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What does the FDA's recent announcement on a new regulatory pathway CBD mean?

What does the FDA's recent announcement on a new regulatory pathway CBD mean? - SOL✿CBD

We know that the latest FDA announcements on CBD regulations have you curious — so we want to explain it in a way that makes sense. 

What was the announcement?

The U.S. Food and Drug Administration (FDA) has announced plans to establish a new regulatory pathway for hemp-derived cannabidiol (CBD). 

This comes as the agency recognizes that existing food and dietary supplement authorities offer limited tools for managing many of the so-called “risks” associated with CBD products

How could this announcement impact the CBD industry?

Disappointment is in the air for CBD companies, and those looking to invest in the industry.

Since the 2018 farm bill was passed legalizing hemp-derived CBD with less than 0.3% THC - not much has happened, and the CBD industry has been left in limbo. 

Not to mention the fact that murky federal restrictions and state-specific laws have made it very hard to navigate and grow in a sustainable way…

However recently we started to see light at the end of the tunnel with the trend of states legalizing marijuana for medical purposes at an all-time high - 37, to be exact! - advocates were hopeful that federal regulation could soon follow. 

In addition, President Joe Biden’s pardoning of federal offenses related to cannabis and calling on his administration to review how it's classified under the law. 

It really looked as though significant progress was being made in advocating change...

However, now with this most recent announcement, it seems we’re back in limbo, worrying about the possibility of

  • A complete stall in momentum to infuse CBD into foods and drinks until the FDA has made its decision.

  • The FDA's new legislative path giving an advantage to larger, well-funded companies, like big pharma, that have the resources to navigate complex regulatory processes.

  • The new regulations making it more difficult for smaller CBD companies to market and sell their products at affordable price points - leading to many of them closing their doors.

Many CBD advocates and companies feel, that completely rehauling the regulatory process is an unnecessary step. While we would like to see growth and more inclusion for CBD, what many don't know is that CBD is already very strictly regulated…

Some of the existing regulations are:

  • any claims made about the potential health benefits of CBD must be backed up by scientific evidence and have prior FDA approval.

  • CBD products must contain accurate labeling that indicates the amount of active ingredients per serving and any other relevant information such as allergen warnings or storage instructions.

  • CBD products need to comply with all Good Manufacturing Practices (cGMPS) to help prevent contamination and adulteration, as well as detailed requirements for ensuring sanitary practices, proper training of personnel, cleaning of equipment,

  • manufacturers must ensure they are compliant with the Food Safety and Modernization Act to avoid violation of FDA regulations. Companies need to register facilities and provide proof safety standards are met through notification procedures or GRAS approval processes for ingredients used in their products—all outlined by law set forth by the U.S Food & Drug Administration.

The FDA also has the authority to conduct inspections and take enforcement action against companies that violate federal laws related to food safety, drug manufacturing, or false advertising. 

In addition to the above, all reputable CBD companies have taken even more steps to build consumer trust and protect public health in the form of quality control, safety testing, and product transparency.

How do we feel about it?

Our highest priority is always your safety and the quality of our products.

While we acknowledge the importance of the FDA in upholding quality standards in the industry we worry that the FDA is relying upon studies conducted by big pharma to influence its new regulatory path for CBD, these studies typically involve much higher doses than any responsible company would recommend.

Our concern is that this is a “stall tactic” that could place the CBD industry in the hands of big pharmaceutical companies, knocking out CBD companies that deliver quality products at affordable prices to consumers.

For now, all we can do is hope that they uphold their promise to work with CBD companies when laying out the framework for the new regulations.

Once they decide we sincerely hope that our products remain accessible at an affordable price point for you.

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We test all our products to make sure that they are high quality & free from contaminants.