By Congress recently I was demanded to More information on regulation of CBD and other cannabinoids. This is a federal regulatory requirement for cannabinoid-containing products made from cannabis sativa L. plant extracts, which can be classified as “hemp” products, while clearly requiring safety standards well in excess of state minimum compliance requirements. It happened immediately after the dissatisfaction with the inaction. .
Historical déjà vu?
The authors will join colleagues leading a seed-to-market safety workshop at the Cannabis Quality Conference on October 16th. Click here for more information. Product safety standards predate our country (and many others).since the time first pharmacopoeia This is comparable to the oldest documented usage. cannabis plant, to modern regulations, the pursuit of safety has always been a theme. But just like the saying goes, “old habits don’t die easily,” so does the issue of safety. From peanuts to thalidomide to cigarettes, we’ve seen this movie before, but it’s time for a new ending.
universal desire for safety
No one in the cannabis industry (and its end uses, including industrial hemp) wants to intentionally produce unsafe products, whether you’re an investor, operator, technologist, or anything in between. The risks of neglecting safety are real and visible.whether it is 20 years or more in prison selling a deliberately adulterated product and being an officer of a company involved in seven deaths; or 10,000+ deformed children, many of whom died at birth due to drugs approved for morning sickness. There is no shortage of examples from which we can learn. Even cannabis has been known to cause injuries and deaths in consumers, but this is not d9-THC’s fault. impurities. As the industry continues to innovate and develop new product form factors, whether it be new ways of supplying d9-THC in the form of soluble beverages or the rise of manufactured cannabinoids in unregulated markets, the production process It is important to understand the overall risks and in order to mitigate them.Cannabis companies aren’t immune from manufacturing costly and dangerous mistakes. More than just compliance – it is public health and safety.
Safety can be a touchy subject
Safety is certainly a complicated issue, especially when it comes to cannabis products. For example, the tolerance limits for microbial contaminants in the inflorescences of the Cannabis sativa L. plant are literally all over the map. What will be the route of administration? Compare inhaled products (such as vape pens) with ingested products (such as edibles). Many outdoorsy people like myself may enjoy the aroma of cooking s’mores over a campfire, but particles and VOCs can irritate the lungs, especially with prolonged exposure. We don’t inhale s’mores, so making marshmallows, chocolate, and graham crackers comes with a variety of risks that need to be evaluated. It’s not just the product that matters, it’s how it’s consumed.
safety standards – the structure of our society
Standards are the shadow protagonists of our daily lives. To keep planes from falling out of the sky, to keep cribs and chests from crushing infants, to keep trains from derailing, to ensure food and medicine safety, the standards are the same as grandma’s quilts. like protect us.Absence of standards can be expensive and d9-THC lab shopping and exaggerated label claims We know the cannabis industry is the epitome of that.
Congress has long recognized the importance of standards in protecting everyday consumers, as demonstrated by numerous pieces of legislation. Here are some notable things related to cannabis:
- Drug Import Act of 1848: The first major law against the importation of substandard and inferior drugs imported into the country from abroad, which had a major impact on soldiers in the Mexican-American War. This law included legal requirements for drugs to meet US Pharmacopeia standards for strength, quality, and purity.
- The Food and Drugs Act of 1906: After the proliferation of adulterated and counterfeit branded foods and drugs made famous by Upton Sinclair’s The Jungle, Dr. It became famous due to the relentless activities of its “Poison Squad”. – Leading to significant oversight of adulterated food and drug products, including legal compliance with the United States Pharmacopoeia, which paved the way for his current FDA.
- Food, Drug and Cosmetic Act of 1938: A flaw in the Food and Drug Act of 1906 was caused by a silver bullet similar to antifreeze that caused protests and led to the passage of the FDC&A, resulting in more than 100 deaths. Ta. From factory inspections, to strict marketing and labeling requirements, to legally enforceable food standards and tolerances for certain toxic substances, the FDA has substantial more oversight to protect the growing United States. was given. His USP quality standards for pharmaceuticals are also expressly recognized, and the USP standards are binding on dietary supplement manufacturers who label their products as complying with his USP specifications.
- The Dietary Supplements Health Education Act (DSHEA) of 1994 defined and regulated dietary supplements and provided significant exemptions for the dietary and herbal supplement industry from most FDA drug regulations. The law has been met with significant controversy because it severely limited the FDA’s ability to ban or restrict supplements until evidence of serious safety or adverse events can be tied to the product of concern.
- National Technology Transfer Acceleration Act of 1995 (NTTAA) – A little-known law that focuses on standards and technology and requires the participation of federal agencies. Voluntary Consensus Standards Body. Beyond food and medicine, the law covers a wide range of infrastructure and technical regulations that ensure our social fabric operates (mostly) without problems.
Over 1,000 ASTM standards are incorporated by reference into the US Code of Federal Regulations across approximately 30 federal agencies (searchable) here), demonstrating the value and impact public voluntary standards have on our society.
The FDA uses ASTM standards every day to keep us safe. Measuring the Absorbency of Tampons (21 CFR 801.430) Enforcing Safety Specifications for Synthetic and Natural Wax Coatings Used in Coatings such as Our Produce and Gummies (21 CFR 178.3770) Quantifying Impurities in Our Bottled Water These have long been recognized as a de facto minimum standard that balances the need to protect consumers without imposing an undue burden on innovation by the industry.
ASTM standard development process. This standard was developed and used to prevent train derailment. 125 years ago, is currently home to over 510 cannabis industry-specific standards.whether it is acceptable water activity level The cannabis flower is a truly universal symbol that warns consumers of intoxicating cannabinoids. Specification of medical cannabis flower Much work has already been done in the industry, including those developed under the strict guidance of the United States Pharmacopeia and how to apply HACCP principles to cannabis products.it’s just a matter of knowing where to look And how to use it!
The path to safe and sustainable cannabis products is clear and the tools are available. The time has come for us to learn from the past, apply current standards, and mitigate future risks. Now more than ever, creating safe cannabis products and a trusted marketplace is easier than just a goal and a reality.
