typically administered or taught by a trained practitioner or teacher. These practices are increasingly being studied for their potential roles in managing symptoms and promoting well-being, which is defined for each person individually. Examples include:
Acupuncture: A modern technique derived from Traditional Chinese Medicine involving the insertion of thin needles into the skin at specific points. Moderate quality research suggests it may help ease chronic pain conditions like low-back pain, neck pain, and osteoarthritis, as well as reduce the frequency of certain types of headaches.
Massage Therapy: The manipulation of the body's soft tissues. Studies indicate it may provide short-term improvements in pain and mood.
Meditation and Yoga: Practices that combine physical postures, breathing techniques, and meditation or relaxation.
Chiropractic and Osteopathic Manipulation: Western practices focused on the structure of the body, particularly the spine, and its functioning. Originally the beliefs of these practitioners relied on metaphysical ideas, but over time, most have abandoned the metaphysical approach for a more evidence-based approach.
Other Complementary Health Approaches: This broader category includes entire systems of theory and practice that have developed outside of the Western medical tradition, such as Traditional Chinese Medicine, Ayurvedic medicine from India, homeopathy, and naturopathy.
The Philosophical Underpinnings and Growing Popularity
The sustained growth of these practices over the past two decades, even amidst remarkable advances in biotechnology and conventional medicine, points to a deep-seated public interest. This popularity is driven by several factors. A core philosophical tenet of many of these approaches is a holistic focus, treating the patient as an integrated whole of mind, body, and spirit, rather than concentrating on a specific disease or organ system. This resonates with people seeking more personalized and comprehensive care.
There is a widespread public perception that products labeled "natural" are inherently safer and healthier than manufactured, or allopathic, medications. I will discuss later how this belief, however, can be a dangerous oversimplification. As the NCCIH cautions, "natural" does not necessarily mean "safe". Many natural substances, from wild mushrooms to botanical extracts, can be toxic, carcinogenic, or have potent biological effects. This disconnect between public perception and pharmacological reality can be bridged by more rigorous scientific evidence, a standard that is applied with vastly different levels of stringency across the healthcare marketplace.
Despite significant advancements in conventional medicine and biotechnology over the past two decades, a considerable portion of the population continues to favor or at least incorporate “natural” healing modalities in a more holistic approach. This emphasis on comprehensive, apparently personalized care resonates strongly with people who often feel like just another number in the traditional healthcare system. There are many reasons to question the assumption that "natural" products are inherently safer, more personalized, and more efficacious than traditional pharmaceuticals. To start, we should review the ways that evidence for these different products and services is generated.
The FDA Drug Approval Pathway
To understand the differences in evidence between natural medicines and supplements, it is helpful to contrast it with something: the U.S. Food and Drug Administration (FDA) approval process for new drugs. This process is a lengthy, expensive, and methodologically rigorous system designed to ensure that any medication reaching the public has demonstrated that its health benefits outweigh its known risks.
Foundational Principles: Safety and Efficacy
The central mandate of the FDA's Center for Drug Evaluation and Research (CDER) is to evaluate new drugs to ensure they are both "safe and effective" for their intended use. The burden of proof rests on the drug's manufacturer (the sponsor) to provide comprehensive and convincing scientific evidence according to preset standards. The journey from laboratory discovery to market approval often takes a decade or more and involves a high rate of failure at every stage.
From Laboratory to Clinic: The Preclinical Research Phase
The process begins long before any human is involved. After a promising compound is identified during the initial discovery phase, it must undergo extensive preclinical research.
Laboratory and Animal Testing: The compound is subjected to in vitro (laboratory) and in vivo (animal) studies to assess its basic pharmacological profile and to identify potential toxicity. These studies, governed by the FDA's Good Laboratory Practices (GLP), provide data on how the substance is absorbed, metabolized, and excreted, and what adverse effects it might cause at various doses. The primary goal is to determine if the compound is reasonably safe to proceed to human testing.
Investigational New Drug (IND) Application: If the preclinical data are favorable, the sponsor submits an Investigational New Drug (IND) application to the FDA. This contains all preclinical data, detailed information on the drug's chemistry and manufacturing processes, and the proposed protocols for the human clinical trials. The FDA review team has 30 days to examine the IND to ensure that the proposed studies do not place human subjects at unreasonable risk. Only after the FDA gives its assent can clinical trials begin.
Human Trials Clinical Phases
Clinical research is the heart of the drug development process, where the drug is tested in humans in a series of carefully controlled and escalating phases. These trials are overseen not only by the FDA but also by an Institutional Review Board (IRB), an independent committee of scientists and non-scientists that ensures the rights and welfare of study participants are protected.
Phase 1: The primary focus of this phase is safety. A small group of participants, typically 20 to 80 healthy volunteers, are given the drug to assess its side effects, how it is metabolized, and to establish a safe dosage range. These studies are intensely monitored and last for about a year. Despite extensive preclinical testing, this is often the first time the drug is introduced into the human body, and it is a critical safety checkpoint. Approximately 70% of drugs successfully complete Phase 1.
Phase 2: If the drug is found to be reasonably safe in Phase 1, it moves to Phase 2, which focuses on effectiveness. The drug is administered to a larger group of several hundred patients who have the specific disease or condition the drug is intended to treat.8 These studies aim to gather preliminary data on efficacy and to further evaluate the drug's short-term side effects and risks. Phase 2 trials often compare the investigational drug against a placebo or an existing standard treatment and help to refine the optimal dose. This phase can take up to two years, and only about 33% of drugs move on to the next stage.
Phase 3: These are large-scale, pivotal trials designed to definitively establish efficacy and monitor for adverse reactions. They involve several hundred to a few thousand patients and can last for several years. Phase 3 trials are typically randomized, double-blind, controlled studies that provide the substantial evidence of a drug's safety and effectiveness needed for FDA approval. Because of their large size and longer duration, they are more likely to detect rarer or long-term side effects. Only 25-30% of drugs that enter Phase 3 trials are successful.
This entire multi-stage process is based on a conservative, risk-averse philosophy. It is a system of progressive and cumulative evidence generation, where each phase builds upon the last and acts as a filter to eliminate unsafe or ineffective compounds. The default assumption is that a new chemical entity is potentially harmful, and the system is designed to minimize risk to the public by requiring an overwhelming mountain of positive data before widespread exposure is permitted.
The New Drug Application (NDA): Scrutiny and Review
Upon successful completion of Phase 3 trials, the sponsor submits a New Drug Application (NDA) to the FDA. This often runs thousands of pages and contains all the data from preclinical and clinical studies, as well as information on manufacturing, pharmacology, and proposed labeling. A committee of experts who are independent of the FDA, including physicians, statisticians, and pharmacologists, conducts a thorough review of the NDA, which includes inspecting the manufacturing facilities where the drug will be produced. The standard review period is 10 months, though this can be shortened for drugs that address serious conditions or offer significant advances.
Phase 4: Post-Market Surveillance and Ongoing Safety Monitoring
FDA approval is not the end of the story. After a drug is on the market, the agency continues to monitor its safety through Phase 4 post-marketing surveillance. These studies can identify rare or long-term adverse effects that were not apparent in the pre-market trials. The FDA's MedWatch program allows healthcare professionals and consumers to report adverse events, and its Sentinel Initiative uses large electronic health databases to actively monitor for safety signals in real-time. This is intended to ensure that the understanding of a drug's risk-benefit profile continues to evolve throughout its lifecycle, but it relies on consistent reporting.
The Regulatory Framework for Dietary Supplements
In stark contrast to the rigorous pre-market approval system for drugs, dietary supplements in the United States are governed by a separate and far less stringent regulatory framework. This framework was established by a landmark piece of legislation that fundamentally altered the FDA's authority and created the two-tiered system that exists today.
The Dietary Supplement Health and Education Act (DSHEA) of 1994
In 1994, the U.S. Congress unanimously passed the Dietary Supplement Health and Education Act (DSHEA), which was signed into law by President Bill Clinton. Enacted in response to the growing popularity of supplements and strong lobbying from the industry, DSHEA's stated goals were to ensure consumer access to a wide variety of products and to provide more information about their intended use.
The most consequential provision of DSHEA was its legal definition of dietary supplements (including vitamins, minerals, herbs, and amino acids) as a special category of food, not drugs. This reclassification is the cornerstone of the entire regulatory structure for supplements. It effectively removed these products from the FDA's pre-market approval authority for safety and efficacy.
Manufacturer Responsibilities vs. FDA Authority
DSHEA created a regulatory environment that is fundamentally different from the one governing pharmaceuticals, most notably by inverting the burden of proof.
No Pre-Market Approval: Unlike drug manufacturers, companies that produce or sell dietary supplements are not required to obtain FDA approval before bringing their products to market. They do not need to submit evidence of safety or efficacy to the agency for review.
Manufacturer's Responsibility: Under DSHEA, the manufacturer is personally responsible for ensuring that its products are safe and that the claims on the label are truthful and not misleading. The company is expected to have scientific substantiation for its claims on file (not randomized controlled trials), but it is not required to submit this evidence to the FDA.
FDA's Post-Market Role: The FDA's authority over supplements is primarily reactive and post-market. The agency can take action, such as issuing a warning letter or seeking a product recall, only after a product is on the market and has been shown to be adulterated (e.g., contaminated) or misbranded (e.g., making illegal claims). The burden of proof is on the FDA to demonstrate that a supplement is unsafe, a reversal of the drug approval paradigm where the manufacturer must prove that its product is safe.
This legislative framework was designed to prioritize market access and consumer choice over the pre-market assurance of safety and efficacy that characterizes drug regulation. The primary assumption was that food derived products are far more likely to be safe than those produced by modern chemistry. The law's congressional findings explicitly state that the federal government should not impose "unreasonable regulatory barriers" that limit the flow of these products to consumers. The result is a system that presumes products are safe until proven otherwise, allowing thousands of supplements of widely varying quality and utility to be sold under a similar regulatory umbrella. This places a significant burden on consumers and clinicians to evaluate products for themselves.
Safety and Manufacturing Standards
While DSHEA does not require pre-market approval, it does include provisions related to safety and manufacturing quality.
"New Dietary Ingredient" (NDI) Notification: For any dietary ingredient that was not sold in the U.S. before October 15, 1994, the manufacturer must notify the FDA at least 75 days before marketing the product. This notification must include evidence that the NDI is "reasonably expected to be safe" for use in the supplement. However, this is merely a notification process, not an approval, and critics have noted that this requirement is often bypassed by companies.
Good Manufacturing Practices (GMPs): The FDA has established GMPs for dietary supplements, which are regulations that require companies to ensure their products meet certain quality standards for identity, purity, strength, and composition. These GMPs are intended to prevent the inclusion of the wrong ingredient, the addition of too much or too little of the correct ingredient, and to reduce the risk of contamination or improper packaging. The FDA conducts inspections of manufacturing facilities to ensure compliance with these standards, though its ability to do this on a large scale is poor.
Allowable Claims on Labels
A critical element of DSHEA is the distinction it draws between the types of marketing claims that are permissible for supplements versus those that are reserved for drugs.
Structure/Function Claims: These are the most common type of claim found on supplement labels. They are broad statements that describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body (e.g., "calcium builds strong bones") or in promoting general well-being (e.g., "supports a healthy immune system"). These claims are legal as long as they are not misleading and the manufacturer has substantiation for them, though there is no real standard for what substantiates the claim.
The DSHEA Disclaimer: Any product label that includes a structure/function claim is legally required to carry the following disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease". This language is intended to inform consumers that the product is not a drug and has not undergone FDA review for efficacy.
Prohibited Disease Claims: Supplement manufacturers are explicitly forbidden from making claims that their product can diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. Such a claim would automatically classify the product as an unapproved (and therefore illegal) new drug.
Health Claims: These are claims that describe a relationship between a substance and a reduced risk of a disease (e.g., "adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life"). These claims are permitted but are subject to a higher standard of evidence and require pre-authorization from the FDA based on "significant scientific agreement" among experts.
A Tale of Two Standards
The United States effectively operates a two-tiered system for regulating products intended for human health. One tier, for pharmaceutical drugs, is built on a foundation of rigorous, pre-market scientific validation. The other, for dietary supplements, is based on a post-market model that prioritizes consumer access. A direct comparison of these two paradigms reveals profound differences in the standards of evidence required for safety, efficacy, and labeling.
The Central Dichotomy: Pre-Market Approval vs. Post-Market Surveillance
The most fundamental difference lies in when regulatory oversight occurs.
Drugs: The FDA operates under a "prove it first" principle. A new drug is considered unsafe until extensive clinical trials have proven it to be safe and effective for its intended use. It cannot be legally sold without formal FDA approval.
Supplements: The system for supplements is a "market it first" model. Products can be sold to the public without any prior review or approval from the FDA. The agency's role is reactive; it can only take action against a product after it is on the market and evidence emerges that it is harmful or misbranded.
Efficacy: "Proven Effective" vs. "Substantiation for Claims"
The standards for proving that a product works are worlds apart.
Drugs: Efficacy must be demonstrated through "substantial evidence," a high legal and scientific standard that typically requires at least two adequate and well-controlled Phase 3 clinical trials involving hundreds or thousands of patients. The results must show a statistically significant therapeutic benefit for a specific medical condition.
Supplements: The FDA does not evaluate whether supplements are effective before they are marketed. The law only requires that the manufacturer has "substantiation" that its claims are truthful and not misleading. The standard for this substantiation, often defined by the Federal Trade Commission (FTC) as "competent and reliable scientific evidence," is far less rigorous and enforceable than the FDA's standard for drugs and does not mandate large-scale, randomized human trials.
Safety: Proving Safety Pre-Market vs. Proving Unsafe Post-Market
The approach to ensuring safety is similarly divergent.
Drugs: A drug's safety profile is meticulously built through every phase of development, from preclinical animal studies to multi-year trials in thousands of human subjects. This process is designed to identify both common and rare side effects before the drug is made widely available.
Supplements: For the vast majority of supplements containing ingredients marketed before 1994, no safety data must be submitted to the FDA at all. For new ingredients, the manufacturer must provide evidence of a "reasonable expectation of safety," a much, much lower bar than that for drugs. The FDA can only remove a supplement from the market if it can prove the product poses a "significant or unreasonable risk of illness or injury". This means that public harm often must occur and be reported before regulatory action is taken.
Labeling and Claims: Precision vs. Ambiguity
The information provided to consumers and healthcare professionals on product labels reflects these differing standards.
Drugs: The drug label, or package insert, is a detailed, FDA-approved legal document. It precisely outlines the drug's approved indications for use, dosage instructions, contraindications, all known side effects identified in clinical trials, and potential drug interactions.
Supplements: Supplement labels are not pre-approved by the FDA. They are permitted to make vague structure/function claims (e.g., "supports joint health") that can create a "health halo" around the product. This permissive environment allows marketing to appeal to consumers seeking solutions for health conditions without making an explicit, illegal disease claim. For example, a person with arthritis (a disease) may interpret "supports joint health" as a treatment claim, even though the product has never been tested or approved for that purpose. The legally required DSHEA disclaimer, while a safeguard for the manufacturer, is often overlooked by consumers who are more influenced by the primary marketing message. This creates a significant disconnect between consumer expectation and regulatory reality.
Table: Comparative Analysis of Regulatory and Evidence Standards
The following table summarizes the key distinctions between the two regulatory frameworks.
Navigating the Information Ecosystem: Evaluating Science-Based Resources
The regulatory vacuum created by DSHEA has resulted in an information ecosystem that mirrors its permissive nature. Consumers are inundated with marketing claims from manufacturers, anecdotal testimonials, and media reports of widely varying quality. This environment of "caveat emptor" (let the buyer beware) places a tremendous responsibility on individuals and their healthcare providers to seek out objective, scientifically grounded information. In the absence of strong pre-market government regulation, the role of authoritative, evidence-based third-party resources becomes critically important for public health.
The Challenge of Misinformation and the Need for Scientific Rigor
The marketplace presents consumers with a confusing array of products, from benign but useless, to maybe beneficial, to potentially harmful, all of which may be labeled and shelved in a similar manner. The challenge is to distinguish between marketing hype and scientific fact. The widespread but mistaken belief that "natural" equals "safe" can lead to dangerous situations, particularly when supplements interact with prescription medications or when they are contaminated with undeclared substances, such as hidden prescription drugs (especially sports supplements). Therefore, relying on independent, science-based resources is not just advisable; it is essential for making informed decisions.
Criteria for Evaluation: Hallmarks of a Trustworthy Resource
A trustworthy resource for evaluating natural medicines and supplements can be identified by several key characteristics:
Evidence-Based (hopefully science-based) Approach: The resource must prioritize and transparently cite high-quality scientific evidence, such as data from randomized controlled trials, systematic reviews, and meta-analyses. The claims must match the evidence.
Objectivity and Lack of Bias: The information should be free from commercial influence. Resources funded by government agencies, academic institutions, or non-profit organizations are generally more reliable than information provided by product manufacturers or sellers.
Expertise and Peer Review: The content should be authored and reviewed by qualified experts with relevant credentials, such as physicians, pharmacists, and research scientists. If the same names are appearing in most or all of the reviews, then this is a sign that the expert may be “fringe.”
Comprehensive Scope: A reliable resource will discuss not only the purported benefits of a product but also its potential risks, including side effects, contraindications, and, crucially, its interactions with prescription drugs, over-the-counter medications, and other supplements.
Transparency: The resource should be clear about its methodology for evaluating evidence and acknowledge the limitations or gaps in the existing scientific literature.
Where to Start for Evidence-Based Inquiry
Based on the criteria above, three online resources stand out for their commitment to scientific rigor, objectivity, and comprehensive reporting. These organizations perform a quasi-regulatory function by providing the critical analysis of safety and efficacy that the formal regulatory system for supplements does not require pre-market.
National Center for Complementary and Integrative Health (NCCIH)
Identity and Mission: The NCCIH is the U.S. government's lead agency for scientific research on complementary and integrative health. It is one of the 27 institutes and centers that comprise the National Institutes of Health (NIH). Its mission is twofold: to fund and conduct rigorous scientific research on NCAM modalities and to disseminate reliable, evidence-based information to the public, clinicians, and researchers.
Methodology and Content: The NCCIH sets its research priorities based on scientific promise, amenability to rigorous investigation, and potential public health impact. The "Health Topics A-Z" section provides summaries on a wide range of therapies, while the "Herbs at a Glance" series offers concise, evidence-based fact sheets on popular botanicals. Its "Know the Science" initiative is designed to improve health literacy by teaching users how to interpret scientific research, understand clinical trials, and evaluate health news critically.
The NCCIH is the foundational source. It is the primary engine that generates much of the high-quality, government-funded research that other authoritative resources rely upon. Its dual role as a research institution and a public information clearinghouse, combined with its status as part of the NIH, makes it the most authoritative and unbiased starting point for any inquiry into the science of complementary and integrative health.
Practical Guidance When Considering “Natural”
The burden of proof, which rests squarely on manufacturers in the drug world, is effectively shifted to consumers and the healthcare system in the supplement world. Consumers must become discerning evaluators of scientific claims, understanding that marketing language is not equivalent to clinical evidence and that the term "natural" is not a guarantee of safety. Clinicians, in turn, have a professional responsibility to proactively inquire about their patients' use of all supplements, educate them about the vast differences in regulation and evidence, and use authoritative resources to check for potential interactions and provide guidance on safety.
A Framework for Safe and Informed Use of NCAM
Navigating this complex landscape requires a deliberate and cautious approach. The following framework can help guide responsible decision-making:
Prioritize Full Disclosure: The single most important step for any individual using or considering a complementary therapy is to communicate openly and honestly with all of their healthcare providers. Full disclosure of all supplements, herbs, and mind-body practices is essential for ensuring coordinated, safe care and avoiding potentially harmful interactions.
Question the Source and Demand Evidence: Be skeptical of claims made by manufacturers or promoters of a product. They stand to benefit from being gullible, but you can only lose. Always ask for the independent, scientific evidence that supports a claim, not just personal testimonials or marketing materials.
Consult Authoritative Resources: Before using any dietary supplement, consult the evidence-based resources detailed in this report. Start with the NCCIH to gain a foundational understanding. Most sources on the web are designed to promote a product and not criticize it. You can ask your physician for advice, though, because of the immense number of products and claims, it may be hard for them to keep up. They may be able to help guide you to more science-based sources.
Distinguish Between Products and Practices: Recognize that the safety profile of mind-body practices like yoga, meditation, or tai chi is generally much higher than that of ingestible products like herbal supplements. While these practices still require proper instruction, they do not carry the same risks of pharmacological interactions or contamination. The FDA does not regulate these or traditional psychotherapies.
The Indispensable Role of Healthcare Provider Consultation
Ultimately, self-prescribing dietary supplements, especially for individuals with pre-existing medical conditions or those taking any prescription or over-the-counter medications, is a risk. The potential for supplements to interfere with the actions of life-saving drugs is significant and well-documented. Consultation with a knowledgeable physician, pharmacist, or other qualified healthcare provider is an essential component of safe and responsible health management. Only through a collaborative partnership between an informed patient and a trusted healthcare professional can the potential benefits of integrative approaches be explored while minimizing the very real risks that exist in a dual-standard regulatory environment.
RESOURCES
Evidence and General Complementary/Integrative Health
Evidence-Based Complementary and Alternative Medicine in Current Medical Practice - NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC10857488/
Complementary and Alternative Medicine - Collection Development Guidelines of the National Library of Medicine - NCBI Bookshelf, https://www.ncbi.nlm.nih.gov/books/NBK518811/
Complementary, Alternative, or Integrative Health: What's In a Name ..., https://www.nccih.nih.gov/health/complementary-alternative-or-integrative-health-whats-in-a-name
Are You Considering a Complementary Health Approach? | NCCIH - NIH, https://www.nccih.nih.gov/health/are-you-considering-a-complementary-health-approach
Introduction | NCCIH - NIH, https://www.nccih.nih.gov/about/strategic-plans/introduction
NIH Center for Complementary and Integrative Health - NNLM, https://www.nnlm.gov/BJSR7
National Center for Complementary and Integrative Health, https://www.nccih.nih.gov/
Dietary Supplement Health and Education Act (DSHEA) and Regulation
Dietary Supplement Health and Education Act of 1994 | Research Starters - EBSCO, https://www.ebsco.com/research-starters/nutrition-and-dietetics/dietary-supplement-health-and-education-act-1994
"Regulation of Dietary Supplements: Five Years of DSHEA" by Laura A.W. Khatcheressian, https://scholarship.richmond.edu/law-faculty-publications/35/
History and overview of DSHEA - PubMed, https://pubmed.ncbi.nlm.nih.gov/20837113/
Dietary Supplement Health and Education Act of 1994 - Wikipedia, https://en.wikipedia.org/wiki/Dietary_Supplement_Health_and_Education_Act_of_1994
Dietary Supplement Health and Education Act of 1994, https://ods.od.nih.gov/About/DSHEA_Wording.aspx
Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act | FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food
Food and Dietary Supplement Labeling Claims: FDA Regulation and Select Legal Issues, https://www.congress.gov/crs-product/R48623
Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims | FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-evidence-based-review-system-scientific-evaluation-health-claims
A Comparison of Current Regulatory Frameworks for Nutraceuticals in Australia, Canada, Japan, and the United States - NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC8326690/
FDA Drug Approval and Comparison to Supplements
FDA Drug Approval Process - Drugs.com, https://www.drugs.com/fda-approval-process.html
Drug Approval Process - Friends of Cancer Research, https://friendsofcancerresearch.org/glossary-term/drug-approval-process/
How are Drugs Approved in the United States? - HealthyChildren.org, https://www.healthychildren.org/English/health-issues/conditions/treatments/Pages/FDAs-Role-in-the-Drug-Approval-Process.aspx
How Do Drugs Get Approved (and Fast-Tracked) by the FDA? | LUNGevity Foundation, https://www.lungevity.org/blogs/how-do-drugs-get-approved-and-fast-tracked-by-fda
The Drug Development Process | FDA, https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
The Scientist's Guide to Understanding FDA Drug Approval - Excedr, https://www.excedr.com/blog/fda-drug-approval-process-guide
Dietary Supplements | FDA, https://www.fda.gov/consumers/consumer-updates/dietary-supplements
Dietary Supplements: What You Need to Know - Consumer, https://ods.od.nih.gov/factsheets/WYNTK-Consumer/
Medications vs. Supplements | U.S. Anti-Doping Agency (USADA), https://www.usada.org/dietary-supplements/medications-vs-supplements/
Dietary Supplements | FDA, https://www.fda.gov/food/dietary-supplements
Drugs, Biologics, and Dietary Supplements | Division of Research and Innovation | Oregon State University, https://research.oregonstate.edu/ori/irb/policies-and-guidance-investigators/guidance/drugs-biologics-and-dietary-supplements
Herbal and Natural Medicine Resources/Databases
About Herbs - Apps on Google Play, https://play.google.com/store/apps/details?id=org.mskcc.AboutHerbs
Herbal Remedies and Cancer Treatment - Memorial Sloan Kettering Cancer Center, https://www.mskcc.org/cancer-care/patient-education/herbal-remedies-and-treatment
NatMed Pro | Natural Medicines Database | TRC Healthcare, https://trchealthcare.com/product/natmed-pro/
About Herbs, Botanicals & Other Products | Memorial Sloan ..., https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs
Herbal Remedies and Cancer Treatment, https://www.mskcc.org/pdf/cancer-care/patient-education/herbal-remedies-and-treatment
Natural Medicines - PMC - NIH, https://pmc.ncbi.nlm.nih.gov/articles/PMC5079512/
Author: Dr. T. Ryan O’Leary, MD
The author(s) may use Ai Large Language Models to assist with the content creation. The content is edited and fact checked by the author based on their expertise. All content should be considered the opinion of the author and not that of any civil or government agency for which they may work or contract. None of the content should be considered personal medical advice and all readers should consult with their physician for personal medical advice.
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