Regulations bring litigation. As the legal cannabis industry gains legitimacy on an international level, new regulations are changing the
marketplace. While the regulated sale of cannabis creates myriad business opportunities, those same regulations
lay the groundwork for new scrutiny and, undoubtedly, class action litigation against suppliers.
This document provides information on bath salts and K2/spice. It describes bath salts as synthetic stimulants often found in retail products containing chemicals like mephedrone and MDPV that produce effects similar to cocaine and MDMA. K2 is a mixture of herbs sprayed with synthetic THC compounds and marketed as incense that produces marijuana-like effects when smoked. Both are dangerous and have unpredictable effects. While some ingredients are now controlled, the legal status of bath salts and K2 can vary as manufacturers modify ingredients to circumvent laws.
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many stakeholders shared their experiences and challenges and convinced the FDA to open a docket for public comments until July 16, 2019...
The document discusses the legal status of CBD and THC in foods and dietary supplements according to the FDA. The FDA states that CBD and THC cannot be used as ingredients in supplements because they are the active ingredients in approved drug products. The FDA has sent warning letters to companies marketing CBD supplements. Unless a company can establish legal ingredient status for THC or CBD with the FDA, it is recommended to not use them in foods or supplements, leaving those products to the medical marijuana industry.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
Alice P. Mead gave a presentation on the history of medical marijuana and the potential for developing marijuana-based medicines. She summarized that while crude marijuana extracts were used medically in the past, modern synthetic medicines replaced them. Identification of cannabinoids like THC in the 1960s renewed scientific interest. GW Pharmaceuticals is developing standardized pharmaceutical cannabinoid medicines and conducting international clinical trials through the FDA process to establish safety and efficacy. Developing marijuana as a modern medicine requires meeting standards for composition, dosage, and delivery unlike herbal "medical marijuana".
Regulation of herbal medicine effect both herbal products and clinical practicesBhodi Tims
This document discusses current practices and regulations regarding herbal medicine in the US. It covers several key topics: the legal status and classification of different plants and herbs; the various government agencies that regulate herbal products; how herbal products are regulated depending on their intended use as foods, dietary supplements, or drugs; and major laws like DSHEA that established regulatory frameworks for dietary supplements. It also discusses good manufacturing practices, labeling requirements, substantiating claims, adverse event reporting, and non-regulatory science organizations that help develop standards.
This document provides information on bath salts and K2/spice. It describes bath salts as synthetic stimulants often found in retail products containing chemicals like mephedrone and MDPV that produce effects similar to cocaine and MDMA. K2 is a mixture of herbs sprayed with synthetic THC compounds and marketed as incense that produces marijuana-like effects when smoked. Both are dangerous and have unpredictable effects. While some ingredients are now controlled, the legal status of bath salts and K2 can vary as manufacturers modify ingredients to circumvent laws.
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many stakeholders shared their experiences and challenges and convinced the FDA to open a docket for public comments until July 16, 2019...
The document discusses the legal status of CBD and THC in foods and dietary supplements according to the FDA. The FDA states that CBD and THC cannot be used as ingredients in supplements because they are the active ingredients in approved drug products. The FDA has sent warning letters to companies marketing CBD supplements. Unless a company can establish legal ingredient status for THC or CBD with the FDA, it is recommended to not use them in foods or supplements, leaving those products to the medical marijuana industry.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
Alice P. Mead gave a presentation on the history of medical marijuana and the potential for developing marijuana-based medicines. She summarized that while crude marijuana extracts were used medically in the past, modern synthetic medicines replaced them. Identification of cannabinoids like THC in the 1960s renewed scientific interest. GW Pharmaceuticals is developing standardized pharmaceutical cannabinoid medicines and conducting international clinical trials through the FDA process to establish safety and efficacy. Developing marijuana as a modern medicine requires meeting standards for composition, dosage, and delivery unlike herbal "medical marijuana".
Regulation of herbal medicine effect both herbal products and clinical practicesBhodi Tims
This document discusses current practices and regulations regarding herbal medicine in the US. It covers several key topics: the legal status and classification of different plants and herbs; the various government agencies that regulate herbal products; how herbal products are regulated depending on their intended use as foods, dietary supplements, or drugs; and major laws like DSHEA that established regulatory frameworks for dietary supplements. It also discusses good manufacturing practices, labeling requirements, substantiating claims, adverse event reporting, and non-regulatory science organizations that help develop standards.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Your CBD business plan has to cover a lot of ground. Regulatory hurdles. Supply chain inconsistency. Marketing restrictions. And even if all those issues are addressed, you still have to create a credible brand in a crowded marketplace.
Fortunately, GemmaCert is here to help. We’ve assembled this guide with valuable information for creating a great CBD business. Because our executive team has extensive experience in the dietary supplement industry — and because CBD is regulated like a dietary supplement in many
jurisdictions — we can help CBD businesses navigate the market.
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The document discusses several key legal and ethical issues related to pharmacology and medication administration for nurses. It covers the nurse's responsibilities to understand each medication, adhere to safety procedures like the "5 rights", and report any errors. It also summarizes various US laws governing drug legislation, approval processes, and scheduling of controlled substances.
The document summarizes several important drug regulatory news and safety updates from regulatory authorities including Health Canada and the US FDA. It provides warnings and updates to healthcare professionals in Nepal about potential drug interactions and risks, including:
1) The risk of high anion gap metabolic acidosis with concomitant use of flucloxacillin and paracetamol.
2) The possible risk of hypothyroidism in infants given iodine-containing contrast agents.
3) The removal of a boxed warning about asthma deaths for medicines containing inhaled corticosteroids and long-acting beta agonists.
4) The rare risk of subacute cutaneous lupus erythematosus with proton
Drug Use, Regulation, and the LawChapter 3Guid.docxjacksnathalie
This document discusses guidelines for controlling drug development and marketing, including strategies for preventing drug abuse through supply reduction, inoculation, and demand reduction. It also summarizes regulations that have been implemented related to drug labeling, safety testing, and advertising in response to issues like fraudulent patent medicines and the thalidomide tragedy. Current drug scheduling is explained based on abuse potential and medical usefulness.
The US Food and Drug Administration (FDA) is responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and tobacco. The FDA oversees products representing 25% of US consumer spending. It has over 11,500 employees located across the country and overseas. The FDA regulates a wide range of products and enforces numerous laws relating to public health and safety. Its mission is to promote public health by reviewing research and regulating products efficiently.
This document discusses medical marijuana. It provides background on marijuana and its classification. It assesses the efficacy and safety of medical marijuana for conditions like nausea, pain, appetite stimulation, and others. It also explains the legal implications of medical marijuana in the US and in states like Colorado and Illinois that have legalized it. Remaining challenges include a lack of standardized dosing and quality control. The pharmacist's role could include counseling patients, assessing drug interactions, and producing customized dosage forms.
This document discusses CBD products and their potential impact on employment. It notes that while CBD products containing less than 0.3% THC are legal, many CBD products are unregulated and may contain higher and illegal levels of THC. This could lead to failing a drug test at work. It advises checking with your employer about their policies on CBD and marijuana use, as a positive drug test may jeopardize your employment even if you used CBD legally.
This presentation will review the current research around medical marijuana and discuss the issues around the recent legalization of recreational use. We will explore common clinical questions regarding marijuana use including testing and concurrent controlled substance use.
- The document outlines the major steps in the US drug approval process, including preclinical testing in animals, filing an Investigational New Drug (IND) application with the FDA to begin clinical trials, and completing four phases of clinical trials on humans. It also defines key terms and legislative acts that have shaped the current drug regulation system.
- It describes the four phases of clinical trials that increase in size and explore safety, efficacy, optimal dosing, and comparison to existing treatments. After phase III trials, a New Drug Application is submitted to the FDA for marketing approval review.
- The drug approval process is designed to demonstrate a drug is safe and effective before being approved and made available to the public, as
This document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the history and legislation supporting generic drugs. The key points covered include:
- ANDA is an application to the FDA to manufacture and market a generic drug in the US that is equivalent to an approved brand name drug.
- ANDAs are abbreviated because generic drugs do not require clinical trials and provide less information than an NDA for a new drug.
- The objectives of ANDAs are to reduce drug prices, reduce development time, and increase bioavailability compared to reference listed drugs.
- Generic drugs must be identical to the brand name drug in active ingredients, route of administration, dosage
Background note for ad hoc group on medJames Andrews
The document discusses standards for registered pharmacies, particularly regarding medicines safety. It notes key principles like ensuring standards are proportionate and allow for innovation. Specific issues are raised around supplying licensed medicines over unlicensed ones, exempting extemporaneous methadone preparation, and pharmacy manufacturing of medicines. Further discussion is needed on whether standards comply with policy, contradict law, and which body (GPhC or MHRA) leads on each issue. Patient safety is the overarching principle.
Should Health Insurance Cover Medical Marijuana Costs?Cannabis News
Should you HMO or PPO cover medical marijuana prescriptions, read this https://cannabis.net/blog/opinion/should-health-insurance-cover-medical-marijuana
This document discusses natural health products (NHPs) in Canada, including regulatory requirements and market opportunities. NHPs include vitamins, minerals, herbal remedies, probiotics, and other supplements. Health Canada regulates NHPs through product licensing, site licensing, and good manufacturing practices. There are three classes of NHPs with different approval pathways and timelines. While Canada has a large NHP market and export opportunities due to Health Canada's reputation, herbal medicines face challenges due to variability and innovation is limited for Class I and II products. A SWOT analysis identifies strengths, weaknesses, opportunities and threats for the Canadian NHP industry.
Why do Cannabis Businesses Need In-House Testing?gsetton
Cannabis companies need to adopt pharmaceutical testing standards from seed to sale to ensure product safety and consistency. While 3rd party labs are necessary for regulatory compliance, they are expensive and slow. GemmaCert offers an in-house testing solution that tests cannabis and hemp throughout the growth and production process for attributes like THC, CBD, moisture and mold to optimize harvests, production and product quality. Their system provides quick, easy and non-destructive testing.
The document provides instructions for using a device called GemmaCert to test the water activity (Aw) of cannabis before storage or transport. It explains that an Aw level between 0.55-0.65 is optimal as it indicates the flower is dry enough to prevent mold growth but not too dry that it loses potency. Any Aw level above 0.65 indicates the flower is too moist and at risk for mold, while below 0.55 means the flower is very dry and potency may be reduced. The test takes minutes and provides the Aw reading on a smartphone to help determine if the cannabis is safe for transport and storage or presents a health or profit risk.
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IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Your CBD business plan has to cover a lot of ground. Regulatory hurdles. Supply chain inconsistency. Marketing restrictions. And even if all those issues are addressed, you still have to create a credible brand in a crowded marketplace.
Fortunately, GemmaCert is here to help. We’ve assembled this guide with valuable information for creating a great CBD business. Because our executive team has extensive experience in the dietary supplement industry — and because CBD is regulated like a dietary supplement in many
jurisdictions — we can help CBD businesses navigate the market.
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The document discusses several key legal and ethical issues related to pharmacology and medication administration for nurses. It covers the nurse's responsibilities to understand each medication, adhere to safety procedures like the "5 rights", and report any errors. It also summarizes various US laws governing drug legislation, approval processes, and scheduling of controlled substances.
The document summarizes several important drug regulatory news and safety updates from regulatory authorities including Health Canada and the US FDA. It provides warnings and updates to healthcare professionals in Nepal about potential drug interactions and risks, including:
1) The risk of high anion gap metabolic acidosis with concomitant use of flucloxacillin and paracetamol.
2) The possible risk of hypothyroidism in infants given iodine-containing contrast agents.
3) The removal of a boxed warning about asthma deaths for medicines containing inhaled corticosteroids and long-acting beta agonists.
4) The rare risk of subacute cutaneous lupus erythematosus with proton
Drug Use, Regulation, and the LawChapter 3Guid.docxjacksnathalie
This document discusses guidelines for controlling drug development and marketing, including strategies for preventing drug abuse through supply reduction, inoculation, and demand reduction. It also summarizes regulations that have been implemented related to drug labeling, safety testing, and advertising in response to issues like fraudulent patent medicines and the thalidomide tragedy. Current drug scheduling is explained based on abuse potential and medical usefulness.
The US Food and Drug Administration (FDA) is responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and tobacco. The FDA oversees products representing 25% of US consumer spending. It has over 11,500 employees located across the country and overseas. The FDA regulates a wide range of products and enforces numerous laws relating to public health and safety. Its mission is to promote public health by reviewing research and regulating products efficiently.
This document discusses medical marijuana. It provides background on marijuana and its classification. It assesses the efficacy and safety of medical marijuana for conditions like nausea, pain, appetite stimulation, and others. It also explains the legal implications of medical marijuana in the US and in states like Colorado and Illinois that have legalized it. Remaining challenges include a lack of standardized dosing and quality control. The pharmacist's role could include counseling patients, assessing drug interactions, and producing customized dosage forms.
This document discusses CBD products and their potential impact on employment. It notes that while CBD products containing less than 0.3% THC are legal, many CBD products are unregulated and may contain higher and illegal levels of THC. This could lead to failing a drug test at work. It advises checking with your employer about their policies on CBD and marijuana use, as a positive drug test may jeopardize your employment even if you used CBD legally.
This presentation will review the current research around medical marijuana and discuss the issues around the recent legalization of recreational use. We will explore common clinical questions regarding marijuana use including testing and concurrent controlled substance use.
- The document outlines the major steps in the US drug approval process, including preclinical testing in animals, filing an Investigational New Drug (IND) application with the FDA to begin clinical trials, and completing four phases of clinical trials on humans. It also defines key terms and legislative acts that have shaped the current drug regulation system.
- It describes the four phases of clinical trials that increase in size and explore safety, efficacy, optimal dosing, and comparison to existing treatments. After phase III trials, a New Drug Application is submitted to the FDA for marketing approval review.
- The drug approval process is designed to demonstrate a drug is safe and effective before being approved and made available to the public, as
This document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the history and legislation supporting generic drugs. The key points covered include:
- ANDA is an application to the FDA to manufacture and market a generic drug in the US that is equivalent to an approved brand name drug.
- ANDAs are abbreviated because generic drugs do not require clinical trials and provide less information than an NDA for a new drug.
- The objectives of ANDAs are to reduce drug prices, reduce development time, and increase bioavailability compared to reference listed drugs.
- Generic drugs must be identical to the brand name drug in active ingredients, route of administration, dosage
Background note for ad hoc group on medJames Andrews
The document discusses standards for registered pharmacies, particularly regarding medicines safety. It notes key principles like ensuring standards are proportionate and allow for innovation. Specific issues are raised around supplying licensed medicines over unlicensed ones, exempting extemporaneous methadone preparation, and pharmacy manufacturing of medicines. Further discussion is needed on whether standards comply with policy, contradict law, and which body (GPhC or MHRA) leads on each issue. Patient safety is the overarching principle.
Should Health Insurance Cover Medical Marijuana Costs?Cannabis News
Should you HMO or PPO cover medical marijuana prescriptions, read this https://cannabis.net/blog/opinion/should-health-insurance-cover-medical-marijuana
This document discusses natural health products (NHPs) in Canada, including regulatory requirements and market opportunities. NHPs include vitamins, minerals, herbal remedies, probiotics, and other supplements. Health Canada regulates NHPs through product licensing, site licensing, and good manufacturing practices. There are three classes of NHPs with different approval pathways and timelines. While Canada has a large NHP market and export opportunities due to Health Canada's reputation, herbal medicines face challenges due to variability and innovation is limited for Class I and II products. A SWOT analysis identifies strengths, weaknesses, opportunities and threats for the Canadian NHP industry.
Similar to Class Action Lawsuits and the Cannabis Industry (20)
Why do Cannabis Businesses Need In-House Testing?gsetton
Cannabis companies need to adopt pharmaceutical testing standards from seed to sale to ensure product safety and consistency. While 3rd party labs are necessary for regulatory compliance, they are expensive and slow. GemmaCert offers an in-house testing solution that tests cannabis and hemp throughout the growth and production process for attributes like THC, CBD, moisture and mold to optimize harvests, production and product quality. Their system provides quick, easy and non-destructive testing.
The document provides instructions for using a device called GemmaCert to test the water activity (Aw) of cannabis before storage or transport. It explains that an Aw level between 0.55-0.65 is optimal as it indicates the flower is dry enough to prevent mold growth but not too dry that it loses potency. Any Aw level above 0.65 indicates the flower is too moist and at risk for mold, while below 0.55 means the flower is very dry and potency may be reduced. The test takes minutes and provides the Aw reading on a smartphone to help determine if the cannabis is safe for transport and storage or presents a health or profit risk.
Cannabis Potency Variability and Cost-Effective Testinggsetton
Near-infrared spectroscopy may soon prove the industry standard for cannabis potency testing because of its lower labor costs, material costs, and higher speed. Furthermore, faster testing protocols can enable smaller batch sizes. The attentive selection of smaller batches based on the subjective qualities of the specimens will reduce variability and mitigate labeling inconsistencies.
Protocol for Wet (Fresh) Flower Potency Testing by GemmaCertgsetton
If you are a hemp grower, then during the two or three weeks before harvest, you should be testing your product daily to minimize the chance of harvesting crop with Total THC levels
above the legal threshold of 0.3%.
Sending samples to an external lab is costly and can take a few days before you get results. By then, your crop’s THC levels are higher. The GemmaCert Protocol for Wet (Fresh) Flower Potency Testing is a practical solution for analyzing crop potency within 24 hours at a fraction of the cost of an external lab.
Natural variation in cannabis composition can cause huge differences in potency between plants, between different buds from the same plant, and even within the same bud. In addition to the natural variation which presents high levels of non-homogeneity and hinders accurate potency testing, there is very little standardization in how different labs test for potency. Labs use different diagnostic equipment, varying testing protocols and each has its own measurements of uncertainty. It is highly likely that lab results will differ from one another.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
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Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
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Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
2. 2
Executive Summary
As the legal cannabis industry gains legitimacy on an international level, new regulations are changing the
marketplace. While the regulated sale of cannabis creates myriad business opportunities, those same regulations
lay the groundwork for new scrutiny and, undoubtedly, class action litigation against suppliers.
Much of the legal scrutiny in cannabis’ future hinges on the definition of the drug. Cannabis sativa meets
the description of a pharmaceutical drug, as per the United States Food and Drug Administration. Although
cannabis is federally illegal in the United States, as of this publication, both tetrahydrocannabinol (THC) and
cannabidiol (CBD) fulfill the definition of a medicinal drug. However, at the same time, the cannabis flower
might also be classified as a dietary supplement because it is a biological matrix with myriad undocumented and
unregulated compounds.
By reflecting on the regulations, definitions, and litigation of the dietary supplement and pharmaceutical
industries, cannabis product suppliers can anticipate problems. Furthermore, in-house testing can mitigate legal
and consumer health risks by facilitating quality control and documentation, particularly by increasing the
number of samples analyzed during the process.
Defining Pharmaceuticals and Dietary Supplements
According to the United States Food and Drug Administration (FDA), pharmaceutical drugs and dietary
supplements are categorically different. In the case of pharmaceutical drugs,1 a specific chemical compound
is tested in clinical trials performed by the manufacturer. Then, the FDA’s Center for Drug Evaluation and
Research (CDER) reviews the manufacturer’s evidence before approving a drug for sale. CDER assesses the
proposed drug’s known risks in consideration of its confirmed benefits. If the drug is approved, the FDA suggests
labeling practices to explain its benefits and risks.
Unlike dietary supplements, pharmaceutical drugs are assumed to be unsafe by the FDA until proven otherwise;
thus, the burden of proof falls on the drug manufacturers. Vitamins, minerals, amino acids, enzymes, botanicals,
and botanical extracts, however, are defined as dietary supplements.2 As such, the FDA regulates them as food
products; therefore, these supplements are considered safe until proven otherwise. The burden of disproving the
safety of supplements is on the FDA. Until incidents of harm arise from a dietary supplement, the FDA allows
its sale. Because dietary supplements are untested, any claims that they can treat or cure a disease are prohibited.
However, some vitamin supplements may claim disease prevention, like in the case of folic acid that has been
shown to help prevent birth defects.3
Yet, some naturally occurring botanical extracts such as morphine, which occurs in the opium poppy, may be
classified as drugs rather than as dietary supplements. This is because such drugs are a proven treatment for
specific conditions or diseases.
Additionally, some natural substances (e.g., morphine, psilocybin) may present dangers involving intoxication,
overdose, or abuse. This, too, is a reason for a substance’s classification as a drug rather than as a dietary
supplement. Undoubtedly, cannabis fits this profile as an intoxicant.
3. 3
Classifying Cannabis as a Pharmaceutical Drug
If the medicinal benefits of cannabis are validated for specific conditions, then cannabis – or its constituent
cannabinoids – will necessarily be considered a drug or drugs, per the FDA. Furthermore, tetrahydrocannabinol
(THC) is an intoxicant, which doubly confirms the need for THC’s classification as a drug rather than as a
dietary supplement. If THC-containing cannabis is legalized on a federal level in the United States, the U.S.
Drug Enforcement Administration (DEA) will reassess its abuse potential and regulate its pharmaceutical
distribution accordingly. THC – when isolated from the rest of the plant – is clearly a drug.
Cannabidiol (CBD) is also clearly a drug. In 2018, the DEA reassessed
the legality of CBD medicines – but only for specific CBD products
pre-approved by the FDA on a case-by-case basis.4 According to the
DEA’s tiered system of pharmaceutical drug classification, CBD – long
an illegal, Schedule I drug – is now a Schedule V drug, which indicates
a low potential for harm or abuse.
Therefore, CBD and THC, the two major cannabinoids in cannabis, align well with the FDA's definition of a
drug. The cannabis plant, however, is not so simple or easily classified. The plant itself is a complex botanical
matrix, completely unlike a single-compound pharmaceutical, such as Prozac or Oxycontin.
Classifying Cannabis as a Dietary Supplement, Not Just a Drug
The cannabis flower is a not a single drug; it is a matrix of dozens of bioactive compounds that may have
medicinal benefits or other effects. The plant contains no fewer than 113 cannabinoids and dozens of other
compounds, including terpenes, flavonoids, waxes, and plant metabolites.5
As a botanical matrix, the cannabis plant is similar to an herbal supplement that contains many presumably safe
compounds. The dietary supplement saw palmetto, which is believed to benefit men with prostate conditions,
can serve as a paralleling example.
The constituents of saw palmetto fruit that provide the purported benefits have not been verified, although
researchers speculate that the plant’s combination of fatty acids, phytosterols, and other bioactive compounds
play a role.6 Yet, because saw palmetto is classified as a dietary supplement rather than a drug, defining the
active ingredient is unnecessary. In addition, because clinical trials have not proven that saw palmetto is an
effective treatment, supplement manufacturers may not make direct efficacy claims.
In the case of cannabis, the FDA will not have the capacity or resources to assess or regulate the dozens of
cannabinoids that may be present in any given sample. Furthermore, naturally occurring compounds may not
be patented, so it would not be sensible for any individual business to fund the clinical trials necessary to classify
minor cannabinoids as drugs. This will likely mean that these less understood, anecdotally safe compounds will
be considered dietary supplements without confirmed medical benefits.
Cannabinoids
are not cannabis.
Cannabis is not a
cannabinoid.
4. 4
Minor Cannabinoids as Contaminants?
Medicinal cannabis, when sold as an intact flower, does not fit the delivery format of existing pharmaceutical
drugs. While dietary supplements may be sold in whole plant form, drugs are plant isolates or synthetic
compounds bound in an approved delivery vehicle, such as a tablet or an oral solution.
So, if THC and CBD are the cannabinoids listed on the label of retail cannabis – and the cannabis product as
a whole is considered to be a pharmaceutical drug – the other cannabinoids and natural compounds may fit
the definition of contaminants. Yet in the case of cannabis, the incidental compounds are beneficial. Major and
minor cannabinoids have been found to provide benefits that surpass the effects of any single cannabinoid alone,
a phenomenon labeled the ‘Entourage Effect.’ This is why cannabis straddles the definition of drug and dietary
supplement, and why a new definition is needed to regulate cannabis when federal legalization occurs.
Defining Cannabis
To avoid litigation and increase consumer awareness, a formal definition of cannabis is required. The Dietary
Supplement Health and Education Act 1994 (DSHEA) provided such a definition for the dietary supplement
industry in the United States.2 It also outlined the regulatory statutes that govern the supplement industry today.
Therefore, the DHSEA may serve as an example for cannabis.
The Dietary Supplement Health and Education Act:
• Defined “dietary supplement”
• Classified supplements as food, rather than drugs
• Prohibited claims of disease treatment
• Required manufacturers to use Current Good Manufacturing Practices (cGMP)
• Established the FDA’s regulatory authority to remove products from the market in
incidents of harm.
A definition of cannabis as a botanical matrix of many compounds, along with standardized labeling, would help
consumers and it might also prevent suits against cannabis suppliers. Similar to the DHEA, a Cannabis Health
and Education Act would mandate cGMP and establish the testing protocols that are critical for quality control.
This would build the confidence of prescribing physicians and consumers unfamiliar with cannabis, improve the
consistency of patient outcomes, increase safety, and legitimize the industry.
5. 5
A Health and Education Act for cannabis products might:
• Define cannabis as a collection of compounds that may – or may not – be present
in a particular cultivar or product
• Establish potency labeling standards for the most prevalent cannabinoids (e.g., THC, CBD)
• List all known cannabinoids, cannabis terpenes, and flavonoids
• Require testing and the implementation of cGMP
• State the precautions for using high-THC cannabis
Class Action Lawsuits and Cannabis
The dietary supplement industry is rife with lawsuits and recalls, both in the form of class action suits from
consumers and suits from the FDA. As the cannabis industry evolves, it may be subject to this scrutiny or, worse,
legal discrimination by anti-cannabis groups.
Class litigation is often driven by opportunistic attorneys and prompted by recalls or cautionary notices from
the FDA. Once a problem is identified, attorneys will assess the sales volume of the product in question and the
extent to which it harmed consumers. If the case is profitable – and supported by consumer complaints – it is
likely to proceed. Even a successful defense will create sizable legal fees for the product manufacturer.
In the dietary supplement industry, three types of suits arise most frequently against product manufacturers and
retailers, and these themes are likely to occur in the cannabis businesses also.
False Claims
False advertising is the most common claim of loss or injury against dietary supplement manufacturers. Because
health benefits are the presumed value of supplements, companies walk a fine line between promotion and
penalty.
Improper claims in the cannabis industry are already drawing the scrutiny of the FDA. The FDA has – on three
occasions – threatened CBD companies for making illegal health claims.8 The companies had listed specific
conditions in their marketing materials, prompting regulators to issue warning letters that threatened product
seizure if the claims continued.
In the dietary supplement industry, the success of the 2007 suit against Dannon Yogurt acted as a floodgate
for class litigation. Dannon’s Activa and DanActive branded yogurts claimed to help regulate digestion with
beneficial bacteria. However, after consumer complaints, tests showed that the products were no different than
other yogurts and that the claims were exaggerated. Dannon accepted a settlement that reimbursed consumers
$35 million and required modification of their advertising. The size and scope of the Dannon suit legitimized
class litigation for false claims and brought a wave of lawsuits in its wake. A similar cannabis-related case could
do the same.
6. 6
Purity
Because dietary supplements are unregulated, they are not tested prior to sale. Therefore, adulterated or
contaminated products frequently enter the market without notice. The term adulteration refers to the intentional
substitution of an active ingredient for a less costly one; contamination, by contrast, occurs accidentally.
Cannabis companies are liable to experience fallout over contamination. Mold is the most common contaminant
and, in emerging markets without testing laws, aspergillus mold could prove lethal to immunocompromised
patients.8 Steep Hill Laboratories, a leading cannabis testing firm in California, estimated that 20%-30% of the
flower they tested in 2017 contained significant mold contamination.9
The FDA has banned companies from the market on the grounds of adulterated product and mislabeling, and
also for the failure to establish testing procedures for active ingredients.10 Testing verification and adherence to
cGMP are seen as critical by the FDA, even in the less-regulated dietary supplement industry.
Potency
The variable potency of cannabis is well-documented. Potency varies between crops and between individual buds
from the same plant. Additionally, potency decreases as plant material ages. Some extract products may even
experience an eight-month half-life, meaning 50% of the potency is lost every eight months.11
In the dietary supplement industry, potency degradation has proven troublesome. A 2017 lawsuit against
Nutraceutical Corporation claimed that the levels of its B12 liquid vitamins were rendered negligible and
ineffective due to the instability of the formulation. In 2015, the New York State Attorney General demanded
recalls of herbal products sold at Target, Walgreens, WalMart, and GNC due to a lack of the labeled ingredient
or an absence of the ingredient altogether. In 2017, a class action suit was filed against Costco when its fish oil
supplements were found to contain significantly less omega-3 fatty acid than advertised.
Class action lawsuits attract many plaintiffs. This is because anyone who has purchased the product in question
may sign on to receive part of a damage award. When cannabis – possibly aged several months – tests below
the stated cannabinoid percentage, consumer suits become viable.
Cannabis is overdue for class litigation. Since 2015, the FDA has issued warning letters to dozens of CBD
manufacturers whose products have tested below the labeled quantity of the drug. Potency variance or claims
of harm stemming from a false advertising claim will eventually trigger a wave of class action litigation in the
cannabis industry.
7. 7
In-House Testing for Preparedness and Propriety
Ultimately, chemical analysis is the only means to address the quality control issues of cannabis medicines.
The objectivity brought by testing is, in fact, the cornerstone of consumer safeguards brought by legalization.
While many of the testing requirements of cannabis will need to be fulfilled by laboratories (e.g., residual
solvents, heavy metals, pesticides), in-house testing is becoming increasingly popular with cannabis companies.
Forward-thinking businesses are using small testing units to refine their products, increase quality control, and
create an extra line of defense against regulatory and legal problems.
In-house testing units can provide valuable data logging. For instance, the GemmaCert portable testing unit
stores testing data on a secure server for easy download. Such documentation is a powerful tool against claims of
negligence or poor quality control. Voluntary testing creates an image of propriety that impresses regulators and
customers.
Testing allows retailers to create objectivity-based customer loyalty. When customers are better informed about
the potency issues that affect their cannabis – and when they see testing in action – they trust the retailer
providing the education. Testing with GemmaCert is non-destructive to the cannabis flower; therefore, retailers
can test the actual product the customer is purchasing in front of the customer, if desired. This satisfies customer
curiosity and engages them in conversation on a deeper level. Public understanding of potency variance,
degradation, and the struggle for representative sample selection help prevent litigation as well.
Quick, inexpensive testing with units such as those offered by GemmaCert make possible what laboratories
cannot: a better assessment of potency variance with more frequent sample analysis. Because THC and CBD
content can vary widely from flower-to-flower, selecting a representative sample is difficult. Testing multiple
samples – even with a testing unit slightly less accurate than conventional laboratory equipment – provides a far
better understanding of the potency of a crop. A representative assessment of potency with multiple tests is more
relevant to quality control than a highly-accurate test from a single specimen.
Quick potency testing complements the role of laboratories. Some tests must be performed with resource-
intensive laboratory technology, such as pesticide analysis. A single sample from a crop satisfies a pesticide
or heavy metal inquiry because pesticides and heavy metals are present throughout the crop. Cannabinoids,
however, vary between plants and between flowers from the same plant. Testing multiple times for cannabinoids
makes sense to resolve this variance. Conventional laboratory tests, which require thirty minutes and the use
of costly solvents, are ill-suited to this task. GemmaCert technology requires no solvents, measurements, or
specially trained personnel, and it requires only a few minutes to complete. The ability of the unit to test more
frequently greatly benefits quality control throughout the supply chain.
Cultivators, distributors, and processors benefit from frequent testing, too. Beyond compliance and legal defense,
testing allows transactions to be fair and objective. Superior cultivators and processors find that testing improves
their bargaining position,13 with more potent products fetching higher prices than average fare. Testing units
like the GemmaCert are accurate for transactional and comparative purposes, and they offer in-the-moment
information that a third-party laboratory cannot. In the future, point-of-sale testing will prove standard for
business-to-business cannabis transactions.
8. 8
In Conclusion
Regulation brings litigation. While class action suits have yet to
affect cannabis, the legal environment of the dietary supplement
industry affirms that they will. The reasons for oncoming litigation
will be determined, in part, by how regulators classify cannabis
medicines. Whole flower cannabis is a novel drug delivery medium,
unlike capsules, solutions, or intravenous drugs.
The cannabis flower may be best described as a dietary supplement
that contains a regulated drug. This definition applies because
of the numerous compounds that cannabis contains in addition
to those considered to be the active ingredients. Regardless of
the definition of cannabis medicines or attorneys’ approaches
to litigation, in-house testing will serve as a tool against large
settlements and damage awards. Testing improves consumer safety
and satisfaction while advancing the legitimacy of legal cannabis.
9. 9
Company Bio
GemmaCert is a biotechnology company, based in Israel since
2015, aiming to become a market leader in medicinal plant
composition and potency analysis, starting with cannabis.
GemmaCert’s skilled team of chemists, molecular biologists,
biotechnologists, data scientists and programmers work tirelessly
to advance cannabis analytical solutions.
In the long run, GemmaCert’s breakthrough technology will enable
patients and doctors to correlate cannabis composition with
specific health conditions, significantly enhancing therapeutic
treatment by cannabis and transforming the medical cannabis
industry.
Address
Web: www.gemmacert.com
Trademarks and Copyright
GemmaCert is a Trademark of GemmaCert Ltd.
Copyright @ 2017 GemmaCert Ltd. All rights reserved
Disclaimer
Information in this document is subject to change without notice
and does not represent a commitment on GemmaCert Ltd.
GemmaCert Ltd is not liable for errors contained in this document
or for incidental or consequential damages in connection with
furnishing or use of this material.
GemmaCert products are protected by U.S. and international
copyright laws.
10. 10
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www.fda.gov/drugs/developmentapprovalprocess
2. United States Dietary Health and Supplement Education Act of 1994.
3. United States CFR Title 21, Chapter I, Subchapter B, Part 101: Food
Labeling.
4. Hemp Industry Daily. “DEA takes some CBD off Schedule 1 - with FDA
approval.” 2018.
5. Aizpurua-Olaizola, O. “Evolution of the Cannabinoid and Terpene Content
during the Growth of Cannabis sativa Plants from Different Chemotypes.” J.
Nat. Prod. 2016.
6. Penugonda, K. “Fatty Acid and Phytosterol Content of Commercial Saw
Palmetto Supplements.” Nutrients MDPI. 2013.
7. Wallace, A. “FDA sends warning letters to CBD companies, including
Colorado’s CW Hemp.” The Cannabist. 2017.
8. Hamadeh, R. “Fatal aspergillosis associated with smoking contaminated
marijuana, in a marrow transplant recipient.” Chest. 1988.
9. Walker, W. “Fungus In Medical Marijuana Eyed As Possible Cause In
California Man’s Death.” CBS SF Bay Area. 2017.
10. Department of Justice. “United States Files Enforcement Action Against
Long Island Company and Its Owner to Prevent Distribution of Adulterated
and Misbranded Dietary Supplements.” 2017.
11. Smith, B. “Determination of Cannabis Oil Potency Degradation Rate and
Mechanism by Infrared Spectroscopy.” Terpenes and Testing Magazine.
2017.
12. Beginner’s Guide to Cannabis Testing. Terpenes and Testing Magazine. 2017.