Quality, Safety and Legislation for herbal products in USA.pptx

Quality, Safety and Legislation for herbal products in USA.pptx

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  Quality, Safety andLegislation for herbal products in USA Presentation by: Gowthami A H Date:19/02/2024 Department of Pharmaceutical Regulatory Affairs Regulatory Aspects of Herbals and Biologics
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  Contents Herbal products Regulation ofHerbal drug in USA Quality of Herbal drugs in USA Good manufacturing practice Safety of Herbal drugs in USA Good Agriculture and collection practice Global Regulatory Differences on Botanicals Conclusion and References
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  Herbal products  Herbalproducts, 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. 1
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  How a botanicalproduct is regulated is dependent on its intended use and how the product is labeled. Botanical Product Regulated as A Drug Botanical Product Regulated as A Dietary Supplement 2
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  Botanical Product Regulatedas a Drug  Botanical drugs are therapeutic materials derived from plants, plant extracts, algae, fungi, or other natural sources.  These materials may come from a single plant or a combination of multiple plants.  As per the regulations of the US FDA, the collective combination of these components is recognized as the Active Pharmaceutical Ingredient (API) for a botanical drug. 3
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  Botanical products doesnot include: Products that contain animals or animal parts and/or minerals, except when these are a minor component in a traditional botanical preparation Materials derived from botanical species that are genetically modified with the intention of producing a single molecular entity Products produced by fermentation of yeast, bacteria, plant cells, or other microscopic organisms, including plants used as substrates Highly purified substances, either derived from a naturally occurring source or chemically modified 4
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  Approved botanical drugs Todate, two botanical products have fulfilled the Botanical Guidance definition of a botanical drug product. Both botanical drug products have been approved for marketing as prescription drugs (sinecatechins, Veregen® and crofelemer, Mytesi™). There are some botanical drugs, including cascara, psyllium, and senna, that are included in the over-the-counter (OTC) drugs. 5
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  Botanical Drug DevelopmentUnder INDs  In the United States, to transform a product into a prescription medicine, it must undergo the US FDA Investigational New Drug (IND) Application process.  This process is a crucial regulatory step for herbal medicines to become prescription botanical drugs, manufacturers must submit a botanical drug IND application to the US FDA.  This botanical drug IND pathway shares similarities with the traditional IND processes for small molecules, large molecules, cell therapies, and gene therapies. 6
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  Marketing of BotanicalDrugs Under NDAs  Any person who wishes to market a new drug in the United States must submit an NDA and obtain Agency approval prior to marketing the new drug product for the proposed use ( 505 of the FD&C Act).  FDA may approve a drug product containing such a drug substance for OTC sale pursuant to an application submitted under section 505 of the FD&C Act. 7
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  Botanical Product Regulatedas a Dietary Supplement  A botanical product is regulated under the general umbrella of foods as a dietary supplement if it is intended to supplement a diet. A botanical-based dietary supplement is taken orally and cannot make a disease claim to diagnose, cure, mitigate, treat, or prevent disease.  FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) 8
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   FDA generallydoes not approve dietary supplement claims or other labeling before use.  Under the FD&C Act, a firm is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated, misbranded, or otherwise in violation of federal law.  The FDA mandates that manufacturers notify them of “New dietary ingredients (NDIs)” or ingredients used in dietary supplements that were not marketed in the USA before 1994. 9
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  FDA Labeling Requirementsfor Dietary Supplements 10
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  Botanical Drug MarketReport 11  The global botanical drug market size was USD 3268 million in 2021 and market is projected to touch USD 48537 million by 2031, at a CAGR of 4.0% during forecast period.  Products like Ginkgo Biloba, ginseng, echinacea, and garlic are the major selling botanical products in the U.S.
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  Preference of consumersfor natural therapies Concern regarding undesirable side effects of modern medicines The belief that herbal medicines might be of effective benefit Tendency towards self-medication Improvement in quality, proof of efficacy and safety of herbal medicines. High cost of synthetic medicines Several important factors have contributed to the growth of phytotherapeutic market 12
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  Factors affecting qualityof herbal medicines • Substitution of inferior varieties • Substitution of exhausted drugs (cloves, fennel) • Artificially manufactured substitutes • Objects added to increase weight of material for sale (stones, lead shot) Adulteration • Light • Temperature • Humidity • oxidation Deterioration of herbal products • Synthetic pharmaceuticals added to the plant material for pharmacological activity ( Herbal Viagra) • Adding citral to oil of lemon • Benzyl benzoate to balsam of peru Addition of synthetic principles 13
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  Examples  Senna isa natural laxative commonly used in herbal teas and supplements to relieve constipation.  Adulteration may involve the addition of cheaper substitutes or fillers, which can compromise the quality and effectiveness of the product.  Dog senna , palthe senna and mecca or Arabian and Bombay senna are common adulterants of senna. 14
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   Chinese staranise ( Illicium verum) is a well- known spice used in many culture.  Caribbean and Latino populations typically use a tea infusion of its fruit as a carminative and sedative for treatment of infants.  Japanese star anise ( Illicium anisatum) is a close relative that has been well documented to cause neurologic and GI toxicities 15
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  Public Notification: HerbViagra Male Sexual Stimulant contains hidden drug ingredient  FDA laboratory analysis confirmed that Herb Viagra contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction.  FDA’s approval of Viagra is restricted to use under the supervision of a licensed health care professional.  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. 16
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   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. 17 Quality of Herbal Drugs in USA
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  18 21 CFR Part111- Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements Subpart A - General Provisions Subpart B - Personnel Subpart C - Physical Plant and Grounds Subpart D - Equipment and Utensils
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  Subpart E -Requirement to Establish a Production and Process Control System Subpart F - Requirements for Quality Control Subpart G - Requirements for Components, Packaging, and Labels and for Product that you receive for Packaging or Labeling as a Dietary Supplement Subpart H - Requirements for the Master Manufacturing Record 19
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  Subpart I -Requirements for the Batch Production Record Subpart J - Requirements for Laboratory Operations Subpart K - Requirements for Manufacturing Operations Subpart L - Requirements for Packaging and Labeling Operations 20
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  Subpart M -Holding and Distributing Subpart N - Returned Dietary Supplements Subpart O - Product Complaints Subpart P - Records and Recordkeeping 21
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   The safetyof 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. 22 Safety of Herbal Drugs in USA
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   Good Agriculturaland Collection Practices (GACP) is a quality assurance system for medicinal plants. It's a set of guidelines for medicinal plant producers on how to improve the safety, efficacy, and quality standards of raw materials used in the preparation of herbal medicines.  GACP consists of the practices used during agricultural production, from planting and harvesting until it's packaged and then transported. 23 Good Agricultural and collection practices
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  Botanical identity and quality Post-harvest handling Harvest of plants Generalfarm standards Wild collection Cultivation 24 GACP
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  In EU memberstates, botanicals are regulated as herbal medicinal products by EMA's Committee on Herbal Medicinal Products (HMPC). To market a herbal medicine in EU member states, three key pathways can be taken: traditional use registration, well-established use marketing authorisation, and stand-alone or mixed application. Global Regulatory Differences on Botanicals 25
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  In Canada, botanicalsare regulated as natural health products under HC’s Natural and Non-prescription Health Products Directorate (NNHPD). HC defines NHPs as naturally occurring substances that are used to restore or maintain good health including herbal remedies, homeopathic medicines, and traditional medicines. To market a natural health product in Canada, the sponsor must obtain a natural product number (NPN), or DIN-HM for homeopathic medicines, from the NNHPD. 26
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  Pre-market authorizations requirements 27
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  Herbal products offerpromising benefits, ensuring their quality and safety requires collaboration among regulatory bodies, manufacturers, healthcare professionals, and consumers. Continuous vigilance, transparent labeling, adherence to Good Manufacturing Practices (GMP), and evidence-based research are crucial in maintaining public trust and maximizing the potential benefits of herbal products while mitigating potential risks. By upholding rigorous standards and fostering open communication, the USA is promoting marketplace where herbal products contribute positively to health and wellness. Conclusion 28
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  1. What isa Botanical Drug? [Internet]. Available from: https://www.fda.gov/about- fda/center-drug-evaluation-and-research-cder/what-botanical-drug (accessed on 15- 02-2024) 2. Bailey RL. Current regulatory guidelines and resources to support research of dietary supplements in the United States. Crit Rev Food Sci Nutr. 2020;60(2):298-309. 3. Sapoliya, Niravkumar & Shah, Mamta. (2022). Regulations on Herbal Products in India, United States and European Union: A Review. Int. J. Drug Regul. Aff. 10. 67- 72. 4. Thakkar S, Anklam E, Xu A, et al. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regul Toxicol Pharmacol. 2020;114:10464. References
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  5. Thillaivanan S,Samraj K. Challenges, constraints and opportunities in herbal medicines-a review. Int. J. Herb. Med. 2014;2(1):21-4 6. Good Agriculture and Collection Practices [Internet]. Available from: https://www.ahpa.org/good_agriculture_and_collection_practices (accessed on 17- 02-2024) 7. Botanical Drug Development: Guidance for Industry (2016) [Internet]. Available from: https://fda.gov/regulatory-information/search-fda-guidance- documents/botanical-drug-development-guidance-industry (accessed on 17-02-2024)
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