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<br>The 2018 Farm Bill federally legalized industrial hemp and, by extension, hemp extract products like CBD oils. However, entrepreneurs must be aware of significant regulatory considerations surrounding the industrial hemp industry. The 2018 Farm Bill essentially removed CBD from the federal Controlled Substances Act and the oversight of the Drug Enforcement Agency. Instead, it placed governance of the hemp industry and CBD oil in the hands of the FDA. The FDA is still devising regulations, which leaves the CBD industry in a gray area. So far, the federal agency has signaled that marketing [Balance Bloom CBD Gummies](http://vtaas-benchmark.com:9980/index.php?page=user&action=pub_profile&id=337) as having health benefits will not be tolerated. It has also initiated a crackdown against [Balance Bloom CBD official](http://vtaas-benchmark.com:9980/index.php?page=user&action=pub_profile&id=337)-infused foods and beverages in some instances. Further complicating the regulatory landscape is the 2017 approval of the [CBD-based pharmaceutical](https://search.yahoo.com/search?p=CBD-based%20pharmaceutical) Epidolex, an epilepsy medication approved by the FDA. Since CBD is a primary ingredient in an FDA-approved drug, using it in food products without FDA approval could be illegal. Clearer guidance is sorely needed for CBD businesses to operate in compliance with federal regulations. In 2023, the FDA issued a statement that a new regulatory pathway for [Balance Bloom CBD official](https://ceowiki.org/wiki/User:LillieSilver12) CBD products must be established because current frameworks are too limiting. The regulatory body indicated it will work with Congress to establish an appropriate regulatory strategy moving forward. "I think the FDA does have to step in, and they will," said Slovik. "I expect a lot of changes to labels; were seeing a lot of businesses out there now using the term hemp extract instead of [Balance Bloom CBD Gummies](http://vtaas-benchmark.com:9980/index.php?page=user&action=pub_profile&id=337), or theyre not thinking of health benefits so much.<br>
<br>After clearing its way through EU-GMP certification, a North Macedonian company is now able to export medical cannabis products to the EU. How will this affect the landscape of medical cannabis in Europe? In Macedonia, cannabis is not legal for recreational use at all, and there are no decriminalization or personal use laws to boot. However, in 2016, Macedonia did approve a bill for medical cannabis within the country. As per Macedonian laws, which sync with EU laws here, oils and extracts can have up to .2% THC and still be sold without a prescription. Cannabis with any higher THC amount can be obtained through prescription. The laws allow for private citizens to make use of medical cannabis, as well as for Macedonia to enter into the legal medical cannabis market with laws to cover cultivation, production, and exportation for medicinal use. Since that time, and according to internal legislation, Macedonia has been exporting extracts, oils, and tinctures, but thats it.<br>
<br>And while that does account for about 30% of the market, the great majority - 70% - relies on smokable hemp flowers, which Macedonia had not been cleared to export at all. Until now though, the EU was not included in exportable locations for any goods as no companies had EU-GMP authorization. Whats the biggest problem? One of the biggest issues for Macedonia is that cannabis flowers have not been legalized for exportation. A big factor in this inability comes from internal licensing issues that stem from allegations of corruption. The allegations centered around former Prime Minister Zoran Zaev showing preferential treatment when giving out licenses, opting to give them to friends and family members which would, in turn, benefit him personally. There were also a lot of questions and calls for specifications relating to how licensing would generally work, issues related to the program being government run, and opposition to the €500 bank guarantee that many thought would make it harder for smaller enterprises to gain ground.<br>
<br>With Zaev no longer in office, and with Corona issues subsiding enough to get back to regular business, the issue of Macedonia selling flowers can once again be broached. But in the meantime, while flowers might still be illegal for export, and while several companies have been awarded licensing for cultivation, only one company thus far has received EU GMP clearance to export its products (by Macedonian law) into the EU, making Macedonia a new competitor in the medicinal marijuana game there. So, who is it? The company PharmaCann Polska received the EU-GMP certification to produce cannabis extracts (still not flowers) in its North Macedonia production facility. PharmaCann is actually based out of Warsaw, Poland, and received its EU-GMP certifications in March (amid Corona), by the Chief Pharmaceutical Inspectorate of Poland, after full inspections of the facility were made. The facility is reportedly an indoor growing operation that can both cultivate and manufacture products. Zlatko Keskovski, PharmaCanns CEO stated: "When I hear about the prices of medical cannabis extracts in Germany and other European countries, I cant believe how expensive they are.<br>