Cannabis Compliance CBD HEMP Industry Marijuana Legislation NEWS 2020 FDA GMP Auditing Service [PGgmHRQGJB5]
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Cannabis Compliance CBD HEMP Industry Marijuana Legislation NEWS 2020 FDA GMP Auditing Service Do you want to know the currently projected Cannabis & HEMP cGMP Market Requirements for 2020 and beyond? Cannabis products consumed, ingested, inhaled, applied to skin may impact human health. Congress explicitly preserved the FDAs authority to regulate products derived from cannabis THC less than 0.3% THC (per Farm Bill 2018) Products currently consumed (food, dietary supplements, drugs), inhaled for medical reasons (medical devices) or applied to skin (cosmetics) are required to comply with Good Manufacturing Practices (GMPs) enacted by the FDA. Therefore, products created for human/vet consumption, ingestion, application to body containing cannabis or derived from cannabis must meet GMP requirements as per the FDA and FD&C Act. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and subsequent amending statutes are codified into Title 21 Chapter 9 of the United States Code. Therefore, cannabis & hemp related cGMP regulations will require that the cannabis production supply chain complies with the GMP requirements through the controlled documentation of its processes. How does the FDA enforce these regulations? There have been numerous instances of the FDA enforcing its authority on cannabis/CBD manufacturers. What can you learn from that? These examples reinforce the critical need for cannabis businesses to recognize the importance of the FD&C Act and implement systems that are GMP compliant. It is clear that any misstep will result in enforcement action by the FDA which would invariably lead to a seized operation. How about federal law? Recent Legislation has been introduced at the federal level (HR 5587) that would allow CBD to be marketed and sold as dietary supplements which are required to meet the federal GMP manufacturing standards. Many states will likely not wait for the FDA to act with respect to GMP requirements. As an example, under New York's existing Hemp Research Program, processors are required to meet the strict standards of federal GMP requirements applicable to dietary supplements. Recent legislation passed by New York State NYS (S6184A) would require hemp processors to comply with federal GMP requirements in rules to be established by the Commissioner. Ohio similarly adopted rules that, although don't reference the federal GMP rules explicitly, would require all CBD extractors to implement "standards and guidelines for processing...establish training and safety policies for the safe operation and maintenance of equipment; document and processing of extraction methods, techniques and standards..." all consistent with acceptable GMP standards. What is interesting about the State requirements is that even if your products are not manufactured in a particular state, your products may be subject to the standards established by the State in which your products are sold. Under the recently passed NYS legislation, product extracted outside the state can only be distributed in the state if they meet the standards that will be established. Our recommendation: CBD manufacturers, particularly smaller companies, shouldn't wait. GMP standards take time to implement particularly if facilities need to be modified. By understanding of how these legislations and other legislations pertain to your business will help you to stay one step ahead of the competition and keep legislators at arm’s length allowing you to focus on business operations with a peace of mind that you are always compliant. Get GMP and FD&C Act compliant now and request a GMP Gap Analysis from us. Cannabis Compliance CBD HEMP Industry Marijuana Legislation NEWS 2020 FDA GMP Auditing Service We are here for your needs in Cannabis Compliance. Contact our nationwide Cannabis Compliance Office for a free QUOTE now. For more information please contact: JJK Consulting Andrew Cole Cannabis Compliance Office 2 Industrial Rd in Fairfield New Jersey Telefon 973 402 5889 Or send us an email to [email protected] For more information go to: This presentation contains images that were used under a Creative Commons License. Click here to see the full list of images and attributions: Cannabis Compliance CBD HEMP Industry Marijuana Legislation NEWS 2020 FDA GMP Auditing Service #cbd gummies texas legal #vivid cbd gummies #lucid dreams cbd gummies #cbd cbn gummy
Aired: January 05, 2025
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