The new age of cannabis dosing with gummies is sweeping the globe, but a quality crisis threatens the industry’s pharmaceutical credibility. What started in Australia has quickly moved to the UK and now Germany, where EU-GMP cannabis gummies struggle to compete against a flood of inferior products rushing to market.
The Expanding Marketshare of Cannabis Gummies
Gummies represent a paradigm shift in cannabis consumption, appealing to demographics, like new consumers, that traditional smoking and oral drops do not entice. Gummies are tasty, and everything from vitamins to herbal supplements comes in a delicious chewable format. These single-dose, socially acceptable products have created a paradigm shift as consumers increasingly share stories that begin with “that one time I took a gummy” without the stigma attached to other cannabis consumption methods. Gummies are making cannabis taste good again.
Regulators in Europe are watching the US cannabis market and questioning whether sugar-coated THC products qualify as medical products, despite precedent in pharmaceutical candy formats like Vicks ZzzQuil, gummy vitamins, and fentanyl lollipops. Masking medicines taste better is nothing new and will surely open up relief for more demographics if the industry adheres to pharma standards rather than taking shortcuts.
Speed vs. Standards: The Quality Crisis that Every New Market Faces
Low-Quality Manufacturing Threatens Industry Credibility
The dark side of the gummies boom involves low-quality oil being pumped into premixed gummies, sugar-coated, and packaged across new markets. Current local manufacturing lacks standardized quality protocols, relies on non-EU-GMP harvested products and non-EU-GMP manufactured oil from global suppliers, and focuses on regulatory arbitrage rather than actual compliance. Prioritizing speed over cannabis quality damages the image of medical cannabis products and hurts the regulatory chances of sensible policies as markets become established.
In the real world of pharma, when alternatives in finished dosage form are available, these low-quality producers like compound pharmacists typically phase out as higher-quality products with proper regulatory frameworks enter the system. However, this natural market correction isn’t happening in cannabis, which will cause issues down the line.
Compound Pharmacy Concerns
Despite regulatory guidance, including Australia’s October decisions stating compound pharmacy cannabis production should cease, these facilities continue operating in a quality gray area. Germany’s requirement for compound pharmacies to continue to make cannabis products raises questions about why the largest market hasn’t recognized finished dosage forms with superior stability and quality standards. In the UK, the same low-quality local producers that made questionable vapes in early stages are mixing and serving up gummies with no real quality standard, using cheap oil from around the world.
Regardless of country, local manufacturing and compound pharmacists buy cheaper oil from non-EU-GMP-processed manufacturers and then bill these products as premium offerings when the reality is far different. This rush to release products and claim gummy production success is going to backfire for the entire industry as people are already waking to homogenization issues like placebo dosages and double dosage gummies.
EU-GMP Cannabis Gummies are the Pharmaceutical Standard
Pharmaceutical-Grade Gummies Take Years to Develop
Creating legitimate EU-GMP cannabis gummies requires substantial time and capital investment — a completely different manufacturing process from other cannabis products made at compound pharmacies or local repackaging and manufacturing hubs. Even if manufacturers have production facilities ready, an EU-GMP fully registered product take 2 ½ to 3 years to deliver a finished dodge form. The formulation alone takes several months for novel ingredient mixing since there are no pre-mix shortcuts available. These require each ingredient to be systematically mixed, then tested for stability, which cannot occur in an accelerated format due to heat increases that risk melting the gummies. Regulatory approval adds a significant time for final batch authorization, creating a multi-year timeline from concept to shelves. These barriers decrease the number of brands entering the market and increase the short-cut of compounding.
EU-GMP Certification for Cannabis is the Key to Global Market Access
The global market is open to brands that can afford to invest capital, resources, and time in EU-GMP-certified products, ensuring their products command premium pricing and can go to almost every country. The companies that make truly pharmaceutical-looking and feeling gummies will succeed. By providing consumers with consistent, safe and quality gummies and establishing trust with regulators, legit businesses can lead the way in the global cannabis industry.
Global Cannabis Market Dynamics
Being Late to Market Hurts EU-GMP Manufacturers
EU-GMP cannabis gummies face a critical market timing challenge. Local manufacturers flood markets with inferior products first, making consumer education difficult once low-quality products establish price expectations. Premium pricing for quality products becomes harder to justify, and market saturation occurs before pharmaceutical-grade alternatives arrive. By the time EU-GMP gummies reach the market, it’s already saturated with low-quality alternatives, and consumers cannot distinguish the difference. The EU-GMP gummies will face difficulty in short-term competing in the established market but will be the only allowed versions in other markets.
Low-Quality Gummies Create a Credibility Crisis
The rush to market with candy-like THC products risks regulatory backlash that could impact the entire industry. Already there are questions swirling about the wide-spresd sugar coating as a candy or medicine format. When markets become inundated with gummies, distinguishing between pharmaceutical-grade and garage-style products becomes crucial for maintaining medical cannabis credibility. There will be no doubt that these shortcut-based products will reach the market first, and similarly, no doubt they will cause the industry and regulators to distrust cannabis.
Defining the Future of Cannabis Gummies’ Credibility
The future of pharmaceutical cannabis quality in gummies hangs in the balance as the first to market movers rush to make THC-infused candy, while only a few EU-GMP manufacturers will make products that can circulate around the globe. Quality has become an abused word in the industry, and there is no such thing as compound pharmacy or local manufacturing quality standards in the same way EU-GMP certification is tested, trusted and standardized.
In a future where the market is inundated with gummies, significant education will be needed for all sides to maintain industry credibility. The companies investing in true EU-GMP cannabis gummies are positioning for long-term global success, but only if they can effectively communicate quality differences to consumers and regulators who may already be skeptical due to the flood of inferior products.
The industry must balance innovation speed with pharmaceutical standards to avoid regulatory backlash that could undermine cannabis medicine credibility worldwide. The gummies market represents both tremendous opportunity and significant risk — the path forward will determine whether cannabis maintains its medical legitimacy or gets dismissed as candy masquerading as medicine.
About the author
Michael Sassano is one of the most respected executives in the pharmaceutical cannabis space today. Currently, Michael serves as Interim CEO and Chairman of the Board for SOMAÍ, a leading EU-GMP vertically integrated Multi-Country Operator (MCO) company with a global distribution footprint for the largest and most advanced EU-GMP-certified cannabinoid-containing pharmaceutical extract portfolio.
Somaí is set to launch multiple versions of Oral Gums from October through January. The lineup will include medical Somaí extract and terpene Oral Gums, Rosin Oral Gums, and fast-acting Oral Gums. In addition, Cookies, Sherbinskis, and Jack Herer-branded Oral Gums will roll out across three countries.
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